On May 9, 2016 Juno Therapeutics, Inc. (NASDAQ:JUNO), a biopharmaceutical company focused on re-engaging the body’s immune system to revolutionize the treatment of cancer, reported financial results and business highlights for the first quarter 2016 (Press release, Juno, MAY 9, 2016, View Source;p=RssLanding&cat=news&id=2166580 [SID:1234512138]).

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"In the first quarter, we continued to advance our CD19-directed portfolio – enrolling multiple trials, commencing manufacturing of clinical trial material from our Juno-operated facility, and securing Celgene’s opt-in to product candidates in our CD19 program, which will accelerate our pace outside of North America. Also, we recently reported encouraging early data for product candidates against two other targets, CD22 and WT-1, as our pipeline and research continue to progress beyond CD19," said Hans Bishop, Juno’s President and Chief Executive Officer. "Juno’s capabilities are growing, and we look forward to sharing more data with you later this quarter at ASCO (Free ASCO Whitepaper) and throughout 2016."

First Quarter 2016 and Recent Corporate Highlights
Clinical Progress:
CD19 Portfolio – An investigational new drug (IND) amendment cleared the FDA, allowing Juno to begin clinical manufacturing of JCAR015 for the Phase II ROCKET trial out of a Juno-operated manufacturing facility in Bothell, Washington. Juno plans to use this facility to manufacture product for Juno’s first commercial launches. Juno also announced the initiation of enrollment for its trial combining JCAR014 and MedImmune’s anti-PDL-1 immune checkpoint inhibitor, durvalumab.

JCAR018 – This CD22-directed, fully-human chimeric antigen receptor (CAR) T cell product candidate has the potential to treat or prevent CD19-negative relapses. JCAR018 reached two clinical milestones in a Phase I trial conducted at the National Cancer Institute (NCI) in pediatric and young adult relapsed or refractory (r/r) acute lymphoblastic leukemia (ALL) patients, which triggered payments to Opus Bio in the first quarter of 2016 totaling 603,364 shares of Juno common stock. Investigators presented data from the ongoing Phase I study in pediatric and young adult r/r ALL patients at the American Association for Clinical Research (AACR) (Free AACR Whitepaper) 2016, showing all three patients at dose level 2 (1 x 106 cells/kg) achieved a complete remission and complete molecular remission as measured by flow cytometry. These patients remain in complete remission with follow-up ranging from 3 to 6 months. Limited cytokine release syndrome (CRS) and no severe neurotoxicity was seen at dose level 2. Dose limiting toxicity was observed at higher doses, so dosing will continue at dose level 2 (1 x 106 cells/kg). CD22-directed CAR T treatment has the potential, when combined with CD19-directed CARs, to meaningfully increase the percentage of ALL patients that experience long-term remissions.
JTCR016 – This WT-1-directed, T cell receptor (TCR) cell product candidate is currently being studied in acute myeloid leukemia (AML), refractory mesothelioma, and non-small cell lung cancer. In the first three solid organ tumor patients treated to date, all with mesothelioma, preliminary data presented at AACR (Free AACR Whitepaper) 2016 showed one patient with an ongoing partial response to the WT-1 TCR and one with stable disease. The clinical activity appeared to correlate with the pharmacokinetics of the engineered T cells, as the patient with the partial response had the best T cell expansion and persistence. JTCR016 was generally well-tolerated in these three refractory mesothelioma patients, with no evidence of severe CRS or severe neurotoxicity.

