On March 1, 2016 Nektar Therapeutics (Nasdaq: NKTR) reported its financial results for the fourth quarter and year ended December 31, 2015 (Press release, Nektar Therapeutics, MAR 1, 2016, View Source [SID:1234509335]).

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Cash and investments in marketable securities at December 31, 2015 were $308.9 million as compared to $262.8 million at December 31, 2014. Cash and investments include the net proceeds from the $250 million private placement of 7.75% Senior Secured Notes due in 2020, which was closed on October 5, 2015. A portion of the proceeds from this secured debt financing was used to fully redeem the $125.0 million of 12% Senior Secured Notes due in 2017.

"Nektar begins 2016 with two new medicines launched by our partners in the past year and multiple late-stage drug candidates advancing in the clinic," said Howard W. Robin, President and Chief Executive Officer of Nektar. "MOVANTIK is performing very well with positive feedback from physicians and patients. ADYNOVATE was launched in the U.S. in December 2015 and Baxalta recently submitted BLA filings in the U.S. to expand use of ADYNOVATE to pediatric and surgical settings. The NKTR-181 Phase 3 efficacy study in patients with chronic low back pain is on track to provide top-line results in early 2017. Finally, NKTR-214, our immuno-oncology candidate, is advancing nicely in a first-in-human trial evaluating its safety and efficacy in patients with solid tumors. We remain on track to report initial top-line data from the dose-escalation stage of the NKTR-214 study in the second half of 2016."

Revenue for the year ended December 31, 2015 was $230.8 million as compared to $200.7 million in 2014. Revenue for the fourth quarter of 2015 was $39.4 million as compared to $19.6 million in the fourth quarter of 2014. Revenue for the year ended December 31, 2015 includes the recognition of $90.0 million of the $100.0 million milestone payment from AstraZeneca following the first commercial sale of MOVANTIK in the U.S., recognition of the $40.0 million milestone payment from AstraZeneca following the first commercial sale of MOVENTIG in the EU and recognition of the $10 million milestone payment from Baxalta for the approval and first commercial sale of ADYNOVATE in the U.S. In addition, product sales and royalty revenue increased by $17.6 million in 2015 as compared to the same period in 2014.

Revenue also included non-cash royalty revenue, related to our 2012 royalty monetization, of $7.3 million and $22.1 million in the fourth quarter and the full year of 2015, respectively, and $5.2 million and $21.9 million in the fourth quarter and the full year of 2014, respectively. This non-cash royalty revenue is substantially offset by non-cash interest expense, also incurred in connection with the 2012 royalty monetization. Non-cash interest expense was $5.2 million and $20.6 million in the fourth quarter and year ended December 31, 2015, respectively, as compared to $5.2 million and $20.9 million in the fourth quarter and year ended December 31, 2014, respectively. Total operating costs and expenses for the year ended December 31, 2015 were $260.2 million as compared to $217.2 million in 2014. Total operating costs and expenses increased primarily as a result of higher research and development (R&D) expense. Total operating costs and expenses in the fourth quarter of 2015 were $68.7 million as compared to $57.0 million in the fourth quarter of 2014.

For the year ended December 31, 2015, R&D expense was $182.8 million as compared to $147.7 million in 2014. R&D expense in the fourth quarter of 2015 was $47.1 million as compared to $38.5 million for the fourth quarter of 2014. R&D expense was higher in the fourth quarter of 2015 and the year ended December 31, 2015 as compared to the same periods in 2014 primarily due to the initiation of the Phase 3 efficacy trial of NKTR-181 in chronic low back pain and the long-term safety study for NKTR-181. R&D expense for the full year 2015 also increased as a result of initiation of the Phase 1/2 clinical program for NKTR-214.

General and administrative (G&A) expense for the year ended December 31, 2015 was $43.3 million as compared to $40.9 million in 2014. G&A expense for the quarter and year ended December 31, 2015 includes the expense and payment of a $3.0 million settlement of a commercial litigation matter. G&A expense was $13.2 million in the fourth quarter of 2015 as compared to $12.2 million in the fourth quarter of 2014.

Net loss for the year ended December 31, 2015 was $81.2 million or $0.61 loss per share as compared to a net loss of $53.9 million or $0.42 loss per share for the year ended December 31, 2014. Net loss for the fourth quarter of 2015 was $54.1 million or $0.40 loss per share as compared to a net loss of $45.7 million or $0.35 loss per share in the fourth quarter of 2014.

