On March 15, 2016 Fortress Biotech, Inc. (NASDAQ: FBIO) announces its financial results for the fourth quarter and year ended December 31, 2015 (Filing, Q4/Annual, Fortress Biotech, 2015, MAR 15, 2016, View Source [SID:1234509552]).

Dr. Lindsay A. Rosenwald, Fortress Biotech’s Chairman, President and CEO, said, "2015 was a transformational year for Fortress Biotech both strategically and operationally. We continued to make progress executing our unique business plan of creating a portfolio of marketed and development-stage products under one umbrella. We believe this combination will enhance shareholder value. As a result of our aggressive efforts in 2015, Fortress Biotech now has several subsidiaries, or Fortress Companies, focused on a number of important, growing therapeutic areas. We plan to expand the number of Fortress Companies and expect to see continued advancement of our current pipeline as well as revenue growth in 2016 and beyond."

Financial Highlights:

· At December 31, 2015, Fortress Biotech’s consolidated cash and marketable securities totaled $98.2 million compared to $65.5 million at September 30, 2015 and $69.8 million at December 31, 2014, an increase of $32.7 million for the fourth quarter and an increase of $28.4 million for the year. This total excludes restricted cash of $14.6 million.
· Revenue totaled $0.9 million at December 31, 2015.
· License acquisitions totaled $11.4 million for the year ended December 31, 2015.
· Research and development expenses were $18.4 million for the year ended December 31, 2015, compared to $10.2 million for 2014. Noncash stock-based compensation expenses included in research and development were $5.8 million for the year ended December 31, 2015 and $1.1 million for 2014.
· General and administrative expenses were $21.6 million for the year ended December 31, 2015, compared to $10.4 million for 2014. Noncash stock-based compensation expenses included in general and administrative expenses were $8.5 million for the year ended December 31, 2015 and $4.4 million for 2014.
· For the year ended December 31, 2015, Fortress Biotech reported a net loss of $48.4 million, or $1.24 per share, compared to a net loss of $20.4 million, or $0.56 per share, for 2014.

Recent Corporate Events:

Avenue Therapeutics, Inc.
· In February 2015, Fortress Biotech purchased an exclusive license to an intravenous formulation of Tramadol for the U.S. market from Revogenex Ireland Limited. Fortress transferred the license and rights to Avenue during the first quarter of 2015.

Checkpoint Therapeutics, Inc.
· In March 2015, Checkpoint Therapeutics, Inc. ("Checkpoint") licensed a portfolio of fully human immuno-oncology targeted antibodies generated at the Dana-Farber Cancer Institute ("Dana Farber"). The portfolio includes antibodies targeting programmed-death ligand 1 ("PD-L1"), glucocorticoid-induced TNFR-related protein ("GITR") and carbonic anhydrase 9 ("CAIX"). Additionally, Fortress assigned its license from NeuPharma, Inc. for a small molecule inhibitor of epidermal growth factor receptor mutations to Checkpoint, effective March 2015.

· In connection with the license agreement with Dana-Farber, Checkpoint entered into a collaboration agreement with TG Therapeutics, Inc. ("TGTX") to develop and commercialize the Anti-PD-L1 and Anti-GITR antibody research programs in the field of hematological malignancies. Further, in connection with the NeuPharma license, Checkpoint entered into an option agreement with TGTX for a global collaboration in connection with the future development of the certain licensed compounds. Both programs are currently in preclinical development.
· In December 2015, Checkpoint licensed the exclusive worldwide rights to develop and commercialize a PARP (poly (ADP-ribose) polymerase) inhibitor from Teva Pharmaceutical Industries Ltd.’s subsidiary, Cephalon, Inc.
· Also in 2015, Checkpoint raised net proceeds of approximately $51.5 million from a series of private placement financings.

Escala Therapeutics, Inc.
· In July 2015, Escala Therapeutics, Inc. acquired from New Zealand Pharmaceuticals Limited a license from the National Institutes of Health and cooperative research and development agreements for the development of oral N-acetyl-D-mannosamine, a key compound in the sialic biosynthetic pathway for the treatment of hyposialylation disorders, including GNE myopathy and various forms of nephropathy.

