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MD Anderson Cancer Center and Cellectis Announce a Broad Preclinical and Clinical Strategic Alliance in Cancer Immunotherapy

On September 3rd 2015 Cellectis (Alternext: ALCLS – Nasdaq: CLLS), the gene editing company employing proprietary technologies to develop best-in-class CAR Tcell products in adoptive immunotherapy for cancer, and The University of Texas MD Anderson Cancer Center reported that they have entered into a research and development alliance aimed at bringing novel cellular immunotherapies to patients suffering from different types of liquid tumors (Press release, Cellectis, SEP 3, 2015, View Source [SID:1234507393]).

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The alliance is aimed at developing novel cancer immunotherapies based on Cellectis’ allogeneic chimeric antigen receptor (CAR) platform. MD Anderson Cancer Center’s leukemia and myeloma teams will work with Cellectis to bring better treatments to patients suffering from cancers with high unmet needs, particularly multiple myeloma (MM), acute lymphocytic leukemia (ALL), T-cell acute lymphocytic leukemia (ALL) and blastic plasmacytoid dendritic cell neoplasm (BPDCN).

The alliance will build on MD Anderson’s outstanding translational and state-of-the-art preclinical and clinical teams in leukemia and myeloma, coupled with Cellectis’ first-in-class allogeneic CAR T-cell therapy approach and manufacturing capabilities, to pursue the development of Cellectis’ candidate products UCARTCS1, UCART22, UCART38 in T-cell ALL and UCART123 in a rare non curable disease BPDCN. Cellectis has built an allogeneic CAR T-cell approach based on proprietary gene editing technologies, aimed at developing off-the-shelf cellular therapies for cancer treatment.

At MD Anderson, the alliance will be brought forward under the direction of Hagop Kantarjian, MD, Chair, Department of Leukemia, and Robert Orlowski, MD, PhD, Department Ad Interim Chair, Department of Lymphoma/Myeloma. MD Anderson’s Leukemia Department is known for its clinical trials and patient treatment using chemotherapies, tyrosine kinase inhibitors and monoclonal antibodies.

"We are extremely proud to have our research teams partnering with MD Anderson as we aim to address treatments for different types of liquid tumors," said Mathieu Simon, MD, Executive Vice President and Chief Operating Officer at Cellectis. "This alliance could potentially drive to 5 clinical developments within a time horizon of 3 years. Together, we are confident that we will quickly bring new therapeutic solutions to patients."

"Our efforts are always focused on providing more effective care for our patients," said Kantarjian. "Alliances such as this one are one more way that we can explore how to bring the latest therapies to the patients who need them."

"Significant unmet medical need exists in many types of liquid tumors. Cellectis is committed to changing patient expectations as we’re building a portfolio of candidate products in immune-oncology through our own research and key collaborations such as with MD Anderson," said André Choulika, Ph.D., Chief Executive Officer and Chairman of Cellectis.

"We’re highly encouraged by the potential of our product candidate pipeline to deliver innovative, best-in-class treatment options to patients."

"Immunotherapy is increasingly a significant element in cancer treatment," said Orlowski. "It is my hope that patients with multiple myeloma and other cancers will benefit through this alliance."

Sandoz launches ZarxioTM (filgrastim-sndz), the first biosimilar in the United States

On September 3, 2015 Sandoz, a Novartis company, reported that Zarxio(TM) (filgrastim-sndz) is now available in the United States. Zarxio is the first biosimilar approved by the US Food and Drug Administration (FDA) and the first to launch in the US (Press release, Novartis, SEP 3, 2015, View Source [SID:1234507390]).

"As the pioneer and global leader in biosimilars, Sandoz has maintained a commitment to bringing high-quality biosimilar medicines to patients and healthcare professionals around the world," said Richard Francis, Global Head, Sandoz. "With the launch of Zarxio, we look forward to increasing patient, prescriber and payor access to filgrastim in the US by offering a high-quality, more affordable version of this important oncology medicine."

"While biologics have had a significant impact on how diseases are treated, their cost and co-pays are difficult for many patients and the healthcare budget in general. Biosimilars can help to fill an unmet need by providing expanded options, greater affordability and increased patient access to life-saving therapies," said Dr. Ralph Boccia, Medical Director of the Center for Cancer and Blood Disorders, and Chief Medical Officer for the International Oncology Network (ION).

Sandoz understands the importance of providing comprehensive patient support services in the oncology setting. With the launch of Zarxio, Sandoz is also proud to offer Sandoz One SourceTM a patient services center, providing support that connects the patient to the information and resources they need.

