On August 1, 2016 Varian reported that Cancer patients in Ethiopia will gain access to modern radiotherapy treatments for the first time with the announcement that Varian Medical Systems (NYSE: VAR) has been selected to supply advanced medical linear accelerators to six hospitals in the country (Press release, InfiMed, AUG 1, 2016, View Source [SID:1234514162]). The Clinac iX treatment systems will be the first such devices offering treatments to cancer patients in a country of more than 90 million people.

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The first phase of a cancer plan being rolled out by the Ethiopian government will see Varian supplying the treatment systems to Ethiopian university hospitals in the cities of Harar, Mek’ele, Jima, Hawasa, Gondar, and the capital Addis Ababa. The first of these projects is intended to start offering clinical treatments by the end of this year. The order for the six treatment machines was received by Varian in June.

"This is a well-considered plan by the Ethiopian government and Varian is delighted to be able to contribute by extending advanced care to an area of the world that is severely under-equipped," says Tom Duffy, Varian’s senior manager of Channel Management & Nile Delta Sales.

The Clinac iX systems will be capable of delivering fast and precise RapidArc treatments with image-guidance tools on each system. Each site will have an Eclipse system for treatment planning and 3 ARIA oncology information management workstations, and each hospital will have two radiotherapy bunkers to enable future expansion. Varian and Elsmed, one of its local representatives, are also working with the Ethiopian government to establish clinical education and training resources in the country.

"More than 70% of cancer patients require radiotherapy as part of their treatment and precise radiotherapy delivery requires image-guided treatments on modern machines, which is why a modern linear accelerator will be so important for our center," added Dr. Mathewos Assefa Woldegeorgis, of Black Lion University Hospital in Addis Ababa. "This machine will also help in the training of health professionals such as radiation oncologists, radiotherapists and medical physicists."

Udi Baruch, managing director of Israel-based Elsmed, said, "We will support this ambitious project through maintenance of the systems, intensive training programs for operators and also an ongoing knowledge sharing program between leading oncology institutes in Israel and the centers in Ethiopia in order to ensure the highest level of treatment in the most efficient and latest techniques."

On August 1, 2016 DURECT Corporation (Nasdaq: DRRX) reported financial results for the second quarter of 2016 (Filing, Q2, DURECT, 2016, AUG 1, 2016, View Source [SID:1234514170]). Total revenues were $3.2 million and net loss was $9.0 million for the three months ended June 30, 2016 as compared to total revenues of $4.4 million and net loss of $5.5 million for the three months ended June 30, 2015.

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At June 30, 2016, we had cash and investments of $33.9 million, compared to cash and investments of $29.3 million at December 31, 2015. At June 30, 2016, we had $19.8 million in short and long term debt.

"The REMOXY ER PDUFA date of September 25, 2016 is now less than two months away and, if approved, this would be the first pharmaceutical product in our pipeline authorized for commercialization," stated James E. Brown, D.V.M., President and CEO of DURECT. "Our first two DUR-928 patient studies are progressing in Australia and we are moving forward with preparing two INDs which are required to enable future clinical trials in the U.S. For POSIMIR, we are in the process of amending the PERSIST Phase 3 trial in response to FDA advice while we continue enrollment in the trial."

Update of Selected Programs:

Epigenomic Regulator Program. DUR-928, our Epigenomic Regulator Program’s lead product candidate, is an endogenous, small molecule, new chemical entity (NCE), which may have broad applicability in several metabolic diseases such as nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH), and in acute organ injuries such as acute kidney injury.

Our first patient trial utilizing DUR-928 is an open-label single-ascending-dose safety and pharmacokinetic (PK) Phase 1b trial of DUR-928 in NASH patients and matched control subjects. This study is being conducted in successive cohorts evaluating single-dose levels of oral DUR-928. After a PK/safety review at each dose, the study can proceed to a higher dose. The study is being conducted in Australia, and we anticipate that we will start obtaining results from this trial in the third quarter of 2016. This study is designed to enable and inform a subsequent multi-dose study in NASH and/or other patients with other liver function impairment. We are also preparing to request in the near future a pre-IND meeting with the FDA as precursor to submitting an IND later this year which is required to enable future clinical trials in liver diseases in the U.S.

