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Verastem Reports Second Quarter 2015 Financial and Corporate Results

On August 10, 2015 Verastem, Inc. (NASDAQ:VSTM), focused on discovering and developing drugs to treat cancer by the targeted killing of cancer stem cells, reported financial results for the second quarter ended June 30, 2015, and also provided an overview of certain corporate accomplishments and plans (Press release, Verastem, AUG 10, 2015, View Source;p=RssLanding&cat=news&id=2078274 [SID:1234507190]).

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"Execution of the ongoing COMMAND trial continues to progress well and we remain on track to report the outcome of the interim analysis during the third quarter of 2015," said Robert Forrester, President and Chief Executive Officer of Verastem. "The independent Data and Safety Monitoring Board (DSMB) will examine pre-specified efficacy and safety data sets to decide whether to recommend continuation in all patients as planned, or to enrich the study population based upon merlin status, or to stop the study early for futility. This will be an important milestone for Verastem."

Q2 2015 and Recent Highlights

VS-6063 (Focal Adhesion Kinase Inhibition)

COMMAND (Control Of Mesothelioma with MAinteNance Defactinib) Study

Registration-directed, randomized, double-blind, placebo-controlled study of VS-6063 as a switch maintenance treatment in patients with malignant pleural mesothelioma benefiting from frontline therapy with pemetrexed (Alimta) and platinum
Co-primary endpoints are Progression Free Survival (PFS) and Overall Survival (OS). The study is designed to provide 90% power to assess the superiority of PFS, with a 1 sided type I error rate of 0.025, assuming a hazard ratio of 0.67
308 patients enrolled at 72 centers in 15 countries as of August 6, 2015
Interim analysis to define the primary patient population anticipated in Q3 2015

Presentations and Publications
Reported encouraging scientific data in support of Verastem’s cancer stem cell inhibitors (VS-6063, VS-4718, and VS-5584) in multiple tumor types, including mesothelioma, small cell lung cancer, breast cancer, and hematologic malignancies, at the 2015 American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. Copies of the presentations can be accessed at: http://bit.ly/12otlcV

Corporate
Appointed Lou Vaickus, MD, FACP as Interim Chief Medical Officer
Hosted an analyst and investor event at the 2015 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. Guest speakers Professor Dean Fennell, Ph.D., FRCP, and Max Wicha, M.D., gave presentations on mesothelioma and the rationale and importance of targeting cancer stem cells through FAK inhibition

Upcoming Clinical Milestones
Verastem’s anticipated upcoming data milestones include:

VS-6063

COMMAND interim analysis: Q3 2015
Phase 2 results in KRAS-mutated NSCLC at the World Conference of Lung Cancer in Denver, CO on September 6-9th
Updated results from the VS-6063/paclitaxel combination in patients with ovarian cancer: H2 2015
Biomarker "Window of Opportunity" mesothelioma study with preliminary results from the extended treatment cohort: H1 2016

VS-4718
Preliminary Phase 1 results in patients with advanced solid tumors: H2 2015

VS-5584
Preliminary Phase 1 results in patients with advanced solid tumors: H2 2015

Second Quarter 2015 Financial Results
As of June 30, 2015, Verastem had cash, cash equivalents and investments of $132.1 million compared to $92.7 million as of December 31, 2014. Verastem used $12.0 million for operating activities in the second quarter ended June 30, 2015 (the "2015 Quarter").

Net loss for the 2015 Quarter was $15.4 million, or $0.42 per share, as compared to net loss of $13.0 million, or $0.51 per share, for the same period in 2014 (the "2014 Quarter"). Net loss includes stock-based compensation expense of $2.6 million and $3.2 million for the 2015 Quarter and 2014 Quarter, respectively.

Research and development expense for the 2015 Quarter was $11.0 million compared to $8.3 million for the 2014 Quarter. The $2.7 million increase from the 2014 Quarter to the 2015 Quarter was primarily related to an increase of $2.1 million in contract research organization expense for outsourced biology, development and clinical services, which includes Verastem’s clinical trial costs, and an approximate $732,000 increase in personnel costs. These increases were partially offset by a decrease in stock-based compensation expense of approximately $162,000.

