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Archive for February, 2017

  • Zafgen to Present at Upcoming Investor Conferences

    by on February 28th, 2017

    BOSTON, Feb. 28, 2017 (GLOBE NEWSWIRE) — Zafgen, Inc. (Nasdaq:ZFGN), a biopharmaceutical company dedicated to significantly improving the health and well-being of patients affected by metabolic diseases including type 2 diabetes and obesity, ann…

  • Portola Pharmaceuticals Reports Fourth Quarter and Year-End 2016 Financial Results and Provides Corporate Update

    by on February 28th, 2017

    SOUTH SAN FRANCISCO, Calif., Feb. 28, 2017 (GLOBE NEWSWIRE) — Portola Pharmaceuticals, Inc.® (NASDAQ:PTLA) today provided a corporate update and reported its financial results for the fourth quarter and year ended December 31, 2016.

    “We are working towards gaining approval of both betrixaban, our investigational oral Factor Xa inhibitor, and andexanet alfa, our investigational antidote for oral Factor Xa inhibitors, in the United States and Europe over the next year,” said Bill Lis, chief executive officer of Portola. “Each has the potential to become the first product approved for their respective indications and both are highly anticipated by the medical community. We are confident in the robust clinical data for both products, and are focused on addressing the regulatory risks that remain.”

    Recent Achievements, Upcoming Events and Milestones

    Betrixaban – an oral Factor Xa inhibitor anticoagulant in development for extended prophylaxis of venous thromboembolism (VTE) in acute medically ill patients with risk factors for VTE; designated Fast Track status by the U.S. Food and Drug Administration (FDA)

    • The FDA accepted the New Drug Application (NDA), granted priority review, and established a Prescription Drug User Fee Act (PDUFA) action date of June 24, 2017
    • FDA informed Portola at the mid-cycle review that it does not plan to schedule an Advisory Committee meeting to discuss the NDA
    • The European Medicines Agency (EMA) validated the Marketing Authorization Application (MAA) under a standard 210-day review period; the Committee for Medicinal Products for Human Use (CHMP) opinion is expected by the end of the year

    AndexXa™ (andexanet alfa) – a Factor Xa inhibitor antidote in development for patients treated with a Factor Xa inhibitor when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding; designated a Breakthrough Therapy and an Orphan Drug by the FDA

    • Expanded the existing agreement with Daiichi Sankyo; Portola received a $15 million upfront payment and is eligible to receive up to an additional $10 million upon meeting certain milestones; upon AndexXa’s approval, Daiichi will be eligible to receive a capped royalty
    • Resubmission of the Biologics License Application (BLA) is anticipated in the second quarter of 2017
    • Continued to enroll patients in the ongoing Phase 3b/4 ANNEXA®-4 Study in patients with acute major bleeding; the Data and Safety Monitoring Board (DSMB) successfully completed its third review

    Cerdulatinib – an oral, dual Syk/JAK inhibitor in development to treat resistant or relapsed hematologic cancer patients

    • Continued to enroll patients in a Phase 2a study evaluating the safety and efficacy of cerdulatinib in patients with relapsed/refractory B-cell malignancies who have failed multiple therapies
    • Entered into an exclusive worldwide licensing agreement with Dermavant Sciences for the development and commercialization of cerdulatinib in topical applications beyond oncology; Portola retains full rights to all non-topical formulations of cerdulatinib, including oral formulations

    Corporate

    • Entered into a $50 million loan agreement with Bristol-Myers Squibb Company and Pfizer Inc. for continued development and clinical studies of andexanet alfa
    • Entered into a $150 million royalty agreement in the first quarter of 2017 with HealthCare Royalty Partners in exchange for a tiered, mid-single-digit royalty based on worldwide andexanet alfa sales

    Fourth Quarter and Year-End Financial Results
    Collaboration and license revenue earned under Portola’s collaboration and license agreements with Bristol-Myers Squibb Company and Pfizer, Bayer Pharma and Janssen Pharmaceuticals, Daiichi Sankyo and Dermavant Sciences was $13.7 million for the fourth quarter of 2016 compared with $4.4 million for the fourth quarter of 2015. Collaboration and license revenue for the year ended December 31, 2016, was $35.5 million compared with $12.1 million for the year ended December 31, 2015.

    Total operating expenses for the fourth quarter of 2016 were $68.9 million compared with $70.7 million for the same period in 2015. Total operating expenses for the fourth quarter of 2016 included $7.9 million in stock-based compensation expense compared with $6.8 million for the same period in 2015. Total operating expenses for the year ended December 31, 2016, were $305.1 million compared with $239.2 million for 2015. Total operating expenses for the full year ended December 31, 2016, included $30.4 million in stock-based compensation expense compared with $22.9 million for 2015.

    Research and development expenses for the fourth quarter of 2016 were $56.0 million compared with $59.8 million for the same period in 2015. Research and development expenses were $246.9 million for the year ended December 31, 2016, compared with $200.4 million for 2015. The increase in R&D expenses was primarily due to increased program costs to advance andexanet alfa of $64.7 million, including a $27.3 million one-time charge to write off certain prepaid manufacturing costs and increased program costs to support cerdulatinib and early research programs of $3.8 million, partially offset by decreased program costs related to betrixaban of $22.0  million following the completion of the APEX clinical trial enrollment.

    Selling, general and administrative expenses for the fourth quarter of 2016 were $12.9 million compared with $10.9 million for the same period in 2015. Selling, general and administrative expenses for the year ended December 31, 2016, were $58.2 million compared with $38.9 million for 2015. The increase in SG&A expenses was primarily due to increased headcount-related costs, commercial launch preparation activities and business development-related costs, and costs associated with professional and accounting fees of $2.0 million.

    For the fourth quarter of 2016, Portola reported a net loss of $53.8 million, or $0.95 net loss per share, compared with a net loss of $66.1 million, or $1.23 net loss per share, for the same period in 2015. Shares used to compute net loss per share attributable to common stockholders were 56.5 million for the fourth quarter of 2016 compared with 53.6 million for the same period in 2015. Net loss for the year ended December 31, 2016, was $269.0 million, or $4.76 net loss per share, compared with a net loss of $226.5 million, or $4.36 net loss per share, for the same period in 2015. Shares used to compute net loss per share attributable to common stockholders were 56.5 million for 2016 compared with 52.0 million for 2015.

    Cash, cash equivalents and investments at December 31, 2016, totaled $318.8 million compared with cash, cash equivalents and investments of $460.2 million as of December 31, 2015.

    2017 Annual Financial Guidance
    For the fiscal year 2017, Portola expects total GAAP operating expenses to be between $323 million and $344 million. For the fiscal year 2017, Portola expects total pro-forma operating expenses to be between $290 million and $310 million, excluding stock-based compensation. These expenses will be primarily for manufacturing of both andexanet and betrixaban, support of ongoing clinical trials and preparation for the potential commercial launches of betrixaban and AndexXa.

    Non-GAAP Financial Projection
    This press release and the reconciliation table included herein include a non-GAAP projection of 2017 operating expenses, excluding stock-based compensation. A reconciliation to projected GAAP 2017 operating expenses is provided in the accompanying table entitled “Reconciliation of GAAP to Non-GAAP Projected Operating Expenses.” Portola management believes this non-GAAP information is useful for investors because it provides information about the Company’s ability to independently fund and advance its operations with existing capital resources. Share-based compensation is not an expense that requires cash settlement, and therefore, the Company excludes these charges for purposes of evaluating our ability to fund future operations.

    Conference Call Details
    The live conference call today, Tuesday, February 28, 2017, at 4:30 p.m. Eastern Time, can be accessed by phone by calling (844) 452-6828 from the United States and Canada or 1 (765)-507-2588 internationally and using the passcode 71935945. The webcast can be accessed live on the Investor Relations section of the Company’s website at http://investors.portola.com. It will be archived for 30 days following the call. 

    About Portola Pharmaceuticals, Inc.    
    Portola Pharmaceuticals is a biopharmaceutical company developing product candidates that could significantly advance the fields of thrombosis and other hematologic diseases. The Company is advancing three programs, including betrixaban, an oral, once-daily Factor Xa inhibitor; AndexXa™ (andexanet alfa), a recombinant protein designed to reverse the anticoagulant effect in patients treated with an oral or injectable Factor Xa inhibitor; and cerdulatinib, a Syk/JAK inhibitor in development to treat hematologic cancers. Portola’s partnered program is focused on developing selective Syk inhibitors for inflammatory conditions. For more information, visit www.portola.com and follow the Company on Twitter @Portola_Pharma.

    Forward-looking Statements 
    Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, anticipated product approvals, the potential of our product candidates to advance the field of thrombosis and benefit patients and the timing of our regulatory events and statements regarding the timing and ability to achieve other milestones and events, including those described under the section “Recent Achievements, Upcoming Events and Milestones” and “2017 Annual Financial Guidance.”  Risks that contribute to the uncertain nature of the forward-looking statements include: failure to obtain FDA and/or EMA approval for one or more of our product candidates, our expectation that we will incur losses for the foreseeable future and will need additional funds to finance our operations; the accuracy of our estimates regarding our ability to initiate and/or complete our clinical trials and the timing and expense of these trials; the results of our clinical trials related to the efficacy and safety of our product candidates; our potential inability to manufacture our product candidates on a commercial scale in a timely or cost-efficient manner; the accuracy of our estimates regarding expenses and capital requirements; our ability to successfully build a hospital-based sales force and commercial infrastructure; regulatory developments in the United States and foreign countries; our ability to obtain and maintain intellectual property protection for our product candidates; and our ability to retain key scientific or management personnel. These and other risks and uncertainties are described more fully in our most recent filings with the Securities and Exchange Commission, including our most recent quarterly report on Form 10-Q. All forward-looking statements contained in this press release speak only as of the date on which they were made. We undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

    Unaudited Condensed Consolidated Statements of Operations 
    (In thousands, except share and per share data)  
      Three Months Ended December 31, Twelve Months Ended December 31, 
       2016   2015   2016   2015  
    Collaboration and license revenue  $  13,693  $  4,414  $  35,504  $  12,070  
    Operating expenses:         
    Research and development     56,032     59,814     246,854     200,376  
    Selling, general and administrative     12,861     10,881     58,235     38,869  
        Total operating expenses     68,893     70,695     305,089     239,245  
    Loss from operations     (55,200)    (66,281)    (269,585)    (227,175) 
    Interest and other income (expense), net     436     (190)    1,472     305  
    Loss before taxes    (54,764)    (66,471)    (268,113)    (226,870) 
    Income tax benefit    —     365     —     365  
    Net loss    (54,764)    (66,106)    (268,113)    (226,505) 
    Net income attributable to noncontrolling interest (SRX Cardio)    923     —     (930)    —  
    Net loss attributable to Portola $  (53,841) $  (66,106) $  (269,043) $  (226,505) 
    Net loss per share attributable to Portola common stockholders:         
    Basic and diluted $  (0.95) $  (1.23) $  (4.76) $  (4.36) 
    Shares used to compute net loss per share attributable to Portola common stockholders:         
    Basic and diluted    56,543,875     53,623,313     56,480,647     51,981,463  
              

     

    Consolidated Balance Sheet Data 
    (In thousands) 
      December 31, 2016 December 31, 2015
      (Unaudited) 
         
    Cash, cash equivalents and investments $  318,771 $  460,161
    Receivables from collaborators    —  1,000
    Prepaid research and development    7,299  16,976
    Total current assets    328,928    465,577
    Property and equipment, net    6,143    6,243
    Intangible asset    3,151    3,151
    Prepaid and other long-term assets    5,214    11,993
    Total assets    343,436    502,924
    Accounts payable    14,546    10,279
    Accrued research and development    23,818    24,195
    Accrued compensation and other liabilities    6,502    8,285
    Deferred revenue (current portion and long-term)    45,763    27,016
    Total current liabilities    65,664    51,146
    Long term obligation to Collaborator    8,000    –
    Notes payable, long-term    50,061    –
    Total liabilities    150,747    72,601
    Total stockholders’ equity    190,532    427,396
    Noncontrolling interest (SRX Cardio)    2,157    2,927
    Total stockholders’ equity    192,689    430,323
    Total liabilities and stockholders’ equity    343,436    502,924

    Reconciliation of GAAP to Non-GAAP  Projected Operating Expenses     
    (in millions)    
         
      Low  High
         
    2017 Projected Operating Expenses-GAAP  $  323 $  344
    Stock-based compensation expenses    33    34
    2017 Projected Operating Expenses-Non-GAAP     290    310
    CONTACT: Investor Contact: 
    Ana Kapor     
    Portola Pharmaceuticals 
    ir@portola.com      
    
    Media Contact:
    Julie Normart
    Pure Communications
    jnormart@purecommunications.com 
    415.946.1087
  • TRACON Pharmaceuticals Reports Fourth Quarter and Year-End 2016 Financial Results and Provides Corporate Update

    by on February 28th, 2017

    SAN DIEGO, Feb. 28, 2017 (GLOBE NEWSWIRE) — TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted therapeutics for cancer, wet age‐related macular degeneration and fibrotic diseases, today announced financial results for the fourth quarter and year ended December 31, 2016.

