On May 3, 2017 RedHill Biopharma Ltd. (NASDAQ:RDHL) (Tel-Aviv Stock Exchange:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company primarily focused on the development and commercialization of late clinical-stage, proprietary, orally-administered, small molecule drugs for gastrointestinal and inflammatory diseases and cancer, reported its financial results for the quarter ended March 31, 2017.

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The Company will host a conference call on Wednesday, May 3, 2017, at 9:00 am EDT to review the financial results and business highlights. Dial-in details are included below.

Financial highlights for the quarter ended March 31, 20174

Research and Development Expenses for the first quarter of 2017 were $8.1 million, up 74% compared to the first quarter of 2016 and up 9% compared to the fourth quarter of 2016. The increase was mainly due to the ongoing Phase III and Phase II studies with BEKINDA (RHB-102)5 for gastroenteritis and diarrhea-predominant irritable bowel syndrome (IBS-D), respectively, the ongoing Phase III study with RHB-104 for Crohn’s disease, ongoing studies with YELIVA (ABC294640)6 for multiple indications and preparations for the upcoming confirmatory Phase III study with RHB-105 for H. pylori infection.

Selling, Marketing and Business Development Expenses for the first quarter of 2017 were $0.6 million, up 94% compared to the first quarter of 2016. The increase was mainly due to activities related to the Company’s U.S. commercial operations.

General and Administrative Expenses for the first quarter of 2017 were $1.3 million, up 44% compared to the first quarter of 2016 and up 12% compared to the fourth quarter of 2016. The increase was mainly due to expanded operations.

Operating Loss for the first quarter of 2017 was $10.1 million, up 71% compared to the first quarter of 2016 and up 12% compared to the fourth quarter of 2016. The increase was mainly due to an increase in Research and Development Expenses, as detailed above.

Financial Income, net for the first quarter of 2017 was $1.5 million, compared to $379 thousand in the first quarter of 2016. The increase was mainly due to a fair value gain on derivative financial instruments related to investors’ warrants from the December 2016 financing.

Net Cash Used in Operating Activities for the first quarter of 2017 was $10.3 million, up 107% compared to the first quarter of 2016 and up 1% compared to the fourth quarter of 2016. The increase was mainly due to the increase in Operating Loss, as detailed above.

Net Cash Used in Investment Activities for the first quarter of 2017 was $18.6 million, compared to $4.6 million in the first quarter of 2016. The increase was mainly due to investments of the cash in bank deposits and purchase of marketable securities.

Net Cash Provided by Financing Activities for the first quarter of 2017 was $4.5 million compared to an immaterial amount for the first quarter of 2016. The increase was mainly due to proceeds from the exercise of warrants and options into ordinary shares.

Cash Balance as of March 31, 2017 was $61 million, a decrease of $5 million, compared to $66 million as of December 31, 2016. The decrease was a result of cash used in operating activities and investment activities, offset by cash provided by financing activities, as described above.

Micha Ben Chorin, RedHill’s CFO, said: "We are pleased with the achievements in the first quarter of 2017, which included securing rights for two commercial GI products in the U.S. as part of RedHill’s strategic plan of becoming a revenue-generating, gastrointestinal-focused, specialty pharmaceutical company in the U.S. and setting the stage for our late clinical-stage pipeline drugs, if approved. Our cash position of $61 million at the end of the first quarter should allow us to continue to execute our strategic plans for 2017 and diligently advance our late-stage clinical programs. We look forward to important events expected in the coming months, including top-line results from the Phase III GUARD study with BEKINDA for gastroenteritis, initiation of the confirmatory Phase III study with RHB-105 for H. pylori infection, a second independent DSMB meeting for the ongoing Phase III MAP US study with RHB-104 for Crohn’s disease and the initiation of promotional activities in the U.S. with Donnatal and EnteraGam."

Conference Call and Webcast Information:

The Company will host a conference call on Wednesday, May 3, 2017, at 9:00 am EDT to review the financial results and business highlights.