General and administrative expense for the 2015 Quarter was $4.4 million compared to $4.8 million for the 2014 Quarter. The $400,000 decrease was primarily due to a decrease in stock-based compensation expense.
There were 36,853,805 common shares outstanding as of June 30, 2015.

Financial Guidance
Based on current operating plans, the Company expects to have sufficient cash, cash equivalents and investments to fund its research and development programs and operations into the first half of 2017.

About VS-6063
VS-6063 (defactinib) is an orally available compound designed to target cancer stem cells through the potent inhibition of focal adhesion kinase (FAK). Cancer stem cells are an underlying cause of tumor resistance to chemotherapy, recurrence and ultimate disease progression. Research has demonstrated that FAK activity is critical for the growth and survival of cancer stem cells. VS-6063 is currently being studied in the registration-directed COMMAND trial in mesothelioma (www.COMMANDmeso.com), a "Window of Opportunity" study in patients with mesothelioma prior to surgery, a Phase 1/1b study in combination with paclitaxel in patients with ovarian cancer, a trial in patients with KRAS-mutated non-small cell lung cancer and a trial evaluating the combination of VS-6063 and VS-5584 in patients with relapsed mesothelioma. VS-6063 has been granted orphan drug designation for use in mesothelioma in the U.S. and EU.

About VS-4718
VS-4718 is an orally available compound designed to target cancer stem cells through the potent inhibition of focal adhesion kinase (FAK). VS-4718 is currently being studied in a Phase 1 dose escalation study in patients with advanced cancers.

About VS-5584
VS-5584 is an orally available compound that has demonstrated potent and highly selective activity against class 1 PI3K enzymes and dual inhibitory actions against mTORC1 and mTORC2. In preclinical studies, VS-5584 has been shown to reduce the percentage of cancer stem cells and induce tumor regression in chemotherapy-resistant models. Verastem is currently conducting a dose escalation trial of VS-5584 in patients with advanced solid tumors as a single agent and a combination trial of VS-5584 and VS-6063 in patients with relapsed mesothelioma. VS-5584 has been granted orphan drug designation for use in mesothelioma in the U.S. and EU.

TG Therapeutics, Inc. Announces Second Quarter 2015 Financial Results and Business Update

On August 10, 2015 TG Therapeutics, Inc. (NASDAQ:TGTX) reported its financial results for the second quarter ended June 30, 2015 and recent company developments (Press release, TG Therapeutics, AUG 10, 2015, View Source [SID:1234507189]).

Michael S. Weiss, the Company’s Executive Chairman and Interim Chief Executive Officer, stated, "The second quarter was a busy and exciting time for the Company, as the data presentations made during the quarter continue to reinforce our belief that the safety and efficacy profiles of TG-1101 and TGR-1202, alone or in combination together in our "1303" regimen, allow for safe and efficacious multiple drug regimens, which we firmly believe is the future of patient care in the treatment of B-cell malignancies. We remain focused on commencing additional combination registration trials in the coming months, and aggressively recruiting into our ongoing GENUINE Phase 3 clinical trial." Mr. Weiss continued, "From a financial perspective, with cash on hand of more than $125 million on a pro forma basis, we are well positioned to execute on our goals and bring the Company to substantial value creating milestones."

Recent Developments and Highlights

Clinical data on the combination of TG-1101 and TGR-1202 was presented at the 51st American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting held in Chicago, Illinois, as well as in poster presentations at the European Hematology Association (EHA) (Free EHA Whitepaper) Annual Meeting held in Vienna, Austria and the International Congress on Malignant Lymphoma (ICML), held in Lugano, Switzerland

Single agent clinical data for TGR-1202 was presented at the ASCO (Free ASCO Whitepaper) Annual Meeting, as well as in oral presentations at the EHA (Free EHA Whitepaper) and Lugano ICML meetings

