TCON TRACON Pharmaceuticals Inc.

1.93
-0.01  -1%
Previous Close 1.94
Open 1.96
52 Week Low 0.95
52 Week High 6.4
Market Cap $10,615,749
Shares 5,500,388
Float 5,455,705
Enterprise Value $1,241,752
Volume 163,380
Av. Daily Volume 378,215
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Upcoming Catalysts

Drug Stage Catalyst Date
TRC102
Mesothelioma cancer
Phase 2
Phase 2
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TJ004309
Solid tumors
Phase 1
Phase 1
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Envafolimab
Sarcomas
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
TRC253
Prostate cancer
Phase 1/2
Phase 1/2
Phase 3 ready.
DE-122 and Lucentis - AVANTE
Wet age-related macular degeneration (Wet-AMD)
Phase 2
Phase 2
Development to be discontinued - March 9, 2020.
TRC105 + Opdivo
Non-small cell lung cancer (NSCLC)
Phase 1/2
Phase 1/2
Enrolment to be terminated - April 12, 2019.
TRC105 (TAPPAS)
Angiosarcoma cancer
Phase 3
Phase 3
Phase 3 interim analysis April 12, 2019 noted trial to be terminated due to futility.
TRC102 and Temodar
Glioblastoma - cancer
Phase 2
Phase 2
Phase 2 primary endpoint not met - November 19, 2018.
TRC105 and Inlyta
Renal Cell Carcinoma (RCC) - cancer
Phase 2
Phase 2
Phase 2 data December 21, 2018 did not meet primary endpoint.
TRC105 and Avastin
Glioblastoma - cancer
Phase 2
Phase 2
Phase 2 data released February 9, 2017 - primary endpoint not met.

Latest News

  1. NEW YORK, June 22, 2020 (GLOBE NEWSWIRE) -- Proactive, the digital financial news organization, will be showcasing four rising stars of the life sciences industry with its first North American virtual investor conference.

    The event will feature live webcast presentations from companies based in the US and Canada. Delegates will also be given the opportunity to put their questions to the presenters.

    Joining Proactive's One2One Investor Forum at 1pm EST on June 23 are:

    • Charles Theuer, chief executive of TRACON Pharma (NASDAQ:TCON
    • Heman Chao, CEO of Helix BioPharma (TSX:HBP, OTC:HBPCF)
    • Guy Chamberland, CEO of Tetra Bio-Pharma (TSXV:TBP)
    • Pat McCutcheon, CEO of MediPharm Labs (TSX:LABS)

    Proactive chief executive, Ian Mclelland, said: "Proactive…

    NEW YORK, June 22, 2020 (GLOBE NEWSWIRE) -- Proactive, the digital financial news organization, will be showcasing four rising stars of the life sciences industry with its first North American virtual investor conference.

    The event will feature live webcast presentations from companies based in the US and Canada. Delegates will also be given the opportunity to put their questions to the presenters.

    Joining Proactive's One2One Investor Forum at 1pm EST on June 23 are:

    • Charles Theuer, chief executive of TRACON Pharma (NASDAQ:TCON
    • Heman Chao, CEO of Helix BioPharma (TSX:HBP, OTC:HBPCF)
    • Guy Chamberland, CEO of Tetra Bio-Pharma (TSXV:TBP)
    • Pat McCutcheon, CEO of MediPharm Labs (TSX:LABS)

    Proactive chief executive, Ian Mclelland, said: "Proactive is at the forefront of bringing growth companies and investors together digitally.

    "Our Virtual One2One, an online variant of the popular conference format we've run for more than a decade, is a yet another innovative way we are enabling communication between motivated private shareholders and some of the US and Canada's most innovative businesses."

    For more information about the Proactive One2One Investor Forum on June 23 at 1pm EST, click the link.

    To book a future event, contact John Joyce on .

    For press queries call Ian Lyall on +44 7739 717 275.

    About Proactive

    Proactive is one of the fastest-growing financial media portals in the world, providing breaking news, commentary, and analysis on listed companies and pre-IPO businesses across the globe. Editorial and video content is featured on Proactive's platforms, and through syndication, it reaches many of the world's largest news amalgamators, financial websites, and news tracking services. News coverage takes place around the clock via six offices on three continents, and dedicated teams regularly organize large investor events in London, New York, and Sydney. Proactive is proud to serve more than 600 clients worldwide.