Corporate News:
Juno announced that Celgene exercised its option to develop and commercialize product candidates from Juno’s CD19 program outside North America and China. With the exercise of this option, Celgene paid Juno a fee of $50.0 million and the companies will now share global development expenses for product candidates in the CD19 program. Celgene has commercial rights outside of North America and China, and will pay Juno a royalty at a percentage in the mid-teens on any future net sales in Celgene’s territories of therapeutic products developed through the CD19 program. Juno retains commercialization rights in North America and China.
Juno acquired AbVitro, a leading next-generation single cell sequencing platform company that will augment Juno’s capabilities to create best-in-class engineered T cells against a broad array of cancer targets, including significantly improving the speed of generating TCR binders, while also enabling comprehensive profiling of functional immune repertoires with cancer tissues. Juno and Celgene have agreed in principle to enter an agreement to license Celgene a subset of the acquired technology and grant Celgene options to certain related potential product rights emanating from the acquired technology.
Juno announced, along with WuXi AppTec, the formation of a new company, JW Biotechnology (Shanghai) Co., Ltd., with a mission to develop novel cell-based immunotherapies for patients with hematologic and solid organ cancers in China. The new company will leverage Juno’s world-class CAR and TCR technologies and WuXi AppTec’s research and development and manufacturing platform and local expertise.
Juno announced the creation of a new, best-in-class clinical trials unit dedicated to immuno-oncology, in collaboration with the University of Washington, the Seattle Cancer Care Alliance, and the Fred Hutchinson Cancer Research Center (FHCRC). The clinical trials unit has been established to accelerate the clinical care of patients and the generation of translational medicine insights with cutting-edge immuno-oncology therapeutic candidates.
Juno reported that Celgene exercised its annual "top-up" right, purchasing 1,137,593 shares of Juno common stock at a price of $41.32 per share for an aggregate cash purchase price of $47.0 million.
First Quarter 2016 Financial Results
Cash Position: Cash, cash equivalents, and marketable securities as of March 31, 2016 were $1.13 billion compared to $1.22 billion as of December 31, 2015. The decrease of $91.0 million is due to cash used in connection with the acquisition of AbVitro and cash used to fund operations, offset by cash proceeds of $47.0 million from Celgene for the purchase of 1,137,593 shares of Juno’s common stock. Celgene’s CD19 opt-in payment of $50.0 million occurred after the end of the first quarter.
Cash Burn: Excluding cash inflows and outflows from business development activities, cash burn in the first quarter of 2016 was $61.0 million including $4.0 million of capital expenditures, compared to $26.4 million in the first quarter of 2015. The increase of $34.6 million was primarily driven by cash outflows in connection with the overall growth of the business.
Revenue: Revenue for the three months ended March 31, 2016 was $9.8 million and included milestone revenue of $5.8 million received from Novartis and revenue recognized in connection with the Celgene collaboration agreement of $3.8 million.
R&D Expenses: Research and development expenses in the first quarter of 2016, inclusive of non-cash expenses and computed in accordance with GAAP, were $73.7 million compared to $57.8 million in the first quarter of 2015. The increase of $15.9 million was due to a $23.2 million non-cash expense associated with milestones achieved under its license agreement with Opus Bio related to Juno’s JCAR018 product candidate, which were paid through the issuance of 603,364 shares of Juno’s common stock, a $5.0 million payment to St. Jude in connection with the milestone achieved by Juno’s sublicensee Novartis, as well as increased costs incurred to execute Juno’s clinical development strategy, manufacture its product candidates, and expand its overall research and development capabilities.