To participate in the conference call, please dial the following numbers 15 minutes prior to the start of the call: United States: +1-877-280-2342; International: +1-212-444-0896; and Israel: +972-3-763-0147. The access code for the call is 1922788.

The conference call will be broadcasted live and available for replay on the Company’s website, View Source, for 30 days. Please access the Company’s website at least 15 minutes ahead of the conference to register, download, and install any necessary audio software.

Recent operational highlights:

On January 3, 2017, RedHill announced the signing of an exclusive co-promotion agreement with a subsidiary7 of Concordia International Corp. (NASDAQ:CXRX) (TSX:CXR) ("Concordia"), granting RedHill certain U.S. promotion rights for Donnatal8, a prescription oral drug used with other drugs for the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis (inflammation of the small bowel). Under the terms of the agreement, RedHill and Concordia will share the revenues generated from the promotion of Donnatal by RedHill, based on an agreed upon split.

On January 5, 2017, RedHill announced the signing of a new collaboration agreement with the Department of Molecular Biology and Genetics of Denmark-based Aarhus University for the evaluation of RedHill’s Phase II-stage oncology drug candidate, MESUPRON (upamostat). The new research collaboration follows previous non-clinical studies conducted with Denmark’s Aarhus University and is designed to identify additional high affinity molecular targets of MESUPRON. A Phase I/II study with MESUPRON in pancreatic cancer is planned to be initiated in the second half of 2017.

On January 10, 2017, RedHill announced first dosing in a three-way crossover pharmacokinetic (PK) study with RHB-105 in 18 subjects (healthy volunteers), intended to evaluate the bioavailability of RHB-105 actives versus the comparator in the planned confirmatory Phase III study (dual therapy of amoxicillin and omeprazole) and a food-effect study with RHB-105. The confirmatory Phase III study with RHB-105 for H. pylori infection is planned to be initiated in the second quarter of 2017. Subject to a successful outcome, the confirmatory Phase III study and the supportive PK program are expected to complete the package required for a U.S. NDA for RHB-105.

On January 11, 2017, RedHill announced that RHB-104 had been granted Qualified Infectious Disease Product (QIDP) designation by the FDA for the treatment of nontuberculous mycobacteria (NTM) infections. The QIDP designation was granted under the FDA’s Generating Antibiotic Incentives Now (GAIN) Act, which is intended to encourage development of new antibiotic drugs for the treatment of serious or life-threatening infections. Under the FDA’s GAIN Act, QIDP designation allows for Fast-Track status and Priority Review, potentially leading to a shorter NDA review time by the FDA, and, if approved, an additional five years of U.S. market exclusivity on top of the standard exclusivity period. RedHill plans to consult with the FDA regarding the RHB-104 development program for NTM infections.

On February 21, 2017, RedHill announced that the last patient enrolled in the randomized, double-blind, placebo-controlled Phase III clinical study with BEKINDA 24 mg in the U.S. for the treatment of acute gastroenteritis and gastritis (the GUARD study) had completed the treatment course and observation period for the primary endpoint evaluation. The GUARD study treated 321 adults and children over the age of 12 in 29 U.S. clinical sites. Top-line results are expected in the second quarter of 2017. Furthermore, on April 18, 2017, RedHill announced that it had received notices of allowance from the United States Patent and Trademark Office (USPTO) for two new patents covering BEKINDA. Once granted, the patents are expected to be valid until at least 2034.

On March 21, 2017, RedHill announced dosing of the first patient in the open-label extension study to the Phase III study with RHB-104 for the treatment of Crohn’s disease (the MAP US study). The open-label extension study (the MAP US2 study) is intended to assess the safety and efficacy of RHB-104 in patients who have completed 26 weeks of treatment in the ongoing MAP US study and remain with active Crohn’s disease (CDAI > 150); these patients have the opportunity to receive treatment with RHB-104 for a 52-week period in the open-label extension study.