The company also announced upcoming presentations at the following scientific congresses during the first half of 2016:

ISICEM (International Symposium on Intensive Care and Emergency Medicine), Brussels, Belgium:

Abstract Title: "In vitro evaluation of Amikacin Inhale and other commercial nebulizers in mechanical ventilator", Challoner, P., et al.
Date: March 17, 2016
AACR Annual Meeting, New Orleans, LA:

Abstract 558: "Durable antitumor activity of the CD122-biased immunostimulatory cytokine NKTR-214 combined with immune checkpoint blockade", Langowski, J., et al.
Poster Session: Immune Modulating Agents 1
Date: April 17, 2016, 1:00 p.m. – 5:00 p.m. Central Time

Effective March 1, 2016 Håkan Wickholm has succeeded Unni Hjelmaas as CEO in Lytix Biopharma.
Mr. Wickholm’s appointment reflects the new phase in Lytix Biopharma’s development with increasing focus on Business Development (Press release, Lytix Biopharma, MAR 1, 2016, View Source [SID:1234509331]). Håkan Wickholm will continue as head of Business Development.

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Board Chair Gert W. Munthe says:

"The entire Board is delighted that Håkan Wickholm now takes on this role as the clinical program is starting to show substantial immune responses in patients treated with LTX-315. This lays the foundation for successful business development activities. At the same time the Board would like to express their thanks to Unni Hjelmaas for her hard work and dedication to Lytix Biopharma in her four years as CEO."

Håkan Wickholm says:

"I am very excited by this opportunity to take on the role of CEO at this stage, when important immune response data develops, allowing us to intensify business development activities and further clinical development. ’’

On March 1, 2016 CEL-SCI Corporation (NYSE MKT: CVM) ("CEL SCI" or the "Company") reported that during the month of February it has enrolled 27 patients in its ongoing Phase 3 trial of its investigational immunotherapy Multikine* (Leukocyte Interleukin, Injection) in patients with advanced primary head and neck cancer (Press release, Cel-Sci, MAR 1, 2016, View Source [SID:1234509319]). Total patient enrollment for the trial is now 724 as of February 29, 2016 in the world’s largest Phase 3 study in head and neck cancer.

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"Through clinical centers in 24 countries, we continue to enroll patients at an average rate of about one per day. With enrollment numbers now over 700, we are nearing our full enrollment goal," stated CEL-SCI CEO Geert Kersten.

The current study goal is to enroll 880 patients through approximately 100 clinical centers in over 20 countries.

About the Multikine Phase 3 Study

The Multikine Phase 3 study is enrolling patients with advanced primary squamous cell carcinoma of the head and neck. The objective of the study is to demonstrate a statistically significant improvement in the overall survival of enrolled patients who are treated with the Multikine treatment regimen plus standard of care ("SOC") vs. subjects who are treated with SOC only.

About Multikine

Multikine (Leukocyte Interleukin, Injection) is an investigational immunotherapeutic agent that is being tested in an open-label, randomized, controlled, global pivotal Phase 3 clinical trial as a potential first-line treatment for advanced primary squamous cell carcinoma of the head and neck. Multikine is designed to be a different type of therapy in the fight against cancer: one that is given BEFORE surgery, radiation and chemotherapy because that is when the immune system is thought to be the strongest, one that appears to have the potential to work with the body’s natural immune system in the fight against tumors.

Multikine is also being tested in a Phase 1 study under a Cooperative Research and Development Agreement ("CRADA") with the U.S. Naval Medical Center, San Diego, and at University of California, San Francisco (UCSF), as a potential treatment for peri-anal warts in HIV/HPV co-infected men and women. Dr. Joel Palefsky, a world-renowned scientist and Key Opinion Leader (KOL) in human papilloma virus (HPV) research and the prevention of anal cancer, is the Principal Investigator at UCSF, which was added to the study in July 2015.

CEL-SCI has also entered into two additional co-development agreements for up to $3 million each with Ergomed Clinical Research Limited to further the development of Multikine for cervical dysplasia/neoplasia in women who are co-infected with HIV and HPV and for peri-anal warts in men and women who are co-infected with HIV and HPV.