Clinical data on the triple combination of TG-1101, TGR-1202, and ibrutinib was presented in an oral presentation at the ASCO (Free ASCO Whitepaper) Annual Meeting, and in an oral presentation at the Lugano ICML meeting

Updated results from a Phase 2 clinical trial of TG-1101 in combination with ibrutinib in relapsed/refractory Chronic Lymphocytic Leukemia (CLL) was presented in an oral presentation at the Lugano ICML meeting

Presently have over 120 sites open for the Company’s GENUINE Phase 3 Clinical Trial of TG-1101 in combination with ibrutinib in patients with High-Risk Chronic Lymphocytic Leukemia
Reaffirming 2015 Milestones

Continue to aggressively recruit into the GENUINE Phase 3 Clinical Trial of TG-1101 in combination with ibrutinib
Commence additional combination Phase 3 clinical trials, particularly for the Company’s proprietary "1303" combination of TG-1101 plus TGR-1202 in patients with Chronic Lymphocytic Leukemia (CLL) and non-Hodgkin’s Lymphoma (NHL)
Launch new triple therapy combination trials in addition to the currently enrolling Phase 1/2 trial of TG-1101 plus TGR-1202 plus ibrutinib

Continue to push forward our preclinical development programs, including the IRAK4, anti-PD-L1, and anti-GITR programs, as well as opportunistically seek to identify drug candidates with complimentary mechanisms of action
Commence clinical development program for the treatment of autoimmune diseases

Present updated data on Phase 1 and 2 clinical trials at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, in December 2015, held in Orlando, Florida

Financial Results for the Second Quarter 2015

At June 30, 2015 the Company had cash, cash equivalents, investment securities, and interest receivable of $110.6 million, which includes approximately $51.2 million of net proceeds from the utilization of the Company’s at-the-market ("ATM") sales facility during the year (approximately $42 million of which was previously disclosed in connection with our last quarterly update), as compared to December 31, 2014 when we had $78.9 million.

Pro-forma cash, cash equivalents, investment securities, and interest receivable as of June 30, 2015 are approximately $126.4 million, including $15.8 million of net proceeds from the utilization of the ATM sales facility during the third quarter of 2015.

Our consolidated net loss for the second quarter ended June 30, 2015, excluding non-cash items, was approximately $10.9 million, which included approximately $4.8 million of manufacturing and CMC expenses in preparation for Phase 3 clinical trials and commercialization. The consolidated net loss for the second quarter ended June 30, 2015, inclusive of non-cash items, was $17.1 million, or $0.38 per diluted share, compared to a consolidated net loss of $12.0 during the comparable quarter in 2014, representing an increase in consolidated net loss of $5.1 million. The increase in consolidated net loss during the second quarter ended June 30, 2015 was primarily the result of other research and development expenses for TG-1101 and TGR-1202 increasing approximately $5.8 million and $1.3 million, respectively, over the comparable period in 2014. The increase in other research and development expenses related to TG-1101 was primarily the result of increased manufacturing and clinical trial expenses related to ongoing and planned future Phase 3 registration programs. These increases were partially offset by the $1.2 million of non-cash stock expense recorded in conjunction with the license to the IRAK4 inhibitors program during the quarter ended June 30, 2014 and a decrease of $1.5 million in non-cash compensation expense related to equity incentive grants over the comparable period in 2014.

Our consolidated net loss for the six months ended June 30, 2015, excluding non-cash items, was approximately $20.1 million, which included approximately $9.1 million of manufacturing and CMC expenses in preparation for Phase 3 clinical trials and commercialization. The consolidated net loss for the six months ended June 30, 2015, inclusive of non-cash items, was $31.7 million, or $0.73 per diluted share, compared to a consolidated net loss of $19.5 million during the comparable period in 2014, representing an increase in consolidated net loss of $12.2 million. The increase in consolidated net loss during the six months ended June 30, 2015 was primarily the result of other research and development expenses for TG-1101 and TGR-1202 increasing approximately $9.8 million and $2.5 million, respectively, over the comparable period in 2014. The increase in other research and development expenses related to TG-1101 was primarily the result of increased manufacturing and clinical trial expenses related to ongoing and planned future Phase 3 registration programs.