The launch follows the FDA approval of Zarxio on March 6, 2015. The approval, via the new biosimilars pathway established under the Biologics Price Competition and Innovation Act, was based on a comprehensive package of analytical, nonclinical, and clinical data, which confirmed that Zarxio is highly similar with no clinically meaningful differences to the US-licensed reference product. The successful Sandoz pivotal head-to-head PIONEER study was the final piece of data contributing to the totality of evidence used by FDA to approve Zarxio as biosimilar to the reference product. Importantly, the data demonstrating high similarity was sufficient to allow extrapolation of use of Zarxio to five indications of the reference product.

Sandoz has an unwavering commitment to increasing patient access to high-quality, life-enhancing biosimilars. Sandoz is the global market leader and currently markets three biosimilars outside the US. Sandoz has a leading pipeline with several biosimilars across the various stages of development, including five programs in Phase III clinical trials/filing preparation.

For more information on Zarxio, please visit www.zarxio.com (link is external).

INDICATIONS

Patients with Cancer Receiving Myelosuppressive Chemotherapy: to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever.

Patients with Acute Myeloid Leukemia Receiving Induction or Consolidation Chemotherapy: to reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML).

Patients with Cancer Undergoing Bone Marrow Transplantation: to reduce the duration of neutropenia and neutropenia-related clinical sequelae, e.g., febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation.

Patients Undergoing Autologous Peripheral Blood Progenitor Cell Collection and Therapy: for the mobilization of autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis.

Patients with Severe Chronic Neutropenia: for chronic administration to reduce the incidence and duration of sequelae of neutropenia (e.g, fever, infections, oropharyngeal ulcers) in symptomatic patients with congenital neutropenia, cyclic neutropenia, or idiopathic neutropenia.
IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

ZARXIO is contraindicated in patients with a history of serious allergic reactions to human granulocyte colony-stimulating factors such as filgrastim or pegfilgrastim.

WARNINGS AND PRECAUTIONS

Splenic rupture, including fatal cases, has been reported following the administration of filgrastim products. Patients who report left upper abdominal or shoulder pain should be evaluated.

Acute respiratory distress syndrome (ARDS) has been reported in patients receiving filgrastim products. Patients who develop fever and lung infiltrates or respiratory distress should be evaluated. Discontinue ZARXIO in patients with ARDS.

Serious allergic reactions, including anaphylaxis, have been reported in patients receiving filgrastim products. The majority of reported events occurred upon initial exposure. Provide symptomatic treatment for allergic reactions. Allergic reactions, including anaphylaxis, in patients receiving filgrastim products can recur within days after the discontinuation of initial anti-allergic treatment. Permanently discontinue ZARXIO in patients with serious allergic reactions.

Sickle cell crisis, in some cases fatal, has been reported with the use of filgrastim products in patients with sickle cell trait or sickle cell disease.

Glomerulonephritis has occurred in patients receiving filgrastim products. The diagnoses were based upon azotemia,hematuria (microscopic and macroscopic), proteinuria, and renal biopsy. Generally, events of glomerulonephritis resolved after dose reduction or discontinuation of filgrastim. If glomerulonephritis is suspected, evaluate for cause. If causality is likely, consider dose-reduction or interruption of ZARXIO.

Alveolar hemorrhage manifesting as pulmonary infiltrates and hemoptysis requiring hospitalization have been reported in healthy donors treated with filgrastim undergoing peripheral blood progenitor cell (PBPC) collection mobilization. Hemoptysis resolved with discontinuation of filgrastim. The use of ZARXIO for PBPC mobilization in healthy donors is not an approved indication.
Capillary leak syndrome (CLS) has been reported after G-CSF administration, including filgrastim products, and is characterized by hypotension, hypoalbuminemia, edema and hemoconcentration. Episodes vary in frequency, severity and may be life-threatening if treatment is delayed. Patients who develop symptoms of capillary leak syndrome should be closely monitored and receive appropriate treatment.

Confirm the diagnosis of severe chronic neutropenia (SCN) before initiating ZARXIO therapy. Myelodysplastic syndrome (MDS) and acute myelogenous leukemia (AML) have been reported to occur in the natural history of congenital neutropenia without cytokine therapy. Cytogenetic abnormalities, transformation to MDS, and AML have also been observed in patients treated with filgrastim for SCN. Abnormal cytogenetics and MDS have been associated with the eventual development of myeloid leukemia. The effect of filgrastim products on the development of abnormal cytogenetics and the effect of continued filgrastim administration in patients with abnormal cytogenetics or MDS are unknown. If a patient with SCN develops abnormal cytogenetics or myelodysplasia, the risks and benefits of continuing ZARXIO should be carefully considered.