For the three months ended March 31, 2016, Juno recorded a gain of $6.6 million related to the success payment liability and an expense of $38.9 million for the same period in 2015. The gain recorded in the first quarter of 2016 was primarily due to a decline in Juno’s stock price at March 31, 2016 compared to December 31, 2015.
Non-GAAP R&D Expenses: Non-GAAP research and development expenses for the three months ended March 31, 2016 and 2015 were $80.1 million and $17.0 million, respectively. Non-GAAP research and development expenses for the first quarter of 2016 include $9.1 million of stock-based compensation expense, $2.2 million of which was paid in connection with the acquisition of AbVitro, as well as the milestone payments described above. Non-GAAP research and development expenses for the first quarter of 2015 include $1.7 million of non-cash stock-based compensation expense. Non-GAAP research and development expenses for the first quarter of 2016 exclude the following:
A gain of $6.6 million associated with the change in the estimated value and elapsed service period for Juno’s potential success payment liabilities to FHCRC and Memorial Sloan Kettering Cancer Center (MSK).
Non-cash stock-based compensation expense of $1.2 million related to a 2013 restricted stock award to a co-founding director that became a consultant upon his departure from Juno’s board of directors in 2014.
A gain of $1.0 million associated with the change in estimated fair value of the contingent consideration recorded in connection with the Stage and X-Body acquisitions.
Non-GAAP research and development expenses for the first quarter of 2015 exclude the following:
An expense of $38.9 million associated with the change in the estimated value and elapsed service period for Juno’s potential success payment liabilities to FHCRC and MSK.
Non-cash stock-based compensation expense of $1.9 million related to a 2013 restricted stock award to a co-founding director that became a consultant upon his departure from Juno’s board of directors in 2014.
G&A Expenses: General and administrative expenses on a GAAP basis for the first quarter of 2016 were $16.0 million compared to $7.4 million for the first quarter of 2015. The increase of $8.6 million was primarily due to increased personnel expenses, including non-cash stock-based compensation expense, an increase in consulting fees including costs related to commercial readiness, and other expenses related to the growth of the business. General and administrative expenses include $4.9 million and $1.8 million of non-cash stock-based compensation expense for the three months ended March 31, 2016 and 2015, respectively.
GAAP Net Loss: Net loss for the three months ended March 31, 2016 was $71.1 million, or $0.72 per share, compared to $65.0 million, or $0.79 per share, for the same period in 2015.
Non-GAAP Net Loss: Non-GAAP net loss, which incorporates the non-GAAP R&D expense, for the three months ended March 31, 2016 was $77.5 million, or $0.78 per share, compared to $24.2 million, or $0.30 per share, for the same period in 2015.
A reconciliation of GAAP net loss to non-GAAP net loss is presented below under "Non-GAAP Financial Measures."
2016 Financial Guidance
Juno expects 2016 cash burn, excluding cash inflows or outflows from business development activities, to be between $220 million and $250 million.
Operating burn estimated to be between $170 million and $195 million.
Capital expenditures estimated to be between $40 million and $55 million, the vast majority of which are related to one-time infrastructure build-outs.

On May 09, 2016 Apricus Biosciences, Inc. (Nasdaq:APRI), a biopharmaceutical company advancing innovative medicines in urology and rheumatology, reported financial results for the first quarter of 2016 and provided a corporate update on its priorities for 2016 (Press release, Apricus Biosciences, MAY 9, 2016, View Source;p=RssLanding&cat=news&id=2166289 [SID:1234512311]). Apricus will hold a previously announced webcast this morning at 8:00 am PDT with Edward D. Kim, M.D., a member of the Company’s Scientific Advisory Board and a Vitaros clinical investigator, to discuss the Vitaros opportunity as part of the Company’s corporate activities concurrent with the American Urological Association’s 2016 Annual Meeting, May 6 – 10 in San Diego. Please join the webcast at www.apricusbio.com to view the presentation slides or, to participate by telephone, dial (877) 841-3961 (Domestic) or (201) 689-8589 (International). The conference ID number is 13633850.

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"In March, we sharpened our focus on growth of the Vitaros brand, as we streamlined our organization in an effort to align our corporate strategy and our financial resources with the goal of achieving profitability in 2017," stated Richard W. Pascoe, Chief Executive Officer. "Importantly, we experienced record Vitaros royalties in Europe in the first quarter of 2016 and we continue to have a productive dialogue with the Food and Drug Administration ("FDA") regarding the Vitaros New Drug Application ("NDA") resubmission content and format. As such, we remain on track to resubmit the NDA for Vitaros U.S. in the third quarter of 2016 with an approval decision expected after a six month review period. Finally, we will continue to work closely with our partners to grow Vitaros revenue by supporting additional regulatory approvals and launches, licensing additional territories, and leveraging our existing partnerships to help ensure Vitaros is actively commercialized in all approved territories."