Helocyte, Inc.
· In April 2015, Helocyte, Inc. ("Helocyte") entered into an agreement with the City of Hope National Medical Center ("COH") to secure exclusive worldwide rights for two T-cell immunotherapeutic vaccines, known as Triplex and PepVax, for controlling cytomegalovirus ("CMV") in allogeneic hematopoietic stem cell transplant ("HSCT") and solid organ transplant recipients. Triplex entered into a Phase 2 clinical study in February 2016 and PepVax is expected to enter Phase 2 clinical studies later this year. Both programs are supported by grants paid and payable to COH from the National Cancer Institute.
· In connection with the licensing of Triplex and PepVax, Helocyte further entered into an option agreement with COH for exclusive worldwide rights to Pentamer, a universal immunotherapeutic vaccine being developed for the prevention of CMV transmission in utero, and exercised this option on April 28, 2015.
· In December 2015, the results of the PepVax Phase 1b study in allogeneic HSCT CMV(+) recipients were published in Lancet Haematology.
· In February 2016, Helocyte entered into a Clinical Trial Agreement with the COH to support a Phase 2 Study of its Triplex vaccine for CMV control in allogeneic stem cell transplant recipients. The Phase 2 study is additionally supported by grants from the National Institutes of Health / National Cancer Institute. Helocyte expects data to emerge from this Phase 2 study in the first half of 2017.

Journey Medical Corporation
· In March 2015, Journey Medical Corporation ("JMC") entered into a license and supply agreement to acquire rights to distribute a dermatological product for the treatment of acne.
· In October 2015, JMC entered into a co-promotion agreement to sell a 2% topical lotion, Dermasorb HC, for the treatment of corticosteroid-responsive dermatoses.
· In January 2016, JMC entered into a product license and supply agreement with a third party to distribute a topical cream to promote wound healing for surgical treatments such as cryosurgery, Mohs surgery and biopsies.
· Additionally in January 2016, JMC entered into a distribution agreement with a third party to promote an emollient for the treatment of eczema.
· Both new products will be marketed under the Journey brand.

Mustang Bio, Inc.
· In March 2015, Fortress formed Mustang Bio, Inc. ("Mustang") to develop immunotherapies based on Chimeric Antigen Receptor T-Cells ("CAR-T") and Mustang entered into a license agreement with the COH to acquire such technology. In connection with the license agreement, Mustang also entered into a sponsored research agreement with COH in which Mustang will fund continued research at COH related to CAR-T.
· In the second half of 2015, Mustang entered the clinic with novel CAR-T studies for brain tumors and acute myeloid leukemia.

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On March 15, 2016 Calithera Biosciences, Inc. (Nasdaq:CALA), a clinical-stage pharmaceutical company focused on discovering and developing novel small molecule drugs directed against tumor metabolism and tumor immunology targets for the treatment of cancer, reported its financial results for the fiscal fourth quarter and year ended December 31, 2015 (Press release, Calithera Biosciences, MAR 15, 2016, View Source;p=RssLanding&cat=news&id=2148507 [SID:1234509553]). As of December 31, 2015, cash, cash equivalents and investments totaled $71.9 million.

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"In 2015, we made significant progress executing on our clinical development plan for CB-839, enrolling several monotherapy cohorts on our Phase 1 trials, while remaining on track with our IND-enabling studies for our immunotherapy arginase inhibitor, CB-1158, all while advancing internal preclinical programs," said Susan Molineaux, PhD, President and Chief Executive Officer of Calithera. "Looking forward to 2016, we expect to highlight new clinical data and scientific progress at oncology meetings, including CB-839 Phase 1b updates from our ongoing trials, dosing CB-839 in combination with other therapies. This is expected to occur initially in the second quarter of 2016, with further updates in the second half of the year. In addition, we plan on initiating a clinical trial of CB-839 in combination with a checkpoint inhibitor by mid-year. Our arginase inhibitor, CB-1158, is progressing towards the clinic with an IND filing expected mid-year."

