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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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 9, 2016 Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD), a commercial biotechnology company, reported an update on its first quarter 2016 results and recent business activities (Press release, Ironwood Pharmaceuticals, MAY 9, 2016, View Source [SID:1234512137]).

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"In the first few months of 2016, Ironwood made significant progress building a top-performing commercial biotech company. We delivered strong operational performance, advanced a second program into Phase IIb trials, and executed a license agreement that leverages our strong commercial capabilities and puts us on track for at least five U.S. commercial product launches by 2020," said Peter Hecht, chief executive officer of Ironwood. "The quarter’s results also demonstrate continued strong LINZESS growth: more than 4.5 million prescriptions have now been filled by more than 1 million patients since launch, and market research has shown high physician and patient satisfaction with LINZESS as an effective and safe treatment option for adults suffering from IBS-C or CIC."

First Quarter 2016 and Recent Highlights

Irritable Bowel Syndrome with Constipation (IBS-C) / Chronic Idiopathic Constipation (CIC) Franchise

Ironwood estimates its IBS-C/CIC franchise, including LINZESS and linaclotide colonic release (if approved), which are jointly owned in the U.S. by Ironwood and Allergan with both companies sharing equally in any profits or losses, may represent a peak U.S. sales opportunity exceeding $2 billion, with additional global potential.

LINZESS. U.S. net sales, as provided by Allergan, were $137.1 million in the first quarter of 2016, a 44% increase compared to the first quarter of 2015.
Nearly 600,000 total LINZESS prescriptions were filled in the first quarter of 2016, a 30% increase compared to the first quarter of 2015, according to IMS Health.
Net profit for the LINZESS U.S. brand collaboration, including commercial and research and development (R&D) expenses, was $58.4 million in the first quarter of 2016.
LINZESS commercial margin was 55% in the first quarter of 2016, compared to 39% in the first quarter of 2015.
Ironwood and Allergan launched a new direct to consumer marketing campaign, and the companies increased LINZESS managed care coverage and expanded the entry into new market segments including long term care.
Ironwood and Allergan continue to expect to launch a 72 mcg dose of linaclotide in early 2017, if approved. The companies anticipate that the 72 mcg dose will accelerate physician prescribing of LINZESS within the large, heterogeneous adult CIC patient population.
Linaclotide Colonic Release. A Phase IIb clinical trial is enrolling patients, with data expected in the second half of 2016. This second-generation guanylate cyclase-C (GC-C) agonist product candidate has the potential to provide greater and faster abdominal pain relief in adult IBS-C patients and to expand the IBS-C and CIC market, if approved.
Refractory Gastroesophageal Reflux Disease (GERD) Franchise

IW-3718. Ironwood initiated a dose-ranging Phase IIb clinical trial with IW-3718, a wholly-owned asset, for the potential treatment of refractory GERD. Data from the Phase IIb trial are expected in 2017. If approved, Ironwood estimates peak sales for IW-3718 may exceed $2 billion.
Uncontrolled Gout Franchise

On April 26, Ironwood announced that it signed a licensing agreement with AstraZeneca for the exclusive U.S. rights to all products containing lesinurad. This includes FDA-approved ZURAMPIC (lesinurad 200mg tablets) as well as a fixed-dose combination of lesinurad and allopurinol, which AstraZeneca plans to submit for FDA regulatory review in the second half of 2016.

For as many as two million gout patients in the U.S., treatment with a xanthine oxidase inhibitor (XOI) such as allopurinol to decrease production of uric acid is not sufficient to achieve treatment goals. ZURAMPIC complements XOI therapy by increasing excretion of uric acid and is indicated for use in combination with an XOI for the treatment of hyperuricemia associated with uncontrolled gout. ZURAMPIC is not recommended for the treatment of asymptomatic hyperuricemia and should not be used as monotherapy.

The transaction is expected to close in the second quarter of 2016, and Ironwood expects to launch ZURAMPIC in the middle of the second half of 2016.

Vascular and Fibrotic Franchise

Ironwood is leveraging its pharmacologic expertise in guanylate cyclases to advance soluble guanylate cyclase (sGC) stimulators for the potential treatment of vascular and fibrotic diseases. Ironwood believes this opportunity has the potential to deliver multiple products, a number of which could generate peak sales exceeding $1 billion if approved. All vascular and fibrotic assets are wholly-owned by Ironwood. Highlights during the first quarter and recent period include:

IW-1701. Ironwood announced positive top-line results from a Phase Ia study of IW-1701 and is in the process of initiating a Phase Ib multiple ascending dose study, with topline data expected in the second half of 2016.
IW-1973. Ironwood is currently enrolling healthy volunteers in a Phase Ib clinical study with IW-1973 designed to assess its safety, tolerability, pharmacokinetic profile and pharmacodynamic effects. Data from this study are expected in the second half of 2016.
Data from pre-clinical and early clinical studies of these compounds are being presented at several scientific conferences this spring.
Ironwood expects to initiate multiple Phase II studies with its sGC stimulators this year.