On April 4, 2017, RedHill announced that the FDA had granted YELIVA (ABC294640) Orphan Drug designation for the treatment of cholangiocarcinoma. Orphan Drug designation allows RedHill to benefit from a seven-year marketing exclusivity period for the indication, if approved for marketing, as well as other development incentives to develop YELIVA for cholangiocarcinoma. A Phase IIa clinical study with YELIVA in patients with advanced, unresectable, intrahepatic and extrahepatic cholangiocarcinoma is planned to be initiated in the third quarter of 2017.

On April 5, 2017, RedHill announced the signing of an exclusive license agreement with Entera Health Inc. ("Entera Health"), granting RedHill the exclusive U.S. rights to EnteraGam9, a commercially-available medical food intended for the dietary management of chronic diarrhea and loose stools which must be administered under medical supervision. Under the terms of the agreement, RedHill will pay Entera Health royalties based on net sales generated from the sale of EnteraGam by RedHill.

On April 13, 2017, RedHill, together with IntelGenx Corp. (TSX-V:IGX) (OTCQX:IGXT) ("IntelGenx"), announced that the Ministry of Health of Luxembourg had granted national marketing authorization for RIZAPORT (5 mg and 10 mg). The national marketing authorization was granted in Luxembourg on the basis of the European Decentralized Procedure (DCP), in which Luxembourg served as the Concerned Member State. The approval in Luxembourg marks the completion of the current marketing approval process for RIZAPORT under the European DCP.

On April, 24, 2017, RedHill announced enrollment of the last patient in the Phase II study with BEKINDA 12 mg for the treatment of IBS-D. The randomized, double-blind, placebo-controlled Phase II study is evaluating the safety and efficacy of BEKINDA 12 mg in 127 U.S. patients with IBS-D. Top-line results are expected in the third quarter of 2017.
About Donnatal:
Donnatal (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide), a prescription drug, is classified as possibly effective as an adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis. Donnatal slows the natural movements of the gut by relaxing the muscles in the stomach and intestines and acts on the brain to produce a calming effect. Donnatal comes in two formulations: immediate release Donnatal Tablets and immediate release Donnatal Elixir, a fast-acting liquid.

Important Safety Information about Donnatal:
Donnatal is contraindicated in patients who have glaucoma, obstructive uropathy, obstructive disease of the gastrointestinal tract, paralytic ileus, unstable cardiovascular status, severe ulcerative colitis, myasthenia gravis, hiatal hernia with reflux esophagitis, or known hypersensitivity to any of the ingredients. Patients who are pregnant or breast-feeding or who have autonomic neuropathy, hepatic or renal disease, hyperthyroidism, coronary heart disease, congestive heart failure, cardiac arrhythmias, tachycardia or hypertension should notify their doctor before taking Donnatal. Side effects may include: dryness of the mouth, urinary retention, blurred vision, dilation of pupils, rapid heartbeat, loss of sense of taste, headache, nervousness, drowsiness, weakness, dizziness, insomnia, nausea, vomiting and allergic reactions which may be severe.

Further information, including prescribing information, can be found on www.donnatal.com.

Please see the following website for complete important safety information about Donnatal:
View Source

About EnteraGam:
EnteraGam (a serum-derived bovine immunoglobulin/protein isolate, SBI) is a medical food product intended for the dietary management of chronic diarrhea and loose stools. EnteraGam must be administered under medical supervision. EnteraGam binds microbial components10, such as toxic substances released by bacteria, that upset the intestinal environment. This helps prevent them from penetrating the lining of the intestine, which may contribute to chronic diarrhea and loose stools in people who have specific intestinal disorders11 12.

Safety Information about EnteraGam:
EnteraGam contains beef protein; therefore, patients who have an allergy to beef or any other component of EnteraGam should not take this product. EnteraGam has not been studied in pregnant women, in women during labor and delivery, or in nursing mothers. The choice to administer EnteraGam during pregnancy, labor and delivery, or to nursing mothers is at the clinical discretion of the prescribing physician.

EnteraGam does not contain any milk-derived ingredients such as lactose, casein, or whey. EnteraGam is gluten-free, dye-free and soy-free.

Please see full Product Information.