    “During the fourth quarter of 2016 and beginning of this year, we made significant progress toward several important corporate objectives, and anticipate a number of additional potentially value-creating milestones over the remainder of 2017,” said Charles Theuer, M.D., Ph.D., President and CEO of TRACON. “We have recently initiated dosing in the first pivotal study of TRC105 in patients with angiosarcoma in both the U.S. and Europe following beneficial discussions with regulators in both regions. In addition, we intend to initiate the first-in-human clinical trial of TRC253, one of the two compounds in-licensed from Janssen last year, in patients with prostate cancer in the first half of 2017. Finally, we expect our partner, Santen, to initiate Phase 2 development of DE-122, the ophthalmic formulation of TRC105, in wet AMD later this year. Importantly, we are leveraging our unique and differentiated product development platform to complete all of our development activities, and look forward to continued progress throughout the course of the year.”

    Fourth Quarter 2016 and Recent Corporate Highlights

    • In February 2017, the Company initiated dosing in the Phase 3 TAPPAS (a randomized Phase 3 trial of TRC105 And Pazopanib versus Pazopanib alone in patients with advanced AngioSarcoma) trial of TRC105. In January 2017, the Company announced that agreement was reached with the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) for the protocol design, clinical endpoints and statistical analysis approach for the TAPPAS trial. This one-to-one randomized trial of TRC105 in combination with Votrient® (pazopanib) versus single agent Votrient features an adaptive enrichment design which allows for greater flexibility and efficiency to identify potential signs of clinical benefit.
    • In February 2017, the Company announced that the combination of TRC105 and Avastin did not improve median PFS versus single agent Avastin in recurrent GBM patients, although the combination was associated with a non-significant increase in overall survival. Detailed survival data and the correlative analyses are expected to be presented at an oncology conference later this year.
    • In January 2017, the FDA cleared the IND for TRC253, a small molecule competitive inhibitor of the wild type androgen receptor and androgen receptor mutations that confer resistance to Xtandi® (enzalutamide) and other drugs approved to treat prostate cancer. TRC253 was in-licensed as part of the Company’s strategic licensing collaboration with Janssen Pharmaceutica N.V. in September 2016. TRACON expects to initiate dosing in a Phase 1/2 trial of TRC253 in the first half of 2017. 
    • In November 2016, the Company closed an underwritten public offering of a total of 3,018,750 shares of its common stock resulting in total gross proceeds, before deducting underwriting discounts and commissions and other offering expenses, of $17.4 million. 
    • In November 2016, updated data from the ongoing Phase 1b/2 study of TRC105 and Votrient in patients with angiosarcoma were presented at the Connective Tissue Oncology Society (CTOS) annual meeting. The presentation indicated the combination of TRC105 and Votrient continued to demonstrate encouraging signs of activity, including ongoing durable complete responses, and was well-tolerated. 
    • In November 2016, preclinical data from two separate liver fibrosis models were presented in a poster at the American Association for the Study of Liver Diseases (AASLD) Annual Meeting entitled, “Endoglin Antibody Reduces the NAFLD Activity Score in the STAM Model of NASH and Reduces Liver Fibrosis Following Carbon Tetrachloride Treatment.” The poster also highlighted a marked reduction in cutaneous neurofibromatosis in a sarcoma patient following dosing with TRC105 and Votrient in a Phase 2 clinical trial, suggesting the potential clinical utility of an endoglin antibody for the treatment of patients with fibrosis.

    Additional Expected 2017 Milestones

    • Initiation of dosing in the Phase 1/2 trial of TRC253 in patients with prostate cancer.
    • Presentation of data from expanded cohorts in the Phase 1 trial of TRC102 and Temodar® (temozolomide) by the National Cancer Institute.
    • Completion of the Phase 1/2 PAVE study of DE-122 in patients with wet AMD by TRACON’s partner, Santen Pharmaceutical Co., Ltd. (Santen).
    • Initiation of dosing in Santen’s Phase 2 AVANTE study, a randomized controlled Phase 2 trial of DE-122 and Lucentis® (ranibizumab) versus single agent Lucentis in patients with wet AMD.
    • Announcement of top-line data from the randomized Phase 2 TRAXAR trial of TRC105 in combination with Inlyta® (axitinib) in patients with advanced or metastatic renal cell carcinoma.
    • Completion of dose escalation in the Phase 1/2 clinical trial of TRC253.

    Fourth Quarter 2016 Financial Results

    • Cash, cash equivalents and short-term investments were $44.4 million at December 31, 2016, compared to $35.1 million and $52.2 million at September 30, 2016 and December 31, 2015, respectively.
    • Collaboration revenue for the fourth quarter of 2016 was $0.6 million, compared to $1.4 million for the fourth quarter of 2015.
    • Research and development expenses for the fourth quarter of 2016 were $4.8 million, compared to $10.6 million for the fourth quarter of 2015. The decrease in 2016 as compared to 2015 primarily resulted from decreased TRC105 drug manufacturing expenses.
    • General and administrative expenses for the fourth quarter of 2016 were $1.9 million, compared to $1.7 million for the fourth quarter of 2015.
    • The net loss for the fourth quarter of 2016 was $6.3 million, compared to a loss of $11.0 million for the fourth quarter of 2015.

    Investor Conference Call

    The Company will hold a conference call today at 4:30 p.m. EST / 1:30 p.m. PST to provide an update on corporate activities and to discuss the financial results of its fourth quarter 2016. The dial-in numbers are (855) 779-9066 for domestic callers and (631) 485-4859 for international callers. Please use passcode 73756754. A live webcast of the conference call will be available online from the Investor/Events and Presentation page of the Company’s website at www.traconpharma.com.

    After the live webcast, a replay will remain available on TRACON’s website for 60 days.

    About TRC105 and other Endoglin Antibodies

    TRC105 is a novel, clinical stage antibody to endoglin, a protein overexpressed on proliferating endothelial cells that is essential for angiogenesis, the process of new blood vessel formation. TRC105 is currently being studied in one Phase 3 and multiple Phase 2 clinical trials sponsored by TRACON or the National Cancer Institute for the treatment of solid tumors in combination with VEGF inhibitors. TRC105 has received orphan designation for the treatment of soft tissue sarcoma in both the U.S. and EU. The ophthalmic formulation of TRC105, DE-122, is currently in a Phase 1/2 trial for patients with wet AMD. TRC205, a second generation antibody to endoglin, is undergoing preclinical testing in models of fibrosis. For more information about the clinical trials, please visit TRACON’s website at http://www.traconpharma.com/clinical_trials.php.

    About TRACON

    TRACON develops targeted therapies for cancer, ophthalmic and fibrotic diseases. The Company’s clinical-stage pipeline includes: TRC105, an endoglin antibody that is being developed for the treatment of multiple cancers; DE-122, the ophthalmic formulation of TRC105 that is being developed in wet AMD through a collaboration with Santen Pharmaceutical Company Ltd.; and TRC102, a small molecule that is being developed for the treatment of lung cancer and glioblastoma. To learn more about TRACON and its product candidates, visit TRACON’s website at www.traconpharma.com.

    Forward-Looking Statements

    Statements made in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward‐looking statements. Such statements include, but are not limited to, statements regarding TRACON’s plans to further develop its product candidates, expectations regarding the initiation and timing of future clinical trials by TRACON or third parties, expected development milestones, availability of additional clinical data and potential utility of TRACON’s product candidates. Risks that could cause actual results to differ from those expressed in these forward‐looking statements include: risks associated with clinical development; whether TRACON, the NCI or others will be able to complete or initiate clinical trials on TRACON’s expected timelines, if at all; the fact that future preclinical studies and clinical trials may not be successful or otherwise consistent with results from prior studies; the fact that TRACON has limited control over whether or when the NCI completes on-going trials or sponsors additional trials of TRACON’s product candidates; potential changes in regulatory requirements in the United States and foreign countries; TRACON’s reliance on third parties for the development of its product candidates, including the conduct of its clinical trials and manufacture of its product candidates; whether TRACON will be able to obtain additional financing; and other risks described in TRACON’s filings with the Securities and Exchange Commission under the heading “Risk Factors.” All forward‐looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. TRACON undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

    TRACON Pharmaceuticals, Inc. 
    Condensed Consolidated Statements of Operations 
    (in thousands, except share and per share data) 
          
     Three Months Ended
    December 31,
      Twelve Months Ended
    December 31,
     
      2016  2015   2016  2015 
               
     (Unaudited)(Unaudited) 
    Collaboration revenue $617  $1,395   $3,449  $7,904 
    Operating expenses:    
    Research and development 4,767  10,559   21,566  25,680 
    General and administrative 1,925  1,672   7,859  5,691 
    Total operating expenses 6,692  12,231   29,425  31,371 
    Loss from operations (6,075)  (10,836)   (25,976)  (23,467) 
    Total other income (expense) (239)  (211)   (1,032)  (943) 
    Net loss (6,314)  (11,047)   (27,008)  (24,410) 
    Accretion to redemption value of redeemable convertible preferred stock        (31) 
    Net loss attributable to common stockholders $(6,314)  $(11,047)   $(27,008)  $(24,441) 
    Net loss per share attributable to common stockholders, basic and diluted $(0.45)  $(0.91)   $(2.13)  $(2.20) 
    Weighted‑average common shares outstanding, basic and diluted 14,099,380  12,166,905   12,677,910  11,115,651 
                    

    TRACON Pharmaceuticals, Inc.
    Condensed Consolidated Balance Sheets
    (in thousands)
     
       December 31,  December 31,
      2016   2015 
    Assets (Unaudited)   
    Current assets:  
    Cash and cash equivalents$35,710  $41,373 
    Short-term investments 8,703   10,783 
    Prepaid and other assets 1,235   1,150 
    Total current assets 45,648   53,306 
    Property and equipment, net 82   173 
    Other assets    43 
    Total assets$45,730  $53,522 
    Liabilities and Stockholders’ Equity       
    Current liabilities:  
    Accounts payable and accrued expenses$6,213  $8,281 
    Accrued compensation and related expenses 1,588   1,163 
    Current portion of deferred revenue 1,259   3,353 
    Long‑term debt, current portion 333   1,378 
    Final payment due bank 850    
    Total current liabilities 10,243   14,175 
    Other long-term liabilities 21   905 
    Long‑term debt, less current portion 7,130   7,464 
    Commitments and contingencies  
    Stockholders’ equity:  
    Common stock 16   12 
    Additional paid‑in capital 113,918   89,556 
    Accumulated deficit (85,598)   (58,590) 
    Total stockholders’ equity 28,336   30,978 
    Total liabilities and stockholders’ equity$45,730  $53,522 
            
    CONTACT: Company Contact:
    Casey Logan
    Chief Business Officer
    (858) 550‐0780 ext. 236
    clogan@traconpharma.com
    
    Investor Contact:
    Andrew McDonald
    LifeSci Advisors LLC
    646-597-6987
  • Zafgen to Present at Upcoming Investor Conferences

    by on February 28th, 2017

    BOSTON, Feb. 28, 2017 (GLOBE NEWSWIRE) — Zafgen, Inc. (Nasdaq:ZFGN), a biopharmaceutical company dedicated to significantly improving the health and well-being of patients affected by metabolic diseases including type 2 diabetes and obesity, ann…

  • TESARO Announces Fourth-Quarter 2016 Operating Results

    by on February 28th, 2017
    • Niraparib NDA under review by FDA; pre-launch preparations for planned commercial launch well underway
    • Expanded access program (EAP) for niraparib open in U.S.; European EAP expected to open 1H 2017
    • Positive opinion rendered for VARUBY® by the European Medicine Agency’s CHMP; European launch planned for 2Q 2017
    • International headquarters and European operations established to cover 17 target countries
    • Registration program for niraparib in lung cancer to be finalized in 1H 2017
    • TSR-042 (anti-PD-1 antibody) registration program to initiate in 2Q 2017
    • Cash and cash equivalents totaled approximately $786 million as of December 31, 2016

    WALTHAM, Mass., Feb. 28, 2017 (GLOBE NEWSWIRE) — TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, today reported operating results for fourth-quarter 2016 and provided an update on the Company’s development programs.

    “2017 is poised to be an eventful year for TESARO as we prepare for four product launches across the United States and Europe,” said Lonnie Moulder, CEO of TESARO. “2016 was an important year for the Company, highlighted by the landmark NOVA trial results for niraparib, which were published in the New England Journal of Medicine and presented in a presidential session at the European Society of Medical Oncology annual meeting. We intend to build upon these successes in 2017 with the planned launch of niraparib in the U.S. during the first half of this year and in Europe by year end. Looking beyond ovarian and breast cancer, we aim to finalize our registration program for niraparib in lung cancer in the first half of this year. Lastly, we are excited about the progress in our immuno-oncology pipeline, and expect to initiate a registrational program for TSR-042 in the coming months.”

