On August 5, 2015 Nektar Therapeutics (Nasdaq: NKTR) reported its financial results for the second quarter ended June 30, 2015 (Press release, Nektar Therapeutics, AUG 5, 2015, View Source [SID:1234507039]).

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Cash and investments in marketable securities at June 30, 2015 were $279.7 million as compared to $325.8 million at March 31, 2015.

"We are pleased that the MOVANTIK launch in the U.S. is off to an encouraging start with very rapid uptake," said Howard W. Robin, President and Chief Executive Officer of Nektar. "AstraZeneca plans to launch MOVANTIK in both Europe and Canada in the second half of this year. The SUMMIT-07 efficacy study of NKTR-181 in patients with chronic low back pain is well underway and proceeding ahead of schedule. We recently signed an important clinical collaboration with MD Anderson Cancer Center for our immuno-oncology therapy, NKTR-214, which is scheduled to enter a Phase 1 / 2 clinical study before year-end. Finally, Baxalta’s ADYNOVATE, or BAX 855, continues on track to be approved and launched in the U.S. by the end of 2015."

Year-to-date revenue for 2015 was $131.5 million as compared to $48.3 million in the first half of 2014. The increase in revenue in the first half of 2015 as compared to the same period in 2014 is due to the recognition of $90.0 million of the $100.0 million milestone payment from AstraZeneca following the first commercial sale of MOVANTIK in the U.S. Revenue in the second quarter of 2015 was $22.7 million as compared to $28.5 million in the second quarter of 2014. Revenue included non-cash royalty revenue, related to our 2012 royalty monetization, of $4.7 million and $8.7 million in the second quarter and first half of 2015, respectively, and $4.8 million and $10.6 million in the second quarter and first half of 2014, respectively. This non-cash royalty revenue is offset by non-cash interest expense.

Total operating costs and expenses in the first half of 2015 were $131.9 million as compared to $107.6 million in the first half of 2014. Total operating costs and expenses in the second quarter of 2015 were $66.1 million as compared to $51.4 million in the second quarter of 2014. Total operating costs and expenses increased primarily as a result of increased research and development (R&D) expense.

Research and development expense in the second quarter of 2015 was $45.4 million as compared to $36.7 million in the second quarter of 2014. For the first half of 2015, R&D expense was $92.4 million as compared to $75.0 million in the first half of 2014. R&D expense was higher in the second quarter and first half of 2015 as compared to the same periods in 2014 primarily due to the initiation of the Phase 3 efficacy study of NKTR-181 in patients with chronic low back pain. Additionally, R&D expense in the first half of 2015 included costs related to the commercial scale-up of production of devices for Amikacin Inhale, the ongoing Phase 3 study of NKTR-102 in breast cancer, the ongoing Phase 1 study of NKTR-171, and IND enabling activities for NKTR-214, which will enter the clinic in 2015.

General and administrative expense was $10.2 million in the second quarter of 2015 as compared to $9.6 million in the second quarter of 2014. G&A expense in the first half of 2015 was $20.5 million as compared to $19.5 million in the first half of 2014.

Net loss in the second quarter of 2015 was $52.7 million or $0.40 loss per share as compared to $32.6 million or $0.26 loss per share in the second quarter of 2014. Net loss in the first half of 2015 was $18.8 million or $0.14 loss per share as compared to $78.8 million or $0.63 loss per share in the first half of 2014.