To report suspected adverse reactions, contact Entera Health, Inc. at 1-855-4ENTERA (1-855-436-8372), or the FDA at 1-800- FDA-1088 (1-800-332-1088) or www.fda.gov/medwatch.

On May 3, 2017 PDL BioPharma, Inc. (PDL or the Company) (NASDAQ: PDLI) reported financial results for the first quarter ended March 31, 2017 (Press release, PDL BioPharma, MAY 3, 2017, View Source [SID1234518812]).

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Total revenues of $45.4 million for the three months ended March 31, 2017.
GAAP diluted EPS of $0.04 for the three months ended March 31, 2017.

GAAP net income attributable to PDL’s shareholders of $7.2 million for the three months ended March 31, 2017.
Non-GAAP net income attributable to PDL’s shareholders of $13.2 million for the three months ended March 31, 2017. A full reconciliation of all components of the GAAP to non-GAAP financial results can be found in Table 4 at the end of the release.
"We have had a number of positive events related to our income generating assets this year which have resulted in significant cash infusions, including the repayment of the ARIAD investment and the successful settlement of litigation related to Keytruda," said John P. McLaughlin, president and chief executive officer of PDL. "With a cash balance of over $400 million, and a nimble business development process, we are poised to acquire additional specialty pharma drug products in 2017."

Recent Developments
In April 2017, the Company entered into a settlement agreement with Merck to resolve the patent infringement lawsuit between the parties pending in the U.S. District Court for the District of New Jersey related to Merck’s Keytruda humanized antibody product. Under the terms of the agreement, Merck will pay the Company a one-time, lump-sum payment of $19.5 million, and the Company will grant Merck a fully paid-up, royalty-free, non-exclusive license to certain of the Company’s Queen et al. patent rights for use in connection with Keytruda as well as a covenant not to sue Merck for any royalties regarding Keytruda. In addition, the parties agreed to dismiss all claims in the relevant legal proceedings. The payment of $19.5 million is expected to be recognized as license revenue for the second quarter ending June 30, 2017.

On March 1, 2017, the Company announced that its board of directors has authorized the repurchase of up to $30.0 million of the Company’s common stock through March 2018. As of March 31, 2017, the Company has repurchased a total of 3.9 million shares of its common stock in open market transactions under the share repurchase program for an aggregate purchase price of $8.5 million, or an average cost of $2.16 per share. From April 1, 2017 to April 28, 2017, the Company repurchased 3.7 million shares of its common stock under the share repurchase program at a weighted average price of $2.16 per share for a total of $7.9 million. Since the inception of the share repurchase program in March 2017, the Company has repurchased 7.6 million shares of its common stock for a total of $16.4 million.

In April 2017, PDL received a royalty payment from Valeant Pharmaceuticals International, Inc. in the amount of $8.5 million for royalties earned on sales of Glumetza for the month of March. The monthly royalty payment was a result of lower reported gross to net deductions. This payment will be recorded in the second quarter of 2017.
Revenue Highlights

Total revenues of $45.4 million for the three months ended March 31, 2017 included:
Royalties from PDL’s licensees to the Queen et al. patents of $14.2 million, which consisted of royalties earned on sales of Tysabri under a license agreement;

Net royalty payments from acquired royalty rights and a change in fair value of the royalty rights assets of $13.1 million, which consisted of the change in estimated fair value of our royalty right assets, primarily related to the Depomed, Inc., University of Michigan, ARIAD and AcelRx Pharmaceuticals, Inc.;

Interest revenue from notes receivable financings to kaléo and CareView Communications of $5.5 million; and
Product revenues of $12.6 million from sales of Tekturna and Tekturna HCT in the United States of $9.7 million and Rasilez and Rasilez HCT in the rest of the world (collectively, the Noden Products) of $2.9 million.
Total revenues decreased by 56 percent for the three months ended March 31, 2017, when compared to the same period in 2016.

The decrease in royalties from PDL’s licensees to the Queen et al. patents is due to the period ended March 31, 2016 being the last quarter in which PDL received royalties from Genentech, Inc.
The increase in royalty rights – change in fair value was primarily due to the prior year decrease in fair value of the Depomed, Inc. royalty asset.