8-K – Current report

On August 10, 2015 MabVax Therapeutics Holdings, Inc. (OTCQB: MBVX), a clinical-stage oncology drug development company, provided a corporate update and reported financial results for the quarter ended June 30, 2015 (Filing, 8-K, Telik, AUG 10, 2015, View Source [SID:1234507187]).

"We are reporting progress toward achieving our near-term drug development milestones and with our capital formation," stated MabVax’s President and Chief Executive Officer David Hansen. "We completed a $11.7 million equity financing led by OPKO Health, Inc., and its Chairman and Chief Executive Officer, biotech investor and entrepreneur Dr. Phillip Frost, which put MabVax in one of the best financial positions in our corporate history. We finished the second quarter with approximately $7.2 million in cash and equivalents, including the release on June 30, 2015, of $3.5 million of funds from the equity financing to the Company that were being held in escrow by OPKO Health, Inc. and Frost Gamma Investment Trust. We believe that our current cash position is sufficient to support our near-term drug discovery and development efforts."

"The encouraging results from our non-human primate safety study for HuMab 5B1 further support our plan to file two Investigational New Drug applications, or INDs, with the FDA by 2015 year-end and begin both clinical trials in the first quarter of 2016," he added. "The GMP manufacturing of our clinical supplies of HuMab 5B1-based product for both clinical trials is on track for delivery in the fourth quarter of this year."

MabVax plans to initiate two complementary Phase I clinical trials in the first quarter of 2016. One clinical trial is aimed at determining the safety and potential utility of HuMab 5B1 as a therapeutic agent in subjects with metastatic pancreatic cancer. The second clinical trial is aimed at demonstrating the utility of 89Zr-HuMab 5B1, the Company’s radio-labeled HuMab 5B1 antibody, as a next-generation PET imaging agent for the diagnosis, staging, and management of pancreatic cancer.

Second Quarter and Recent Highlights

Significant financing transaction with a leading investor – April 10, 2015 – closed on approximately $11.7 million in a private placement led by OPKO Health, Inc. and its Chairman and CEO Dr. Phillip Frost. On June 30, 2015, OPKO Health, Inc. and Frost Gamma Investment Trust investments in the aggregate of $3.5 million associated with the financing were released from escrow.

Encouraging results of non-human primate toxicology study – On May 5, 2015, announced results from non-GLP toxicology testing of HuMab 5B1 antibody completed by a leading independent contract research organization. These results detailed that the antibody, administered in either a single dose or repeated doses, produced no significant adverse findings even at the highest dosage levels tested. Non-human primates in this acute dose range finding study were challenged with multiple dose levels to assess drug pharmacokinetics, as well as with repeated doses of the antibody to identify any adverse toxicology signals. These studies were conducted in the most relevant animal models with material produced by the Company’s GMP manufacturing partner. The antibody as tested is representative of the clinical supply material scheduled for delivery later this year for the planned Phase I clinical trials.

Rockefeller University Collaboration – In July 2015, entered into a research collaboration agreement to supply Rockefeller University’s Laboratory of Molecular Genetics and Immunology with antibody material to explore the mechanism of action of constant region (Fc) variants of the HuMab 5B1 in the role of tumor clearance. The Company will supply additional research materials as requested by the university, which is evaluating ways to optimize the function.

Second Quarter 2015 Financial Results

• Grant revenues totaled approximately $137,000.

• Research and development expenses were $2.3 million.

• General and administrative expenses totaled approximately $4.2 million.

• Net loss for the quarter was $6.4 million, or $0.29 per share, on approximately 25.2 million shares of common stock outstanding.

• Completed $11.7 million financing including the release of $3.5 million in funds held in escrow.

• At June 30, 2015, cash and cash equivalents totaled $7.2 million.

