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Nektar Therapeutics Reports Financial Results for the Third Quarter of 2018

On November 7, 2018 Nektar Therapeutics (Nasdaq: NKTR) reported its financial results for the third quarter ended September 30, 2018 (Press release, Nektar Therapeutics, NOV 7, 2018, View Source [SID1234531174]).

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Cash and investments in marketable securities at September 30, 2018 were $2.0 billion as compared to $353.2 million at December 31, 2017.

"We have made tremendous progress advancing our portfolio of immuno-oncology, immunology and pain programs in 2018," said Howard W. Robin, President and CEO of Nektar. "We are implementing the broad joint development plan for NKTR-214 with partner Bristol-Myers Squibb across a range of tumor types, with the first Phase 3 trial in melanoma initiated in September and the next seven trials in renal cell carcinoma, urothelial cancer and non-small cell lung cancer starting over the next several months. In addition, our new collaboration with Pfizer underscores the promise of NKTR-214 as a backbone therapy in multiple cancer treatment regimens. NKTR-358 continues to advance with the ongoing clinical study in lupus patients and NKTR-181 is continuing through the NDA review process with the FDA. Finally, we are in an exceptionally strong financial position to execute on our strategy, ending the quarter with $2.0 billion in cash."

Revenue in the third quarter of 2018 was $27.8 million as compared to $152.9 million in the third quarter of 2017. Year-to-date revenue for 2018 was $1.2 billion as compared to $212.2 million in the first nine months of 2017 and included the recognition of $1.06 billion of license revenue from the Bristol-Myers Squibb collaboration agreement. Revenue in the third quarter of 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 2018 were $126.4 million as compared to $83.4 million in the third quarter of 2017. Year-to-date total operating costs and expenses in 2018 were $365.3 million as compared to $247.9 million for the same period in 2017. 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 2018 was $102.9 million as compared to $65.7 million in the third quarter of 2017. Year-to-date R&D expense for 2018 was $290.7 million as compared to $187.0 million for the same period in 2017. R&D expense was higher in the third quarter and first nine months as compared to the same periods in 2017 primarily because of expenses for our pipeline programs, including the continued development of NKTR-214 in Phase 1/2 studies and Phase 3 preparatory activities and related manufacturing costs, costs related to the NKTR-181 New Drug Application and NKTR-181 pre-commercial manufacturing, Phase 1 clinical studies of NKTR-358, the Phase 1 study of NKTR-262 in combination with NKTR-214 and IND-enabling activities for NKTR-255.

General and administrative (G&A) expense was $18.7 million in the third quarter of 2018 as compared to $12.1 million in the third quarter of 2017. G&A expense in the first nine months of 2018 was $57.7 million as compared to $40.0 million for the same period in 2017. G&A expense was higher in the third quarter and first nine months of 2018 as compared to the same periods in 2017 primarily due to an increase in non-cash stock based compensation expense.

Net loss in the third quarter of 2018 was $96.1 million or $0.56 basic and diluted loss per share as compared to net income of $60.9 million or $0.37 diluted earnings per share in the third quarter of 2017. Net income in the first nine months of 2018 was $779.5 million or $4.34 diluted earnings per share as compared to net loss of $62.9 million or $0.41 basic and diluted loss per share in the first nine months of 2017.

Third Quarter 2018 and Recent Business Highlights

·In November, Nektar entered into an oncology clinical collaboration with Pfizer Inc. to evaluate several combination regimens in multiple cancer settings including metastatic castration-resistant prostate cancer (mCRPC) and squamous cell carcinoma of the head and neck (SCCHN). Under the new collaboration, Pfizer will initiate a Phase 1b/2 clinical trial to evaluate the anti-cancer activity of the combined agents, avelumab, talazoparib and NKTR-214, as well as avelumab, enzalutamide and NKTR-214.

·In October, Nektar appointed Karin Eastham as an independent director to its Board of Directors. Ms. Eastham brings more than 35 years of experience as both an executive and independent director in the biotechnology industry, with particular expertise in finance and operations.

·In September, Nektar and Bristol-Myers Squibb initiated a Phase 3 study of NKTR-214 combined with nivolumab versus nivolumab in participants with previously untreated unresectable or metastatic melanoma.

·In July, the U.S. Food and Drug Administration accepted Nektar’s New Drug Application (NDA) for NKTR-181, a first-in-class opioid investigational drug candidate, to treat chronic low back pain in adult patients new to opioid therapy. The NDA has been assigned a PDUFA (Prescription Drug User Fee Act) target action date of May 29, 2019 by the FDA.