PDL received $13.5 million in net cash royalties from its royalty rights in the first quarter of 2017, compared to $17.2 million for the same period of 2016.

The decrease in interest revenues was primarily due to the early repayment of the Paradigm Spine, LLC note receivable investment and the non-accrual status of the LENSAR, Inc. note receivable investment.
Product revenues were derived from sales of the Noden Products, which PDL did not begin to recognize until the third quarter of 2016.

Operating Expense Highlights
Operating expenses were $26.9 million for the three months ended March 31, 2017, compared to $9.8 million for the same period of 2016. The increase in operating expenses for the three months ended March 31, 2017, as compared to the same period in 2016, was primarily a result of the $15.5 million in expenses related to the Noden operations, including $7.5 million of non-cash intangible asset amortization and a change in fair value of contingent consideration.

Other Financial Highlights
PDL had cash, cash equivalents, and short-term investments of $409.3 million at March 31, 2017, compared to $242.1 million at December 31, 2016. The current cash balance includes a $111.3 million payment from ARIAD as a result of PDL’s exercise of its put option under the ARIAD royalty agreement.
Net cash provided by operating activities in the three months ended March 31, 2017 was $45.8 million, compared with $92.5 million in the same period in 2016.

On May 3, 2017 BioLineRx Ltd. (NASDAQ/TASE: BLRX, BLRX.TA), a clinical-stage biopharmaceutical company focused on oncology and immunology, reported that it has met with the U.S. Food and Drug Administration (FDA) and has gained clarity on the development program and the design of a Phase 3 pivotal study for BL-8040, its robust platform for multiple oncology indications, as a novel stem cell mobilization treatment for autologous bone-marrow transplantation (Press release, BioLineRx, MAY 3, 2017, View Source [SID1234518796]). Following its successful meeting with the FDA, the Company anticipates the initiation of a registrational Phase 3 trial during the second half of 2017. The study will investigate BL-8040 in combination with granulocyte colony-stimulating factor (G-CSF) for mobilization of stem cells from the bone marrow to the peripheral blood, followed by collection and subsequent autologous transplantation in patients with multiple myeloma.

“BL-8040 given as a single injection in a Phase 1/2 study in multiple myeloma patients was previously shown to be highly effective in mobilizing stem cells in combination with G-CSF,” said Philip Serlin, Chief Executive Officer of BioLineRx. “Following our recent successful meeting with the FDA, we believe we have a clear development path forward towards registration of BL-8040 as a novel stem cell mobilization treatment for autologous transplantation. We look forward to the initiation of the Phase 3 pivotal study later this year, which, if successful, could pave the way for future commercialization of BL-8040.”

“We see clear potential for BL-8040 to benefit multiple myeloma patients undergoing autologous bone marrow transplantation. In parallel, we are continuing to expand the potential of our unique BL-8040 oncology platform, with multiple clinical studies for additional indications that are up and running or expected to commence during 2017. These include several combination studies with immune checkpoint inhibitors, a Phase 2b study in consolidation AML and a Phase 2 study in allogeneic stem-cell mobilization as a monotherapy with topline results expected by the end of 2017,” added Mr. Serlin.

About BL-8040

BL-8040 is a short peptide for the treatment of acute myeloid leukemia, solid tumors, and stem cell mobilization. It functions as a high-affinity antagonist for CXCR4, a chemokine receptor that is directly involved in tumor progression, angiogenesis, metastasis and cell survival. CXCR4 is over-expressed in more than 70% of human cancers and its expression often correlates with disease severity. In a number of clinical and pre-clinical studies, BL-8040 has shown robust mobilization of cancer cells from the bone marrow, thereby sensitizing these cells to chemo- and bio-based anti-cancer therapy, as well as a direct anti-cancer effect by inducing apoptosis. In addition, BL-8040 has also demonstrated robust stem-cell mobilization, including the mobilization of colony-forming cells, and T, B and NK cells. BL-8040 was licensed by BioLineRx from Biokine Therapeutics and was previously developed under the name BKT-140.