Fourth Quarter 2015 and Recent Highlights

CB-839 clinical date presented at major medical meetings. The three phase I clinical trials with CB-839 in solid tumors and hematological malignancies continued to enroll throughout 2015, with 184 patients enrolled as of January 2016, across the three trials. New data presented at the AACR (Free AACR Whitepaper)-NCI-EORTC meeting in November demonstrate stable disease across a variety of tumor types, as well as a single agent partial response in a renal cell carcinoma (RCC) patient. This patient showed a 32% reduction in target lesions by RECIST with generalized shrinkage of lymph node metastases. Among the fifteen evaluable patients with RCC, nine (60%) had stable disease or better, with stable disease lasting three cycles (63 days). Among efficacy-evaluable patients across a range of tumor types treated on the current dosing schedule of twice-daily, 22 of 50 patients (44%) experienced stable disease or better. Five stable disease patients currently on study have been treated with CB-839 for over 8 months without progression (2 triple negative breast cancer, 1 RCC, 1 mesothelioma and 1 IDH1 mutant chondrosarcoma). In addition, the first results of CB-839 dosed in combination therapy were presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December.

Arginase inhibitor CB-1158 preclinical data presented at the AACR (Free AACR Whitepaper)-NCI-EORTC Meeting. CB-1158, a highly selective, orally bioavailable, small molecule inhibitor of human arginase with nanomolar potency, demonstrated single agent efficacy in animal models. Inhibition of tumor growth was accompanied by a rapid increase in the local concentration of arginine, and the induction of multiple pro-inflammatory changes in the tumor microenvironment. CB-1158, when administered with anti-CTLA-4, increased CD8+ T-cell infiltrates in the tumor. The addition of CB-1158 to anti-CTLA-4 and anti-PD-1, significantly inhibited tumor growth in a mouse model that was resistant to dual checkpoint inhibitor therapy. CB-1158 was well tolerated as a single agent and in combination with checkpoint inhibitors in animal studies.

Selected Fourth Quarter and Year-end 2015 Financial Results

Cash, cash equivalents and investments totaled $71.9 million at December 31, 2015 compared with $102.0 million at December 31, 2014.

Research and development expenses for the full year 2015 were $23.7 million, compared with $16.4 million in the prior year. The increase of $7.4 million in 2015 was primarily attributed to higher expenses associated with Calithera’s arginase inhibitor program, including the selection of CB-1158 and its advancement through preclinical development, and continued enrollment of CB-839, Calithera’s first-in-class glutaminase inhibitor, in phase 1 clinical trials. Calithera expects to file an IND for the arginase inhibitor program mid-2016. Research and development expenses for the fourth quarter of 2015 were $5.8 million, compared to $5.0 million for the same period last year.

General and administrative expenses for the full year 2015 were $9.1 million, compared with $5.4 million in the prior year. The increase of $3.7 million in 2015 was primarily due to higher employment related expenses, including stock based compensation expense, and professional service fees relating to Calithera’s costs associated with operating as a publicly traded company. General and administrative expenses for the fourth quarter of 2015 were $2.3 million, compared to $1.9 million for the same period last year.

Loss from operations for the three months and year end ended December 31, 2015 was $8.1 million and $32.6 million, respectively.

Financial Guidance for 2016

Calithera expects that its cash, cash equivalents and investments will be at least $35 million at the end of 2016, exclusive of any funds arising from new collaborations or partnerships, equity financings or other new sources.

On March 15, 2016 Diffusion Pharmaceuticals Inc. (OTCQX: DFFN), a clinical stage biotechnology company focused on the development of novel small molecule therapeutics for cancer, reported the online publication of a reviewed article on RES-529 ahead of print in Anti-Cancer Drugs (Press release, Diffusion Pharmaceuticals, MAR 15, 2016, View Source [SID:1234509556]).

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Diffusion Pharmaceuticals recently acquired RES-529, a novel PI3K/AKT/mTOR pathway inhibitor that targets both mTORC1 and mTORC2 through mTOR complex dissociation, from RestorGenex Corporation at the closing of its reverse merger on January 8, 2016. RES-529 is being developed for oncology and ophthalmology with a primary focus in the treatment of glioblastoma multiforme (GBM). Orphan drug designation has been granted by the FDA for this indication.

The article entitled "RES-529: a PI3K/AKT/mTOR pathway inhibitor that dissociates the mTORC1 and mTORC2 complexes," reviews the potential of RES-529 to inhibit tumorigenesis in glioblastoma, prostate cancer, and breast cancer. RES-529 treatment has been shown to be effective in preclinical models of glioblastoma as well as synergistic with radiation therapy in these models. In preclinical models of prostate cancer, RES-529 has been shown to be synergistic with all three common modalities of treatment: radiation therapy, chemotherapy, and hormonal therapy. The article was authored by Mark Weinberg, MD, MBA, who was previously Senior VP of Clinical Development at RestorGenex.