First Quarter Highlights and Recent Developments

Apricus recently updated its corporate goals to focus on increasing Vitaros’ value through the fostering and expansion of its commercial partnerships, in the U.S. and globally, and strengthening the Company’s financial position. First quarter and recent highlights include:

Closed on a $10 million registered direct offering with certain institutional investors, including existing investors Sarissa Capital and Aspire Capital;
Reported top-line Phase 2b data for fispemifene in symptomatic secondary hypogonadism that failed to achieve statistical significance in key clinical benefit endpoints and abandoned further clinical activities surrounding fispemifene; and
Expanded the Company’s exclusive distribution agreement with Ferring Pharmaceuticals to market Vitaros in the United Kingdom as part of the Company’s ongoing initiative to consolidate Vitaros territories with existing partners in an effort to maximize efficiencies and revenue.
2016 Priorities

Apricus is focused on achieving the following key strategic objectives:

Vitaros* (alprostadil)

Continue implementation of the U.S. regulatory approval strategy to address the safety and manufacturing issues raised by the FDA in the original Vitaros NDA submission, with an NDA resubmission on target for the third quarter of 2016;
Continue to support the Company’s ex-U.S. partners’ efforts to increase revenue in countries where partners have launched Vitaros, seek solutions to ensure that Vitaros is available to patients in every country where it is approved but not currently marketed, support new commercial launches by the Company’s partners and assist the Company’s partners in obtaining additional regulatory approvals in their respective territories; and
Continue to generate the required data in 2016 to support delivery device improvements and related regulatory submission(s) with a priority to support the U.S. NDA resubmission of the refrigerated version of Vitaros.
RayVa (alprostadil)

Complete the formulation development for at-home dosing;
Finalize the Phase 2b study protocol;
Explore Orphan Drug Designation in the U.S. and EU; and
Explore global or regional partnerships prior to initiating the Phase 2b study.
First Quarter Financial Results

Revenue during the quarter ended March 31, 2016 was $0.6 million, compared to revenue of $0.5 million during the first quarter of 2015. Revenue during the quarter ended March 31, 2016 was comprised of $0.4 million in royalty revenues, an increase of $0.3 million or 317% over the quarter ended March 31, 2015. Revenue during the quarter ended March 31, 2015 included $0.4 million in license fee revenue related to the expansion of the Company’s license agreement with Sandoz to commercialize Vitaros in certain Asian and Pacific countries. Basic net loss for the quarter ended March 31, 2016 was $2.5 million, or basic loss per share of $0.05, compared to a net loss of $6.4 million, or $0.13 per share for the first quarter of 2015. Reducing the net loss for the quarter ended March 31, 2016 was a non-cash change in the fair value of the Company’s warrant liability in the amount of $2.6 million.

As of March 31, 2016, cash and cash equivalents totaled $6.9 million, compared to $3.9 million as of December 31, 2015.

2016 Financial Outlook

Early in the second quarter of 2016, Apricus reduced its staff, including the executive team, by approximately 30%, decreased the size of the Board by one member and reduced the Board’s cash compensation. Apricus plans to continue to reduce operating expenses (excluding non-cash stock-based compensation expense and depreciation expense), with a goal of achieving reductions of approximately 30% in 2016 and 60% in 2017 as compared to 2015 operating expenses (excluding non-cash stock-based compensation expense and depreciation expense).

In 2016, Apricus expects to continue to generate cash from milestone or licensing payments and royalty revenues from its partners’ sales of Vitaros. Apricus will also continue to pursue out-licensing opportunities for Vitaros in Asia-Pacific. Apricus’ expenditures will include minimal costs for the preparatory Phase 2b clinical development of RayVa, as well as costs for activities associated with supporting the regulatory approval of Vitaros in the U.S. and the commercialization of Vitaros in Europe.