The Company also announced the following upcoming presentations through year-end 2018:

2018 Society for Immunotherapy and Cancer (SITC) (Free SITC Whitepaper) Annual Meeting, Washington D.C.:

· Oral Presentation: "Immune monitoring after NKTR-214 plus nivolumab (PIVOT-02) in previously untreated patients with metastatic Stage IV melanoma"
o Session: Cytokines Reinvented
o Presenter: Dr. Adi Diab, MD Anderson Cancer Center
o Date: Friday, November 9, 2018, 5:05 p.m. – 6:30 p.m. Eastern Standard Time

Poster Presentations:

Session: Combination Therapy

· Abstract #P348: "Survival and immune modulation in homologous recombination deficient murine ovarian tumors using the PARP inhibitor, rucaparib and immune agonist, NKTR-214", Charych, D., et al.
o Date: Friday, November 9th from 8 a.m. – 8 p.m. and Saturday, November 10th from 8 a.m. – 8:30 p.m. Eastern Standard Time

· Abstract #P364: "Systemic anti-tumor immunity and immune memory formation by a novel TLR7/8 targeting agent NKTR-262 combined with CD122-biased immunostimulatory cytokine NKTR-214", Kivimae, S., et al.
o Date: Friday, November 9th from 8 a.m. – 8 p.m. and Saturday, November 10th from 8 a.m. – 8:30 p.m. Eastern Standard Time

· Abstract #P368: "Combination of a Dipeptidyl Peptidase Inhibitor BXCL701 and Biased CD122 Agonist NKTR-214 with Anti-PD1 Provides Functional Immunological Memory through Inflammatory Cell Death", MacDougall, J., et al.
o Date: Friday, November 9th from 8 a.m. – 8 p.m. and Saturday, November 10th from 8 a.m. – 8:30 p.m. Eastern Standard Time

· Abstract #P378: "NKTR-214 (CD122-biased agonist) and NKTR-262 (TLR7/8 agonist) combination treatment pairs local innate immune activation with systemic CD8+ T cell expansion to enhance anti-tumor immunity", Rolig, A., et al.
oDate: Friday, November 9th from 8 a.m. – 8 p.m. and Saturday, November 10th from 8 a.m. – 8:30 p.m. Eastern Standard Time

Session: Cytokines in Anti-Tumor Immunity

·Abstract #P418: "Pre-clinical investigation of NKTR-255, a polymer-conjugated IL-15 with a potent NK cell dependent anti-tumor efficacy", Miyazaki, T., et al.
oDate: Friday, November 9th from 8 a.m. – 8 p.m. and Saturday, November 10th from 8 a.m. – 8:30 p.m. Eastern Standard Time

·Abstract #P419: "NKTR-214 in combination with radiation produces a potent in situ vaccine in the syngeneic B78 melanoma model", Sondel, P., et al.
oDate: Friday, November 9th from 8 a.m. – 8 p.m. and Saturday, November 10th from 8 a.m. – 8:30 p.m. Eastern Standard Time

·Abstract #P422: "A polymer-associated human IL-15 (NKTR-255) has optimized biological activity and unique mechanisms of action on CD8 T Cells and NK Cells", Robinson T., et al.
oDate: Friday, November 9th from 8 a.m. – 8 p.m. and Saturday, November 10th from 8 a.m. – 8:30 p.m. Eastern Standard Time

·Abstract #P424: "NKTR-214, an engineered IL-2, selectively depletes intratumoral Tregs and expands immunotherapy-induced effector T cell responses", Sharma, M., et al.
oDate: Friday, November 9th from 8 a.m. – 8 p.m. and Saturday, November 10th from 8 a.m. – 8:30 p.m. Eastern Standard Time

Session: Mechanisms of Resistance to Immunotherapy

·Abstract #P557: "Overcoming genetically-based resistance mechanisms to PD-1 blockade", Torrejon, D., et al.
oDate: Friday, November 9th from 8 a.m. – 8 p.m. and Saturday, November 10th from 8 a.m. – 8:30 p.m. Eastern Standard Time

2018 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, San Diego, CA;

·Publication #2952: "Pharmacokinetic and Pharmacodynamic Study of NKTR-255, a Polymer-Conjugated Human IL-15, in Cynomolgus Monkey", Miyazaki, T., et al.
oSession 625: Lymphoma: Pre-Clinical—Chemotherapy and Biologic Agents: Poster II
oDate: Sunday, December 2nd from 6:00 p.m. – 8:00 p.m. Pacific Time
oLocation: San Diego Convention Center, Hall GH

Conference Call to Discuss Third Quarter 2018 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 today, Wednesday, November 7, 2018.

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 10, 2018.

To access the conference call, follow these instructions:

Dial: (877) 881-2183 (U.S.); (970) 315-0453 (international)

Passcode: 9395678 (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 Investors page at the Nektar website as soon as practical after the conclusion of the conference call.