Thrombocytopenia has been reported in patients receiving filgrastim products. Monitor platelet counts.

Leukocytosis:
Patients with Cancer Receiving Myelosuppressive Chemotherapy: White blood cell counts of 100,000/mm3 or greater were observed in approximately 2% of patients receiving filgrastim at dosages above 5 mcg/kg/day. In patients with cancer receiving ZARXIO as an adjunct to myelosuppressive chemotherapy, to avoid the potential risks of excessive leukocytosis, it is recommended that ZARXIO therapy be discontinued if the ANC surpasses 10,000/mm3 after the chemotherapy-induced ANC nadir has occurred. Monitor CBCs at least twice weekly during therapy.

Peripheral Blood Progenitor Cell (PBPC) Collection and Therapy: During the period of administration of ZARXIO for PBPC mobilization in patients with cancer, discontinue ZARXIO if the leukocyte count rises to >100,000/mm3.

Cutaneous vasculitis has been reported in patients treated with filgrastim products. In most cases, the severity of cutaneous vasculitis was moderate or severe. Most of the reports involved patients with SCN receiving long-term filgrastim therapy. Hold ZARXIO therapy in patients with cutaneous vasculitis. ZARXIO may be started at a reduced dose when the symptoms resolve and the ANC has decreased.

The possibility that filgrastim acts as a growth factor for any tumor type, including myeloid malignancies and myelodysplasia, diseases for which filgrastim is not approved, cannot be excluded. The safety of filgrastim products in chronic myeloid leukemia (CML) and myelodysplasia has not been established. When ZARXIO is used to mobilize PBPC, tumor cells may be released from the marrow and subsequently collected in the leukapheresis product. Available data is limited and inconclusive.

The safety and efficacy of filgrastim products given simultaneously with cytotoxic chemotherapy have not been established. Do not use ZARXIO in the period 24 hours before through 24 hours after the administration of cytotoxic chemotherapy. The safety and efficacy of filgrastim products have not been evaluated in patients receiving concurrent radiation therapy. Avoid the simultaneous use of ZARXIO with chemotherapy and radiation therapy.

Increased hematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient positive bone-imaging changes on nuclear imaging.

ADVERSE REACTIONS

Most common adverse reactions in patients:

With nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs (>= 5% difference in incidence compared to placebo) are thrombocytopenia, nausea, pyrexia, chest pain, pain, fatigue, back pain, arthralgia, bone pain, pain in extremity, dizziness, cough, dyspnea, rash, blood lactate dehydrogenase increased and blood alkaline phosphatase increased

With AML (>= 2% difference in incidence) are epistaxis, back pain, pain in extremity, erythema, and rash maculo-papular
With nonmyeloid malignancies undergoing myeloablative chemotherapy followed by BMT (>= 5% difference in incidence) are rash and hypersensitivity

Undergoing peripheral blood progenitor cell mobilization and collection (>= 5% incidence) are bone pain, pyrexia, blood alkaline phosphatase increased and headache

With severe chronic neutropenia (SCN) (>= 5% difference in incidence) are arthralgia, bone pain, back pain, muscle spasms, musculoskeletal pain, pain in extremity, splenomegaly, anemia, upper respiratory tract infection, urinary tract infection, epistaxis, chest pain, diarrhea, hypoesthesia, and alopecia

10-K – Annual report [Section 13 and 15(d), not S-K Item 405]

(Filing, 10-K, MEI Pharma, SEP 2, 2015, View Source [SID:1234507383])

MEI Pharma Reports Fiscal Year 2015 Results

On September 2, 2015 MEI Pharma, Inc. (Nasdaq: MEIP), an oncology company focused on the clinical development of novel therapies for cancer, reported results for its fiscal year ended June 30, 2015 (Press release, MEI Pharma, SEP 2, 2015, View Source [SID:1234507384]).