The company also announced the following upcoming presentations and events:

IASLC 16th World Congress on Lung Cancer, Denver, CO:

Abstract/Poster Title: "Etirinotecan Pegol (NKTR-102) in the Treatment of Patients with Metastatic Non Small Cell Lung Cancer (NSCLC) after Failure of 2nd Line Treatment: A Phase II study", Aggarwal C., et al.
Date: September 9, 2015, 9:30 a.m. – 4:30 p.m. Mountain Time
CRI-CIMT-EATI-AACR Inaugural International Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper), Translating Science into Survival 2015, New York, NY:

Abstract/Poster Title: "Antitumor activity of the CD122-biased immunostimulatory cytokine combined with immune checkpoint blockade requires innate and adaptive immunity", Langowski, J., et al.
Date: September 18, 2015, 4:30-6:30 p.m. Eastern Time
Nektar Investor and Analyst R&D Day, St. Regis Hotel, New York, NY:

Date: October 8, 2015, 12:00-3:30 p.m. Eastern Time

On August 5, 2015 MacroGenics, Inc. (NASDAQ:MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, as well as autoimmune disorders and infectious diseases, today provided a corporate progress update and reported financial results for the second quarter ended June 30, 2015 (Press release, MacroGenics, AUG 5, 2015, View Source [SID:1234507038]).

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"In focusing on our mission to harness the power of the immune system to fight cancer and autoimmune diseases, we continue to make advancements across multiple fronts," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "Our fourth bi-specific DART molecule, MGD011, is in clinical testing with our collaboration partner, Janssen Biotech, Inc., and we expect that our fifth DART molecule, MGD009, will be in the clinic by year-end. In addition, we recently initiated SOPHIA, our Phase 3 study of margetuximab in patients with metastatic breast cancer. Beyond these programs, we continue to advance our other DART molecules as well as MGA271, an Fc-optimized antibody product candidate. Finally, with the additional capital recently raised, we are in an excellent position to accelerate the development of checkpoint inhibitor molecules as well as to expand our manufacturing capacity for anticipated clinical and commercial needs."

Pipeline Update

Margetuximab is an Fc-optimized monoclonal antibody that targets HER2. Recent highlights include:

SOPHIA Phase 3 Metastatic Breast Cancer Study: The Company recently enrolled the first patient in SOPHIA, a Phase 3 pivotal study. This randomized, open-label, two-arm, interventional Phase 3 study will evaluate margetuximab plus chemotherapy against trastuzumab plus chemotherapy in third-line metastatic breast cancer patients with HER2 expression at the 3+ level by IHC or 2+ level by IHC with gene amplification. The purpose of the study is to determine whether patients treated with margetuximab plus chemotherapy have longer progression-free and overall survival than patients treated with trastuzumab plus chemotherapy. MacroGenics plans to enroll 530 patients in this study and projects that it will take approximately three years to complete.

ASCO Presentation of Phase 1 Data: During the second quarter, MacroGenics presented margetuximab Phase 1 clinical data at the 2015 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in a poster discussion. Margetuximab was well tolerated by patients in this dose-escalation study and showed promising activity in patients who have limited treatment options. The updated Phase 1 study results show the potential for margetuximab in the treatment of HER2-expressing tumors.

Gastroesophageal Cancer Opportunity: The Company remains on track to initiate a Phase 1/2 combination study in gastroesophageal cancer starting in the fourth quarter of 2015.

MGA271 is an Fc-optimized monoclonal antibody that targets B7-H3, a member of the B7 family of molecules involved in immune regulation. Recent highlights include:

Recruiting Additional Monotherapy Expansion Cohorts: The Company is recruiting patients in multiple MGA271 monotherapy expansion cohorts in a Phase 1 study across various tumor types, including triple-negative breast cancer, head and neck cancer, renal cell cancer, melanoma (in patients who have progressed despite prior checkpoint inhibitor treatment), non-small cell lung cancer and bladder cancer.

Combination Studies: MacroGenics is currently enrolling a study of MGA271 in combination with ipilimumab in patients with B7-H3 positive melanoma, lung, and head and neck cancers. In the third quarter of 2015, the Company also expects to initiate a study of MGA271 in combination with pembrolizumab in patients with melanoma, non-small cell lung carcinoma and squamous cell carcinoma of the head and neck.

Presentation of Phase 1 MGA271 Data: In the fourth quarter of 2015, MacroGenics plans to present clinical data from the ongoing clinical trial.

