On March 1, 2016 Corcept Therapeutics Incorporated (NASDAQ: CORT), a pharmaceutical company engaged in the discovery, development and commercialization of drugs that treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of cortisol, reported its financial results for the fourth quarter and full year ended December 31, 2015 (Press release, Corcept Therapeutics, MAR 1, 2016, http://www.corcept.com/news_events/view/pr_1456870143 [SID:1234509336]).

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Corcept reported revenue of $15.0 million for the fourth quarter of 2015 and $50.3 million for the full year. GAAP net income for the fourth quarter of 2015 was $1.0 million or $0.01 per share, compared to a net loss of $3.9 million or $0.04 per share in the fourth quarter of 2014. For the full year, the company reported a GAAP net loss of $6.4 million or $0.06 per share for 2015, compared to a net loss of $31.4 million or $0.31 per share in 2014.

The company’s cash and cash equivalents were $40.4 million at year-end, an increase of $4.0 million from September 30, 2015.

The company reiterated its 2016 revenue guidance of $76-81 million.

"2015 was a pivotal year for Corcept," said Dr. Joseph K. Belanoff, Corcept’s Chief Executive Officer. "We made a GAAP profit in the fourth quarter, while conducting our Phase 1/2 trial of mifepristone to treat TNBC and advancing our lead selective cortisol modulator toward Phase 2 trials in Cushing’s syndrome and solid-tumor cancers. In 2016, we plan to expand our pipeline further by advancing additional selective modulators towards human use – funded by our cash on hand and revenue from the sale of Korlym."

Financial Discussion

Corcept’s GAAP net income in the fourth quarter of 2015 was $1.0 million, compared to a net loss of $3.9 million in the fourth quarter of 2014. The company’s net loss for the full year was $6.4 million, compared to a net loss $31.4 million in 2014. Excluding non-cash expenses related to stock-based compensation and accreted interest on the company’s capped royalty obligation (the "Royalty Financing"), Corcept generated $3.1 million of non-GAAP net income in the fourth quarter, compared to a non-GAAP net loss of $1.7 million in the fourth quarter of 2014. Non-GAAP net income for 2015 was $2.5 million, compared to a non-GAAP net loss of $22.5 million for 2014. A reconciliation of GAAP to non-GAAP net operating results is set forth below.

Operating expenses for the fourth quarter of 2015 were $13.3 million, compared to $12.1 million for the fourth quarter of 2014. The increase was primarily due to spending on the company’s expanded sales force and operational costs associated with increased sales volumes. For the full year, operating expenses declined to $53.7 million, from $54.2 million in 2014, as savings from discontinuation of the company’s Phase 3 trial of mifepristone to treat psychotic depression more than offset increased spending on its Phase 1/2 trial of TNBC, clinical development of CORT125134, pre-clinical development of other selective cortisol modulators and costs related to the company’s larger sales force and increased sales volumes.

Corcept’s cash and cash equivalents totaled $40.4 million as of December 31, 2015, compared to $24.2 million as of December 31, 2014. These cash balances reflect Corcept’s scheduled payments due under the Royalty Financing. Pursuant to the terms of the agreement, Corcept paid $2.8 million in the fourth quarter of 2015, with payments totaling $9.2 million for the full year. In 2014, Corcept paid $1.6 million in the fourth quarter and $4.9 million for the year. Corcept expects to make its final payment under the Royalty Financing in 2017.

About Cushing’s Syndrome

Endogenous Cushing’s syndrome is caused by prolonged exposure of the body’s tissues to high levels of the hormone cortisol and is generated by tumors that produce cortisol or ACTH. Cushing’s syndrome is an orphan indication that most commonly affects adults aged 20-50. An estimated 10-15 of every one million people are newly diagnosed with this syndrome each year, resulting in over 3,000 new patients annually in the United States. An estimated 20,000 patients in the United States have Cushing’s syndrome. Symptoms vary, but most people have one or more of the following manifestations: high blood sugar, diabetes, high blood pressure, upper body obesity, rounded face, increased fat around the neck, thinning arms and legs, severe fatigue and weak muscles. Irritability, anxiety, cognitive disturbances and depression are also common. Cushing’s syndrome can affect every organ system in the body and can be lethal if not treated effectively.

About Triple-Negative Breast Cancer (TNBC)

TNBC is a form of the disease in which the three receptors that fuel most breast cancer growth – estrogen, progesterone and the HER-2/neu gene – are not present. Because the tumor cells lack the necessary receptors, treatments that target estrogen, progesterone and HER-2 receptors are ineffective. In 2013, approximately 40,000 women were diagnosed with TNBC. It is estimated that more than 75 percent of these women’s tumor cells expressed the GR receptor to which cortisol binds. There is no FDA-approved treatment and neither a targeted treatment nor an approved standard chemotherapy regimen for relapsed TNBC patients exists.

About Korlym

Korlym modulates the effect of cortisol at GR, one of the two receptors to which cortisol binds, thereby inhibiting the effects of excess cortisol in patients with Cushing’s syndrome. Since 2012, Corcept has made Korlym available as a once-daily oral treatment of hyperglycemia secondary to endogenous Cushing’s syndrome in adult patients with glucose intolerance or diabetes mellitus type 2 who have failed surgery or are not candidates for surgery. Korlym was the first FDA-approved treatment for that illness and the FDA has designated it as an Orphan Drug for that indication.

About CORT125134

CORT125134 is the lead compound in Corcept’s portfolio of selective cortisol modulators. It is a non-steroidal competitive antagonist of GR that does not bind to the body’s other hormone receptors, including the progesterone receptor. It is the affinity of Korlym for the progesterone receptor that results in termination of pregnancy and can cause endometrial thickening and irregular vaginal bleeding in some women. CORT125134 will not have these effects. The compound is proprietary to Corcept and is protected by composition of matter and method of use patents extending to 2033.

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."