Our second patient study with DUR-928, also being conducted in Australia, is currently screening patients with dosing expected shortly. This Phase 1b trial of DUR-928 is an open-label single-ascending-dose safety and pharmacokinetic study in patients with impaired kidney function and matched control subjects. This study will be conducted in successive cohorts evaluating single-dose levels of DUR-928 administered by injection. After a PK/safety review at each dose, the study can proceed to a higher dose. We anticipate that this study will be completed in 2016, and that this study will enable and inform subsequent trials for patients with either acute kidney injury or other kidney function impairment. Our request for a pre-IND meeting has been granted by the FDA; we anticipate that feedback from that meeting will enable the filing of an IND later in the year which is required to enable future clinical trials in kidney diseases in the U.S.

REMOXY ER (oxycodone) Extended-Release Capsules CII. Based on our ORADUR technology, REMOXY is a unique long-acting formulation of oxycodone designed to discourage common methods of tampering associated with opioid misuse and abuse. The extended release oxycodone market is greater than $2 billion in the U.S. alone, and we are eligible for a potential royalty on REMOXY between 6.0% to 11.5% of net sales depending on sales volumes.

Pain Therapeutics (our licensee) resubmitted the NDA for REMOXY in March 2016. In April 2016, Pain Therapeutics announced that the FDA had determined that the NDA was sufficiently complete to permit a substantive review and that September 25, 2016 is the target action date under the Prescription Drug User Fee Act (PDUFA). In May 2016, positive data from a REMOXY human abuse potential study was presented at the 35th Annual Scientific Meeting of the American Pain Society. Also in May 2016, the FDA informed Pain Therapeutics that there was a tentative date of August 5, 2016 for an Advisory Committee meeting to review the REMOXY NDA. In July 2016, Pain Therapeutics announced that the FDA had determined that the Advisory Committee meeting is unnecessary and would not be held on August 5. Pain Therapeutics also stated that the FDA advised them that the regulatory review remains active and is on-going, and the PDUFA date of September 25, 2016 remains unchanged.

POSIMIR (SABER-Bupivacaine) Post-Operative Pain Relief Depot. POSIMIR is our investigational post-operative pain relief depot that utilizes our patented SABER technology and is intended to deliver bupivacaine to provide up to 3 days of pain relief after surgery. We are in discussions with potential partners regarding licensing development and commercialization rights to POSIMIR, for which we hold worldwide rights. We are also continuing to evaluate the requirements for commercializing POSIMIR on our own in the U.S., in the event that we determine that to be the preferred route of commercialization.

In November 2015, we began enrolling patients for PERSIST, a new POSIMIR Phase 3 clinical trial consisting of patients undergoing laparoscopic cholecystectomy (gallbladder removal) surgery. We began recruiting patients for this trial comparing POSIMIR to placebo. Based on recommendations from the FDA received subsequent to the start of the trial, in April 2016 we decided to amend the PERSIST trial. Starting in August 2016, we are implementing Part 2 of the PERSIST trial to evaluate POSIMIR against standard bupivacaine HCl rather than placebo as we have been doing in Part 1. Additionally, we are switching in Part 2 the primary efficacy endpoint (pain reduction on movement) from 0-72 hours after surgery to 0-48 hours after surgery. Assessing pain reduction on movement from 0-72 hours is now the key secondary efficacy endpoint and other efficacy endpoints, including 72-hour opioid use, remain the same. We expect to enroll approximately 264 patients in Part 2 of PERSIST, and we expect this part of the trial to take approximately one year to enroll. We believe that a positive outcome from this new trial design would result in a stronger NDA resubmission and potential commercial advantages. In a previous clinical trial of 50 patients in the same surgical model (laparoscopic cholecystectomy), POSIMIR was compared with the active control bupivacaine HCl, against which POSIMIR demonstrated in a post hoc analysis an approximately 25% reduction in pain intensity on movement for the first 3 days after surgery (p=0.024) and for the first 2 days after surgery (p=0.0198), using the same statistical methodology specified for the current trial.