David Kalergis, Chairman and Chief Executive Officer of Diffusion Pharmaceuticals, said, "The acquisition of RES-529 has strengthened our oncology pipeline. Concurrent with our primary focus of advancing our lead candidate, trans sodium crocetinate (TSC), into a Phase III clinical program in GBM and a Phase II/III trial in pancreatic cancer, we are also assessing the future opportunities and plans for RES-529."

On March 15, 2016 AVEO Oncology (NASDAQ:AVEO) reported financial results for the full year ended December 31, 2015 and provided a business update (Press release, AVEO, MAR 15, 2016, View Source;p=RssLanding&cat=news&id=2148504 [SID:1234509532]).

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"Over the course of 2015, AVEO has streamlined its organization and taken a fresh strategic direction to create increased shareholder value. In 2016, we are squarely focused on furthering the execution of this strategy," said Michael Bailey, president and chief executive officer. "We remain focused on retaining rights to develop our three oncology-focused clinical programs in North America, while seeing our pipeline advanced by partners in the lab, clinic and through the regulatory process in geographies or disease areas outside of our strategic focus." Mr. Bailey concluded: "We are evaluating all options for funding the clinical and regulatory development of tivozanib in North America, including TIVO-3, the Company’s Phase 3 U.S. pivotal study of tivozanib in the third line treatment of patients with renal cell cancer, and a PD1 combination study. Subject to the outcome of our settlement discussions with the SEC, the Company could be in a position to begin patient enrollment in the TIVO-3 Study in the second quarter of 2016."

Recent Updates

Exclusive Licensing Agreement for Tivozanib in Europe with EUSA Pharma and Submission of a Marketing Authorization Application for Tivozanib in Renal Cell Carcinoma. In February 2016, AVEO and EUSA Pharma announced that EUSA Pharma has submitted a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) for tivozanib as a first line treatment for renal cell carcinoma (RCC). In December 2015, AVEO and EUSA Pharma announced an exclusive license agreement in which AVEO granted EUSA Pharma European rights to tivozanib for the treatment of advanced RCC. The agreement also includes a number of additional territories outside North America, including South America and South Africa, and potential additional indications. Under the terms of the agreement, AVEO received an upfront research and development funding payment of $2.5 million, and is eligible for up to $394 million in potential payments and milestones, assuming successful achievement of specified development, regulatory and commercialization objectives, as well as a tiered royalty ranging from a low double-digit up to mid-twenty percent on net sales of tivozanib in the agreement’s territories. A percentage of milestone and royalty payments received by AVEO are due to Kyowa Hakko Kirin as a sublicensing fee.

Exclusive Licensing Agreement for Tivozanib in Russia and other territories with Pharmstandard Group and Acceptance of Registration Dossier for Tivozanib in RCC by the Ministry of Health of the Russian Federation. In February 2016, AVEO announced that a registration dossier seeking to obtain marketing authorization of tivozanib as a first line treatment of advanced RCC has been accepted by the Ministry of Health of the Russian Federation. The dossier was submitted in December 2015 by Pharmstandard Group. In August 2015, AVEO licensed Pharmstandard rights to the development, manufacture and commercialization of tivozanib in the territories of Russia, Ukraine and the Commonwealth of Independent States, for all indications other than non-oncologic diseases or conditions of the eye. AVEO is eligible to receive up to $7.5 million in connection with the first marketing authorization of tivozanib in Russia. AVEO is also eligible to receive a high single-digit royalty on net sales, if any, in the above mentioned territories. A percentage of any milestone and royalty payments received by AVEO are due to Kyowa Hakko Kirin as a sublicensing fee.

Settlement discussions with the Securities and Exchange Commission. AVEO previously announced that the staff (the "SEC Staff") of the Securities and Exchange Commission (the "SEC") and AVEO have entered into discussions for the settlement of potential claims that the SEC may bring against the Company asserting that the Company previously violated federal securities laws by omitting to disclose to investors a recommendation made to the Company by the U.S. Food and Drug Administration in May 2012 that the Company conduct an additional clinical trial with respect to tivozanib. The Company’s settlement discussions with the SEC have continued, and the Company has accrued an estimated settlement liability, for accounting purposes, of $4.0 million in its financial statements as of December 31, 2015. There can be no assurance, however, that a settlement will be achieved with the SEC, or that any settlement we enter into with the SEC will be within the estimated settlement liability accrued.