About Stem Cell Mobilization

High-dose chemotherapy followed by stem cell transplantation has become an established treatment modality for a variety of hematologic malignancies, including multiple myeloma, as well as various forms of lymphoma and leukemia. Stem cells are mobilized from the bone marrow using granulocyte colony-stimulating factor (G-CSF), harvested from the peripheral blood by apheresis, and infused to the patient after chemotherapy. This type of treatment often replaces the use of traditional bone marrow transplantation, because the stem cells are easier to collect and the treatment allows for a quicker recovery time and fewer complications.

On May 3, 2017 ArQule, Inc. (Nasdaq: ARQL) reported its financial results for the first quarter of 2017 (Press release, ArQule, MAY 3, 2017, View Source [SID1234518795]).

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For the quarter ended March 31, 2017, the Company reported a net loss of $7,576,000 or $0.11 per share, compared with net loss of $4,981,000 or $0.08 per share, for the quarter ended March 31, 2016.

At March 31, 2017, the Company had a total of approximately $37,540,000 in cash and marketable securities.

Key Highlights

ARQ 087, our FGFR inhibitor, will be featured in a poster discussion session highlighting the phase 1/2 trial in second-line intrahepatic cholangiocarcinoma (iCCA) at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) on June 3, 2017. A registrational phase 3 trial in this patient population is planned to commence in the third quarter of 2017.
ARQ 092, our lead AKT inhibitor, phase 1/2 company-sponsored trial in Overgrowth Diseases with genetic alterations of the PI3K/AKT1 pathway is open and the first patient has been identified. The phase 1/2 trial will enroll patients ages six and older with a spectrum of Overgrowth Diseases driven by genetic alterations of the PI3K/AKT1 pathway such as PROS (PIK3CA-Related Overgrowth Spectrum) and Proteus syndrome.
ARQ 531, our orally bioavailable, potent and reversible BTK inhibitor, received Investigational New Drug (IND) clearance from the FDA. A phase 1 trial is planned to commence by the third quarter of 2017 in patients with B-cell malignancies who are refractory to other therapeutic options.
ARQ 531 was issued a U.S. Patent by the U.S. Patent and Trademark Office covering composition of matter. ArQule will be entitled to patent protection through December 2035 in the U.S. for the allowed claims.
"We achieved two important milestones already this year, the initiation of our company-sponsored trial in Overgrowth Diseases with ARQ 092 and the clearance of the IND for ARQ 531 in B-cell malignancies," said Paolo Pucci, Chief Executive Officer of ArQule. "These milestones enable ArQule to execute the next phase of its business plan. In addition, we are looking forward to presenting data from our iCCA trial with ARQ 087 at ASCO (Free ASCO Whitepaper) in June and initiating the registrational trial in this indication."

"The clearance of the IND for ARQ 531 keeps us on track to begin the phase 1 trial by the third quarter," said Dr. Brian Schwartz, M.D., Head of Research and Development and Chief Medical Officer at ArQule. "The therapeutic need for a reversible, non-covalent BTK inhibitor that works in wild type and C481S-mutant BTK is significant and we have the potential to be best-in-class in this therapeutic area."

Revenues and Expenses

Revenues for the quarter ended March 31, 2017, were zero compared with revenues of $1,227,000 for the quarter ended March 31, 2016. Research and development revenue in 2016 includes revenue from the Daiichi Sankyo tivantinib development agreement and the Kyowa Hakko Kirin exclusive license agreement. No further revenue is anticipated from these agreements.

Research and development expenses in the first quarter of 2017 were $5,194,000, compared with $4,198,000 for the first quarter 2016.

Research and development expense increased $1.0 million in the first quarter of 2017 compared to the first quarter of 2016 primarily due to higher outsourced pre-clinical, clinical and product development costs.

General and administrative expenses in the first quarter of 2017 were $2,074,000, compared with $2,044,000 for the first quarter of 2016.

On May 3, 2017 CTI BioPharma Corp. (NASDAQ and MTA:CTIC) reported financial results for the first quarter ended March 31, 2017 (Press release, CTI BioPharma, MAY 3, 2017, View Source [SID1234518805]).