About HuMab 5B1

In pre-clinical research, MabVax’s HuMab 5B1 antibody has demonstrated high specificity, affinity and lack of cross-reactivity with closely related antigens. The antibody has also shown potent cancer cell killing capacity and efficacy in animal models of pancreatic, colon and small cell lung cancer. When combined with a radio-label as a novel PET imaging agent, 89Zr-HuMab 5B1 has demonstrated high image resolution of tumors in established xenograft animal models, making it attractive as a potential companion diagnostic for the therapeutic product.

Stemline Therapeutics Reports Second Quarter 2015 Financial Results

On August 10, 2015 Stemline Therapeutics, Inc. (Nasdaq:STML), a clinical stage biopharmaceutical company developing novel oncology drugs that primarily target cancer stem cells (CSCs) and tumor bulk, reported financial results for the quarter ended June 30, 2015 (Press release, Stemline Therapeutics, AUG 10, 2015, View Source [SID:1234507184]).

Ivan Bergstein, M.D., Stemline’s Chief Executive Officer, commented, "This quarter, we began enrollment in the expansion stage of our SL-401 pivotal trial in BPDCN, a highly aggressive malignancy of unmet medical need. This follows completion of the lead-in stage of this trial, wherein we evaluated multiple cycle SL-401 administration at escalating doses in first-line and relapsed/refractory BPDCN as well as relapsed/refractory AML. In the lead-in, we established a dose and schedule for the expansion stage, and observed major objective responses, including complete responses, some with gross clearance of bulky disease in multiple organ systems in BPDCN. We are encouraged by both the lack of cumulative side effects and cases of ongoing efficacy seen thus far with multiple cycles. The expansion stage focuses on relapsed/refractory BPDCN patients, which we believe could support registration. We look forward to updating and reporting detailed data at upcoming medical conferences."

Dr. Bergstein continued, "With the expansion stage of our BPDCN pivotal trial underway, we continue to pursue additional opportunities to expand SL-401’s potential in other malignancies, and have opened trials in early and late stage AML and high-risk myeloproliferative neoplasms. We also continue to advance and position our other pipeline candidates, SL-701 and SL-801. With a strong cash position and multiple programs advancing in a variety of indications, we remain well positioned to achieve our objective of building a leading commercial stage biopharmaceutical company."

Second Quarter 2015 Financial Results Review

Stemline ended the second quarter of 2015 with $109.0 million in cash, cash equivalents and investments, as compared to $58.6 million as of December 31, 2014. In the first quarter of 2015, the Company completed an equity offering raising $68.6 million in gross cash proceeds on the sale of 4.4 million common shares.

For the second quarter of 2015, Stemline had a net loss of $10.2 million, or $0.58 per share, compared with a net loss of $6.0 million, or $0.47 per share, for the same period in 2014.

Research and development expenses were $8.2 million for the second quarter of 2015, which reflects an increase of $4.1 million compared with $4.1 million for the second quarter of 2014. The higher expenses during the second quarter were primarily attributable to the SL-401 clinical program due largely to the ramp up of patient accrual.

General and administrative expenses were $2.2 million for the second quarter of 2015, which reflects an increase of $0.2 million compared with $2.0 million for the second quarter of 2014. The higher costs were primarily attributable to an increase in stock based compensation expense relating to administrative employees.

8-K – Current report

On August 10, 2015 Puma Biotechnology, Inc. (NYSE: PBYI), a development stage biopharmaceutical company, reported financial results for the second quarter ended June 30, 2015 (Filing, 8-K, Puma Biotechnology, AUG 10, 2015, View Source [SID:1234507176]).

Unless otherwise stated, all comparisons are for the second quarter and first half of the year 2015 compared to the second quarter and first half of the year 2014.

Based on accounting principles generally accepted in the United States (GAAP), Puma reported a net loss applicable to common stock of $64.7 million, or $2.01 per share, for the second quarter of 2015, compared to a net loss of $38.8 million, or $1.29 per share, for the second quarter of 2014. Net loss applicable to common stock for the first half of 2015 was $117.1 million, or $3.68 per share, compared to $58.6 million, or $1.96 per share, for the first half of 2014.