"Despite a challenging end to the fiscal year, I am quite pleased with how the Company is positioned entering fiscal year 2016," said Daniel P. Gold, Ph.D., President and Chief Executive Officer of MEI Pharma. "While we were obviously disappointed with the top-line data from our randomized study of Pracinostat in front-line myelodysplastic syndrome (MDS), our subsequent findings from the study, combined with the continued maturation of data from our ongoing study in acute myeloid leukemia (AML) and discussions with our clinical advisors, suggest that Pracinostat, in combination with hypomethylating agents (HMA) or other drug candidates, may still play a meaningful role in the treatment of patients with advanced hematologic diseases.

"Meanwhile," continued Dr. Gold, "recent data surrounding the two other drug candidates currently in our pipeline, ME-344 and PWT143, only increase our enthusiasm regarding the potential of these assets and help to inform the next clinical studies anticipated to commence during the first half of calendar year 2016. In the meantime, abstracts relating to all three of our drug candidates have been submitted for presentation at the upcoming American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2015. We are poised for an exciting year ahead and I look forward to providing updates on our progress."

Fiscal Year 2015 Company Highlights

Top-line data from randomized Phase II study of Pracinostat in front-line MDS. In March 2015, the Company reported that the addition of Pracinostat to azacitidine (marketed as Vidaza) did not increase the overall CR rate, the study’s primary endpoint, compared to azacitidine alone in this population of intermediate-2 or high-risk patients with previously untreated MDS. Fatigue, gastrointestinal toxicities and myelosuppression occurred more frequently in the combination group and resulted in a higher rate of drug discontinuations compared to azacitidine alone. Data from event-driven endpoints, including overall survival, are still immature. Exploratory follow-up data suggest that patients receiving Pracinostat plus azacitidine for more than four cycles may derive benefit. These data have been submitted for presentation at the ASH (Free ASH Whitepaper) Annual Meeting in December 2015.

Positive data from open-label Phase II study of Pracinostat in AML. The combination of Pracinostat and azacitidine continues to produce a high rate of durable responses in this population of elderly patients with newly diagnosed AML. To date, the primary endpoint of complete response (CR) plus complete response with incomplete blood count recovery (CRi) plus morphologic leukemia-free state (MLFS) has been observed in 27 out of 50 patients (54%), of which 21 (42%) have achieved a CR. Most responses occured within the first two cycles and many continued to improve with ongoing therapy. Median overall survival has not yet been reached in the study; 31 patients (62%) continue to be followed (range: 9-19 months). The combination of Pracinostat and azacitidine was generally well tolerated in this study. The most common treatment-emergent adverse events include febrile neutropenia, thrombocytopenia, nausea and fatigue. Updated response and overall survival data have been submitted for presentation at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2015.

Clinical milestone in Phase II study of Pracinostat in refractory MDS. The objective of this study was to determine if the addition of Pracinostat to a HMA can improve clinical responses in MDS patients who progressed while on their HMA alone. Of the first 28 patients who received Pracinostat in combination with azacitidine or decitabine (marketed as Dacogen), one achieved a partial response and two achieved marrow complete responses, exceeding the pre-specified clinical improvement rate for the study. The Company completed enrollment with 39 patients in this group and will continue to follow these patients for response and survival. A second group, patients with stable disease following initial HMA therapy, was closed due to insufficient enrollment. Pracinostat plus azacitidine or decitabine was generally well tolerated in the study. The most common treatment-emergent adverse events included anemia, fatigue and gastrointestinal disorders.

Initiation of Phase II study of Pracinostat in myelofibrosis. The goal of this study is to learn if Pracinostat, when given in combination with ruxolitinib (marketed as Jakafi and Jakavi), can help to control myelofibrosis, a rare disease of the bone marrow. The study, sponsored by the M.D. Anderson Cancer Center, began enrollment earlier this year and is expected to enroll 25 patients.
Cohort expansion in Phase Ib study of mitochondrial inhibitor ME-344. The Company’s study of ME-344 plus topotecan (marketed as Hycamtin) advanced to the cohort-expansion stage after confirming the maximum tolerated dose of the combination in 14 patients. The expansion stage enrolled patients into two cohorts, ovarian cancer and small cell lung cancer, at nine sites in the U.S. and U.K. The combination of ME-344 and topotecan has been generally well tolerated in the study. The most frequent side effects are fatigue and gastrointestinal disturbances. The Phase Ib study enrolled a total of 13 small cell lung cancer patients and 28 ovarian cancer patients. The Company will continue to follow these patients for response and survival.