    Recent Business Highlights

    • The U.S. launch of VARUBI® continues, with sequential unit volume growth for the fourth quarter of 2016. For the month of December, VARUBI achieved greater than 40% market share in the oral NK-1 market in the U.S., which represents the market-leading position in the category.
    • The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) rendered a positive opinion for the marketing authorization application (MAA) for VARUBY® for the prevention of delayed nausea and vomiting associated with highly and moderately emetogenic cancer chemotherapy in adults.
    • In January, TESARO received a Complete Response Letter regarding the rolapitant IV New Drug Application (NDA) for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy. TESARO expects to be able to address the questions from the U.S. Food and Drug Administration (FDA) and resubmit the NDA to enable approval in the first half of 2017.
    • The NDA for niraparib was accepted for review by the FDA for patients with recurrent ovarian cancer following response to platinum-based chemotherapy. The FDA granted priority review for the niraparib NDA and established a Prescription Drug User Fee Act (PDUFA) goal date of June 30, 2017.
    • An expanded access program (EAP) for niraparib opened in the U.S. in January, through which niraparib is being made available for eligible women with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer following a complete or partial response to platinum-based chemotherapy. An EAP for niraparib is planned to open in Europe in the first half of 2017, and will be initiated on a country-by-country basis.
    • Enrollment continues in the Phase 3 PRIMA trial of niraparib for patients with first-line ovarian cancer, the Phase 3 BRAVO trial for patients with germline BRCA-mutated, metastatic breast cancer, and in the QUADRA trial of niraparib for the treatment of patients with ovarian cancer who have received three or more prior lines of chemotherapy.
    • Based upon the anti-tumor activity observed in Phase 1 of the TOPACIO trial of niraparib plus KEYTRUDA® (pembrolizumab) in patients with ovarian cancer or with triple negative breast cancer, the trial has expanded to Phase 2 and is enrolling patients. Initial data are expected at an upcoming medical meeting.
    • Following the presentation of data at ASCO in 2016, the Phase 2 portion of the AVANOVA trial of niraparib plus bevacizumab in patients with ovarian cancer continues to enroll, and updated data are expected in 2H 2017.
    • Dose escalation and identification of a fixed dose and schedule was completed for the Phase 1 trial of TSR-042, an anti-PD-1 antibody candidate, and a registration trial is planned to begin in 1H 2017.
    • Enrollment continues in the Phase 1 dose escalation study of TSR-022, an anti-TIM-3 antibody candidate.
    • A lead PD-1/LAG-3 bi-specific antibody candidate was identified.

    Fourth Quarter 2016 Financial Results

    TESARO reported revenue of $4.2 million for the fourth quarter of 2016, compared to revenue of $0.2 million for the fourth quarter of 2015. Net product revenue for the fourth quarter of 2016 totaled $2.5 million and included sales of VARUBI from specialty pharmacy customers to patients and from specialty distributors to providers that were made during the fourth quarter. License, collaboration and other revenue for the fourth quarter of 2016 totaled $1.8 million and included amortization of up-front payments and shipments of clinical materials under our license agreements with Hengrui and Janssen.

    Research and development expenses increased to $71.5 million for the fourth quarter of 2016, compared to $42.9 million for the fourth quarter of 2015, driven primarily by higher costs related to the ongoing registration trials of niraparib, manufacturing and other research and development costs related to niraparib, advancement of our immuno-oncology portfolio, and increased headcount.

    Selling, general and administrative expenses increased to $54.5 million for the fourth quarter of 2016, compared to $27.9 million for the fourth quarter of 2015, primarily due to commercial activities in support of the launch of VARUBI, pre-launch activities related to niraparib, expansion of the European commercial organization, increased headcount and higher professional service fees.

    Acquired in-process research and development expenses totaled $9.0 million for the fourth quarter of 2016 and included milestone payments related to niraparib, compared to $1.0 million for the fourth quarter of 2015, which included a milestone payment related to our immuno-oncology portfolio.

    Operating expenses, as described above, include total non-cash, stock-based compensation expense of $14.4 million for the fourth quarter of 2016, compared to $8.4 million for the fourth quarter of 2015.

    Net loss totaled $136.9 million, or ($2.60) per share, for the fourth quarter of 2016, compared to a net loss of $75.8 million, or ($1.89) per share, for the fourth quarter of 2015.

    As of December 31, 2016, TESARO had approximately $785.9 million in cash and cash equivalents and approximately 53.6 million outstanding shares of common stock. Excluding the proceeds from the November 2016 financing, our cash and cash equivalents balance declined $95.7 million in the fourth quarter.

    Full-Year 2016 Financial Results

    TESARO reported revenue of $44.8 million for 2016, compared to revenue of $0.3 million for 2015. Net product revenue for 2016 totaled $6.9 million and included sales of VARUBI from specialty pharmacy customers to patients and from specialty distributors to providers through December 31, 2016. License, collaboration and other revenue for 2016 totaled $37.9 million and included amortization of up-front payments and shipments of clinical materials under our license agreements with Hengrui and Janssen.

    Research and development expenses increased to $235.1 million for 2016, compared to $155.4 million for 2015, driven primarily by three ongoing registration trials of niraparib, increased headcount, and advancement of our immuno-oncology portfolio.

    Selling, general and administrative expenses increased to $158.6 million for 2016, compared to $78.7 million for 2015, primarily due to increased headcount, commercial and pre-launch activities in support of VARUBI and niraparib, expansion of the European commercial organization, and higher professional service fees.

    Acquired in-process research and development expenses totaled $18.9 million for 2016 and included milestone payments related to niraparib and our immuno-oncology portfolio, compared to $2.0 million for 2015, which included milestone payments related to our immuno-oncology portfolio.

    Operating expenses, as described above, include total non-cash, stock-based compensation expense of $48.5 million for 2016, compared to $25.9 million for 2015.

    Net loss totaled $387.5 million, or ($8.13) per share, for 2016, compared to a net loss of $251.4 million, or ($6.38) per share, for 2015.

    In anticipation of four product launches in 2017, TESARO will continue to invest in pre-launch inventory manufacturing and development of supply chain capabilities and capacity, in addition to making milestone payments for regulatory submissions. TESARO expects its cash and cash equivalents balance to decline by approximately $110 to $120 million on average, per quarter, during the first half of 2017, excluding one-time regulatory milestones of $35 million expected to be paid at the time of the first commercial sale of VARUBY oral in Europe and approval of niraparib in the U.S.

    2017 Corporate Objectives

    TESARO anticipates achieving the following key objectives:

    VARUBI (rolapitant):

    • Launch VARUBI IV into the U.S. market in mid-2017, pending FDA approval; and
    • Launch VARUBY oral in Europe in 2Q 2017, pending EMA approval.

          Niraparib:

    • Continue commercial preparations in support of the launches of niraparib in the U.S. in 1H 2017 and Europe by year-end 2017, pending regulatory approvals;
    • Report initial data from TOPACIO trial at upcoming medical meeting;
    • Report QUADRA data in 2H 2017;
    • Report Phase 3 BRAVO data in 2H 2017;
    • Continue to enroll the Phase 3 PRIMA trial throughout 2017;
    • Finalize a potential lung cancer registration strategy in 1H 2017 and initiate the development program;
    • Update AVANOVA data in 2H 2017; and
    • Describe the potential registration strategy for niraparib plus TSR-042 in ovarian and other cancers in 2H 2017.

          Immuno-Oncology Portfolio:

    • Identify a dose and schedule for TSR-022 (anti-TIM-3 antibody) by mid-2017;
    • Submit an IND for TSR-033 (anti-LAG-3 antibody) in 2Q 2017;
    • Finalize the TSR-042 registration strategy and initiate a registration program in 1H 2017;
    • Identify the first clinical candidate within the MD Anderson collaboration in 1H 2017; and
    • Initiate a Phase 1 clinical trial of TSR-022 in combination with an anti-PD-1 antibody in mid-2017.

    Today’s Conference Call and Webcast

    TESARO will host a conference call to discuss the Company’s fourth quarter operating results and provide an update on the Company’s development programs and the VARUBI® launch today at 4:15 P.M. Eastern time. The accompanying slide presentation and live webcast of the conference call can be accessed by visiting the TESARO website at www.tesarobio.com. The call can be accessed by dialing (877) 853-5334 (U.S. and Canada) or (970) 315-0307 (international). A replay of the webcast will be archived on the Company’s website for 30 days following the call.

    About TESARO

    TESARO is an oncology-focused biopharmaceutical company devoted to providing transformative therapies to people bravely facing cancer. For more information, visit www.tesarobio.com.

    Forward Looking Statements

    To the extent that statements contained in this press release are not descriptions of historical facts regarding TESARO, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “expect,” “anticipate,” “estimate,” “intend,” and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements. Examples of forward-looking statements contained in this press release include, among others, statements regarding the expected timing of the launches of niraparib and VARUBI IV in the U.S., the expected timing of our planned commercial launches of niraparib and oral rolapitant in Europe, the expected launch of our EAP in Europe, the expected timing of finalizing our registration program for niraparib in lung cancer, the expected timing of initiation of our TSR-042 registration program, the expected approval of the rolapitant IV NDA, the expected timing of data from our TOPACIO, AVANOVA and other ongoing clinical trials, our expected cash utilization during the first half of 2017, and our expectation to achieve our various key 2017 corporate objectives. Forward-looking statements in this release involve substantial risks and uncertainties that could cause our research and pre-clinical development programs, clinical development programs, future results, performance, or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the execution and completion of clinical trials,  uncertainties surrounding our ongoing discussions with and potential actions by regulatory authorities, uncertainties regarding regulatory approvals, including with respect to the ultimate approval and indication for niraparib, uncertainties regarding certain expenditures, risks related to manufacturing and supply, and other matters that could affect the availability or commercial potential of our drug candidates. TESARO undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the Company in general, see TESARO’s Annual Report on Form 10-K for the year ended December 31, 2015, and Quarterly Report on Form 10-Q for the quarter ended September 30, 2016.

    TESARO, Inc.
    Unaudited Condensed Consolidated Statements of Operations
    (in thousands, except per share amounts)
              
       Three Months Ended
    December 31,
     Twelve Months Ended
    December 31,
       2015 2016 2015 2016
              
    Revenues:        
     Product revenue, net $  $2,469  $  $6,877 
     License, collaboration and other revenues  230   1,756   317   37,946 
    Total revenues  230   4,225   317   44,823 
              
    Expenses:        
     Cost of sales – product     518      1,256 
     Cost of sales – intangible asset amortization  268   464   268   1,855 
     Research and development (1)  42,852   71,514   155,390   235,144 
     Selling, general and administrative (1)  27,910   54,526   78,701   158,578 
     Acquired in-process research and development  1,000   9,000   2,000   18,940 
    Total expenses  72,030   136,022   236,359   415,773 
    Loss from operations  (71,800)  (131,797)  (236,042)  (370,950)
    Interest income (expense), net  (3,959)  (3,670)  (15,366)  (15,047)
    Loss before income taxes  (75,759)  (135,467)  (251,408)  (385,997)
    Provision for income taxes     1,475      1,475 
    Net loss $(75,759) $(136,942) $(251,408) $(387,472)
              
    Net loss per share applicable to        
     common stockholders – basic and diluted $(1.89) $(2.60) $(6.38) $(8.13)
              
    Weighted-average number of common        
     shares used in net loss per share applicable
    to common stockholders – basic and diluted
      40,151   52,589   39,387   47,652 
              
              
    (1) Expenses include the following amounts of non-cash stock-based compensation expense:  
              
     Research and development $3,274  $5,957  $11,082  $19,783 
     Selling, general and administrative  5,130   8,434   14,832   28,672 
                      

    TESARO, Inc.
    Unaudited Condensed Consolidated Balance Sheets
    (in thousands)
          
       December 31,
    2015
     December 31,
    2016
          
    Assets    
    Current assets:    
     Cash and cash equivalents $230,146 $785,877
     Accounts receivable  679  5,343
     Inventories  1,106  14,700
     Other current assets  4,560  8,919
    Total current assets  236,491  814,839
          
    Intangible assets, net  14,732  12,877
    Property and equipment, net  2,779  6,640
    Restricted cash  500  1,694
    Other assets  779  3,795
     Total assets $255,281 $839,845
          
    Liabilities and stockholders’ equity    
    Current liabilities:    
     Accounts payable $8,019 $5,236
     Accrued expenses  36,628  68,271
     Deferred revenue, current  500  288
     Other current liabilities  1,534  2,978
    Total current liabilities  46,681  76,773
          
    Convertible notes, net  121,325  131,775
    Deferred revenue and customer deposit, non-current  288  15,000
    Other non-current liabilities  113  5,086
     Total liabilities  168,407  228,634
          
    Total stockholders’ equity  86,874  611,211
     Total liabilities and stockholders’ equity $255,281 $839,845
            
    CONTACT: Investor/Media Contact:
    
    Jennifer Davis
    +1.781.325.1116 or jdavis@tesarobio.com
    
    Kate Rausch
    +1.781.257.2505 or krausch@tesarobio.com
  • Portola Pharmaceuticals Reports Fourth Quarter and Year-End 2016 Financial Results and Provides Corporate Update

    by on February 28th, 2017

    SOUTH SAN FRANCISCO, Calif., Feb. 28, 2017 (GLOBE NEWSWIRE) — Portola Pharmaceuticals, Inc.® (NASDAQ:PTLA) today provided a corporate update and reported its financial results for the fourth quarter and year ended December 31, 2016.