Adjusted net loss applicable to common stock was $36.5 million, or $1.13 per share, for the second quarter of 2015, compared to adjusted net loss applicable to common stock of $31.6 million, or $1.05 per share, for the second quarter of 2014. Adjusted net loss applicable to common stock for the first half of 2015 was $68.8 million, or $2.16 per share, compared to $46.3 million, or $1.55 per share, for the first half of 2014. Adjusted net loss applicable to common stock excludes stock-based compensation expense, which represents a significant portion of overall expense and has no impact on the cash position of the Company. For a reconciliation of adjusted net loss applicable to common stock to reported net loss applicable to common stock, please see the financial tables at the end of this news release.

Net cash used in operating activities for the second quarter of 2015 was $34.6 million. Net cash used in operating activities for the first half of 2015 was $84.6 million. At June 30, 2015, Puma had cash and cash equivalents of $59.8 million and marketable securities of $222.5 million, compared to cash and cash equivalents of $38.5 million and marketable securities of $102.8 million at December 31, 2014. Puma’s current level of cash and cash equivalents and marketable securities includes net proceeds of approximately $205.0 million from a public offering of the Company’s common stock, which was completed in January 2015.

"During the second quarter of 2015 we presented data from the Phase III ExteNET trial at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting," said Alan H. Auerbach, chairman and chief executive officer of Puma. "The positive study demonstrated that treatment with neratinib as extended adjuvant treatment following adjuvant treatment with trastuzumab in women with early-stage HER2 positive breast cancer reduced the risk of disease recurrence by 33%. The two-year disease-free survival rate was 93.9% in the neratinib arm versus 91.6% in the placebo arm. We anticipate our NDA filing for neratinib for the extended adjuvant setting during the first quarter of 2016. Also in the second quarter of 2015, we expanded the second cohort in the Phase II basket trial, which is evaluating the safety and efficacy of neratinib in patients with solid tumors who have an activating HER2 mutation. The second cohort includes patients with metastatic non-small cell lung cancer and whose tumors have a HER2 mutation.

"We expect to continue to execute on our ongoing Phase II and Phase III trials of PB272 in the second half of 2015 and beyond.
In addition, during the second half of 2015, we expect to (i) publish Phase III
ExteNET trial results in the extended adjuvant treatment of early stage HER2-positive breast cancer (anticipated in the third quarter of 2015); (ii) perform additional presentations of the ExteNET Phase III trial (anticipated in the third and fourth quarters of 2015); (iii) complete our ongoing Phase II FB-7 trial of PB272 as a neoadjuvant treatment for patients with HER2-positive breast cancer (anticipated in the third quarter of 2015); (iv) report data from our Phase II trial of PB272 in HER2 non-amplified breast cancer that has a HER2 mutation (anticipated in the fourth quarter of 2015); (v) report initial data from the Phase II trial of neratinib in extended adjuvant HER2 positive early stage breast cancer using loperamide prophylaxis (anticipated in the fourth quarter of 2015); (vi) complete the ongoing Phase II trial of PB272 in patients with HER2-positive metastatic breast cancer that has metastasized to the brain (anticipated in the second half of 2015); and (vii) expand additional cohorts in our Phase II basket trial of PB272 in patients with solid tumors with activating HER2 mutations (anticipated in the second half of 2015)."

Operating Expenses
Based on GAAP, operating expenses were $64.9 million for the second quarter of 2015, compared to $38.9 million for the second quarter of 2014. Operating expenses for the first half of 2015 were $117.5 million compared to $58.7 million for the first half of 2014.

General and Administrative Expenses:
Based on GAAP, general and administrative expenses were $5.5 million in the second quarter of 2015, compared to $3.9 million in the second quarter of 2014. General and administrative expenses for the first half of 2015 were $13.4 million compared to $7.4 million for the first half of 2014.

Research and Development Expenses:
Based on GAAP, research and development expenses were $59.4 million in the second quarter of 2015, compared to $35.0 million in the second quarter of 2014. Research and development expenses for the first half of 2015 were $104.1 million, compared to $51.3 million for the first half of 2014.