ORADUR-ADHD Program. In 2013, we selected a formulation for the lead program in our ORADUR-ADHD (Attention Deficit Hyperactivity Disorder) program, ORADUR-Methylphenidate. This formulation was chosen based on its potential for rapid onset of action, long duration with once-a-day dosing and target pharmacokinetic profile as demonstrated in a Phase 1 trial. In addition, this product candidate utilizes a small capsule size relative to the leading existing long acting products on the market and incorporates our ORADUR anti-tampering technology. Orient Pharma, our licensee in defined Asian and South Pacific countries, has initiated a Phase 3 study in Taiwan and anticipates completing it in 2016. We retain rights to all other markets in the world, notably including the U.S., Europe and Japan, and are engaged in licensing discussions with other companies.

Business Development Activities. We have multiple programs that may potentially be licensed over the next 12-18 months. These include POSIMIR, DUR-928, ORADUR-ADHD (territories outside certain Asian and South Pacific markets), as well as various other programs which we have not described publicly in detail.

Debt Refinancing. In July 2016, we refinanced our existing $20 million term loan with Oxford Finance into a new term loan that results in an extended maturity (to four years) and an extended interest only period (to 18 months).

Spring Bank Pharmaceuticals has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Spring Bank Pharmaceuticals, 2018, AUG 1, 2016, View Source [SID1234527560]).

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On August 1, 2016 MorphoSys AG (FSE: MOR; Prime Standard Segment; TecDAX, OTC: MPSYY) reported its half-year report, outlining the key events of the first six months ending June 30, 2016 (Press release, MorphoSys, JUL 31, 2016, View Source [SID:1234514151]).

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Financial results for the first half of 2016

Group revenue in the first half of 2016 totaled EUR 24.3 million and EBIT amounted to
EUR -19.2 million. The previous year’s figures (revenue H1/2015: EUR 82.6 million; EBIT H1/2015: EUR 46.1 million) each included extraordinary effects in the amount of approximately EUR 59 million.
The Group’s liquidity position on June 30, 2016 equaled EUR 279.7 million (December 31, 2015: EUR 298.4 million).
The Company confirms its 2016 guidance for revenue in the range of EUR 47 million to EUR 52 million and EBIT between EUR -58 million and EUR -68 million.
Operating highlights of the second quarter of 2016

In early June 2016, MorphoSys presented updated clinical data from an ongoing phase 1/2a dose escalation study of MOR202 in multiple myeloma (MM) at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. MOR202 in combination with immunomodulatory drugs showed a good response in heavily pretreated patients. Two complete responses were shown at a dose of 8 mg/kg in combination with pomalidomide. In the meantime, response rates further deepened under ongoing treatment. The next higher and final treatment cohort with a dose of 16 mg/kg plus pomalidomide has been started meanwhile.
MorphoSys also presented updated clinical data on the safety and efficacy of MOR208 in non-Hodgkin’s lymphoma (NHL) at the 2016 ASCO (Free ASCO Whitepaper) Annual Meeting. Patients with diffuse large B cell lymphoma (DLBCL) and indolent NHL showed long-lasting responses to the therapy up to 26 months.
In early April 2016, MorphoSys announced the initiation of a phase 2 clinical combination trial of MOR208 with the cancer drug lenalidomide (Revlimid) in patients suffering from DLBCL.
In mid-April, MorphoSys announced its partner GSK had initiated a phase 2 clinical study with GSK3196165 (formerly known as MOR103) in patients with inflammatory hand osteoarthritis.
Also in April 2016, MorphoSys announced the initiation of a phase 1 trial of MOR106, which is being co-developed with Galapagos against inflammatory diseases.
In May 2016, MorphoSys and the University of Texas MD Anderson Cancer Center announced a strategic alliance for the discovery and development of therapeutic antibodies against cancer.
On April 21, 2016, MorphoSys announced that its partner Novartis had confirmed that a phase 2b/3 study examining bimagrumab (BYM338) in sporadic Inclusion Body Myositis (sIBM) did not meet its primary endpoint. Clinical development will continue in sarcopenia and muscular atrophy after hip operations.
On April 4, 2016, MorphoSys announced it had filed a lawsuit with the United States (U.S.) District Court of Delaware against Janssen Biotech and Genmab for patent infringement. MorphoSys is seeking redress for the infringing manufacture, use and sale of Janssen’s and Genmab’s daratumumab, an antibody targeting CD38.
In early July, MorphoSys announced the receipt of a milestone payment from Novartis recorded in the second quarter of 2016. The payment was triggered by the initiation of a phase 1 clinical study of a novel HuCAL antibody for the prevention of thrombosis.
At the end of the second quarter of 2016, MorphoSys’s product pipeline comprised a total of 104 therapeutic antibodies, 27 of which are in clinical development.
In EURO million* 6-Months 2016 6-Months 2015