MGD006 is a humanized DART molecule that recognizes both CD123 and CD3. CD123, the Interleukin-3 receptor alpha chain, is expressed on leukemia and leukemic stem cells. The primary mechanism of action of MGD006 is its ability to redirect T cells, via their CD3 component, to kill CD123-expressing cells. MacroGenics continues to enroll patients in the dose escalation portion of a Phase 1 study of MGD006 for the treatment of acute myeloid leukemia.

MGD007 is a humanized DART molecule that recognizes both the glycoprotein A33 antigen, or gpA33, and CD3. gpA33 is a gastrointestinal antigen with high expression in colorectal cancer. The primary mechanism of action of MGD007 is its ability to redirect T cells, via their CD3 component, to kill gpA33-expressing cells. MacroGenics continues to enroll patients in the dose escalation portion of a Phase 1 study of MGD007 for the treatment of colorectal cancer.

MGD010 is a humanized DART molecule that simultaneously targets CD32B and CD79B, two B-cell surface proteins. MGD010 is being developed for the treatment of autoimmune disorders and is designed to inhibit B-cell activation by exploiting the inhibitory function of CD32B, a checkpoint molecule expressed by B cells. MacroGenics continues to enroll patients in a Phase 1a study in normal healthy volunteers.

MGD011 is a humanized DART molecule that targets both CD19 and CD3 and is being developed for the treatment of B-cell hematological malignancies. MGD011 is designed to redirect T cells, via their CD3 component, to eliminate cells expressing CD19, a marker expressed in B-cell hematological malignancies. MGD011 has been engineered to address half-life challenges posed by other programs targeting CD19 and CD3, allowing for convenient intermittent dosing regimens in the clinical setting.

Pursuant to a collaboration agreement executed with Janssen Biotech, Inc. in December 2014, Janssen is developing MGD011. The first patient in an open-label Phase 1 study received the first dose of MGD011 in late July, triggering a $10 million milestone payment to MacroGenics. Janssen’s Phase 1 study will evaluate the safety, tolerability and preliminary clinical activity of MGD011 when administered to patients with relapsed or refractory B-cell malignancies, including diffuse-large B cell lymphoma, follicular lymphoma, mantle-cell lymphoma, chronic lymphocytic leukemia and acute lymphoblastic leukemia. MacroGenics retains options to co-promote the product in the United States and Canada and to invest in later-stage development in exchange for a profit-share.

MacroGenics continues to advance several additional antibody and DART-based pre-clinical molecules, including MGD009, for which MacroGenics retains worldwide development and commercialization rights.

Corporate Update

Equity Offering: In July, the Company completed an equity offering, raising $141 million in net proceeds, which includes exercise of the underwriters’ option to acquire additional shares in full. MacroGenics intends to use the proceeds of this offering to expand its manufacturing capacity, accelerate development of undisclosed immune checkpoint-based product candidates, advance other research and development programs, in-license or acquire other products or technologies, or for general corporate purposes.

Manufacturing Expansion: The Company recently signed a lease for additional space with a focus on expanding its commercial manufacturing capabilities. MacroGenics expects to complete the design of the new manufacturing space this year.

R&D Day: The Company plans to host an R&D Day in New York on Tuesday, October 13, 2015.

Second Quarter 2015 Financial Results

Cash Position: Cash and cash equivalents as of June 30, 2015 were $235.0 million, compared to $157.6 million as of December 31, 2014. Subsequent to June 30, 2015, MacroGenics completed an equity offering of 4,053,750 shares (including full exercise of the underwriters’ option to acquire additional shares) with net proceeds of $141 million to the Company.
Revenue: Total revenues, consisting primarily of revenue from collaborative research, were $6.7 million for the three-month period ended June 30, 2015 compared to $9.2 million for the three-month period ended June 30, 2014. Collaborative research revenue includes the recognition of deferred revenue from payments received in previous periods as well as payments received during the quarter.