    “We are working towards gaining approval of both betrixaban, our investigational oral Factor Xa inhibitor, and andexanet alfa, our investigational antidote for oral Factor Xa inhibitors, in the United States and Europe over the next year,” said Bill Lis, chief executive officer of Portola. “Each has the potential to become the first product approved for their respective indications and both are highly anticipated by the medical community. We are confident in the robust clinical data for both products, and are focused on addressing the regulatory risks that remain.”

    Recent Achievements, Upcoming Events and Milestones

    Betrixaban – an oral Factor Xa inhibitor anticoagulant in development for extended prophylaxis of venous thromboembolism (VTE) in acute medically ill patients with risk factors for VTE; designated Fast Track status by the U.S. Food and Drug Administration (FDA)

    • The FDA accepted the New Drug Application (NDA), granted priority review, and established a Prescription Drug User Fee Act (PDUFA) action date of June 24, 2017
    • FDA informed Portola at the mid-cycle review that it does not plan to schedule an Advisory Committee meeting to discuss the NDA
    • The European Medicines Agency (EMA) validated the Marketing Authorization Application (MAA) under a standard 210-day review period; the Committee for Medicinal Products for Human Use (CHMP) opinion is expected by the end of the year

    AndexXa™ (andexanet alfa) – a Factor Xa inhibitor antidote in development for patients treated with a Factor Xa inhibitor when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding; designated a Breakthrough Therapy and an Orphan Drug by the FDA

    • Expanded the existing agreement with Daiichi Sankyo; Portola received a $15 million upfront payment and is eligible to receive up to an additional $10 million upon meeting certain milestones; upon AndexXa’s approval, Daiichi will be eligible to receive a capped royalty
    • Resubmission of the Biologics License Application (BLA) is anticipated in the second quarter of 2017
    • Continued to enroll patients in the ongoing Phase 3b/4 ANNEXA®-4 Study in patients with acute major bleeding; the Data and Safety Monitoring Board (DSMB) successfully completed its third review

    Cerdulatinib – an oral, dual Syk/JAK inhibitor in development to treat resistant or relapsed hematologic cancer patients

    • Continued to enroll patients in a Phase 2a study evaluating the safety and efficacy of cerdulatinib in patients with relapsed/refractory B-cell malignancies who have failed multiple therapies
    • Entered into an exclusive worldwide licensing agreement with Dermavant Sciences for the development and commercialization of cerdulatinib in topical applications beyond oncology; Portola retains full rights to all non-topical formulations of cerdulatinib, including oral formulations

    Corporate

    • Entered into a $50 million loan agreement with Bristol-Myers Squibb Company and Pfizer Inc. for continued development and clinical studies of andexanet alfa
    • Entered into a $150 million royalty agreement in the first quarter of 2017 with HealthCare Royalty Partners in exchange for a tiered, mid-single-digit royalty based on worldwide andexanet alfa sales

    Fourth Quarter and Year-End Financial Results
    Collaboration and license revenue earned under Portola’s collaboration and license agreements with Bristol-Myers Squibb Company and Pfizer, Bayer Pharma and Janssen Pharmaceuticals, Daiichi Sankyo and Dermavant Sciences was $13.7 million for the fourth quarter of 2016 compared with $4.4 million for the fourth quarter of 2015. Collaboration and license revenue for the year ended December 31, 2016, was $35.5 million compared with $12.1 million for the year ended December 31, 2015.

    Total operating expenses for the fourth quarter of 2016 were $68.9 million compared with $70.7 million for the same period in 2015. Total operating expenses for the fourth quarter of 2016 included $7.9 million in stock-based compensation expense compared with $6.8 million for the same period in 2015. Total operating expenses for the year ended December 31, 2016, were $305.1 million compared with $239.2 million for 2015. Total operating expenses for the full year ended December 31, 2016, included $30.4 million in stock-based compensation expense compared with $22.9 million for 2015.

    Research and development expenses for the fourth quarter of 2016 were $56.0 million compared with $59.8 million for the same period in 2015. Research and development expenses were $246.9 million for the year ended December 31, 2016, compared with $200.4 million for 2015. The increase in R&D expenses was primarily due to increased program costs to advance andexanet alfa of $64.7 million, including a $27.3 million one-time charge to write off certain prepaid manufacturing costs and increased program costs to support cerdulatinib and early research programs of $3.8 million, partially offset by decreased program costs related to betrixaban of $22.0  million following the completion of the APEX clinical trial enrollment.

    Selling, general and administrative expenses for the fourth quarter of 2016 were $12.9 million compared with $10.9 million for the same period in 2015. Selling, general and administrative expenses for the year ended December 31, 2016, were $58.2 million compared with $38.9 million for 2015. The increase in SG&A expenses was primarily due to increased headcount-related costs, commercial launch preparation activities and business development-related costs, and costs associated with professional and accounting fees of $2.0 million.

    For the fourth quarter of 2016, Portola reported a net loss of $53.8 million, or $0.95 net loss per share, compared with a net loss of $66.1 million, or $1.23 net loss per share, for the same period in 2015. Shares used to compute net loss per share attributable to common stockholders were 56.5 million for the fourth quarter of 2016 compared with 53.6 million for the same period in 2015. Net loss for the year ended December 31, 2016, was $269.0 million, or $4.76 net loss per share, compared with a net loss of $226.5 million, or $4.36 net loss per share, for the same period in 2015. Shares used to compute net loss per share attributable to common stockholders were 56.5 million for 2016 compared with 52.0 million for 2015.

    Cash, cash equivalents and investments at December 31, 2016, totaled $318.8 million compared with cash, cash equivalents and investments of $460.2 million as of December 31, 2015.

    2017 Annual Financial Guidance
    For the fiscal year 2017, Portola expects total GAAP operating expenses to be between $323 million and $344 million. For the fiscal year 2017, Portola expects total pro-forma operating expenses to be between $290 million and $310 million, excluding stock-based compensation. These expenses will be primarily for manufacturing of both andexanet and betrixaban, support of ongoing clinical trials and preparation for the potential commercial launches of betrixaban and AndexXa.

    Non-GAAP Financial Projection
    This press release and the reconciliation table included herein include a non-GAAP projection of 2017 operating expenses, excluding stock-based compensation. A reconciliation to projected GAAP 2017 operating expenses is provided in the accompanying table entitled “Reconciliation of GAAP to Non-GAAP Projected Operating Expenses.” Portola management believes this non-GAAP information is useful for investors because it provides information about the Company’s ability to independently fund and advance its operations with existing capital resources. Share-based compensation is not an expense that requires cash settlement, and therefore, the Company excludes these charges for purposes of evaluating our ability to fund future operations.

    Conference Call Details
    The live conference call today, Tuesday, February 28, 2017, at 4:30 p.m. Eastern Time, can be accessed by phone by calling (844) 452-6828 from the United States and Canada or 1 (765)-507-2588 internationally and using the passcode 71935945. The webcast can be accessed live on the Investor Relations section of the Company’s website at http://investors.portola.com. It will be archived for 30 days following the call. 

    About Portola Pharmaceuticals, Inc.    
    Portola Pharmaceuticals is a biopharmaceutical company developing product candidates that could significantly advance the fields of thrombosis and other hematologic diseases. The Company is advancing three programs, including betrixaban, an oral, once-daily Factor Xa inhibitor; AndexXa™ (andexanet alfa), a recombinant protein designed to reverse the anticoagulant effect in patients treated with an oral or injectable Factor Xa inhibitor; and cerdulatinib, a Syk/JAK inhibitor in development to treat hematologic cancers. Portola’s partnered program is focused on developing selective Syk inhibitors for inflammatory conditions. For more information, visit www.portola.com and follow the Company on Twitter @Portola_Pharma.

    Forward-looking Statements 
    Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, anticipated product approvals, the potential of our product candidates to advance the field of thrombosis and benefit patients and the timing of our regulatory events and statements regarding the timing and ability to achieve other milestones and events, including those described under the section “Recent Achievements, Upcoming Events and Milestones” and “2017 Annual Financial Guidance.”  Risks that contribute to the uncertain nature of the forward-looking statements include: failure to obtain FDA and/or EMA approval for one or more of our product candidates, our expectation that we will incur losses for the foreseeable future and will need additional funds to finance our operations; the accuracy of our estimates regarding our ability to initiate and/or complete our clinical trials and the timing and expense of these trials; the results of our clinical trials related to the efficacy and safety of our product candidates; our potential inability to manufacture our product candidates on a commercial scale in a timely or cost-efficient manner; the accuracy of our estimates regarding expenses and capital requirements; our ability to successfully build a hospital-based sales force and commercial infrastructure; regulatory developments in the United States and foreign countries; our ability to obtain and maintain intellectual property protection for our product candidates; and our ability to retain key scientific or management personnel. These and other risks and uncertainties are described more fully in our most recent filings with the Securities and Exchange Commission, including our most recent quarterly report on Form 10-Q. All forward-looking statements contained in this press release speak only as of the date on which they were made. We undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

    Unaudited Condensed Consolidated Statements of Operations 
    (In thousands, except share and per share data)  
      Three Months Ended December 31, Twelve Months Ended December 31, 
       2016   2015   2016   2015  
    Collaboration and license revenue  $  13,693  $  4,414  $  35,504  $  12,070  
    Operating expenses:         
    Research and development     56,032     59,814     246,854     200,376  
    Selling, general and administrative     12,861     10,881     58,235     38,869  
        Total operating expenses     68,893     70,695     305,089     239,245  
    Loss from operations     (55,200)    (66,281)    (269,585)    (227,175) 
    Interest and other income (expense), net     436     (190)    1,472     305  
    Loss before taxes    (54,764)    (66,471)    (268,113)    (226,870) 
    Income tax benefit    —     365     —     365  
    Net loss    (54,764)    (66,106)    (268,113)    (226,505) 
    Net income attributable to noncontrolling interest (SRX Cardio)    923     —     (930)    —  
    Net loss attributable to Portola $  (53,841) $  (66,106) $  (269,043) $  (226,505) 
    Net loss per share attributable to Portola common stockholders:         
    Basic and diluted $  (0.95) $  (1.23) $  (4.76) $  (4.36) 
    Shares used to compute net loss per share attributable to Portola common stockholders:         
    Basic and diluted    56,543,875     53,623,313     56,480,647     51,981,463  
              

     

    Consolidated Balance Sheet Data 
    (In thousands) 
      December 31, 2016 December 31, 2015
      (Unaudited) 
         
    Cash, cash equivalents and investments $  318,771 $  460,161
    Receivables from collaborators    —  1,000
    Prepaid research and development    7,299  16,976
    Total current assets    328,928    465,577
    Property and equipment, net    6,143    6,243
    Intangible asset    3,151    3,151
    Prepaid and other long-term assets    5,214    11,993
    Total assets    343,436    502,924
    Accounts payable    14,546    10,279
    Accrued research and development    23,818    24,195
    Accrued compensation and other liabilities    6,502    8,285
    Deferred revenue (current portion and long-term)    45,763    27,016
    Total current liabilities    65,664    51,146
    Long term obligation to Collaborator    8,000    –
    Notes payable, long-term    50,061    –
    Total liabilities    150,747    72,601
    Total stockholders’ equity    190,532    427,396
    Noncontrolling interest (SRX Cardio)    2,157    2,927
    Total stockholders’ equity    192,689    430,323
    Total liabilities and stockholders’ equity    343,436    502,924

    Reconciliation of GAAP to Non-GAAP  Projected Operating Expenses     
    (in millions)    
         
      Low  High
         
    2017 Projected Operating Expenses-GAAP  $  323 $  344
    Stock-based compensation expenses    33    34
    2017 Projected Operating Expenses-Non-GAAP     290    310
    CONTACT: Investor Contact: 
    Ana Kapor     
    Portola Pharmaceuticals 
    ir@portola.com      
    
    Media Contact:
    Julie Normart
    Pure Communications
    jnormart@purecommunications.com 
    415.946.1087
  • TRACON Pharmaceuticals Reports Fourth Quarter and Year-End 2016 Financial Results and Provides Corporate Update

    by on February 28th, 2017

    SAN DIEGO, Feb. 28, 2017 (GLOBE NEWSWIRE) — TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted therapeutics for cancer, wet age‐related macular degeneration and fibrotic diseases, today announced financial results for the fourth quarter and year ended December 31, 2016.

    “During the fourth quarter of 2016 and beginning of this year, we made significant progress toward several important corporate objectives, and anticipate a number of additional potentially value-creating milestones over the remainder of 2017,” said Charles Theuer, M.D., Ph.D., President and CEO of TRACON. “We have recently initiated dosing in the first pivotal study of TRC105 in patients with angiosarcoma in both the U.S. and Europe following beneficial discussions with regulators in both regions. In addition, we intend to initiate the first-in-human clinical trial of TRC253, one of the two compounds in-licensed from Janssen last year, in patients with prostate cancer in the first half of 2017. Finally, we expect our partner, Santen, to initiate Phase 2 development of DE-122, the ophthalmic formulation of TRC105, in wet AMD later this year. Importantly, we are leveraging our unique and differentiated product development platform to complete all of our development activities, and look forward to continued progress throughout the course of the year.”