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  2. SAN DIEGO, June 01, 2020 (GLOBE NEWSWIRE) -- TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted cancer therapeutics and utilizing a cost efficient, CRO-independent product development platform to partner with ex-U.S. companies to develop and commercialize innovative products in the U.S., announced today that Charles Theuer, M.D., Ph.D., President and CEO, will present a corporate overview at the 2020 Jefferies Virtual Healthcare Conference on Thursday, June 4th, at 4:00 pm EDT.

    To access a live webcast of the presentation, please visit the "Events and Presentations" page within the "Investors" section of the TRACON Pharmaceuticals website at www.traconpharma.com

    SAN DIEGO, June 01, 2020 (GLOBE NEWSWIRE) -- TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted cancer therapeutics and utilizing a cost efficient, CRO-independent product development platform to partner with ex-U.S. companies to develop and commercialize innovative products in the U.S., announced today that Charles Theuer, M.D., Ph.D., President and CEO, will present a corporate overview at the 2020 Jefferies Virtual Healthcare Conference on Thursday, June 4th, at 4:00 pm EDT.

    To access a live webcast of the presentation, please visit the "Events and Presentations" page within the "Investors" section of the TRACON Pharmaceuticals website at www.traconpharma.com.

    About TRACON

    TRACON develops targeted therapies for cancer utilizing a capital efficient product development platform. The Company's clinical-stage pipeline includes: envafolimab, a subcutaneous PD-L1 single-domain antibody being developed for the treatment of sarcoma with the goal of starting a registrational trial in the U.S. in the second half of 2020; TRC253, a small molecule drug candidate being developed of the treatment of prostate cancer; TRC102, a small molecule drug candidate being developed for the treatment of lung cancer; and TJ004309, a CD73 antibody in Phase 1 development for the treatment of advanced solid tumors. TRACON is actively seeking additional corporate partnerships whereby it leads U.S. regulatory and clinical development and shares in the cost and risk of clinical development and leads U.S. commercialization.  In these partnerships TRACON believes it can serve as a solution for companies without clinical and commercial capabilities in the U.S.  To learn more about TRACON and its product pipeline, visit TRACON's website at www.traconpharma.com.

    Company Contact: Investor Contact:
    Mark Wiggins Andrew McDonald
    Chief Business Officer LifeSci Advisors LLC
    (858) 251-3492 646-597-6987

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  3. Undifferentiated Pleomorphic Sarcoma is the Major Sarcoma Subtype to be Enrolled in
    TRACON's Pivotal ENVASARC Trial
     
    of Envafolimab as a Single Agent and in Combination with Yervoy

    Pivotal ENVASARC Trial to Start in the Second Half of 2020

    SAN DIEGO, May 29, 2020 (GLOBE NEWSWIRE) -- TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted cancer therapeutics and utilizing a cost efficient, CRO-independent product development platform to partner with ex-U.S. companies to develop and commercialize innovative products in the U.S., today highlighted data from poster #11511 at the American Society of Clinical Oncology (ASCO) 2020 Virtual Scientific Program…

    Undifferentiated Pleomorphic Sarcoma is the Major Sarcoma Subtype to be Enrolled in
    TRACON's Pivotal ENVASARC Trial
     
    of Envafolimab as a Single Agent and in Combination with Yervoy

    Pivotal ENVASARC Trial to Start in the Second Half of 2020

    SAN DIEGO, May 29, 2020 (GLOBE NEWSWIRE) -- TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted cancer therapeutics and utilizing a cost efficient, CRO-independent product development platform to partner with ex-U.S. companies to develop and commercialize innovative products in the U.S., today highlighted data from poster #11511 at the American Society of Clinical Oncology (ASCO) 2020 Virtual Scientific Program, entitled,  "Multicenter phase II study of nivolumab +/- ipilimumab for patients with metastatic sarcoma (Alliance A091401): Results of expansion cohorts." Investigators from the Alliance for Clinical Trials in Oncology (Alliance), a broad community of scientists and clinicians who are committed to the prevention and treatment of cancer, reported an impressive 29% confirmed objective response rate (ORR) in patients (n=14) with highly refractory Undifferentiated Pleomorphic Sarcoma (UPS) who received Opdivo in combination with Yervoy in a non-comparative randomized trial. 