R&D Expenses: Research and development expenses were $22.7 million for the three-month period ended June 30, 2015, compared to $17.3 million for the three-month period ended June 30, 2014. This increase was primarily due to recently commenced clinical trial activities and preparations for additional studies, offset in part by a decrease in expenses related to a product candidate transferred to a partner following IND submission.

G&A Expenses: General and administrative expenses were $5.3 million for the three-month period ended June 30, 2015, compared to $4.1 million for the three-month period ended June 30, 2014. This increase was primarily due to higher stock-based compensation expense and labor costs as well as information technology-related expenses.

Net Loss: Net loss was $21.4 million for the three-month period ended June 30, 2015, compared to net loss of $12.3 million for the three-month period ended June 30, 2014.

Shares Outstanding: Shares outstanding as of June 30, 2015 were 30,123,407, excluding the 4,053,750 shares issued in connection with the July equity offering.

On August 5, 2015 Geron Corporation (Nasdaq:GERN) reported financial results for the second quarter ended June 30, 2015 (Press release, Geron, AUG 5, 2015, View Source;p=RssLanding&cat=news&id=2076212 [SID:1234507035]).

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Second Quarter 2015 Results

For the second quarter of 2015, the company reported a net loss of $9.4 million, or $0.06 per share, compared to $8.7 million, or $0.06 per share, for the comparable 2014 period. Revenues for the second quarter of 2015 were $251,000 compared to $341,000 for the comparable 2014 period. Interest and other income for the second quarter of 2015 amounted to $145,000 compared to $99,000 for the comparable 2014 period. The company ended the second quarter of 2015 with $157.0 million in cash and investments.

Total operating expenses for the second quarter of 2015 were $9.7 million compared to $9.0 million for the comparable 2014 period. Research and development expenses for the second quarter of 2015 were $4.8 million compared to $5.2 million for the comparable 2014 period. General and administrative expenses for the second quarter of 2015 were $4.0 million compared to $3.9 million for the comparable 2014 period. Operating expenses for the 2015 second quarter also included restructuring charges of $941,000 in connection with the company’s organizational resizing announced in March 2015.

The decrease in research and development expenses for the 2015 second quarter, compared to the same period in 2014, was primarily the net result of reduced personnel-related and other research costs resulting from the organizational resizing, partially offset by increased costs for the development of imetelstat for hematologic myeloid malignancies in collaboration with Janssen Biotech, Inc. (Janssen). The company expects research and development expenses to increase during the remainder of the year as the development of imetelstat continues in collaboration with Janssen. The increase in general and administrative expenses for the 2015 second quarter, compared to the same period in 2014, was primarily the result of higher non-cash stock-based compensation expense and higher consulting costs in connection with business development activities to identify potential new product candidates.

Six Months Ended 2015 Results

Net loss for the first six months of 2015 was $18.7 million, or $0.12 per share, compared to $17.2 million, or $0.11 per share, for the comparable 2014 period. Revenues for the first six months of 2015 were $788,000 compared to $815,000 for the comparable 2014 period. Interest and other income for the first six months of 2015 was $294,000 compared to $182,000 for the comparable 2014 period. The company has not incurred any impairment charges on its investment portfolio.

Total operating expenses for the first six months of 2015 were $19.7 million compared to $18.2 million for the comparable 2014 period. Research and development expenses for the first six months of 2015 were $9.8 million compared to $10.4 million for the comparable 2014 period. General and administrative expenses for the first six months of 2015 were $8.6 million compared to $7.8 million for the comparable 2014 period. Year-to-date operating expenses for 2015 also included restructuring charges of $1.3 million.

The decrease in research and development expenses for the first six months of 2015, compared to the same period in 2014, was primarily the net result of reduced personnel-related and other research costs resulting from the organizational resizing, partially offset by increased costs for the development of imetelstat in collaboration with Janssen. The increase in general and administrative expenses for the first six months of 2015, compared to the same period in 2014, was primarily the result of higher non-cash stock-based compensation expense and higher consulting costs in connection with business development activities to identify potential new product candidates.