    Fourth Quarter 2016 and Recent Corporate Highlights

    • In February 2017, the Company initiated dosing in the Phase 3 TAPPAS (a randomized Phase 3 trial of TRC105 And Pazopanib versus Pazopanib alone in patients with advanced AngioSarcoma) trial of TRC105. In January 2017, the Company announced that agreement was reached with the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) for the protocol design, clinical endpoints and statistical analysis approach for the TAPPAS trial. This one-to-one randomized trial of TRC105 in combination with Votrient® (pazopanib) versus single agent Votrient features an adaptive enrichment design which allows for greater flexibility and efficiency to identify potential signs of clinical benefit.
    • In February 2017, the Company announced that the combination of TRC105 and Avastin did not improve median PFS versus single agent Avastin in recurrent GBM patients, although the combination was associated with a non-significant increase in overall survival. Detailed survival data and the correlative analyses are expected to be presented at an oncology conference later this year.
    • In January 2017, the FDA cleared the IND for TRC253, a small molecule competitive inhibitor of the wild type androgen receptor and androgen receptor mutations that confer resistance to Xtandi® (enzalutamide) and other drugs approved to treat prostate cancer. TRC253 was in-licensed as part of the Company’s strategic licensing collaboration with Janssen Pharmaceutica N.V. in September 2016. TRACON expects to initiate dosing in a Phase 1/2 trial of TRC253 in the first half of 2017. 
    • In November 2016, the Company closed an underwritten public offering of a total of 3,018,750 shares of its common stock resulting in total gross proceeds, before deducting underwriting discounts and commissions and other offering expenses, of $17.4 million. 
    • In November 2016, updated data from the ongoing Phase 1b/2 study of TRC105 and Votrient in patients with angiosarcoma were presented at the Connective Tissue Oncology Society (CTOS) annual meeting. The presentation indicated the combination of TRC105 and Votrient continued to demonstrate encouraging signs of activity, including ongoing durable complete responses, and was well-tolerated. 
    • In November 2016, preclinical data from two separate liver fibrosis models were presented in a poster at the American Association for the Study of Liver Diseases (AASLD) Annual Meeting entitled, “Endoglin Antibody Reduces the NAFLD Activity Score in the STAM Model of NASH and Reduces Liver Fibrosis Following Carbon Tetrachloride Treatment.” The poster also highlighted a marked reduction in cutaneous neurofibromatosis in a sarcoma patient following dosing with TRC105 and Votrient in a Phase 2 clinical trial, suggesting the potential clinical utility of an endoglin antibody for the treatment of patients with fibrosis.

    Additional Expected 2017 Milestones

    • Initiation of dosing in the Phase 1/2 trial of TRC253 in patients with prostate cancer.
    • Presentation of data from expanded cohorts in the Phase 1 trial of TRC102 and Temodar® (temozolomide) by the National Cancer Institute.
    • Completion of the Phase 1/2 PAVE study of DE-122 in patients with wet AMD by TRACON’s partner, Santen Pharmaceutical Co., Ltd. (Santen).
    • Initiation of dosing in Santen’s Phase 2 AVANTE study, a randomized controlled Phase 2 trial of DE-122 and Lucentis® (ranibizumab) versus single agent Lucentis in patients with wet AMD.
    • Announcement of top-line data from the randomized Phase 2 TRAXAR trial of TRC105 in combination with Inlyta® (axitinib) in patients with advanced or metastatic renal cell carcinoma.
    • Completion of dose escalation in the Phase 1/2 clinical trial of TRC253.

    Fourth Quarter 2016 Financial Results

    • Cash, cash equivalents and short-term investments were $44.4 million at December 31, 2016, compared to $35.1 million and $52.2 million at September 30, 2016 and December 31, 2015, respectively.
    • Collaboration revenue for the fourth quarter of 2016 was $0.6 million, compared to $1.4 million for the fourth quarter of 2015.
    • Research and development expenses for the fourth quarter of 2016 were $4.8 million, compared to $10.6 million for the fourth quarter of 2015. The decrease in 2016 as compared to 2015 primarily resulted from decreased TRC105 drug manufacturing expenses.
    • General and administrative expenses for the fourth quarter of 2016 were $1.9 million, compared to $1.7 million for the fourth quarter of 2015.
    • The net loss for the fourth quarter of 2016 was $6.3 million, compared to a loss of $11.0 million for the fourth quarter of 2015.

    Investor Conference Call

    The Company will hold a conference call today at 4:30 p.m. EST / 1:30 p.m. PST to provide an update on corporate activities and to discuss the financial results of its fourth quarter 2016. The dial-in numbers are (855) 779-9066 for domestic callers and (631) 485-4859 for international callers. Please use passcode 73756754. A live webcast of the conference call will be available online from the Investor/Events and Presentation page of the Company’s website at www.traconpharma.com.

    After the live webcast, a replay will remain available on TRACON’s website for 60 days.

    About TRC105 and other Endoglin Antibodies

    TRC105 is a novel, clinical stage antibody to endoglin, a protein overexpressed on proliferating endothelial cells that is essential for angiogenesis, the process of new blood vessel formation. TRC105 is currently being studied in one Phase 3 and multiple Phase 2 clinical trials sponsored by TRACON or the National Cancer Institute for the treatment of solid tumors in combination with VEGF inhibitors. TRC105 has received orphan designation for the treatment of soft tissue sarcoma in both the U.S. and EU. The ophthalmic formulation of TRC105, DE-122, is currently in a Phase 1/2 trial for patients with wet AMD. TRC205, a second generation antibody to endoglin, is undergoing preclinical testing in models of fibrosis. For more information about the clinical trials, please visit TRACON’s website at http://www.traconpharma.com/clinical_trials.php.

    About TRACON

    TRACON develops targeted therapies for cancer, ophthalmic and fibrotic diseases. The Company’s clinical-stage pipeline includes: TRC105, an endoglin antibody that is being developed for the treatment of multiple cancers; DE-122, the ophthalmic formulation of TRC105 that is being developed in wet AMD through a collaboration with Santen Pharmaceutical Company Ltd.; and TRC102, a small molecule that is being developed for the treatment of lung cancer and glioblastoma. To learn more about TRACON and its product candidates, visit TRACON’s website at www.traconpharma.com.

    Forward-Looking Statements

    Statements made in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward‐looking statements. Such statements include, but are not limited to, statements regarding TRACON’s plans to further develop its product candidates, expectations regarding the initiation and timing of future clinical trials by TRACON or third parties, expected development milestones, availability of additional clinical data and potential utility of TRACON’s product candidates. Risks that could cause actual results to differ from those expressed in these forward‐looking statements include: risks associated with clinical development; whether TRACON, the NCI or others will be able to complete or initiate clinical trials on TRACON’s expected timelines, if at all; the fact that future preclinical studies and clinical trials may not be successful or otherwise consistent with results from prior studies; the fact that TRACON has limited control over whether or when the NCI completes on-going trials or sponsors additional trials of TRACON’s product candidates; potential changes in regulatory requirements in the United States and foreign countries; TRACON’s reliance on third parties for the development of its product candidates, including the conduct of its clinical trials and manufacture of its product candidates; whether TRACON will be able to obtain additional financing; and other risks described in TRACON’s filings with the Securities and Exchange Commission under the heading “Risk Factors.” All forward‐looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. TRACON undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

    TRACON Pharmaceuticals, Inc. 
    Condensed Consolidated Statements of Operations 
    (in thousands, except share and per share data) 
          
     Three Months Ended
    December 31,
      Twelve Months Ended
    December 31,
     
      2016  2015   2016  2015 
               
     (Unaudited)(Unaudited) 
    Collaboration revenue $617  $1,395   $3,449  $7,904 
    Operating expenses:    
    Research and development 4,767  10,559   21,566  25,680 
    General and administrative 1,925  1,672   7,859  5,691 
    Total operating expenses 6,692  12,231   29,425  31,371 
    Loss from operations (6,075)  (10,836)   (25,976)  (23,467) 
    Total other income (expense) (239)  (211)   (1,032)  (943) 
    Net loss (6,314)  (11,047)   (27,008)  (24,410) 
    Accretion to redemption value of redeemable convertible preferred stock        (31) 
    Net loss attributable to common stockholders $(6,314)  $(11,047)   $(27,008)  $(24,441) 
    Net loss per share attributable to common stockholders, basic and diluted $(0.45)  $(0.91)   $(2.13)  $(2.20) 
    Weighted‑average common shares outstanding, basic and diluted 14,099,380  12,166,905   12,677,910  11,115,651 
                    

    TRACON Pharmaceuticals, Inc.
    Condensed Consolidated Balance Sheets
    (in thousands)
     
       December 31,  December 31,
      2016   2015 
    Assets (Unaudited)   
    Current assets:  
    Cash and cash equivalents$35,710  $41,373 
    Short-term investments 8,703   10,783 
    Prepaid and other assets 1,235   1,150 
    Total current assets 45,648   53,306 
    Property and equipment, net 82   173 
    Other assets    43 
    Total assets$45,730  $53,522 
    Liabilities and Stockholders’ Equity       
    Current liabilities:  
    Accounts payable and accrued expenses$6,213  $8,281 
    Accrued compensation and related expenses 1,588   1,163 
    Current portion of deferred revenue 1,259   3,353 
    Long‑term debt, current portion 333   1,378 
    Final payment due bank 850    
    Total current liabilities 10,243   14,175 
    Other long-term liabilities 21   905 
    Long‑term debt, less current portion 7,130   7,464 
    Commitments and contingencies  
    Stockholders’ equity:  
    Common stock 16   12 
    Additional paid‑in capital 113,918   89,556 
    Accumulated deficit (85,598)   (58,590) 
    Total stockholders’ equity 28,336   30,978 
    Total liabilities and stockholders’ equity$45,730  $53,522 
            
    CONTACT: Company Contact:
    Casey Logan
    Chief Business Officer
    (858) 550‐0780 ext. 236
    clogan@traconpharma.com
    
    Investor Contact:
    Andrew McDonald
    LifeSci Advisors LLC
    646-597-6987
  • MacroGenics Provides Update on Corporate Progress and 2016 Financial Results

    by on February 28th, 2017

    ROCKVILLE, Md., Feb. 28, 2017 (GLOBE NEWSWIRE) — 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 year ended December 31, 2016.

    “MacroGenics continues to advance its broad pipeline of clinical compounds, including those in our HER2, B7-H3 and PD-1 franchises as well as the many bispecific product candidates based on our DART® platform,” said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. “Across our portfolio of proprietary antibody and DART-based oncology programs, we now have initial evidence of on-target engagement, manageable safety and anti-tumor activity. In addition, I am very encouraged by the biological activity observed in subjects treated with MacroGenics’ autoimmune DART molecule, MGD010. We will continue to advance our robust pipeline in 2017, including defining future development strategies for multiple programs based on data expected later this year.”

    Pipeline Updates

    Margetuximab. Recent highlights related to the Company’s Fc-optimized monoclonal antibody that targets the human epidermal growth factor receptor 2, or HER2, include:

    • Phase 3 Metastatic Breast Cancer Study. The pivotal SOPHIA study is evaluating the efficacy of margetuximab plus chemotherapy compared to trastuzumab plus chemotherapy in approximately 530 relapsed/refractory HER2-positive metastatic breast cancer patients. MacroGenics continues to expect to complete enrollment of this study by late 2018. In addition, in consultation with the U.S. Food and Drug Administration (FDA) and the Committee for Medicinal Products for Human Use of the European Medicines Agency, the patient population eligible for participation in SOPHIA has been further expanded to include ado-trastuzumab emtansine-naïve patients.
    • Phase 2 Gastric Cancer Study. The Company continues to enroll advanced HER2-positive gastric and gastroesophageal junction cancer patients in its combination study of margetuximab with an anti-PD-1 antibody. Preliminary data from the dose escalation portion of the study, including patients with objective response following progression on previous lines of treatment with trastuzumab and chemotherapy, was presented at the Company’s R&D Day in December 2016. MacroGenics expects to complete enrollment of this study in 2017.

    B7-H3 Franchise. MacroGenics is developing a portfolio of therapeutics that target B7-H3, a member of the B7 family of molecules involved in immune regulation. The Company is advancing multiple programs that target B7-H3 through complementary mechanisms of action that take advantage of this antigen’s broad expression across multiple solid tumor types. These molecules include:

    • Enoblituzumab: The Company continues to recruit patients in multiple ongoing studies of enoblituzumab, an Fc-optimized monoclonal antibody that targets B7-H3. These studies include one monotherapy study expanded to include additional bladder and prostate cancer cohorts and two combination studies with either an anti-CTLA-4 mAb (ipilimumab) or anti-PD-1 mAb (pembrolizumab). In addition, two monotherapy Phase 1 studies were recently initiated: a study for children with various solid tumors, including neuroblastoma, and an investigator-sponsored study in men with localized intermediate and high-risk prostate cancer in the neoadjuvant setting.
    • MGD009: This DART molecule targeting B7-H3 and CD3 is being evaluated in a Phase 1 study across multiple solid tumor types. Adverse events have been manageable to date and initial signs of antitumor activity have been observed, as previously disclosed at the Company’s R&D Day in December 2016. The Company expects to establish the dose and schedule for MGD009 administration as well as initiate dose expansion cohorts in 2017. 
    • MGC018: The Company is conducting Investigational New Drug (IND)-enabling activities to support an IND application for this anti-B7-H3 antibody drug conjugate (ADC) in 2018. The Company will feature a poster presentation on MGC018 at the upcoming American Association for Cancer Research (AACR) Annual Meeting in April.