Receipt of $3.5 Million AV-380 Inventory Reimbursement Payment from Novartis. AVEO previously announced that Novartis exercised its right under its license agreement for AV-380, AVEO’s first-in-class, potent, humanized inhibitory antibody targeting growth differentiation factor 15 (GDF15), to acquire AVEO’s inventory of clinical quality drug substance. This reimbursement payment of approximately $3.5 million was received in the first quarter of 2016. Novartis acquired an exclusive, worldwide license for the development and commercialization of AV-380 and related antibodies in August 2015. Under terms of the agreement, AVEO received an upfront payment of $15 million and the reimbursement payment of approximately $3.5 million, and is eligible to receive clinical, regulatory and sales-based milestone payments totaling $308 million, assuming successful advancement of the product. AVEO will also be eligible to receive tiered royalties on product sales ranging from high single digits to a low double-digit.
Full Year 2015 Financial Highlights

AVEO ended 2015 with $34.1 million in cash and investments.

Total collaboration revenue for 2015 was approximately $19.0 million compared with $18.1 million for 2014. The increase was primarily due to the recognition of $18.5 million of revenue associated with the receipt of a $15.0 million upfront payment for our license of AV-380 to Novartis and Novartis’ subsequent purchase of clinical material for $3.5 million. These amounts were partially offset by a decrease of $3.6 million of revenue from Astellas following the termination of our collaboration agreement in 2014 and a decrease of $14.3 million of revenue recognized from our arrangement with Biogen due to the one-time recognition of previously deferred revenue following an amendment to our agreement in 2014.

Research and development (R&D) expense for 2015 was $12.9 million compared with $38.3 million for 2014. The decrease in R&D expense was primarily due to a reduction in personnel-related, IT, and facilities expenses following AVEO’s January 2015 strategic restructuring as well as a decrease in outsourced services costs primarily related to the completion of the manufacture of AV-380 material in 2014; and a decrease in medical affairs and external clinical trial costs associated with the decreased number of active patients enrolled in our clinical trials.

General and administrative (G&A) expenses for 2015 were $14.2 million compared to $18.6 million for 2014. The decrease is primarily the result of a decrease in personnel-related, facilities, IT, insurance and other infrastructure costs following the Company’s January 2015 strategic restructuring as well as a decrease in external legal costs associated with various ongoing legal matters. These amounts were partially offset by $4.0 million in expense incurred in 2015 related to the accrual of an estimated settlement liability, for accounting purposes, related to the potential SEC claims and an increase in depreciation expense due to the acceleration of depreciation in connection with the termination of our lease agreement of 650 East Kendall Street in September 2014.

Restructuring and lease exit expense for 2015 was $4.4 million compared with $11.7 million for 2014. The expenses incurred during 2015 relate to costs associated with elimination of our research function and the associated reductions in headcount as part of our January 2015 restructuring. The expenses incurred during 2014 relate to costs associated with partially vacating and subsequently terminating the agreement for our leased space at 650 East Kendall Street, which occurred in September 2014.
Net loss for 2015 was $15.0 million, or a loss of $0.27 per basic and diluted share compared with net loss of $52.7 million or a loss of $1.01 per basic and diluted share for 2014.
Updated Financial Guidance

AVEO believe that its cash resources would allow the Company to fund its current operations into the fourth quarter of 2017. This estimate does not include the payment of potential licensing milestones or the uncommitted costs of conducting any contemplated clinical trials, and assumes no milestone payments from AVEO’s partners, no additional funding from new partnership agreements, no equity financings, no debt financings or accelerated repayment thereof and no further sales of equity under the Company’s ATM. This estimate also does not include any amount AVEO may agree to pay in excess of the estimated settlement liability, for accounting purposes, that the Company has established with respect to a potential settlement of claims with the SEC, as described in the Company’s 2015 annual report filed on Form 10-K.

28th Annual ROTH Conference

In lieu of a financial results conference call, AVEO will be presenting a corporate update at the 28th Annual ROTH Conference tomorrow, March 16, 2016, at 9:00 a.m. Pacific Time. A live webcast of the presentation can be accessed by visiting the investors section of the company’s website at www.aveooncology.com. A replay of the webcast will be archived for 30 days following the presentation date.