Additional Programs

Diabetic Gastroparesis

IW-9179. Ironwood previously announced that top-line data from an exploratory Phase IIa clinical study indicated IW-9179 did not meaningfully reduce the severity of symptoms in patients with diabetic gastroparesis and it will discontinue development of IW-9179 for gastroparesis.

Global Collaborations and Partnerships

Ironwood’s strong U.S. commercial organization successfully introduced LINZESS to the market with its partner Allergan and expects to commercialize multiple important products in the U.S. over time. Ironwood expects to out-license ex-U.S. commercialization rights to its pipeline product candidates. Highlights during the first quarter and recent period include:

Astellas Pharma Inc. filed for approval with the Ministry of Health, Labor and Welfare to market linaclotide in Japan for IBS-C in adult patients, which resulted in Ironwood earning a $15 million development milestone payment, which was received in the first quarter.
Ironwood and AstraZeneca AB filed for approval with the China Food and Drug Administration to market linaclotide in China for the treatment of adult patients with IBS-C.
Ironwood continued co-promoting Allergan’s VIBERZI (eluxadoline) for adults suffering from IBS with diarrhea (IBS-D) and Exact Sciences’ Cologuard noninvasive stool DNA screening test for colorectal cancer, in the U.S. Both partnerships represent productive and efficient utilization of Ironwood’s commercial capabilities and continue to generate incremental revenues.
Corporate and Financials

Collaborative Arrangements Revenue
Collaborative arrangements revenue was $66.0 million in the first quarter of 2016 compared to $28.9 million in the first quarter of 2015. Revenue primarily consisted of $46.6 million in revenue associated with Ironwood’s share of the net profits from the sales of LINZESS in the U.S., compared to $25.1 million in the first quarter of 2015.
Ironwood recognized $12.9 million in revenue of the $15.0 million milestone payment from Astellas during the first quarter of 2016.
Operating Expenses
Operating expenses were $68.0 million in the first quarter of 2016 as compared to $57.0 million in the first quarter of 2015. Operating expenses in the first quarter of 2016 consisted of $31.8 million in R&D expenses, and $36.2 million in selling, general and administrative (SG&A) expenses. Non-cash share-based compensation expenses recorded in R&D and SG&A expenses in the first quarter of 2016 were $2.5 million and $4.3 million, respectively.
Other Expense
Interest Expense. Net interest expense was $9.7 million in the first quarter of 2016, in connection with the company’s $175 million debt financing executed in January 2013 and the approximately $336 million convertible debt financing executed in June 2015. Interest expense recorded in the first quarter of 2016 includes $6.3 million in cash expense and $3.6 million in non-cash expense.
Gain/Loss on Derivatives. Ironwood records a gain/loss on derivatives related to the change in fair value of the convertible note hedges and note hedge warrants issued in connection with the convertible debt financing in June 2015. A loss on derivatives of $1.6 million was recorded in the first quarter of 2016.
Net Loss
GAAP net loss was $13.3 million, or $0.09 per share, in the first quarter of 2016, as compared to $33.2 million, or $0.24 per share, in the first quarter of 2015. Non-GAAP net loss excludes the impact of mark-to-market adjustments on the derivatives related to Ironwood’s convertible debt. Non-GAAP net loss was $11.7 million, or $0.08 per share, in the first quarter of 2016, as compared to $33.2 million, or $0.24 per share, in the first quarter of 2015. See Non-GAAP Financial Measures below.
Cash Position
Ironwood ended the first quarter of 2016 with $434 million of cash, cash equivalents and available-for-sale securities, a decrease of $5 million from the end of the fourth quarter of 2015. Ironwood generated $0.2 million in cash from operating activities during the first quarter of 2016. In contrast, in the first quarter of 2015, Ironwood used $36 million of cash for operations.
2016 Financial Guidance
In 2016, Ironwood expects:

Use of less than $70 million in cash for operations in 2016, revised as of April 26, 2016, at the time of the lesinurad deal announcement, from less than $60 million as previously guided.
Combined Allergan and Ironwood total 2016 marketing and sales expenses for LINZESS to be in the range of $230 million to $260 million.
On its second quarter 2016 investor update, following the closing of the lesinurad transaction, Ironwood expects to update its guidance for total annual operating expenses for 2016, including both R&D and SG&A expenses.