    PD-1-Directed Immuno-Oncology Franchise. MacroGenics is advancing several PD-1-directed programs, which will enable both a broad set of combination opportunities across the Company’s portfolio and provide further differentiation from existing PD-1-based treatment options. The first of these are:

    • MGA012. The Company’s Phase 1 clinical study of its proprietary anti-PD-1 monoclonal antibody was initiated in November 2016. With anti-PD-1 therapy becoming a mainstay of cancer treatment across multiple tumor types, MacroGenics believes MGA012 will be the basis for combination therapy with several of the molecules in its pipeline.
    • MGD013. MacroGenics is developing the DART molecule, MGD013, to provide co-blockade of two immune checkpoint molecules expressed on T cells, PD-1 and LAG-3, for the potential treatment of a range of malignancies. The Company has completed IND-enabling studies and plans to submit an IND for MGD013 in the first half of 2017. 

    Additional DART Clinical Programs. Additional DART molecules in Phase 1 clinical development include flotetuzumab (CD123 x CD3, also known as MGD006 and S80880); MGD007 (gpA33 x CD3); MGD010 (CD32B x CD79B); duvortuxizumab (CD19 x CD3, also known as MGD011), which is being developed by Janssen; and PF-06671008 (P-cadherin x CD3), which is being developed by Pfizer. At its R&D Day in December 2016, MacroGenics provided an in-depth update on its portfolio of proprietary, clinical DART programs. The Company highlighted the promising features of these DART molecules, including on-target engagement, manageable safety as well as preliminary evidence of biological activity. Updates on three of these programs for which MacroGenics leads development include:

    • Flotetuzumab. MacroGenics continues to recruit patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) in the U.S. and Europe in the Phase 1 study of flotetuzumab. The Company expects to establish the dose and schedule as well as initiate dose expansion cohorts for this study in 2017. In late 2016, the FDA granted orphan drug designation to flotetuzumab for the treatment of AML.
    • MGD007. MacroGenics continues to recruit patients with colorectal cancer in the Phase 1 study of MGD007. The Company expects to establish the dose and schedule for this study in 2017.  
    • MGD010. During the fourth quarter of 2016, MacroGenics completed the Phase 1 study of MGD010 in healthy subjects. This DART molecule is being developed for the potential treatment of autoimmune disorders. The Company plans to report updated clinical pharmacodynamic activity results from this study in 2017.

    Corporate Update

    • New Board Members: In January 2017, MacroGenics announced the expansion of its Board of Directors from six to eight members and the appointments of Karen J. Ferrante, M.D., and Scott Jackson to fill the newly created vacancies. Dr. Ferrante, a hematologist-oncologist, most recently served as Chief Medical Officer and Head of Research and Development at Tokai Pharmaceuticals. Mr. Jackson served as Chief Executive Officer and as a member of the Board of Directors of Celator Pharmaceuticals, Inc. until its acquisition in July 2016.
    • Commenced Build-out of GMP Manufacturing Suite: In January 2017, the Company began the expansion of its manufacturing capacity by commencing the construction of a GMP suite in its headquarters building in Rockville, MD to support larger-scale clinical and commercial manufacturing.

    2016 Financial Results and Cash Runway Guidance

    • Cash Position: Cash, cash equivalents and marketable securities as of December 31, 2016, were $285.0 million, compared to $339.0 million as of December 31, 2015.
    • Revenue: Total revenue, consisting primarily of revenue from collaborative agreements, was $91.9 million for the year ended December 31, 2016, compared to $100.9 million for the year ended December 31, 2015. Revenue from collaborative agreements includes the recognition of deferred revenue from payments received in previous periods as well as payments received during the year.
    • R&D Expenses: Research and development expenses were $122.1 million for the year ended December 31, 2016, compared to $98.3 million for the year ended December 31, 2015. This increase was due primarily to increased activity in the Company’s preclinical immune checkpoint programs, including MGD013 and MGA012, MGD014 (funded by NIAID/NIH) and the initiation of two Phase 1 clinical trials combining enoblituzumab with other compounds. These increases were partially offset by decreased manufacturing costs for margetuximab.
    • G&A Expenses: General and administrative expenses were $29.8 million for the year ended December 31, 2016, compared to $22.8 million for the year ended December 31, 2015. This increase was primarily due to increased staff, recruiting costs and stock-based (non-cash) compensation expense and patent expense.
    • Net Loss: Net loss was $58.5 million for the year ended December 31, 2016, compared to net loss of $20.1 million for the year ended December 31, 2015.
    • Shares Outstanding: Shares outstanding as of December 31, 2016 were 34,870,607.
    • Cash Runway Guidance: MacroGenics expects that its current cash, cash equivalents and marketable securities, combined with anticipated funding under its current strategic collaborations, should fund the Company’s operations through late 2018.

    Conference Call Information

    MacroGenics will host a conference call today at 4:30 pm (EST) to discuss the 2016 financial results and provide a corporate update. To participate in the conference call, please dial (877) 303-6253 (domestic) or (973) 409-9610 (international) five minutes prior to the start of the call and provide the Conference ID: 58247768.

    The recorded, listen-only webcast of the conference call can be accessed under “Events & Presentations” in the Investor Relations section of the Company’s website at http://ir.macrogenics.com/events.cfm. A replay of the webcast will be available shortly after the conclusion of the call and archived on the Company’s website for 30 days following the call.

    MACROGENICS, INC.
    SELECTED CONSOLIDATED BALANCE SHEET DATA

    (Amounts in thousands)

         
     As of December 31, 
      2016  2015 
    Cash, cash equivalents and marketable securities  $  284,982 $  339,049 
    Total assets   311,263    359,269 
    Deferred revenue   14,306    18,497 
    Total stockholders’ equity   268,751    313,337 

    MACROGENICS, INC.
    CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

    (Amounts in thousands, except share and per share data)

          
                
     Year Ended December 31,      
      2016   2015   2014       
    Revenues:            
    Revenue from collaborative agreements$  86,582  $  99,368  $  47,264       
    Revenue from government agreements   5,298     1,486     533       
    Total revenues   91,880     100,854     47,797       
                
    Costs and expenses:            
    Research and development   122,091     98,271     70,186       
    General and administrative   29,831     22,765     15,926       
    Total costs and expenses   151,922     121,036     86,112       
                
    Loss from operations   (60,042)    (20,182)    (38,315)      
                
    Other income   1,514     42     2       
    Net loss   (58,528)    (20,140)    (38,313)      
                
    Other comprehensive loss:           
      Unrealized loss on investments    (77)    (5)    –        
     Comprehensive loss $  (58,605) $  (20,145) $  (38,313)      
                
    Basic and diluted net loss per common share$(1.69) $(0.63) $(1.40)      
    Basic and diluted weighted average number of common shares     34,685,274     31,801,645     27,384,990       

    About MacroGenics, Inc.

    MacroGenics is 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. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms. The combination of MacroGenics’ technology platforms and protein engineering expertise has allowed the Company to generate promising product candidates and enter into several strategic collaborations with global pharmaceutical and biotechnology companies. For more information, please see the Company’s website at www.macrogenics.com. MacroGenics, the MacroGenics logo and DART are trademarks or registered trademarks of MacroGenics, Inc.

    Cautionary Note on Forward-Looking Statements

    Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company’s strategy, future operations, clinical development of the Company’s therapeutic candidates, milestone or opt-in payments from the Company’s collaborators, the Company’s anticipated milestones and future expectations and plans and prospects for the Company and other statements containing the words “subject to”, “believe”, “anticipate”, “plan”, “expect”, “intend”, “estimate”, “project”, “may”, “will”, “should”, “would”, “could”, “can”, the negatives thereof, variations thereon and similar expressions, or by discussions of strategy constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties inherent in the initiation and enrollment of future clinical trials, expectations of expanding ongoing clinical trials, availability and timing of data from ongoing clinical trials, expectations for regulatory approvals, other matters that could affect the availability or commercial potential of the Company’s product candidates and other risks described in the Company’s filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company’s views only as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company’s views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so, except as may be required by law. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date hereof. 

    CONTACT: Jim Karrels, Senior Vice President, CFO
    MacroGenics, Inc.
    1-301-251-5172, info@macrogenics.com
    
    Karen Sharma, Senior Vice President
    MacDougall Biomedical Communications
    1-781-235-3060, ksharma@macbiocom.com
  • MacroGenics Provides Update on Corporate Progress and 2016 Financial Results

    by on February 28th, 2017

    ROCKVILLE, Md., Feb. 28, 2017 (GLOBE NEWSWIRE) — 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 year ended December 31, 2016.

    “MacroGenics continues to advance its broad pipeline of clinical compounds, including those in our HER2, B7-H3 and PD-1 franchises as well as the many bispecific product candidates based on our DART® platform,” said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. “Across our portfolio of proprietary antibody and DART-based oncology programs, we now have initial evidence of on-target engagement, manageable safety and anti-tumor activity. In addition, I am very encouraged by the biological activity observed in subjects treated with MacroGenics’ autoimmune DART molecule, MGD010. We will continue to advance our robust pipeline in 2017, including defining future development strategies for multiple programs based on data expected later this year.”

    Pipeline Updates

    Margetuximab. Recent highlights related to the Company’s Fc-optimized monoclonal antibody that targets the human epidermal growth factor receptor 2, or HER2, include:

    • Phase 3 Metastatic Breast Cancer Study. The pivotal SOPHIA study is evaluating the efficacy of margetuximab plus chemotherapy compared to trastuzumab plus chemotherapy in approximately 530 relapsed/refractory HER2-positive metastatic breast cancer patients. MacroGenics continues to expect to complete enrollment of this study by late 2018. In addition, in consultation with the U.S. Food and Drug Administration (FDA) and the Committee for Medicinal Products for Human Use of the European Medicines Agency, the patient population eligible for participation in SOPHIA has been further expanded to include ado-trastuzumab emtansine-naïve patients.
    • Phase 2 Gastric Cancer Study. The Company continues to enroll advanced HER2-positive gastric and gastroesophageal junction cancer patients in its combination study of margetuximab with an anti-PD-1 antibody. Preliminary data from the dose escalation portion of the study, including patients with objective response following progression on previous lines of treatment with trastuzumab and chemotherapy, was presented at the Company’s R&D Day in December 2016. MacroGenics expects to complete enrollment of this study in 2017.

    B7-H3 Franchise. MacroGenics is developing a portfolio of therapeutics that target B7-H3, a member of the B7 family of molecules involved in immune regulation. The Company is advancing multiple programs that target B7-H3 through complementary mechanisms of action that take advantage of this antigen’s broad expression across multiple solid tumor types. These molecules include:

    • Enoblituzumab: The Company continues to recruit patients in multiple ongoing studies of enoblituzumab, an Fc-optimized monoclonal antibody that targets B7-H3. These studies include one monotherapy study expanded to include additional bladder and prostate cancer cohorts and two combination studies with either an anti-CTLA-4 mAb (ipilimumab) or anti-PD-1 mAb (pembrolizumab). In addition, two monotherapy Phase 1 studies were recently initiated: a study for children with various solid tumors, including neuroblastoma, and an investigator-sponsored study in men with localized intermediate and high-risk prostate cancer in the neoadjuvant setting.
    • MGD009: This DART molecule targeting B7-H3 and CD3 is being evaluated in a Phase 1 study across multiple solid tumor types. Adverse events have been manageable to date and initial signs of antitumor activity have been observed, as previously disclosed at the Company’s R&D Day in December 2016. The Company expects to establish the dose and schedule for MGD009 administration as well as initiate dose expansion cohorts in 2017. 
    • MGC018: The Company is conducting Investigational New Drug (IND)-enabling activities to support an IND application for this anti-B7-H3 antibody drug conjugate (ADC) in 2018. The Company will feature a poster presentation on MGC018 at the upcoming American Association for Cancer Research (AACR) Annual Meeting in April.

    PD-1-Directed Immuno-Oncology Franchise. MacroGenics is advancing several PD-1-directed programs, which will enable both a broad set of combination opportunities across the Company’s portfolio and provide further differentiation from existing PD-1-based treatment options. The first of these are:

    • MGA012. The Company’s Phase 1 clinical study of its proprietary anti-PD-1 monoclonal antibody was initiated in November 2016. With anti-PD-1 therapy becoming a mainstay of cancer treatment across multiple tumor types, MacroGenics believes MGA012 will be the basis for combination therapy with several of the molecules in its pipeline.
    • MGD013. MacroGenics is developing the DART molecule, MGD013, to provide co-blockade of two immune checkpoint molecules expressed on T cells, PD-1 and LAG-3, for the potential treatment of a range of malignancies. The Company has completed IND-enabling studies and plans to submit an IND for MGD013 in the first half of 2017. 