Recent Company Events

Status of Imetelstat Collaboration with Janssen

In June 2015, the United States Food and Drug Administration (FDA) granted orphan-drug status to imetelstat for the treatment of myelofibrosis.

In July 2015, the IMbark study, a Phase 2 clinical trial to evaluate the activity of two dose levels of imetelstat in patients with DIPSS intermediate-2 or high-risk myelofibrosis who have relapsed after or are refractory to a JAK inhibitor, opened to patient enrollment at the first study site. Multiple medical centers across North America, Europe and Asia are planned to participate in this clinical trial. For more information about the IMbark study being conducted by Janssen, please visit View Source

"We expect our transition activities for the imetelstat program to Janssen to be completed in the third quarter and have been pleased with the progress Janssen has made with imetelstat," said John A. Scarlett, M.D., Geron’s President and Chief Executive Officer. "Our business development efforts continue, as we seek to identify and acquire and/or in-license other oncology products, programs or companies."

On August 5, 2015 Fate Therapeutics, Inc. (NASDAQ: FATE), a biopharmaceutical company engaged in the development of programmed cellular immunotherapeutics for the treatment of severe, life-threatening diseases, reported its financial results for the second quarter ended June 30, 2015, and recent corporate and clinical highlights (Filing, 8-K, Fate Therapeutics, AUG 5, 2015, View Source [SID:1234507034]).

"The interim data from our Phase 2 PUMA study indicate that the therapeutic value proposition of PROHEMA may include the prevention of severe life-threatening infections across a broad spectrum of bacterial, fungal and viral pathogens through a one-time administration at the time of hematopoietic cell transplantation (HCT). This would alleviate a significant cause of morbidity and mortality in patients undergoing HCT and also reduce the need for costly anti-infective treatment regimens following HCT," said Christian Weyer, M.D., M.A.S., President and Chief Executive Officer of Fate Therapeutics. "During the second half of 2015, we look forward to sharing additional clinical data from our adult and pediatric clinical development initiatives for PROHEMA. Additionally, we are aggressively moving to extend the promising observations from our PROHEMA clinical experience to other cell sources used in HCT including mobilized peripheral blood, where severe infections and graft-versus-host disease represent significant unmet medical needs. We remain on track to file an IND by the end of 2015 for PROTMUNE, a programmed mobilized peripheral blood immunotherapeutic designed to enhance the therapeutic properties of donor T cells."

Recent Corporate & Clinical Highlights

· Encouraging Immunoprotection Data from Ongoing PUMA Study Observed. On May 6, 2015, the Company reported interim data from an initial 30 subjects in its ongoing Phase 2 PUMA study of PROHEMA, a programmed hematopoietic cell-based immunotherapeutic derived from umbilical cord blood. Immunocompromised subjects administered PROHEMA had a 54% reduction in the rate of infection-related adverse events, including severe bacterial, fungal and viral infections following HCT. Specifically, subjects administered PROHEMA experienced 0.7 total events per subject (13 total events in 18 subjects) as compared to 1.6 total events per subject in the control cohort (19 total events in 12 subjects). Importantly, the event rate for cytomegalovirus (CMV) infection was 0.0 in subjects administered PROHEMA (0 total events in 18 subjects) as compared to 0.3 in the control cohort (4 total events in 12 subjects); and the event rate for bacterial infections was 0.3 in subjects administered PROHEMA (6 total events in 18 subjects) as compared to 0.6 in the control cohort (7 total events in 12 subjects). The ongoing PUMA study, which is designed to investigate several key measures of hematopoietic reconstitution and immunoprotection in adult subjects undergoing double umbilical cord blood transplantation, is expected to enroll approximately 60 total subjects, randomized at a ratio of 2:1.