On March 1, 2016 Provectus Biopharmaceuticals, Inc. (NYSE MKT: PVCT, www.pvct.com), a clinical-stage oncology and dermatology biopharmaceutical company ("Provectus" or "The Company"), reported that it has received a patent from the U.S. Patent and Trademark Office, U.S. Patent No. 9,273,022 (Filing, 8-K, Provectus Pharmaceuticals, MAR 1, 2016, View Source [SID:1234509318]). The patent extends the scope of protection of the manufacturing process conferred initially by U.S. Patent No. 8,530,675, issued in 2013, to include coverage of the use of an alternative raw material in manufacturing the active ingredient (API) in PV-10.

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Provectus believes that this patent, wholly owned by Provectus and conferring coverage to at least 2031, will provide further protection around the proposed commercial process for manufacturing PV-10. Investigational drug product generated using this proprietary technology is being used in all ongoing clinical trials of PV-10, including the pivotal phase 3 trial in melanoma (NCT02288897).

Provectus’ efforts to bring this process development to fruition were supported by Cambrex Charles City, Inc., a subsidiary of Cambrex Corporation (NYSE:CBM, www.cambrex.com), a life sciences company that provides products and services that accelerate and improve the development and commercialization of new and generic therapeutics.

Dr. Eric Wachter, CTO of Provectus, noted, "It is a pleasure to have Cambrex team members as co-inventors on this process patent. Although the scientists and engineers working behind the scenes aren’t always visible to patients or shareholders, these professionals work tirelessly to enable manufacturing the active ingredient in PV-10 on a commercial scale. Chemistry, Manufacturing and Controls (CMC) is a critical part of any investigational new drug (IND) application and subsequent new drug application (NDA), and this aspect of our PV-10 submission is built on a firm foundation, due in no small part to the efforts of the Cambrex team."

Dr. Kurt Kiewel, Director of R&D at Cambrex Charles City, said, "We feel fortunate to bring the depth of our experience in custom development and API manufacturing to support promising investigational products like PV-10. It has been our pleasure to work with the innovative scientists at Provectus to help advance this potential new cancer treatment toward the market."

On March 1, 2016 Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), reported financial results for the three months and year ended December 31, 2015 and provided an overview of key milestones for the company’s lead drug candidates (Filing, Q4/Annual, Lexicon Pharmaceuticals, 2015, MAR 1, 2016, View Source [SID:1234509309]).

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"This has been a transformative year for Lexicon and our two lead drug candidates, telotristat etiprate and sotagliflozin," said Lexicon President and Chief Executive Officer Lonnel Coats. "We entered 2016 well capitalized with more than $500 million in cash and investments and well positioned to progress our first drug, telotristat etiprate, to an NDA filing and, if approved, into the market."

In November 2015, Lexicon announced that it entered into a collaboration and license agreement with Sanofi for the worldwide development and commercialization of sotagliflozin. Under the terms of the agreement, Lexicon received an upfront payment of $300 million and is eligible to receive development, regulatory and sales milestone payments of up to $1.4 billion. Lexicon is also entitled to tiered, escalating royalties on net sales of sotagliflozin.

Pipeline Progress

Telotristat etiprate is the first investigational drug in clinical studies to target tryptophan hydroxylase (TPH), the rate-limiting enzyme involved in the excess serotonin production within metastatic neuroendocrine tumor cells that can lead to carcinoid syndrome, a condition characterized by serious consequences including frequent and debilitating diarrhea, facial flushing, abdominal pain, and heart valve damage.

In December 2015, Lexicon announced top-line results from its second Phase 3 study, TELECAST, which met its primary efficacy endpoint, the percent change from baseline in urinary 5-hydroxyindoleacetic acid (5-HIAA, the main metabolite of serotonin) at week 12, the final week of the double-blind treatment portion of the study (p<0.001 for both the 250 mg and 500 mg dose arms compared to placebo). In addition, despite a lower baseline bowel movement frequency than in the first Phase 3 study, TELESTAR, telotristat etiprate achieved statistically significant reductions in daily bowel movement frequency over the 12 weeks of the study (p=0.004 for the 250 mg dose arm and p<0.001 for the 500 mg dose arm compared to placebo). Telotristat etiprate was well tolerated during the double-blind treatment period, with profiles similar to placebo for both the 250 mg and 500 mg dose arms and no overall differences observed in gastrointestinal disorders or psychiatric disorders, including changes in mood.