Group Revenues 24.3 82.6
Total Operating Expenses 43.5 40.9
Other Income/Expenses 0.1 4.4
Earnings Before Interest and Taxes – EBIT (19.2) 46.1
Consolidated Net Profit / (Loss) (18.8) 36.5
Total EPS, diluted, in EURO (0.72) 1.39

* Differences due to rounding

"The development of our most advanced proprietary programs MOR208 and MOR202 is progressing well. In the ongoing MOR202 trial, we have started the highest dosage cohorts of MOR202 alone and in combination with lenalidomide and pomalidomide, and we are very encouraged as we see response rates deepening over time," commented Dr. Simon Moroney, Chief Executive Officer of MorphoSys AG. "Meanwhile, Novartis has taken the twelfth antibody to emerge from our partnership into clinical trials, and we are looking forward to additional data from our broad development pipeline, including read-outs from Janssen’s phase 3 trials with guselkumab in psoriasis."

"With the results shown for the first half of 2016 we are on track to meet our targets for the full year," stated Jens Holstein, Chief Financial Officer of MorphoSys AG. "We are convinced that our solid financial position is perfectly used in investing in promising development candidates. We will pursue our strategy and remain focused on the expansion of our pipeline."

Financial Review of the First Six Months of 2016 (IFRS)

In comparison to the previous year, Group revenues declined to EUR 24.3 million (H1/2015: EUR 82.6 million). Revenues in the comparable period of 2016 contained a non-recurring effect in the amount of about EUR 59 million from the termination of the partnership with Celgene to co-develop and co-promote MOR202. Success-based payments amounted to 8%, or EUR 2.0 million (H1/2015: 2%, or EUR 2.0 million), of total revenue. The Proprietary Development segment recorded revenues of EUR 0.3 million (H1/2015: EUR 59.6 million). Revenues in the Partnered Discovery segment comprised EUR 23.9 million (H1/2015: EUR 23.0 million).

Total operating expenses for the first six months of 2016 amounted to EUR 43.5 million (H1/2015: EUR 40.9 million). Total research and development expenses were EUR 36.7 million (H1/2015: EUR 33.9 million). R&D expenses mainly consisted of costs for external laboratory services and personnel costs. General and administrative expenses decreased slightly to EUR 6.9 million (H1/2015: EUR 7.0 million). Earnings before interest and taxes (EBIT) amounted to EUR -19.2 million (H1/2015: EUR 46.1 million).

The Proprietary Development segment reported a segment EBIT of EUR -27.8 million (H1/2015: EUR 40.2 million), while Partnered Discovery showed a segment EBIT of EUR 15.1 million (H1/2015: EUR 12.5 million). Proprietary R&D expenses including technology development amounted to EUR 28.3 million (H1/2015: EUR 25.3 million).

On June 30, 2016, the Group’s liquidity position amounted to EUR 279.7 million compared to EUR 298.4 million on December 31, 2015. The Company’s liquidity is reflected in the balance sheet items "cash and cash equivalents", "available-for-sale financial assets", "bonds, available-for-sale" and current and non-current "financial assets classified as loans and receivables". The decline in liquidity was mainly the result of the use of cash for operations in the first six months of 2016 and the repurchase of shares for the Group’s long-term incentive programs.

Financial guidance for 2016

MorphoSys re-confirmed its guidance for 2016. MorphoSys anticipates total Group revenues in the range of EUR 47 million to EUR 52 million and expects EBIT to be in the range of EUR -58 million to EUR -68 million. Proprietary R&D expenses are expected to rise to EUR 76 million to EUR 83 million. This guidance does not include any potential in-licensing or co-development of additional development candidates.

On July 29, 2016 Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) reported financial results for the second quarter ended June 30, 2016. Loss from operations for the three months ended June 30, 2016 was $10.0 million (Press release, Sunesis, JUL 29, 2016, View Source;p=RssLanding&cat=news&id=2190010 [SID:1234514133]). As of June 30, 2016, cash, cash equivalents and marketable securities totaled $33.1 million.