· First Subject Treated in Pediatric PROVIDE Study Assessing CNS Cellular Replacement Potential of PROHEMA. The first subject in the Company’s Phase 1b PROVIDE study, an open-label clinical study of PROHEMA designed to enroll 12 pediatric subjects undergoing single umbilical cord blood transplantation for the treatment of inherited metabolic disorders, has been treated. The study’s design includes serial neuro-imaging and neuro-cognitive assessments to explore the potential of programmed hematopoietic cells to durably reconstitute in the brain and deliver enzymes which are otherwise missing to the central nervous system. Multiple inherited metabolic disorders, including lysosomal and peroxisomal storage diseases such as Hurler and Hunter syndromes, Krabbe disease and other leukodystrophies, qualify for treatment under the PROVIDE study.

· IND for Programmed Mobilized Peripheral Blood Immunotherapeutic to be Filed in 2H15. The Company expects to file an Investigational New Drug application in the second half of 2015 to conduct a first-in-human clinical assessment of PROTMUNE, a programmed hematopoietic cell-based immunotherapeutic derived from mobilized peripheral blood. In preclinical models of acute graft-versus-host disease (GvHD), host mice that received programmed mobilized peripheral blood cells from a mismatched donor showed a statistically-significant (p<0.0001) reduction in GvHD score and a statistically-significant (p=0.0005) improvement in survival, as compared to mice that received vehicle treated cells. The Company plans to evaluate the potential of PROTMUNE to reduce life-threatening complications of allogeneic HCT, such as acute GvHD, in adult subjects undergoing mobilized peripheral blood HCT.

· Strategic Research Collaboration Formed with Juno Therapeutics to Program CAR T and TCR Immunotherapeutics. On May 4, 2015, the Company entered into a research collaboration and license agreement with Juno to identify and apply small molecule modulators to program genetically-engineered chimeric antigen receptor (CAR) T-cell and T-cell receptor (TCR) immunotherapeutics. Under the collaboration, Juno paid the Company an upfront fee of $5.0 million, purchased one million shares of the Company’s common stock at $8.00 per share, and agreed to fund all of the Company’s collaboration activities during the four-year research term. For each product developed by Juno that incorporates modulators identified through the collaboration, the Company is eligible to receive clinical, regulatory and commercial milestones, plus royalties on net sales.

· Natural Killer Cell-based "Off-the-Shelf" Cancer Immunotherapeutic Programs Launched in Collaboration with University of Minnesota. In July 2015, the Company entered into a collaboration with the University of Minnesota to clinically translate two distinct NK cell-based cancer immunotherapeutic programs, both of which seek to overcome key limitations of adoptive T-cell immunotherapy including the requirement to isolate and engineer cells for each individual patient. In the first program the Company intends to accelerate the development of an "adaptive" NK cell phenotype, which has been shown to have an epigenetic profile similar to that of cytotoxic T lymphocytes and to exhibit long-term persistence in vivo. The second program leverages the Company’s proprietary induced pluripotent stem cell (iPSC) technology, which has the potential to enable the efficient and precise engineering of single pluripotent cells and the large-scale clonal expansion of such cells, in the development of iPSC-derived NK cell-based targeted cancer immunotherapeutics.

Financial Results

· Cash Position: Cash and cash equivalents as of June 30, 2015 were $81.2 million, compared to $49.1 million as of December 31, 2014. The increase is primarily driven by net proceeds from the Company’s public offering of common stock in May 2015 and cash generated from entering into the strategic research collaboration with Juno, offset by cash used to fund operating activities.

· Total Revenue: Revenue was $0.3 million for the second quarter of 2015, which was derived from the Company’s strategic research collaboration with Juno.

· Total Operating Expenses: Total operating expenses were $7.5 million for the second quarter of 2015, compared to $6.0 million for the second quarter of 2014. Operating expenses for the second quarter of 2015 includes $0.7 million of stock compensation expense, compared to $0.4 million for the second quarter of 2014.

· R&D Expenses: Research and development expenses were $4.9 million for the second quarter of 2015, compared to $4.0 million for the second quarter of 2014. The increase in R&D expenses is primarily related to an increase in personnel expense, including stock-based compensation expense, resulting from additional headcount to support the clinical development of PROHEMA and the preclinical evaluation of the Company’s other product candidates.