    Additional DART Clinical Programs. Additional DART molecules in Phase 1 clinical development include flotetuzumab (CD123 x CD3, also known as MGD006 and S80880); MGD007 (gpA33 x CD3); MGD010 (CD32B x CD79B); duvortuxizumab (CD19 x CD3, also known as MGD011), which is being developed by Janssen; and PF-06671008 (P-cadherin x CD3), which is being developed by Pfizer. At its R&D Day in December 2016, MacroGenics provided an in-depth update on its portfolio of proprietary, clinical DART programs. The Company highlighted the promising features of these DART molecules, including on-target engagement, manageable safety as well as preliminary evidence of biological activity. Updates on three of these programs for which MacroGenics leads development include:

    • Flotetuzumab. MacroGenics continues to recruit patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) in the U.S. and Europe in the Phase 1 study of flotetuzumab. The Company expects to establish the dose and schedule as well as initiate dose expansion cohorts for this study in 2017. In late 2016, the FDA granted orphan drug designation to flotetuzumab for the treatment of AML.
    • MGD007. MacroGenics continues to recruit patients with colorectal cancer in the Phase 1 study of MGD007. The Company expects to establish the dose and schedule for this study in 2017.  
    • MGD010. During the fourth quarter of 2016, MacroGenics completed the Phase 1 study of MGD010 in healthy subjects. This DART molecule is being developed for the potential treatment of autoimmune disorders. The Company plans to report updated clinical pharmacodynamic activity results from this study in 2017.

    Corporate Update

    • New Board Members: In January 2017, MacroGenics announced the expansion of its Board of Directors from six to eight members and the appointments of Karen J. Ferrante, M.D., and Scott Jackson to fill the newly created vacancies. Dr. Ferrante, a hematologist-oncologist, most recently served as Chief Medical Officer and Head of Research and Development at Tokai Pharmaceuticals. Mr. Jackson served as Chief Executive Officer and as a member of the Board of Directors of Celator Pharmaceuticals, Inc. until its acquisition in July 2016.
    • Commenced Build-out of GMP Manufacturing Suite: In January 2017, the Company began the expansion of its manufacturing capacity by commencing the construction of a GMP suite in its headquarters building in Rockville, MD to support larger-scale clinical and commercial manufacturing.

    2016 Financial Results and Cash Runway Guidance

    • Cash Position: Cash, cash equivalents and marketable securities as of December 31, 2016, were $285.0 million, compared to $339.0 million as of December 31, 2015.
    • Revenue: Total revenue, consisting primarily of revenue from collaborative agreements, was $91.9 million for the year ended December 31, 2016, compared to $100.9 million for the year ended December 31, 2015. Revenue from collaborative agreements includes the recognition of deferred revenue from payments received in previous periods as well as payments received during the year.
    • R&D Expenses: Research and development expenses were $122.1 million for the year ended December 31, 2016, compared to $98.3 million for the year ended December 31, 2015. This increase was due primarily to increased activity in the Company’s preclinical immune checkpoint programs, including MGD013 and MGA012, MGD014 (funded by NIAID/NIH) and the initiation of two Phase 1 clinical trials combining enoblituzumab with other compounds. These increases were partially offset by decreased manufacturing costs for margetuximab.
    • G&A Expenses: General and administrative expenses were $29.8 million for the year ended December 31, 2016, compared to $22.8 million for the year ended December 31, 2015. This increase was primarily due to increased staff, recruiting costs and stock-based (non-cash) compensation expense and patent expense.
    • Net Loss: Net loss was $58.5 million for the year ended December 31, 2016, compared to net loss of $20.1 million for the year ended December 31, 2015.
    • Shares Outstanding: Shares outstanding as of December 31, 2016 were 34,870,607.
    • Cash Runway Guidance: MacroGenics expects that its current cash, cash equivalents and marketable securities, combined with anticipated funding under its current strategic collaborations, should fund the Company’s operations through late 2018.

    Conference Call Information

    MacroGenics will host a conference call today at 4:30 pm (EST) to discuss the 2016 financial results and provide a corporate update. To participate in the conference call, please dial (877) 303-6253 (domestic) or (973) 409-9610 (international) five minutes prior to the start of the call and provide the Conference ID: 58247768.

    The recorded, listen-only webcast of the conference call can be accessed under “Events & Presentations” in the Investor Relations section of the Company’s website at http://ir.macrogenics.com/events.cfm. A replay of the webcast will be available shortly after the conclusion of the call and archived on the Company’s website for 30 days following the call.

    MACROGENICS, INC.
    SELECTED CONSOLIDATED BALANCE SHEET DATA

    (Amounts in thousands)

         
     As of December 31, 
      2016  2015 
    Cash, cash equivalents and marketable securities  $  284,982 $  339,049 
    Total assets   311,263    359,269 
    Deferred revenue   14,306    18,497 
    Total stockholders’ equity   268,751    313,337 

    MACROGENICS, INC.
    CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

    (Amounts in thousands, except share and per share data)

          
                
     Year Ended December 31,      
      2016   2015   2014       
    Revenues:            
    Revenue from collaborative agreements$  86,582  $  99,368  $  47,264       
    Revenue from government agreements   5,298     1,486     533       
    Total revenues   91,880     100,854     47,797       
                
    Costs and expenses:            
    Research and development   122,091     98,271     70,186       
    General and administrative   29,831     22,765     15,926       
    Total costs and expenses   151,922     121,036     86,112       
                
    Loss from operations   (60,042)    (20,182)    (38,315)      
                
    Other income   1,514     42     2       
    Net loss   (58,528)    (20,140)    (38,313)      
                
    Other comprehensive loss:           
      Unrealized loss on investments    (77)    (5)    –        
     Comprehensive loss $  (58,605) $  (20,145) $  (38,313)      
                
    Basic and diluted net loss per common share$(1.69) $(0.63) $(1.40)      
    Basic and diluted weighted average number of common shares     34,685,274     31,801,645     27,384,990       

    About MacroGenics, Inc.

    MacroGenics is 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. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms. The combination of MacroGenics’ technology platforms and protein engineering expertise has allowed the Company to generate promising product candidates and enter into several strategic collaborations with global pharmaceutical and biotechnology companies. For more information, please see the Company’s website at www.macrogenics.com. MacroGenics, the MacroGenics logo and DART are trademarks or registered trademarks of MacroGenics, Inc.

    Cautionary Note on Forward-Looking Statements

    Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company’s strategy, future operations, clinical development of the Company’s therapeutic candidates, milestone or opt-in payments from the Company’s collaborators, the Company’s anticipated milestones and future expectations and plans and prospects for the Company and other statements containing the words “subject to”, “believe”, “anticipate”, “plan”, “expect”, “intend”, “estimate”, “project”, “may”, “will”, “should”, “would”, “could”, “can”, the negatives thereof, variations thereon and similar expressions, or by discussions of strategy constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties inherent in the initiation and enrollment of future clinical trials, expectations of expanding ongoing clinical trials, availability and timing of data from ongoing clinical trials, expectations for regulatory approvals, other matters that could affect the availability or commercial potential of the Company’s product candidates and other risks described in the Company’s filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company’s views only as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company’s views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so, except as may be required by law. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date hereof. 

    CONTACT: Jim Karrels, Senior Vice President, CFO
    MacroGenics, Inc.
    1-301-251-5172, info@macrogenics.com
    
    Karen Sharma, Senior Vice President
    MacDougall Biomedical Communications
    1-781-235-3060, ksharma@macbiocom.com
  • MacroGenics Provides Update on Corporate Progress and 2016 Financial Results

    by on February 28th, 2017

    ROCKVILLE, Md., Feb. 28, 2017 (GLOBE NEWSWIRE) — 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 year ended December 31, 2016.

    “MacroGenics continues to advance its broad pipeline of clinical compounds, including those in our HER2, B7-H3 and PD-1 franchises as well as the many bispecific product candidates based on our DART® platform,” said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. “Across our portfolio of proprietary antibody and DART-based oncology programs, we now have initial evidence of on-target engagement, manageable safety and anti-tumor activity. In addition, I am very encouraged by the biological activity observed in subjects treated with MacroGenics’ autoimmune DART molecule, MGD010. We will continue to advance our robust pipeline in 2017, including defining future development strategies for multiple programs based on data expected later this year.”

    Pipeline Updates

    Margetuximab. Recent highlights related to the Company’s Fc-optimized monoclonal antibody that targets the human epidermal growth factor receptor 2, or HER2, include:

    • Phase 3 Metastatic Breast Cancer Study. The pivotal SOPHIA study is evaluating the efficacy of margetuximab plus chemotherapy compared to trastuzumab plus chemotherapy in approximately 530 relapsed/refractory HER2-positive metastatic breast cancer patients. MacroGenics continues to expect to complete enrollment of this study by late 2018. In addition, in consultation with the U.S. Food and Drug Administration (FDA) and the Committee for Medicinal Products for Human Use of the European Medicines Agency, the patient population eligible for participation in SOPHIA has been further expanded to include ado-trastuzumab emtansine-naïve patients.
    • Phase 2 Gastric Cancer Study. The Company continues to enroll advanced HER2-positive gastric and gastroesophageal junction cancer patients in its combination study of margetuximab with an anti-PD-1 antibody. Preliminary data from the dose escalation portion of the study, including patients with objective response following progression on previous lines of treatment with trastuzumab and chemotherapy, was presented at the Company’s R&D Day in December 2016. MacroGenics expects to complete enrollment of this study in 2017.

    B7-H3 Franchise. MacroGenics is developing a portfolio of therapeutics that target B7-H3, a member of the B7 family of molecules involved in immune regulation. The Company is advancing multiple programs that target B7-H3 through complementary mechanisms of action that take advantage of this antigen’s broad expression across multiple solid tumor types. These molecules include:

    • Enoblituzumab: The Company continues to recruit patients in multiple ongoing studies of enoblituzumab, an Fc-optimized monoclonal antibody that targets B7-H3. These studies include one monotherapy study expanded to include additional bladder and prostate cancer cohorts and two combination studies with either an anti-CTLA-4 mAb (ipilimumab) or anti-PD-1 mAb (pembrolizumab). In addition, two monotherapy Phase 1 studies were recently initiated: a study for children with various solid tumors, including neuroblastoma, and an investigator-sponsored study in men with localized intermediate and high-risk prostate cancer in the neoadjuvant setting.
    • MGD009: This DART molecule targeting B7-H3 and CD3 is being evaluated in a Phase 1 study across multiple solid tumor types. Adverse events have been manageable to date and initial signs of antitumor activity have been observed, as previously disclosed at the Company’s R&D Day in December 2016. The Company expects to establish the dose and schedule for MGD009 administration as well as initiate dose expansion cohorts in 2017. 
    • MGC018: The Company is conducting Investigational New Drug (IND)-enabling activities to support an IND application for this anti-B7-H3 antibody drug conjugate (ADC) in 2018. The Company will feature a poster presentation on MGC018 at the upcoming American Association for Cancer Research (AACR) Annual Meeting in April.

    PD-1-Directed Immuno-Oncology Franchise. MacroGenics is advancing several PD-1-directed programs, which will enable both a broad set of combination opportunities across the Company’s portfolio and provide further differentiation from existing PD-1-based treatment options. The first of these are:

    • MGA012. The Company’s Phase 1 clinical study of its proprietary anti-PD-1 monoclonal antibody was initiated in November 2016. With anti-PD-1 therapy becoming a mainstay of cancer treatment across multiple tumor types, MacroGenics believes MGA012 will be the basis for combination therapy with several of the molecules in its pipeline.
    • MGD013. MacroGenics is developing the DART molecule, MGD013, to provide co-blockade of two immune checkpoint molecules expressed on T cells, PD-1 and LAG-3, for the potential treatment of a range of malignancies. The Company has completed IND-enabling studies and plans to submit an IND for MGD013 in the first half of 2017. 

    Additional DART Clinical Programs. Additional DART molecules in Phase 1 clinical development include flotetuzumab (CD123 x CD3, also known as MGD006 and S80880); MGD007 (gpA33 x CD3); MGD010 (CD32B x CD79B); duvortuxizumab (CD19 x CD3, also known as MGD011), which is being developed by Janssen; and PF-06671008 (P-cadherin x CD3), which is being developed by Pfizer. At its R&D Day in December 2016, MacroGenics provided an in-depth update on its portfolio of proprietary, clinical DART programs. The Company highlighted the promising features of these DART molecules, including on-target engagement, manageable safety as well as preliminary evidence of biological activity. Updates on three of these programs for which MacroGenics leads development include:

    • Flotetuzumab. MacroGenics continues to recruit patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) in the U.S. and Europe in the Phase 1 study of flotetuzumab. The Company expects to establish the dose and schedule as well as initiate dose expansion cohorts for this study in 2017. In late 2016, the FDA granted orphan drug designation to flotetuzumab for the treatment of AML.
    • MGD007. MacroGenics continues to recruit patients with colorectal cancer in the Phase 1 study of MGD007. The Company expects to establish the dose and schedule for this study in 2017.  
    • MGD010. During the fourth quarter of 2016, MacroGenics completed the Phase 1 study of MGD010 in healthy subjects. This DART molecule is being developed for the potential treatment of autoimmune disorders. The Company plans to report updated clinical pharmacodynamic activity results from this study in 2017.