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"During the second quarter, we strengthened the foundation of our oncology pipeline through the advancement of our vosaroxin program and lead proprietary BTK kinase inhibitor, SNS-062. Achievement of upcoming milestones from both these programs we believe will unlock significant value for the company," said Daniel Swisher, Chief Executive Officer of Sunesis

"We are progressing our regulatory efforts to bring vosaroxin to market in Europe as a treatment for relapsed/refractory AML, and in parallel are maintaining an active dialogue with potential European collaborators toward the goal of supporting a market launch in 2017." Mr. Swisher continued: "As for SNS-062, our differentiated, non-covalent BTK-inhibitor, we look forward to presenting results from our Phase 1A dose escalation study in healthy volunteers at the upcoming International Conference on New Concepts in B-Cell Malignancies in September. We are actively finalizing our protocol with investigator input to begin a Phase 1B/2 study in patients with B-cell malignancies around year-end."

Second Quarter 2016 and Recent Highlights

Presentation of Updated Results from MD Anderson Sponsored Trial in AML and high-risk MDS at EHA (Free EHA Whitepaper) Annual Meeting. In June 2016, results from an ongoing Phase 1B/2 University of Texas MD Anderson Cancer Center-sponsored trial of vosaroxin in combination with decitabine in older patients with previously untreated acute myeloid leukemia (AML) and high-risk myelodyplastic syndrome (MDS) were presented at the 21st Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) in Copenhagen, Denmark. At the optimized induction dose of 70 mg/m2 of vosaroxin (n=41), the combination of vosaroxin and decitabine demonstrated a compelling CR/CRp/CRi rate of 76% and a median overall survival of 16.1 months. The oral presentation, titled "Phase I/ll study of vosaroxin and decitabine in newly diagnosed older patients with acute myeloid leukemia and high-risk myelodysplastic syndrome," is available on the Sunesis website at www.sunesis.com.

Presentation of Results Evaluating the Value of Complete Remission Prior to HCT in Patients with AML at ASCO (Free ASCO Whitepaper) Annual Meeting. In June 2016, Sunesis presented results from a study conducted by the Center for International Blood and Marrow Transplant Research (CIBMTR) at the Medical College of Wisconsin demonstrating the significant value of achieving complete remission prior to allogeneic hematopoietic cell transplantation (HCT) in patients with acute myeloid leukemia (AML) at the 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper). The study was funded jointly by Sunesis and CIBMTR. The poster presentation, titled "Allogeneic transplantation for advanced myelogenous leukemia: The value of complete remission," is available on the Sunesis website at www.sunesis.com.

Strengthened Executive Management Team and Board of Directors. In June 2016, Sunesis announced the appointment of Linda Neuman, M.D., as Vice President, Clinical Development. In March 2016, Sunesis announced the appointment of Geoffrey Parker to the Sunesis Board of Directors.

Supported First-Ever AML Awareness Month. In May 2016, Sunesis announced its support for the first-ever AML Awareness Month, which was held in June with AML spokesperson and sportscaster Craig Sager. The company provided an educational grant to support the sponsor of the campaign, CancerCare.

First Subject Dosed in Phase 1A Healthy Volunteer Study Evaluating Oral Non-Covalent BTK-inhibitor SNS-062. In March 2016, the first patient was dosed in a Phase 1A, randomized, double-blind, placebo-controlled dose-ranging study to investigate the safety, pharmacokinetics and pharmacodynamics of its oral, next-generation, non-covalently binding BTK-inhibitor, SNS-062, in healthy subjects.
Financial Highlights

Cash, cash equivalents and marketable securities totaled $33.1 million as of June 30, 2016, as compared to $46.4 million as of December 31, 2015. The decrease of $13.3 million was primarily due to $20.1 million of net cash used in operating activities and $8.0 million of principal and final payments against notes payable, partially offset by $14.8 million raised from debt financing. This capital is expected to be sufficient to fund operations to the middle of 2017.

Revenue for the three and six months ended June 30, 2016 was $0.6 million and $1.2 million as compared to $0.9 million and $1.7 million for the same periods in 2015. The decrease between the periods was primarily due to the increase in estimated performance period through which the remaining balance of deferred revenue will be amortized.