· G&A Expenses: General and administrative expenses were $2.7 million for the second quarter of 2015, compared to $2.1 million during the second quarter of 2014. The increase in G&A expenses is primarily related to an increase in personnel expense, including stock-based compensation expense, and an increase in intellectual property expenses.

· Common Shares Outstanding: Common shares outstanding as of June 30, 2015 were 28.6 million compared to 20.6 million in December 31, 2014. Common shares outstanding increased primarily as a result of the 6.9 million shares of the Company’s common stock issued pursuant to the May 2015 financing, and the 1.0 million shares of the Company’s common stock issued and sold to Juno pursuant to the strategic research collaboration.

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On August 5, 2015 Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company focused on the discovery, development, and commercialization of targeted cancer therapies, reported financial results for the second quarter 2015 ended June 30, 2015 and provided an update on its pipeline (Press release, Loxo Oncology, AUG 5, 2015, View Source [SID:1234507028]).

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"Over the last several months, Loxo has delivered important advances against our pipeline priorities," said Josh Bilenker, M.D., chief executive officer of Loxo Oncology. "Last week, we achieved an important milestone with the peer-reviewed publication of the first clinical response to LOXO-101, our tropomyosin receptor kinase (TRK) inhibitor. This important early result validates the potential of Loxo’s drug development approach – that selective, purpose-built medicines in genetically well-defined populations can show dramatic and early evidence that justifies continued and rapid drug development. Today we are excited to announce plans for a Phase 2 trial for this program, which accelerate development timelines ahead of previous plans. In addition, we have made significant progress with our preclinical pipeline, allowing us to prioritize our Rearranged during Transfection (RET) and our isoform-sparing Fibroblast Growth Factor Receptor (FGFR) programs, positioning them as our likely next IND filings."

Program Updates

Loxo provided the following updates on its development programs:

LOXO-101: the only potent, oral, selective inhibitor of the TRK family of proteins

Clinical Validation for LOXO-101 Published in Cancer Discovery

The research brief published on July 27, 2015 in Cancer Discovery provides early clinical validation of LOXO-101 against TRK fusion cancer.

The publication, authored in collaboration with Foundation Medicine, Inc. and the Doebele Research Lab at the University of Colorado, includes the case study of the first TRK fusion patient treated in the Phase 1 trial of LOXO-101. A woman with advanced soft tissue sarcoma widely metastatic to the lungs enrolled on study and experienced substantial tumor regression, with imaging studies after one month demonstrating a partial response (PR) as defined by standard RECIST 1.1 criteria. The patient’s shortness of breath rapidly resolved and she was able to discontinue her supplemental oxygen and resume activities of daily living. As discussed in the publication, with four months of treatment, additional CT scans demonstrated almost complete tumor disappearance of the largest tumors. After four months of dosing, the patient did not have any adverse events that were attributed to LOXO-101.

The publication also describes novel assays for assessing LOXO-101’s impact on TRK signaling, patient-derived TRK fusion models in vitro and in vivo which illustrate LOXO-101’s TRK inhibition, and the first-ever description of the molecular epidemiology of TRK fusions in soft tissue sarcoma.

LOXO-101 Phase 2 Trial to Open in the Second Half of 2015

Based on evidence from the Phase 1 trial, including drug exposures that exceeded expectations, Loxo plans to initiate a Phase 2 trial in the second half of this year, earlier than previously anticipated. The trial will be a multicenter, international Phase 2 open label study in adult cancer patients whose tumors harbor TRK fusions. Loxo will provide additional details on the timing, size, and design of the Phase 2 trial after the first clinical site is open.
Loxo believes that a wide variety of tumor types harbor TRK fusions, and plans to work creatively with clinical partners to identify patients with these genetic alterations. Loxo will provide additional details on these plans after the first clinical site of the Phase 2 trial is open.