XOMA Announces Proposed Rights Offering

On November 7, 2018 XOMA Corporation (Nasdaq: XOMA) ("XOMA" or the "Company") reported its intent to commence a rights offering pursuant to which the Company would raise approximately $20 million through the distribution of subscription rights to holders of its common stock and Series X preferred stock, which will entitle the holders to purchase shares of XOMA’s common stock at $13.00 per share (the "Rights Offering") (Press release, Xoma, NOV 7, 2018, View Source [SID1234531171]). The offering will be fully backstopped by BVF Partners L.P., the Company’s largest stockholder, which has agreed to purchase at a minimum its as-converted pro rata share of the offering amount, and will purchase an additional amount of securities, up to a total of approximately $20 million, that are not subscribed for by the Company’s other stockholders in the rights offering.

Under the proposed Rights Offering, the Company plans to distribute non-transferable subscription rights to purchase a portion of a share of Common Stock for each share of Common Stock outstanding and for each share of common stock issuable on conversion of the Company’s outstanding shares of Series X Preferred Stock, at a subscription price per share of $13.00, to its stockholders of record as of the close of business on November 16, 2018 (the "Record Date"). The subscription rights will be exercisable for up to an aggregate of approximately 1,538,460 shares of Common Stock, with participation to be allocated among holders of its Common Stock and Series X Preferred Stock on a pro rata basis (assuming full conversion of the Series X Preferred Stock into shares of Common Stock), subject to the aggregate offering threshold and ownership limitations. The subscription rights are non-transferable and may be exercised only during the anticipated subscription period of Monday, November 19, 2018, through 5:00 PM EDT on Friday, December 14, 2018, unless extended. Any participant in the Rights Offering that, by exercise of its subscription right would become a holder of greater than 9.9% of the outstanding number of shares of Common Stock of the Company following the offering may elect to instead purchase Series Y Preferred Stock of the Company. The company intends to sell the Series Y Preferred Stock at $13,000 per share, and any such holder so electing would have a right to purchase one one-thousandth of a share of Series Y Preferred Stock for each share of Common Stock it had a right to purchase under the subscription rights. Each share of Series Y Preferred Stock will, subject to certain limitations, be convertible into 1,000 shares of common at the election of the holder. The Series Y Preferred Stock will generally have no voting rights, except as required by law, and will participate pari passu with any distribution of proceeds to holders of Common Stock in the event of the Company’s liquidation, dissolution or winding up.

The Rights Offering will be made pursuant to the Company’s effective shelf registration statement on file with the Securities and Exchange Commission ("SEC") and only by means of a prospectus supplement and accompanying prospectus. The Company expects to mail subscription certificates evidencing the subscription rights and a copy of the prospectus supplement and accompanying prospectus for the Rights Offering shortly following the Record Date.

This press release is not intended to and does not constitute an offer to sell or the solicitation of an offer to subscribe for or buy or an invitation to purchase or subscribe for any securities in any jurisdiction, nor shall there be any sale, issuance or transfer of securities in any jurisdiction in contravention of applicable law. No offer of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended.

BVF Partners L.P., the Company’s largest shareholder, owning approximately 17.9% of the Company’s outstanding common stock (and 48.6% on an as-converted basis), will backstop the Rights Offering and has agreed to purchase up to $20 million of Series Y Preferred Stock at price of $13,000 per share in a private placement within five days of conclusion of the Rights Offering, with the dollar amount to be purchased in such private placement reduced by the dollar amount sold by the Company (including to BVF Partners L.P., and its affiliates), in the Rights Offering.

Protagonist Therapeutics to Present at the Stifel 2018 Healthcare Conference Wednesday, Nov. 14

On November 7, 2018 Protagonist Therapeutics, Inc. (NASDAQ:PTGX) reported that Dinesh V. Patel, Ph.D., President and Chief Executive Officer, will provide a corporate overview at the Stifel 2018 Healthcare Conference at 8:45 a.m. EST at the Lotte New York Palace Hotel (Press release, Protagonist, NOV 7, 2018, View Source;p=RssLanding&cat=news&id=2376046 [SID1234531167]).

Presentation details:

Event:

Stifel 2018 Healthcare Conference

Date:

Wednesday, Nov. 14

Time:

8:45 a.m. EST

A live and archived audio webcast of the presentation can be accessed by visiting the Investors page of the Protagonist Therapeutics website at View Source

Tocagen to Participate in Investor Conferences in November

On November 7, 2018 Tocagen Inc. (Nasdaq: TOCA), a clinical-stage, cancer-selective gene therapy company, reported that Marty Duvall, chief executive officer, reported that it will present at the following upcoming investor conferences (Press release, Tocagen, NOV 7, 2018, View Source;p=RssLanding&cat=news&id=2375950 [SID1234531165]):

Wednesday, November 14, 11:00-11:40 a.m. ET in New York City
Stifel Nicolaus Healthcare Conference

Tuesday, November 27, 4:35-4:55 p.m. ET in Boston
Evercore ISI Biopharma Catalyst/Deep Dive Conference

The live audio webcasts from the conferences and subsequent replay may be accessed by visiting the "Events & Presentations" page in the investors section of Tocagen’s website. The webcasts will be available shortly after conclusion of the presentation and archived on the company’s website for 90 days following the presentation.