Non-GAAP Financial Measures

The company presents non-GAAP net loss and non-GAAP net loss per share to exclude the impact of net gains and losses on the derivatives related to our convertible notes that are required to be marked-to-market. These gains and losses may be highly variable, difficult to predict and of a size that could have a substantial impact on the company’s reported results of operations in any given period. Management believes this non-GAAP information is useful for investors, taken in conjunction with Ironwood’s GAAP financial statements, because it provides greater transparency and period-over-period comparability with respect to Ironwood’s operating performance. These measures are also used by management to assess the performance of the business. Investors should consider these non-GAAP measures only as a supplement to, not as a substitute for or as superior to, measures of financial performance prepared in accordance with GAAP. In addition, these non-GAAP financial measures are unlikely to be comparable with non-GAAP information provided by other companies. For a reconciliation of these non-GAAP financial measures to the most comparable GAAP measures, please refer to the table at the end of this press release.

On May 09, 2016 Vical Incorporated (Nasdaq:VICL) reported financial results for the three months ended March 31, 2016 (Press release, Vical, MAY 9, 2016, View Source [SID:1234512130]). Net loss for the first quarter of 2016 was $2.4 million, or $0.03 per share, compared with a net loss of $3.8 million, or $0.04 per share, for the first quarter of 2015. Revenues for the first quarter of 2016 were $4.6 million, compared with revenues of $4.9 million for the first quarter of 2015, reflecting revenues from Astellas Pharma Inc. for manufacturing services performed under our ASP0113 collaborative agreements. ASP0113 is Vical’s therapeutic vaccine designed to prevent cytomegalovirus (CMV) disease and associated complications in transplant recipients.

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Vical had cash and investments of $40.3 million at March 31, 2016. The Company’s net cash use for the first quarter of 2016 was $1.7 million, which was consistent with the Company’s guidance for the full year. The Company is projecting net cash burn for 2016 between $8 million and $11 million.

Program updates include:

ASP0113 CMV Vaccine

The multinational Phase 3 registration trial in 500 hematopoietic cell transplant (HCT) recipients is ongoing and over 80% of the subjects have now been enrolled. Astellas expects enrollment to be completed by the third quarter of 2016, with the top-line data available in the fourth quarter of 2017. The primary endpoint of this trial is a composite of overall mortality and CMV end organ disease. Vical and Astellas have initiated process validation activities for the manufacture of the bulk drug product in anticipation of a potential BLA filing in 2018.

Enrollment in the multinational Phase 2 trial in kidney transplant recipients was completed in May 2015 and the last subject is expected to complete 1 year of follow up later this month. The primary endpoint of this trial is the incidence of CMV viremia and the study is powered to show an approximately 50% reduction in CMV viremia at 1 year after transplantation. Astellas expects the top-line trial data to be available in the third quarter of 2016.

HSV-2 Therapeutic Vaccine

Trial results, including data on multiple endpoints evaluating safety and efficacy, from our recently completed HSV-2 Phase 1/2 trial will be presented in an oral late-breaker presentation at the American Society of Microbiology (ASM) Microbe/ICAAC 2016 conference on June 20, 2016 in Boston, Massachusetts.

VL-2397 Antifungal

Enrollment is ongoing in Vical’s first-in-human Phase 1 trial of its novel antifungal, VL-2397. The randomized, double-blind, placebo-controlled trial is intended to evaluate safety, tolerability and pharmacokinetics of single and multiple ascending doses of VL-2397 in healthy volunteers. The trial is expected to be complete by the end of 2016. The U.S. Food and Drug Administration has granted Vical Fast Track, qualified infectious disease product (QIDP) and orphan drug designations for VL-2397 for the treatment of invasive aspergillosis. This invasive fungal infection is associated with a high rate of mortality in immunocompromised patients, underscoring the need for new antifungal therapies. Vical is working closely with a core team of expert advisors to design a proof of concept efficacy study for VL-2397 in the treatment of patients with invasive aspergillosis.

Vical will conduct a conference call and webcast today, May 9, at noon Eastern Time, to discuss the Company’s financial results and program updates with invited participants. The call and webcast are open on a listen-only basis to any interested parties. To listen to the conference call, dial in approximately ten minutes before the scheduled call to (719) 325-2484 (preferred), or (888) 523-1228 (toll-free), and reference confirmation code 9062407. A replay of the call will be available for 48 hours beginning about two hours after the call. To listen to the replay, dial (719) 457-0820 (preferred) or (888) 203-1112 (toll-free) and enter replay passcode 9062407. The call will also be available live and archived through the events page at www.vical.com. For further information, contact Vical’s Investor Relations department by phone at (858) 646-1127 or by e-mail at [email protected].

On May 9, 2016 The Medicines Company (NASDAQ:MDCO) reported its business and financial results for the first quarter ended March 31, 2016 (Press release, Medicines Company, MAY 9, 2016, View Source;p=RssLanding&cat=news&id=2166297 [SID:1234512129]).