    Corporate Update

    • New Board Members: In January 2017, MacroGenics announced the expansion of its Board of Directors from six to eight members and the appointments of Karen J. Ferrante, M.D., and Scott Jackson to fill the newly created vacancies. Dr. Ferrante, a hematologist-oncologist, most recently served as Chief Medical Officer and Head of Research and Development at Tokai Pharmaceuticals. Mr. Jackson served as Chief Executive Officer and as a member of the Board of Directors of Celator Pharmaceuticals, Inc. until its acquisition in July 2016.
    • Commenced Build-out of GMP Manufacturing Suite: In January 2017, the Company began the expansion of its manufacturing capacity by commencing the construction of a GMP suite in its headquarters building in Rockville, MD to support larger-scale clinical and commercial manufacturing.

    2016 Financial Results and Cash Runway Guidance

    • Cash Position: Cash, cash equivalents and marketable securities as of December 31, 2016, were $285.0 million, compared to $339.0 million as of December 31, 2015.
    • Revenue: Total revenue, consisting primarily of revenue from collaborative agreements, was $91.9 million for the year ended December 31, 2016, compared to $100.9 million for the year ended December 31, 2015. Revenue from collaborative agreements includes the recognition of deferred revenue from payments received in previous periods as well as payments received during the year.
    • R&D Expenses: Research and development expenses were $122.1 million for the year ended December 31, 2016, compared to $98.3 million for the year ended December 31, 2015. This increase was due primarily to increased activity in the Company’s preclinical immune checkpoint programs, including MGD013 and MGA012, MGD014 (funded by NIAID/NIH) and the initiation of two Phase 1 clinical trials combining enoblituzumab with other compounds. These increases were partially offset by decreased manufacturing costs for margetuximab.
    • G&A Expenses: General and administrative expenses were $29.8 million for the year ended December 31, 2016, compared to $22.8 million for the year ended December 31, 2015. This increase was primarily due to increased staff, recruiting costs and stock-based (non-cash) compensation expense and patent expense.
    • Net Loss: Net loss was $58.5 million for the year ended December 31, 2016, compared to net loss of $20.1 million for the year ended December 31, 2015.
    • Shares Outstanding: Shares outstanding as of December 31, 2016 were 34,870,607.
    • Cash Runway Guidance: MacroGenics expects that its current cash, cash equivalents and marketable securities, combined with anticipated funding under its current strategic collaborations, should fund the Company’s operations through late 2018.

    Conference Call Information

    MacroGenics will host a conference call today at 4:30 pm (EST) to discuss the 2016 financial results and provide a corporate update. To participate in the conference call, please dial (877) 303-6253 (domestic) or (973) 409-9610 (international) five minutes prior to the start of the call and provide the Conference ID: 58247768.

    The recorded, listen-only webcast of the conference call can be accessed under “Events & Presentations” in the Investor Relations section of the Company’s website at http://ir.macrogenics.com/events.cfm. A replay of the webcast will be available shortly after the conclusion of the call and archived on the Company’s website for 30 days following the call.

    MACROGENICS, INC.
    SELECTED CONSOLIDATED BALANCE SHEET DATA

    (Amounts in thousands)

         
     As of December 31, 
      2016  2015 
    Cash, cash equivalents and marketable securities  $  284,982 $  339,049 
    Total assets   311,263    359,269 
    Deferred revenue   14,306    18,497 
    Total stockholders’ equity   268,751    313,337 

    MACROGENICS, INC.
    CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

    (Amounts in thousands, except share and per share data)

          
                
     Year Ended December 31,      
      2016   2015   2014       
    Revenues:            
    Revenue from collaborative agreements$  86,582  $  99,368  $  47,264       
    Revenue from government agreements   5,298     1,486     533       
    Total revenues   91,880     100,854     47,797       
                
    Costs and expenses:            
    Research and development   122,091     98,271     70,186       
    General and administrative   29,831     22,765     15,926       
    Total costs and expenses   151,922     121,036     86,112       
                
    Loss from operations   (60,042)    (20,182)    (38,315)      
                
    Other income   1,514     42     2       
    Net loss   (58,528)    (20,140)    (38,313)      
                
    Other comprehensive loss:           
      Unrealized loss on investments    (77)    (5)    –        
     Comprehensive loss $  (58,605) $  (20,145) $  (38,313)      
                
    Basic and diluted net loss per common share$(1.69) $(0.63) $(1.40)      
    Basic and diluted weighted average number of common shares     34,685,274     31,801,645     27,384,990       

    About MacroGenics, Inc.

    MacroGenics is 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. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms. The combination of MacroGenics’ technology platforms and protein engineering expertise has allowed the Company to generate promising product candidates and enter into several strategic collaborations with global pharmaceutical and biotechnology companies. For more information, please see the Company’s website at www.macrogenics.com. MacroGenics, the MacroGenics logo and DART are trademarks or registered trademarks of MacroGenics, Inc.

    Cautionary Note on Forward-Looking Statements

    Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company’s strategy, future operations, clinical development of the Company’s therapeutic candidates, milestone or opt-in payments from the Company’s collaborators, the Company’s anticipated milestones and future expectations and plans and prospects for the Company and other statements containing the words “subject to”, “believe”, “anticipate”, “plan”, “expect”, “intend”, “estimate”, “project”, “may”, “will”, “should”, “would”, “could”, “can”, the negatives thereof, variations thereon and similar expressions, or by discussions of strategy constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties inherent in the initiation and enrollment of future clinical trials, expectations of expanding ongoing clinical trials, availability and timing of data from ongoing clinical trials, expectations for regulatory approvals, other matters that could affect the availability or commercial potential of the Company’s product candidates and other risks described in the Company’s filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company’s views only as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company’s views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so, except as may be required by law. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date hereof. 

    CONTACT: Jim Karrels, Senior Vice President, CFO
    MacroGenics, Inc.
    1-301-251-5172, info@macrogenics.com
    
    Karen Sharma, Senior Vice President
    MacDougall Biomedical Communications
    1-781-235-3060, ksharma@macbiocom.com
  • InteloMed, Inc. to Exhibit Patient Monitoring System for Assessing Dialysis Tolerance at the National Association of Nephrology Technicians Annual Symposium

    by on February 28th, 2017

    PITTSBURGH, PA–(Marketwired – Feb 28, 2017) – InteloMed, Inc., a leader in the development of advanced non-invasive systems for intelligent patient monitoring, will exhibit at the upcoming National Association of Nephrology Technicians (NANT) 34th Annual Symposium. InteloMed will feature the CVInsight® Patient Monitoring & Informatics System for continuous monitoring of cardiovascular stress to assess dialysis treatment tolerance.

    The NANT mission is to promote the highest quality of care for End Stage Renal Disease (ESRD) and Chronic Kidney Disease (CKD) patients through education and professionalism. The symposium will focus on quality care with innovation, education, and motivation. This year’s event is being held February 21 – 22 in Las Vegas, NV.

    InteloMed Clinical Operations Manager Lori Poole MSN, RN will join RJ Picciano BA, CHT, OCDT, CHBT on the podium on Wednesday, February 22, highlighting the topic “Fluid Management: How the Nephrology Clinical Technician Can Help.” Picciano serves as Fluid Management Coordinator for the Centers for Dialysis Care, Cleveland Ohio.

    “The CVInsight System provides new insight on assessing treatment tolerance, and we look forward to demonstrating that at the NANT Symposium,” said InteloMed CEO Jill Schiaparelli.

    The CVInsight Monitoring System will be available at the InteloMed booth, number 303. For more information about the event, visit http://www.dialysistech.net/education/2017-annual-symposium.

    * News distribution and content marketing services provided by 1-800-PublicRelations1800pr

    About InteloMed
    InteloMed is redefining the standard of care in patient monitoring and informatics through its intelligent, multi-dimensional, non-invasive CVInsight® Patient Monitoring & Informatics System.

    Providing an unprecedented level of physiologic insight, the CVInsight® Monitoring System is an easy-to-use, multi-parameter system for monitoring cardiovascular stress. It empowers clinicians with non-invasive, real-time, dynamic, and actionable information about a patient’s dialysis tolerance. Based on patented and proprietary algorithms, the system provides clinician set alerts to notify healthcare providers of changes in the patient’s tolerance to dialysis treatment, allowing them to intervene to avoid dialysis interruptions that can have serious patient consequences.

    The CVInsight® Patient Monitoring and Informatics System is FDA-cleared and CE-marked and has launched commercially in the United States. InteloMed is headquartered in Wexford, PA.

    For more information, visit us at www.InteloMed.com.

    Safe Harbor Statement
    Certain statements in this release are “forward-looking” and as such are subject to numerous risks and uncertainties. Actual results may vary significantly from the results expressed or implied in such statements. Factors that could cause actual results to materially differ from forward-looking statements include, but are not limited to, the need to obtain additional capital in order to grow our business, our ability to engage qualified employees, the acceptance of new products by doctors and hospitals, changes in the regulatory environment and healthcare legislation, the need to keep pace with technological changes, our dependence on third party manufacturers to produce components of our technology platform on time and to our specifications, and the successful implementation of our commercial strategies.

  • InteloMed, Inc. to Exhibit Patient Monitoring System for Assessing Dialysis Tolerance at the National Association of Nephrology Technicians Annual Symposium

    by on February 28th, 2017

    PITTSBURGH, PA–(Marketwired – Feb 28, 2017) – InteloMed, Inc., a leader in the development of advanced non-invasive systems for intelligent patient monitoring, will exhibit at the upcoming National Association of Nephrology Technicians (NANT) 34th Annual Symposium. InteloMed will feature the CVInsight® Patient Monitoring & Informatics System for continuous monitoring of cardiovascular stress to assess dialysis treatment tolerance.

    The NANT mission is to promote the highest quality of care for End Stage Renal Disease (ESRD) and Chronic Kidney Disease (CKD) patients through education and professionalism. The symposium will focus on quality care with innovation, education, and motivation. This year’s event is being held February 21 – 22 in Las Vegas, NV.

    InteloMed Clinical Operations Manager Lori Poole MSN, RN will join RJ Picciano BA, CHT, OCDT, CHBT on the podium on Wednesday, February 22, highlighting the topic “Fluid Management: How the Nephrology Clinical Technician Can Help.” Picciano serves as Fluid Management Coordinator for the Centers for Dialysis Care, Cleveland Ohio.

    “The CVInsight System provides new insight on assessing treatment tolerance, and we look forward to demonstrating that at the NANT Symposium,” said InteloMed CEO Jill Schiaparelli.

    The CVInsight Monitoring System will be available at the InteloMed booth, number 303. For more information about the event, visit http://www.dialysistech.net/education/2017-annual-symposium.

    * News distribution and content marketing services provided by 1-800-PublicRelations1800pr

    About InteloMed
    InteloMed is redefining the standard of care in patient monitoring and informatics through its intelligent, multi-dimensional, non-invasive CVInsight® Patient Monitoring & Informatics System.

    Providing an unprecedented level of physiologic insight, the CVInsight® Monitoring System is an easy-to-use, multi-parameter system for monitoring cardiovascular stress. It empowers clinicians with non-invasive, real-time, dynamic, and actionable information about a patient’s dialysis tolerance. Based on patented and proprietary algorithms, the system provides clinician set alerts to notify healthcare providers of changes in the patient’s tolerance to dialysis treatment, allowing them to intervene to avoid dialysis interruptions that can have serious patient consequences.

    The CVInsight® Patient Monitoring and Informatics System is FDA-cleared and CE-marked and has launched commercially in the United States. InteloMed is headquartered in Wexford, PA.

    For more information, visit us at www.InteloMed.com.

    Safe Harbor Statement
    Certain statements in this release are “forward-looking” and as such are subject to numerous risks and uncertainties. Actual results may vary significantly from the results expressed or implied in such statements. Factors that could cause actual results to materially differ from forward-looking statements include, but are not limited to, the need to obtain additional capital in order to grow our business, our ability to engage qualified employees, the acceptance of new products by doctors and hospitals, changes in the regulatory environment and healthcare legislation, the need to keep pace with technological changes, our dependence on third party manufacturers to produce components of our technology platform on time and to our specifications, and the successful implementation of our commercial strategies.

  • Genomic differences seen in mRCC during first- and second-line therapy

    by on February 28th, 2017

    AT THE GENITOURINARY CANCERS SYMPOSIUM ORLANDO (FRONTLINE MEDICAL NEWS) – In the largest assessment to date of circulating tumor DNA (ctDNA) in patients with metastatic renal cell carcinoma (mRCC), the majority of patients were found to have clinically relevant genomic alterations. The most frequently occurring alterations for the entire cohort were TP53, VHL, NF1, EGFR, […]

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