Research and development expense was $6.6 million and $12.8 million for the three and six months ended June 30, 2016 as compared to $6.3 million and $10.8 million for the same periods in 2015. The increase of $0.3 million and $2.0 million between the comparable three- and six-month periods, respectively, was primarily related to medical scientific affairs activities.

General and administrative expense was $4.0 million and $8.3 million for the three and six months ended June 30, 2016 as compared to $5.2 million and $10.3 million for the same periods in 2015. The decrease of $1.2 million and $2.0 million between the comparable three- and six-month periods, respectively, was primarily due to decrease in outside services costs.

Interest expense was $0.5 million and $0.8 million for the three and six months ended June 30, 2016 as compared to $0.2 million and $0.5 million for the same periods in 2015.

Net other income was nil and $0.1 million for the three and six months ended June 30, 2016 as compared to net other income of $1.9 million and $1.8 million for the same period in 2015. The increases in 2015 periods were primarily comprised of non-cash credits or charges for the revaluation of warrants issued in the October 2010 underwritten offering.

Cash used in operating activities was $20.1 million for the six months ended June 30, 2016, as compared to $19.8 million for the same period in 2015. Net cash used in the 2016 period resulted primarily from the net loss of $20.5 million and changes in operating assets and liabilities of $2.5 million, including the payment of a final fee of $1.2 million under the Oxford Loan Agreement, partially offset by net adjustments for non-cash items of $2.9 million. Net cash used in the 2015 period resulted primarily from the net loss of $18.1 million and changes in operating assets and liabilities of $3.4 million, partially offset by net adjustments for non-cash items of $1.7 million.

Sunesis reported loss from operations of $10.0 million and $19.9 million for the three and six months ended June 30, 2016 as compared to $10.6 million and $19.4 million for the same periods in 2015. Net loss was $10.4 million and $20.5 million for the three and six months ended June 30, 2016, as compared to $8.9 million and $18.0 million for the same periods in 2015.
Conference Call Information

Sunesis will host an update conference call today, July 29th at 11:00 a.m. Eastern Time. The call can be accessed by dialing (877) 771-6242 (U.S. and Canada) or (440) 996-5676 (international) and entering passcode 48017419. To access the live audio webcast, or the subsequent archived recording, visit the "Investors and Media – Calendar of Events" section of the Sunesis website at www.sunesis.com. The webcast will be recorded and available for replay on the company’s website for two weeks.

About QINPREZO (vosaroxin)

QINPREZO (vosaroxin) is an anti-cancer quinolone derivative (AQD), a class of compounds that has not been used previously for the treatment of cancer. Preclinical data demonstrate that vosaroxin both intercalates DNA and inhibits topoisomerase II, resulting in replication-dependent, site-selective DNA damage, G2 arrest and apoptosis. Both the U.S. Food and Drug Administration (FDA) and European Commission have granted orphan drug designation to vosaroxin for the treatment of AML. Additionally, vosaroxin has been granted fast track designation by the FDA for the potential treatment of relapsed or refractory AML in combination with cytarabine. Vosaroxin is an investigational drug that has not been approved for use in any jurisdiction.

Vosaroxin’s Marketing Authorization Application for relapsed refractory AML is currently under review by the European Medicines Agency, and a regulatory decision regarding approval is expected in 2017.

The trademark name QINPREZO is conditionally accepted by the FDA and the EMA as the proprietary name for the vosaroxin drug product candidate.

About SNS-062

SNS-062 is a novel, second-generation BTK inhibitor, a class of kinase inhibitors that selectively inhibits the enzyme Bruton’s tyrosine kinase (BTK). This target mediates signaling through the B-cell receptor, which is critical for adhesion, migration, proliferation and survival of normal and malignant B-lineage lymphoid cells. Unlike other drugs in its class, SNS-062 has a distinct kinase selectivity profile and binds non-covalently to the BTK enzyme, potentially providing an opportunity to address the leading resistance mechanism, a mutation in the enzyme’s binding site required for covalent binding. In preclinical studies, SNS-062 demonstrated potent activity against Cys-481S mutated B-cell malignancies, and is currently being studied in healthy subjects in a Phase 1A, randomized, double-blind, placebo-controlled dose-ranging study to investigate the drug’s safety, pharmacokinetics, and pharmacodynamics. With a successful study outcome, SNS-062 is expected to proceed to a Phase 1B/2 study in patients with B-cell malignancies around year end 2016.