LOXO-101 Phase 1 Update

In the ongoing Phase 1 study, LOXO-101 continues to consistently achieve systemic drug exposures anticipated to inhibit TRK signaling by over 90%.
Loxo anticipates presenting additional data from the Phase 1 study at a leading medical meeting likely by the first half of 2016.
An update on the future direction of the ongoing Phase 1 trial will be provided in conjunction with the start of the Phase 2 trial.

Pre-clinical Programs

Prioritization of RET and FGFR Programs

Loxo’s collaboration with Array BioPharma continues to generate compelling and differentiated chemical matter. Loxo has used its multi-target, prioritize-by-success collaboration structure to focus on RET and FGFR.
Activating fusions and mutations in RET have been identified across a range of cancer histologies. Loxo is designing a highly specific RET inhibitor that optimizes on-target potency for RET fusions, activating mutations, and anticipated resistance mutations.
Activating fusions and mutations in FGFR3 and FGFR2 have also been identified across a range of cancer histologies. However, most small molecule FGFR inhibitors are functionally equipotent against isoforms FGFR1, FGFR2 and FGFR3, and are associated with metabolic and systemic toxicities that limit dose, duration of therapy and target engagement. Loxo is designing an FGFR1-sparing inhibitor that has the potential to avoid many of the side effects that have been endemic to the FGFR class.

Consistent with prior guidance, Loxo has submitted preclinical data abstracts for presentation at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) meeting in November 2015 in Boston, MA. These data will provide evidence of some of the clinically-differentiating features of these programs. Loxo will provide IND guidance for one of these programs by the end of 2015.

Loxo has elected not to file an IND in the first half of 2016 on either of the two unnamed preclinical programs discussed in previous announcements. These programs have identified lead candidates, but still require additional target validation to merit clinical investigation, in the opinion of the Loxo scientific advisory board and management.

Second Quarter 2015 Financial Results

As of June 30, 2015 Loxo had aggregate cash, cash equivalents and investments of $101.8 million, compared to $112.9 million as of December 31, 2014.

The Company continues to expect cash burn of $30-$33 million in 2015, and based on the current operating plan, the Company believes existing capital resources will be sufficient to fund anticipated operations into 2017.

Research and development expenses were $5.7 million for the second quarter 2015 compared to $2.7 million for the second quarter 2014. The increase was primarily due to expanded clinical development activities for LOXO-101 and additional full-time equivalents and other support dedicated to discovery, preclinical, and manufacturing activities at Array BioPharma. The Company also recognized R&D-related stock-based compensation expense of $0.9 million during the second quarter of 2015 compared to $0.3 million for the second quarter of 2014.

Research and development expenses were $9.5 million for the six months ended June 30, 2015 compared to $4.8 million for the six months ended June 30, 2014. The increase was primarily due to expanded clinical development activities for LOXO-101 and additional full-time equivalents and other support dedicated to discovery, preclinical, and manufacturing activities at Array BioPharma. The Company also recognized R&D-related stock-based compensation expense of $1.4 million during the six months ended June 30, 2015 compared to $0.3 million for the six months ended June 30, 2014.

General and administrative expenses were $2.4 million for the second quarter 2015 compared to $1.2 million for the second quarter 2014. The increase was primarily due to additional full-time equivalents, increased compensation costs and increased costs associated with operating as a public company. The Company also recognized G&A-related stock-based compensation expense of $0.8 million during the second quarter of 2015 compared to $0.2 million for the second quarter of 2014.

General and administrative expenses were $4.8 million for the six months ended June 30, 2015 compared to $2.0 million for the six months ended June 30, 2014. The increase was primarily due to additional full-time equivalents, increased compensation costs and increased costs associated with operating as a public company. The Company also recognized G&A-related stock-based compensation expense of $1.3 million during the six months ended June 30, 2015 compared to $0.2 million for the six months ended June 30, 2014.

Net loss attributable to common shareholders was $8.1 million and $14.2 million for the three and six months ended June 30, 2015, respectively, compared to $3.9 million and $6.8 million for the three and six months ended June 30, 2014, respectively.