Protalix BioTherapeutics Reports 2018 Third Quarter Results and Provides Corporate Update

On November 7, 2018 Protalix BioTherapeutics, Inc. (NYSE American:PLX, TASE:PLX), a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell-based expression system, ProCellEx, reported its financial results for the three months and nine months ended September 30, 2018, and provided a corporate update (Press release, Protalix, NOV 7, 2018, View Source [SID1234531160]).

"In the third quarter we achieved two important milestone events for pegunigalsidase alfa, or PRX-102, our differentiated enzyme replacement therapy in development for the treatment of Fabry disease. First, we expanded our partnership with Chiesi Farmaceutici S.p.A. to include exclusive rights to commercialize and develop PRX-102 in the United States, which significantly strengthened our financial position. Second, we reported positive preliminary results from our BRIDGE study on key kidney function," commented Moshe Manor, Protalix’s President and Chief Executive Officer. "Based on the promising preliminary BRIDGE study results, and taking into account the newly issued guidance from the U.S. Food and Drug Administration (FDA), we plan to engage with the FDA during the first half of 2019 to discuss the most optimal regulatory path forward for PRX-102. While we continue to enroll patients in all of our currently ongoing Fabry disease studies, we believe that with over 110 Fabry patients enrolled across the studies included in our PRX-102 clinical program to date, we have a sufficient number of patients for expedited review, including filing an application for accelerated approval," continued Mr. Manor.

2018 Third Quarter Highlights

·Presented preliminary positive data from the BRIDGE study showing Improvement in kidney function in patients switched from agalsidase alfa (Replagal) to pegunigalsidase alfa and further showing the reversal of a deterioration trend in kidney function to an improvement trend when switched.

·Expanded partnership with Chiesi Farmaceutici S.p.A., or Chiesi, to include U.S. rights for the development and commercialization of PRX-102. Terms of the agreement included an up-front payment of $25 million, up to $20 million in development costs and tiered royalties ranging from 15-40% of net sales.

·Expanded our Board of Directors with the addition of Mr. David Granot as an independent director.

·Continued exploring the potential for partnership opportunities mainly for OPRX-106, and for PRX-110. In parallel, the Company is exploring the option of conducting a controlled phase IIb study of OPRX-106 for the treatment of ulcerative colitis in order to maximize the value of this asset in a manner that will best serve the stockholders’ interest.

Financial Results for the Nine Months ended September 30, 2018

·The Company reported a net loss of $36.2 million, or $0.25 per share, basic and diluted for the nine-month period ended September 30, 2018 compared to a net loss of $32.1 million, or $0.25 per share, basic and diluted for the same period of 2017 excluding remeasurement of a derivative.

The Company recorded total revenues of $7.2 million for the nine-month period ended September 30, 2018, compared to $16.8 million for the same period of 2017. The decrease resulted primarily from decreased shipments of alfataliglicerase to Brazil despite the increase in the number of patients treated with alfataliglicerase, and decreased sales of drug substance to Pfizer.

The $25.0 million in proceeds received from Chiesi during the three-month period ended September 30, 2018 as an upfront payment were not recorded as revenues, and were deferred according to the revenue recognition rules of U.S. generally accepted accounting principles. Such proceeds should be recorded upon the commencement of commercial manufacturing. The same accounting treatment was applied to the $25.0 million upfront payment received by the Company in the fourth quarter of 2017, and the $11.8 million of research and development reimbursement payments the Company has received from Chiesi to date.

·Research and development expenses were $23.8 million for the nine-month period ended September 30, 2018, compared to $19.8 million for the same period of 2017.

Selling, general and administrative expenses were $7.3 million for the nine-month period ended September 30, 2018 compared to $8.2 million for the same period of 2017.

As of September 30, 2018, the Company had $41.9 million of cash and cash equivalents. With the expected decrease in cash consumption resulting primarily from the Company’s U.S. license transaction with Chiesi, the Company expects the cash balance to fund the Company through significant regulatory achievements of PRX-102.

Conference Call and Webcast Information

The Company will host a conference call on Wednesday, November 7, 2018 at 8:30 am ET to review the clinical, corporate and financial highlights.

To participate in the conference call, please dial the following numbers prior to the start of the call: United States: +1-844-358-6760; International: +1-478-219-0004. Conference ID number 8567317.

The conference call will also be broadcast live and available for replay for two weeks on the Company’s website, www.protalix.com, in the Events Calendar of the Investors section. Please access the Company’s website at least 15 minutes ahead of the conference to register, download, and install any necessary audio software.