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Recent Highlights

In April 2017, CTI BioPharma announced the expansion of the existing license and development collaboration agreement with Servier for PIXUVRI (pixantrone). Under the expanded agreement, Servier will have rights to PIXUVRI in all markets except in the U.S. where CTI BioPharma will retain the commercialization rights. Servier will pay CTI BioPharma €12 million and is obligated to purchase a certain amount of PIXUVRI drug product for an additional €0.9 million. CTI BioPharma is eligible to receive €76 million in additional sales and regulatory milestone payments as well as royalties on net product sales.
In March 2017, Adam Craig, M.D., Ph.D., became President and CEO and as a Director of CTI BioPharma. Dr. Craig has over 20 years of experience in hematology, oncology and drug development in both the US and Europe. Dr. Craig has worked as an independent consultant providing strategic and operational advice and support to CTI BioPharma and other hematology/oncology biotechnology companies since 2016. Prior to consulting, Dr. Craig was Chief Medical Officer (CMO) and Executive Vice President of Development of Sunesis Pharmaceuticals from 2012 to 2016. From 2008 to 2012, Dr. Craig was CMO and Senior Vice President of Chemgenex Pharmaceuticals Ltd, a publicly-traded biotechnology company which was acquired by Cephalon/Teva Pharmaceuticals in 2011. Dr. Craig is a Member of the Royal College of Physicians (UK) and undertook Post-Graduate Training in Pediatrics and Pediatric Oncology.
“We have made excellent progress since the start of the year on the regulatory/clinical front and operationally. We plan to submit the Marketing Authorization Application for pacritinib to treat patients with myelofibrosis to the European Medicines Agency mid-year,” said Adam R. Craig, M.D., Ph.D., President and Chief Executive Officer of CTI BioPharma. “We are currently preparing to initiate this quarter the PAC203 dose exploration study that was requested by the FDA and would expect to have interim data by the end of 2017. We are also pleased to have recently expanded our partnership with Servier for commercialization of PIXUVRI in the E.U.”

First Quarter Financial Results

Total revenues for the first quarter ended March 31, 2017 were $0.8 million compared to $36.5 million for the same period in 2016. The decrease in total revenues for the first quarter of 2017 is primarily due to recognition of $32 million in milestone revenue related to pacritinib in the first quarter of 2016. Additionally, net product revenues of PIXUVRI for the first quarter of 2017 decreased to $0.7 million compared to $1.2 million for the same period in 2016.

GAAP operating loss for the first quarter of 2017, was $19.3 million compared to GAAP operating income of $4.1 million for the same period in 2016. Non-GAAP operating loss, which excludes non-cash share-based compensation expense, for the first quarter of 2017, was $17.5 million compared to the non-GAAP operating income of $8.0 million for the same period in 2016. The Company’s operating loss for the first quarter of 2017, as compared to an operating income for the same period in 2016, is primarily due to recognition of $32 million in milestone revenue related to pacritinib as mentioned above. Research and development expenses decreased to $9.3 million for the first quarter of 2017 compared to $20.8 million for the same period in 2016. The decrease was primarily attributable to reductions in costs related to pacritinib clinical development due to the timing of completion of the Phase 3 clinical trials. Additionally, the decrease was attributable to a decrease in personnel costs related to a reduction in average headcount between periods and reductions in costs for PIXUVRI clinical development and pacritinib manufacturing. Non-cash share-based compensation expense for the first quarter of 2017, was $1.8 million compared to $3.8 million for the same period in 2016. For information on CTI BioPharma’s use of this non-GAAP measure and a reconciliation of such measure to GAAP operating loss, see the section below entitled “Non-GAAP Financial Measures.”

Net loss for the first quarter of 2017 was $19.8 million, or ($0.71) per share, compared to a net income of $3.3 million, or $0.12 per share, for the same period in 2016.

As of March 31, 2017, cash and cash equivalents totaled $33.3 million, compared to $44.0 million as of December 31, 2016.