On March 15, 2016 Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company innovating the development of highly selective medicines for patients with genetically defined cancers, reported fourth quarter and year-end 2015 financial results and provided an update on its drug development programs (Press release, Loxo Oncology, MAR 15, 2016, View Source [SID:1234509558]). Loxo Oncology will not be conducting a conference call in conjunction with this earnings release.

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"We ended 2015 with great momentum behind LOXO-101 and our pipeline programs," said Josh Bilenker, M.D., chief executive officer of Loxo Oncology. "We are excited to announce that updated LOXO-101 adult Phase 1 data have been selected for an oral plenary session at AACR (Free AACR Whitepaper) in April. This presentation will provide further follow-up on the first three enrolled patients with TRK fusions that responded to LOXO-101, and will provide initial response assessment and follow-up on the next three enrolled patients with TRK fusions. We are also pleased to announce that we have developed a next-generation selective TRK inhibitor, LOXO-195, in collaboration with our partner Array BioPharma. Last year, we supported academic research to anticipate potential mechanisms of acquired resistance to TRK inhibition and we have continued to follow published literature reports that corroborate and add to those results. Should a patient progress on LOXO-101 or another compound, we hope LOXO-195 will be able to induce a new response in the patient and functionally extend time on therapy."

Dr. Bilenker continued, "We are fortunate that our financing in November allows us to fund operations well into 2018, which we believe will provide ample runway for potentially meaningful clinical data events for LOXO-101, LOXO-195, our RET program and other possible Array collaboration projects."

New Announcements

Updated LOXO-101 Phase 1 Data at AACR (Free AACR Whitepaper): Loxo Oncology announced today that updated clinical data from the ongoing LOXO-101 Phase 1 trial were accepted for oral plenary session presentation at the 2016 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in New Orleans, taking place April 16-20, 2016. This presentation will be an update to data presented at the AACR (Free AACR Whitepaper)-NCI-EORTC meeting in November 2015, with a focus on enrolled patients with TRK fusions. The abstract title will be posted online at 4:30 p.m. ET on Wednesday, March 16.
Next-Generation Selective TRK Inhibitor: Acquired resistance to targeted therapies has proven to be an important component of long-term cancer care and targeted therapy drug development. In anticipation of potential resistance to LOXO-101, and in light of recent published literature regarding emerging mechanisms of resistance to TRK inhibition, Loxo Oncology today unveiled its next-generation selective TRK inhibitor, LOXO-195, which is capable of addressing potential mechanisms of acquired resistance that may emerge in patients receiving LOXO-101 or multikinase inhibitors with anti-TRK activity. With the LOXO-195 program, Loxo Oncology has an opportunity to strengthen its leadership position in the field of TRK inhibition and clinically extend the duration of disease control for patients with TRK-driven cancers. Loxo Oncology will begin IND-enabling activities in 2016 that should enable initiation of a LOXO-195 Phase 1 study in 2017.
2015 Financial Results and 2016 Cash Guidance. As of December 31, 2015, Loxo Oncology had cash, cash equivalents and investments of $153.9 million. The company expects a cash burn of $48 to $52 million in 2016. The company believes that based upon its current operating plan, its existing capital resources will be sufficient to fund its anticipated operations well into 2018.

Recent Highlights

LOXO-101 Program

LOXO-101 Phase 1 Pediatric Trial Initiated: In December, Loxo Oncology enrolled the first patient in the LOXO-101 pediatric Phase 1 trial, a multicenter, open-label trial in pediatric patients with advanced solid or primary CNS tumors.
LOXO-101 Phase 1 Data Presented at AACR (Free AACR Whitepaper)-NCI-EORTC: Results from the Phase 1 study of LOXO-101 were reported in a late-breaking oral presentation at the 27th AACR (Free AACR Whitepaper)-NCI-EORTC Symposium on Molecular Targets and Cancer Therapeutics in November. As of the October 20, 2015 cutoff date, six patients with cancers harboring TRK fusions had been enrolled and treated. Three of the six patients with TRK fusion cancers had been on study long enough for their first efficacy assessment, and all three had achieved an objective response at the first response assessment, as defined by standard RECIST criteria. See the full data here.
LOXO-101 Phase 2 Basket Trial Initiated: In October, Loxo Oncology enrolled the first patient in the LOXO-101 Phase 2 trial, a global, multi-center, single-arm, open-label basket trial in adult patients with solid tumors that harbor a TRK fusion.
LOXO-101 Selected for NCI-MATCH Trial: In October, the independent committee of the National Cancer Institute-Molecular Analysis for Therapy Choice (NCI-MATCH) clinical trial chose LOXO-101 as the sole, dedicated treatment arm for patients with TRK gene fusions. Loxo Oncology anticipates that the NCI will activate the TRK fusion arm of this study later in 2016.