New findings show enhanced activity of ME-344 when combined with TKI. The Company recently announced results from several pre-clinical studies demonstrating mitochondria-specific effects of ME-344 in cancer cells, including substantially enhanced anti-tumor activity when combined with a vascular endothelial growth factor receptor (VEGFr) tyrosine-kinase inhibitor (TKI) to inhibit both mitochondrial and glycolytic metabolism. These findings will help to inform the next clinical study of ME-344 in combination with a VEGFr TKI.

Encouraging preliminary data from first-in-human study of PWT143. The Company initiated a first-in-human clinical study of PWT143, a highly selective oral inhibitor of phosphatidylinositide 3-kinase (PI3K) delta, in healthy subjects in June 2015. Preliminary data show measurable plasma levels of PWT143 as well as significant on target activity observed at the 10 mg starting dose level. In addition, the pharmacokinetic results suggest the potential for once-daily dosing. These data have been submitted for presentation at the ASH (Free ASH Whitepaper) Annual Meeting in December 2015. The Company expects to initiate a Phase I study of PWT143 in patients with hematologic cancers during the first half of calendar year 2016.

Pharmaceutical industry veteran Kevan Clemens elected to Board of Directors. Dr. Clemens has a long and distinguished career in the pharmaceutical industry, highlighted by his role as head of Global Oncology at Hoffmann-La Roche.

Strengthened balance sheet with $46 million public offering. The net proceeds from the offering will enable the Company to continue to execute on its clinical development programs.

Fiscal Year 2015 Financial Highlights

As of June 30, 2015, MEI Pharma had $63.8 million in cash, cash equivalents and short-term investments, with no outstanding debt. The Company believes its cash, cash equivalents and short-term investments will be sufficient to fund operations through at least calendar year 2016.

Net cash used in operations was $28.1 million for the year ended June 30, 2015, compared to $19.5 million for 2014. Net cash used in operations was $6.7 million for the quarter ended June 30, 2015.

Research and development (R&D) expenses were $23.8 million for the year ended June 30, 2015, compared to $19.3 million for 2014. The increase was primarily due to costs associated with Phase II clinical trials for Pracinostat, as well as costs associated with a Phase I clinical trial for ME-344 and pre-clinical costs related to PWT143. R&D expenses for the year ended June 30, 2015 included share-based compensation of $1.0 million.

General and administrative expenses were $8.9 million for the year ended June 30, 2015, compared to $7.9 million for 2014. The increase primarily relates to higher levels of salaries and benefits.

Net loss was $32.7 million, or $1.16 per share, for the fiscal year ended June 30, 2015, compared to $27.1 million, or $1.35 per share for 2014.

8-K – Current report

On September 2, 2015 MEI Pharma, Inc. (Nasdaq: MEIP), an oncology company focused on the clinical development of novel therapies for cancer,reported results for its fiscal year ended June 30, 2015 (Filing, 8-K, MEI Pharma, SEP 2, 2015, View Source [SID:1234507382]).

• Top-line data from randomized Phase II study of Pracinostat in front-line MDS. In March 2015, the Company reported that the addition of Pracinostat to azacitidine (marketed as Vidaza) did not increase the overall CR rate, the study’s primary endpoint, compared to azacitidine alone in this population of intermediate-2 or high-risk patients with previously untreated MDS. Fatigue, gastrointestinal toxicities and myelosuppression occurred more frequently in the combination group and resulted in a higher rate of drug discontinuations compared to azacitidine alone. Data from event-driven endpoints, including overall survival, are still immature. Exploratory follow-up data suggest that patients receiving Pracinostat plus azacitidine for more than four cycles may derive benefit. These data have been submitted for presentation at the ASH (Free ASH Whitepaper) Annual Meeting in December 2015.

• Positive data from open-label Phase II study of Pracinostat in AML. The combination of Pracinostat and azacitidine continues to produce a high rate of durable responses in this population of elderly patients with newly diagnosed AML. To date, the primary endpoint of complete response (CR) plus complete response with incomplete blood count recovery (CRi) plus morphologic leukemia-free state (MLFS) has been observed in 27 out of 50 patients (54%), of which 21 (42%) have achieved a CR. Most responses occurred within the first two cycles and many continued to improve with ongoing therapy. Median overall survival has not yet been reached in the study; 31 patients (62%) continue to be followed (range: 9-19 months). The combination of Pracinostat and azacitidine was generally well tolerated in this study. The most common treatment-emergent adverse events include febrile neutropenia, thrombocytopenia, nausea and fatigue. Updated response and overall survival data have been submitted for presentation at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2015.