Sotagliflozin, which is being developed as a potential treatment for type 1 and type 2 diabetes, is a dual inhibitor of sodium-glucose transporters 1 and 2 (SGLT1 and SGLT2), each of which modulates glucose levels, and is the first investigational medicine to target both of these two proteins.

Under the collaboration with Sanofi, Lexicon will continue to be responsible for clinical development activities relating to type 1 diabetes and Sanofi will be responsible for clinical development activities relating to type 2 diabetes. Lexicon is conducting three Phase 3 clinical trials of sotagliflozin in patients with type 1 diabetes, one of which has already completed enrollment, and expects top-line results from its two pivotal Phase 3 clinical trials to be available in the second half of 2016. Lexicon expects that Phase 3 development of sotagliflozin in patients with type 2 diabetes will be initiated by Sanofi by the end of 2016.

Financial Highlights

Revenues: Lexicon’s revenues for the three months ended December 31, 2015 increased to $127.3 million from $21.5 million for the corresponding period in 2014, primarily due to revenues recognized from the collaboration and license agreement with Sanofi. For the year ended December 31, 2015, revenues increased to $130.0 million from $22.9 million for the corresponding period in 2014.

Research and Development Expenses: Research and development expenses for the three months ended December 31, 2015 increased 52 percent to $30.4 million from $20.0 million for the corresponding period in 2014, primarily due to increases in external clinical and nonclinical research and development costs. For the year ended December 31, 2015, research and development expenses increased seven percent to $95.2 million from $89.3 million for the corresponding period in 2014.

Change in Fair Value of Symphony Icon Purchase Liability: In connection with the acquisition of Symphony Icon, Lexicon made an initial estimate of the fair value of the liability for the associated base and contingent payments. Changes in this liability, based on the development of the programs and the time until such payments are expected to be made, are recorded in Lexicon’s consolidated statements of operations. For the three months ended December 31, 2015 and 2014, the fair value of the Symphony Icon purchase liability increased by $0.8 million and $0.9 million, respectively. The increase in fair value of the Symphony Icon purchase liability was $5.9 million and $1.4 million for the year ended December 31, 2015 and 2014, respectively.

General and Administrative Expenses: General and administrative expenses for the three months ended December 31, 2015 increased 62 percent to $6.4 million from $4.0 million for the corresponding period in 2014, primarily due to increased costs in preparation for commercialization of telotristat etiprate. For the year ended December 31, 2015, general and administrative expenses increased 23 percent to $23.8 million from $19.4 million for the corresponding period in 2014.

Impairment Loss on Buildings: In 2014, Lexicon began to market its buildings and land in The Woodlands, Texas for sale. Lexicon recognized non-cash impairment losses on its buildings of $3.6 million and $13.1 million for the year ended December 31, 2015 and 2014, respectively, as a result of writing down the buildings to the estimated net selling price. In January 2016, Lexicon entered into a purchase and sale agreement, under which Lexicon agreed to sell such buildings and land, subject to the negotiation and execution of a leaseback agreement with respect to a portion of the buildings.

Consolidated Net Income (Loss): Net income for the three months ended December 31, 2015 was $86.8 million, or $0.76 per diluted share, compared to a net loss of $2.9 million, or $0.03 per share, in the corresponding period in 2014. Net loss for the year ended December 31, 2015 was $4.7 million, or $0.05 per share, compared to a net loss of $100.3 million, or $1.31 per share, in the corresponding period in 2014. For the three months and year ended December 31, 2015, net loss included non-cash, stock-based compensation expense of $1.4 million and $6.8 million, respectively. For the three months and year ended December 31, 2014, net loss included non-cash, stock-based compensation expense of $1.5 million and $7.1 million, respectively.

Cash and Investments: As of December 31, 2015, Lexicon had $521.4 million in cash and investments, as compared to $256.4 million as of September 30, 2015 and $339.3 million as of December 31, 2014.

Reverse Stock Split: In May 2015, Lexicon completed a one-for-seven reverse stock split. All references to common shares and per-share data for all periods presented in this release have been adjusted to give effect to this reverse stock split.