On May 9, 2016 Flamel Technologies (NASDAQ: FLML) reported its financial results for the first quarter of 2016 (Filing, Q1, Flamel Technologies, 2016, MAY 9, 2016, View Source [SID:1234512418]).

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First Quarter Highlights Include:

· Total revenue for first quarter 2016 was $36.2 million, compared to $32.7 million during the same period last year.

· GAAP net loss for the first quarter was ($6.4) million, or ($0.15) per diluted share, compared to GAAP net income of $11.6 million, or $0.27 per diluted share during the same period last year.

· Adjusted EBITDA was $11.8 million, compared to $12.9 million in the prior year.*

· Adjusted net income for the first quarter was $1.6 million, or $0.04 per diluted share, compared to an adjusted net income of $4.7 million, or $0.11 per diluted share, during the same period last year. *

· Cash and marketable securities at March 31, 2016 were $160.0 million, compared to $144.8 million at December 31, 2015 and $113.2 million at March 31, 2015.

· Special Protocol Assessment (SPA) submitted to the U.S. Food and Drug Administration (FDA) for the once nightly version of Micropump sodium oxybate.

* Non-GAAP financial measure. Descriptions of Flamel’s non-GAAP financial measures are included under the caption "Non-GAAP Disclosures and Adjustments" included within this document and reconciliations of such non-GAAP financial measures to their most closely applicable GAAP financial measures are found in the "Supplemental Information" section within this document.

Michael Anderson, Flamel’s Chief Executive Officer, commented, "We were pleased with our strong revenues of $36.2 million during the first quarter. The entrance of a third competitor to the neostigmine market in December 2015 was less impactful to pricing and share for Bloxiverz during the first quarter than initially anticipated; however, we still expect a decline in market share throughout the year to approximately 30% to 35%. As expected on April 29th, we received FDA approval for our third unapproved marketed drug, Akovaz, which is our formulation of ephedrine sulfate injection. Following launch in the third quarter of this year, Akovaz will provide yet another stream of cash flow to help us continue executing against our strategic plan of advancing our pipeline products and growth through acquisitions, the first of which we made early in the first quarter. We continue to focus on integrating the FSC business and revenues are meeting our expectations. We are particularly excited by physicians’ reception of Karbinal ER, which accounted for the majority of revenues from the FSC product portfolio."

Mr. Anderson continued, "At the end of the first quarter, we submitted our SPA to the FDA for our pivotal trial of Micropump sodium oxybate, which will provide the FDA an opportunity to review our trial protocol and provide feedback. We expect to begin patient registration for our pivotal trial in mid-year 2016. We view sodium oxybate as our most valuable pipeline asset, and will continue to take the necessary steps to ensure the Company returns maximum value to our shareholders."

First Quarter 2016 Results

The Company achieved revenues during the first quarter of 2016 of $36.2 million, compared to $32.7 million during the same period last year. On a GAAP basis, Flamel recorded a net loss of ($6.4) million during the first quarter, or ($0.15) per diluted share, compared to a net income of $11.6 million, or $0.27 per diluted share, for the same period last year. Adjusted net income for the first quarter was $1.6 million, or $0.04 per diluted share, compared to an adjusted net income of $4.7 million, or $0.11 per diluted share, during the same period last year. The decline in adjusted diluted EPS from the previous year was primarily due to higher SG&A resulting from investments made in infrastructure and people in order to execute the Company’s strategic plan. Included in GAAP net loss in the first quarter of 2016 was a $7.9 million charge to its contingent consideration liability resulting from the Company’s reassessment of its long term Éclat revenue forecast. In addition, the Company incurred a foreign currency exchange loss of ($2.9) million, compared to a foreign currency exchange gain of $11.5 million in the prior year quarter. Please see the Supplemental Information section within this document for a reconciliation of adjusted EBITDA, adjusted net income and adjusted diluted EPS to the respective GAAP amounts.

Cash flow from operations was $22.5 million, compared to $25.3 million in the same period last year. Cash and marketable securities at March 31, 2016 were $160.0 million, compared to $144.8 million at December 31, 2015, an increase of $15.2 million.