• Clinical milestone in Phase II study of Pracinostat in refractory MDS. The objective of this study was to determine if the addition of Pracinostat to a HMA can improve clinical responses in MDS patients who progressed while on their HMA alone. Of the first 28 patients who received Pracinostat in combination with azacitidine or decitabine (marketed as Dacogen), one achieved a partial response and two achieved marrow complete responses, exceeding the pre-specified clinical improvement rate for the study. The Company completed enrollment with 39 patients in this group and will continue to follow these patients for response and survival. A second group, patients with stable disease following initial HMA therapy, was closed due to insufficient enrollment. Pracinostat plus azacitidine or decitabine was generally well tolerated in the study. The most common treatment-emergent adverse events included anemia, fatigue and gastrointestinal disorders.

• Initiation of Phase II study of Pracinostat in myelofibrosis. The goal of this study is to learn if Pracinostat, when given in combination with ruxolitinib (marketed as Jakafi and Jakavi), can help to control myelofibrosis, a rare disease of the bone marrow. The study, sponsored by the M.D. Anderson Cancer Center, began enrollment earlier this year and is expected to enroll 25 patients.

• Cohort expansion in Phase Ib study of mitochondrial inhibitor ME-344. The Company’s study of ME-344 plus topotecan (marketed as Hycamtin) advanced to the cohort-expansion stage after confirming the maximum tolerated dose of the combination in 14 patients. The expansion stage enrolled patients into two cohorts, ovarian cancer and small cell lung cancer, at nine sites in the U.S. and U.K. The combination of ME-344 and topotecan has been generally well tolerated in the study. The most frequent side effects are fatigue and gastrointestinal disturbances. The Phase Ib study enrolled a total of 13 small cell lung cancer patients and 28 ovarian cancer patients. The Company will continue to follow these patients for response and survival.

• New findings show enhanced activity of ME-344 when combined with TKI. The Company recently announced results from several pre-clinical studies demonstrating mitochondria-specific effects of ME-344 in cancer cells, including substantially enhanced anti-tumor activity when combined with a vascular endothelial growth factor receptor (VEGFr) tyrosine-kinase inhibitor (TKI) to inhibit both mitochondrial and glycolytic metabolism. These findings will help to inform the next clinical study of ME-344 in combination with a VEGFr TKI.

• Encouraging preliminary data from first-in-human study of PWT143. The Company initiated a first-in-human clinical study of PWT143, a highly selective oral inhibitor of phosphatidylinositide 3-kinase (PI3K) delta, in healthy subjects in June 2015. Preliminary data show measurable plasma levels of PWT143 as well as significant on target activity observed at the 10 mg starting dose level. In addition, the pharmacokinetic results suggest the potential for once-daily dosing. These data have been submitted for presentation at the ASH (Free ASH Whitepaper) Annual Meeting in December 2015. The Company expects to initiate a Phase I study of PWT143 in patients with hematologic cancers during the first half of calendar year 2016.

• Pharmaceutical industry veteran Kevan Clemens elected to Board of Directors. Dr. Clemens has a long and distinguished career in the pharmaceutical industry, highlighted by his role as head of Global Oncology at Hoffmann-La Roche.

• Strengthened balance sheet with $46 million public offering. The net proceeds from the offering will enable the Company to continue to execute on its clinical development programs.
Fiscal Year 2015 Financial Highlights

• As of June 30, 2015, MEI Pharma had $63.8 million in cash, cash equivalents and short-term investments, with no outstanding debt. The Company believes its cash, cash equivalents and short-term investments will be sufficient to fund operations through at least calendar year 2016.

• Net cash used in operations was $28.1 million for the year ended June 30, 2015, compared to $19.5 million for 2014. Net cash used in operations was $6.7 million for the quarter ended June 30, 2015.

• Research and development (R&D) expenses were $23.8 million for the year ended June 30, 2015, compared to $19.3 million for 2014. The increase was primarily due to costs associated with Phase II clinical trials for Pracinostat, as well as costs associated with a Phase I clinical trial for ME-344 and pre-clinical costs related to PWT143. R&D expenses for the year ended June 30, 2015 included share-based compensation of $1.0 million.

• General and administrative expenses were $8.9 million for the year ended June 30, 2015, compared to $7.9 million for 2014. The increase primarily relates to higher levels of salaries and benefits.

• Net loss was $32.7 million, or $1.16 per share, for the fiscal year ended June 30, 2015, compared to $27.1 million, or $1.35 per share for 2014.