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During the first quarter of 2016, the Company has:

PCSK9si (PCSK9 synthesis inhibitor): Continued on pace to recruit up to 480 patients in the ORION-1 clinical program, a Phase 2, placebo-controlled, double-blind, randomized trial to test the efficacy, safety and durability of a range of doses in patients with atherosclerotic cardiovascular disease; we anticipate completion of the trial by the end of 2016.
MDCO-216: Advanced enrollment of patients in the MILANO-PILOT study evaluating the drug’s effects on atherosclerotic plaque burden; trial is set to enroll 120 evaluable patients, with the first 40 patients expected to be analyzed around mid-year 2016;
ABP-700: Transitioned to Phase 2 clinical development with the expectation of enrolling patients for the first study of a global procedural sedation colonoscopy program by end of second quarter; with continued success, we expect to launch Phase 3 clinical testing in 2017;
CARBAVANCE: Announced the granting of fast track status and the anticipated completion of Phase 3 clinical trials during second half 2016; anticipate filing NDA and MAA by end of year;
Revenues for newly- launched products (Kengreal, Cleviprex, Orbactiv, Minocin IV and Ionsys) increased 161% to $10.9 million in the first quarter of 2016 over the same period in 2015.
The Company announced earlier today that it has entered into a definitive agreement to sell its non-core cardiovascular products—Cleviprex (clevidipine), Kengreal (cangrelor) and its rights to Argatroban for Injection—to Chiesi USA, Inc. and its parent company, Chiesi Farmaceutici S.p.A., for up to $792 million, consisting of $260 million in cash payable at closing, up to $480 million in sales-based milestone payments, the assumption by Chiesi of up to $50 million in milestone payment obligations and approximately $2 million for product inventory. The transaction, which is subject to customary closing conditions, including the expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, is expected to close early in the third quarter of 2016.

Clive Meanwell, MD, PhD, Chief Executive Officer of The Medicines Company, stated: "The divestiture of our non-core cardiovascular products will enable us to drive the continued development of our potential blockbuster R&D products without diluting our shareholders. Each of our four products in development have critical data milestones which we expect will be unveiled over the course of the year. In addition to completing and reporting data for the ORION-1 Phase 2 clinical trial of PCSK9si, we plan to initiate ORION-2, a Phase 2 study in familial homozygous hypercholesterolemia patients during 2016. For MDCO-216, we expect to secure clinical re-proof of concept from the MILANO-PILOT study. Finally, we expect to complete and report data for the Phase 3 registrational trial of Carbavance, as well as the Phase 2 trial of ABP-700. We look forward to sharing these critical updates throughout the year."

First-Quarter 2016 Financial Summary from Continuing Operations

Worldwide net revenue was $50.3 million for the first quarter of 2016 compared to $110.1 million in the first quarter of 2015. Worldwide Angiomax/Angiox (bivalirudin) net product sales were $16.9 million in the first quarter of 2016 compared to $100.7 million in the first quarter of 2015, with net product sales in the United States decreasing to $13.2 million in the first quarter of 2016 from $95.1 million in the first quarter of 2015 driven by the loss of Angiomax exclusivity in July 2015. Included in total net revenue for the first quarter of 2016 is $18.9 million of royalty revenues derived from the gross profit of authorized generic sales of Angiomax (bivalirudin) by Sandoz, Inc. Other products including Cleviprex, Argatroban for Injection, Minocin for Injection, Orbactiv, Ionsys and Kengreal recorded sales of $14.5 million during the first quarter of 2016 compared to $9.4 million in the first quarter of 2015.

The net loss from continuing operations attributable to The Medicines Company for the first quarter of 2016 was $90.3 million, or $1.31 per share, compared to net income from continuing operations attributable to The Medicines Company of $4.4 million, or $0.07 per share, for the first quarter of 2015. Adjusted net loss(1) from continuing operations attributable to The Medicines Company for the first quarter of 2016 was $71.2 million, or $1.03(1) per share, compared to adjusted net loss(1) from continuing operations attributable to The Medicines Company of $0.1 million for the first quarter of 2015.

First-Quarter 2016 Financial Summary from Discontinued Operations

In the first quarter of 2016, the Company completed the sale of its hemostasis products. The net loss for the first quarter of 2016 from discontinued operations attributable to The Medicines Company was $2.1 million, or $0.03 per share, compared to net income from discontinued operations attributable to The Medicines Company for the first quarter of 2015 of $0.7 million, or $0.01 per share.

(1) Adjusted net loss and adjusted loss per share from continuing operations attributable to The Medicines Company are non-GAAP financial performance measures with no standardized definitions under U.S. GAAP. For further information and a detailed reconciliation, refer to the Non-GAAP Financial Performance Measures and Reconciliations of GAAP to Adjusted Net Loss and Adjusted Loss Per Share sections of this release for explanations of the amounts excluded and included to arrive at adjusted net loss and adjusted loss per share amounts.

As of March 31, 2016, the Company had $430 million in cash and investments compared to $373 million at the end of 2015.