Pipeline: RET and FGFR Pre-clinical Programs

Data on RET and FGFR Programs Presented at AACR (Free AACR Whitepaper)-NCI-EORTC: Loxo Oncology presented two preclinical posters at AACR (Free AACR Whitepaper)-NCI-EORTC containing the first publicly disclosed data for its Rearranged during Transfection (RET) and Fibroblast Growth Factor Receptor (FGFR) programs showing potential best-in-class selectivity and target coverage.
RET Clinical Trial Initiation: Consistent with prior guidance, the company plans to initiate a Phase 1 study of its RET inhibitor in late 2016 or early 2017.

Corporate Activities

Strengthened Balance Sheet: Loxo Oncology raised $76.2 million in gross proceeds in an equity financing in November 2015. Loxo Oncology’s cash, cash equivalents and marketable securities are expected to be sufficient to fund operations well into 2018.

Fourth Quarter and Year-End 2015 Financial Results

Cash, cash equivalents and investments totaled $153.9 million as of December 31, 2015, compared to $112.9 million as of December 31, 2014. The increase was attributable to $71.3 million in net proceeds from our November 2015 equity financing offset by $30.3 million in cash burn.

Research and development expenses were $9.8 million for the fourth quarter of 2015 compared to $4.6 million in the fourth quarter of 2014. The increase was primarily attributable to expanded Phase 1 and Phase 2 clinical development activities for LOXO-101 and additional full-time equivalents and other support dedicated to discovery, preclinical, and manufacturing activities at Array BioPharma or third-party vendors.

Research and development expenses were $25.6 million for the year ended December 31, 2015, compared to $14.5 million for the year ended December 31, 2014. The increase was primarily due to expanded Phase 1 and Phase 2 clinical development activities for LOXO-101 and additional full-time equivalents and other support dedicated to discovery, preclinical, and manufacturing activities at Array BioPharma or third-party vendors. The company also recognized R&D-related stock-based compensation expense of $3.3 million during the year ended December 31, 2015 compared to $2.0 million for the year ended December 31, 2014.

General and administrative expenses were $3.2 million for the fourth quarter of 2015 compared to $2.6 million in the fourth quarter of 2014. The increase was primarily due to additional full-time equivalents, increased compensation costs and increased costs associated with operating as a public company.

General and administrative expenses were $10.5 million for the year ended December 31, 2015, compared to $6.2 million for the year ended December 31, 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 $2.8 million during the year ended December 31, 2015 compared to $1.0 million for the year ended December 31, 2014.

Net loss attributable to common stockholders was $12.9 million for the fourth quarter of 2015, compared to $7.1 million for the fourth quarter of 2014. Net loss attributable to common stockholders was $35.9 million for the year ended December 31, 2015, compared to $20.7 million for the year ended December 31, 2014.

About LOXO-101

LOXO-101 is a potent, oral and selective investigational new drug in clinical development for the treatment of patients with cancers that harbor abnormalities involving the tropomyosin receptor kinases (TRKs). Growing research suggests that the NTRK genes, which encode for TRKs, can become abnormally fused to other genes, resulting in growth signals that can lead to cancer in many sites of the body. In an ongoing Phase 1 clinical trial, LOXO-101 has demonstrated encouraging preliminary efficacy. LOXO-101 is also being evaluated in a global Phase 2 multi-center basket trial in patients with solid tumors that harbor TRK gene fusions, and a Phase 1 dose escalation trial in pediatric cancer patients. For additional information about both the LOXO-101 clinical trials, please refer to www.clinicaltrials.gov. Interested patients and physicians can contact the Loxo Oncology Physician and Patient Clinical Trial Hotline at 1-855-NTRK-123.