2016 Revenue and R&D Spending Guidance

The Company is maintaining its full year 2016 revenue guidance of $110 – $130 million and expects the recently acquired FSC products, AcipHex Sprinkle, Karbinal ER, Cefaclor for Oral Suspension and Flexichamber, to contribute revenues in the range of $10 – $15 million. As a result of the multiple clinical trials expected to run throughout 2016, the Company expects research & development expenses to be in the range of $35 – $50 million, up from $25.6 million in 2015.

On May 9, 2016 GTx, Inc. (Nasdaq: GTXI) reported the first public presentation of preclinical data from the Company’s selective androgen receptor degrader (SARD) program (Press release, GTx, MAY 9, 2016, View Source;p=RssLanding&cat=news&id=2166265 [SID:1234512115]). The results demonstrate that the Company’s highly potent SARDs selectively bind to the ligand binding domain (LBD) and interact with the N-terminal domain (NTD) of the androgen receptor (AR) and inhibit and degrade the AR at very low concentrations. These preclinical results suggest that the Company’s SARDs may be the first-in-class dual-interacting AR antagonists and degraders.

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The preclinical data are being presented at the 2016 American Urological Association (AUA) Annual Meeting taking place May 6-10, 2016, in San Diego, California.

Poster: Novel Dual-Binding Selective Degraders of Full Length and Splice Variant Androgen Receptors for the Treatment of Castration-Resistant Prostate Cancer

Presenter: Ramesh Narayanan, Ph.D., Director, Center for Cancer Drug Discovery and Associate Professor, Department of Medicine, University of Tennessee and Consultant for GTx, Inc.

Date:
Saturday, May 7 at 10:30 am until Tuesday, May 10 at 1:00 pm

According to Dr. Narayanan, "One of the limitations of current prostate cancer therapy is that some men with castration-resistant prostate cancer do not respond or eventually develop resistance to the therapy. These preclinical results suggest that novel SARD compounds may degrade and inhibit multiple forms of the androgen receptor, including AR splice variants, and may therefore potentially treat CRPC in men who are non-responsive to androgen therapy."

The Company’s lead SARD compounds are currently being evaluated in preclinical studies in order to select the best SARD compounds for continued development, with a goal of initiating first human clinical trials in 2017.

About SARDs

Selective Androgen Receptor Degrader (SARD) technology is being evaluated as a potentially novel treatment for men with castration-resistant prostate cancer (CRPC), including those who do not respond or are resistant to currently approved therapies. GTx believes that its novel SARD compounds will degrade multiple forms of the androgen receptor, including AR splice variants, such as AR-V7. GTx licensed the SARD technology from the University of Tennessee Research Foundation in 2015 with the goal of expanding its portfolio of product candidates targeting hormonal receptors.

About Prostate Cancer

Prostate cancer that is localized to the prostate can be effectively treated with surgery, radiation, brachytherapy and other modalities in an effort to eradicate all of the disease and cure the patient. In some cases, the tumor advances locally or metastasizes; these are examples of advanced prostate cancer. The goal of treatment for advanced prostate cancer is to control the tumor and keep the patient alive for as long as possible.

In advanced prostate cancer, a number of treatments with hormone blocking therapies or chemotherapy are used to slow the spread of metastases, shrink existing tumors, reduce symptoms and improve quality of life. Although most men with advanced prostate cancer are not cured of their disease, they can live a normal life for many years.

CPI-444 is an orally administered antagonist of the adenosine A2A receptor (Company Pipeline, Corvus Pharmaceuticals, MAY 9, 2016, View Source [SID:1234512139]). It is designed to block the action of adenosine that is produced by tumors. CPI-444 will enter a Phase 1b study in early 2016. In collaboration with Genentech, this study will evaluate CPI-444 as a single agent and in combination with the investigational agent, atezolizumab, an anti-PDL-1 antibody.

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