    TRACON recently reported on the results of poster #3021 at ASCO 2020, entitled "Envafolimab (KN035) in Advanced Tumors with Mismatch-Repair Deficiency," which was presented by the Company's corporate partners, 3D Medicines and Alphamab Oncology, and showed that single agent envafolimab demonstrated a 30.0% confirmed ORR in 50 patients with MSI-H/dMMR colorectal cancer (CRC) who failed a fluoropyrimidine, oxaliplatin and irinotecan (n=39) or those with advanced gastric cancer who failed at least one prior systemic treatment (n=11), who had at least two on-study tumor assessments.  The confirmed ORR in MSI-H/dMMR CRC patients treated with envafolimab who failed a fluoropyrimidine, oxaliplatin and irinotecan was 28.2%, which was nearly identical to the 28% confirmed ORR reported in the Opdivo package insert in MSI-H/dMMR CRC patients who failed a fluoropyrimidine, oxaliplatin and irinotecan.

    "The previously reported non-comparative randomized Alliance clinical data indicated that Opdivo combined with Yervoy tripled the ORR in high grade sarcomas compared to single agent Opdivo (ORR of 16% versus 5%). These new data from expansion cohorts indicate that the combination of Opdivo and Yervoy demonstrated a higher ORR than Opdivo alone in UPS, of 29% in highly refractory disease. It has been shown that UPS is one of the sarcoma subtypes with the highest responses to checkpoint inhibitors to date and, given these encouraging combination therapy data, the upcoming ENVASARC pivotal trial is a potentially promising study for patients," said Sandra D'Angelo, M.D., Associated Attending at Memorial Sloan Kettering Cancer Center and lead investigator for the Alliance clinical trial.

    "We believe these data bode well for the ENVASARC trial, which will assess the potential of envafolimab as a single agent and in combination with Yervoy in UPS that has progressed following one or two prior lines of treatment," said James Freddo, M.D., TRACON Chief Medical Officer. "Given the ASCO 2020 data indicating that envafolimab's activity is similar to that of Opdivo in MSI-H/dMMR cancer, but without infusion related reactions, we believe our trial's objective of targeting a 15% ORR in ENVASARC is achievable.  Moreover, given the 4% ORR of Votrient, the only approved therapy for refractory UPS and myxofibrosarcoma (MFS), a sarcoma subtype genetically related to UPS that will also be included in ENVASARC, we believe envafolimab combined with Yervoy could provide a transformative new standard of care for sarcoma patients."

    The complete envafolimab clinical trial poster is available at: https://meetinglibrary.asco.org/record/189156/poster

    The complete Alliance clinical trial poster is available at: https://meetinglibrary.asco.org/record/186749/poster

    About Envafolimab

    Envafolimab is a novel, single-domain antibody against PD-L1 that is administered by subcutaneous injection without the need for an adjuvant.  Envafolimab is currently dosing in Phase 1 trials in the U.S. and Japan and is being studied in China in a Phase 2 registration trial as a single agent in patients with MSI-H/dMMR cancer, and in combination with gemcitabine and oxaliplatin in a Phase 3 registration trial in biliary tract cancer.  3D Medicines and Alphamab Oncology plans to submit a BLA in China for envafolimab in 2020 based on overall response rate and duration of response in MSI-H/dMMR patients.  The submission would be based on the data from the ongoing pivotal phase 2 trial of envafolimab in MSI-H/dMMR cancer. 

    About TRACON

    TRACON develops targeted therapies for cancer utilizing a capital efficient product development platform. The Company's clinical-stage pipeline includes: envafolimab, a subcutaneous PD-L1 single-domain antibody being developed for the treatment of sarcoma with the goal of starting a registrational trial in the U.S. in the second half of 2020; TRC253, a small molecule drug candidate being developed of the treatment of prostate cancer; TRC102, a small molecule drug candidate being developed for the treatment of lung cancer; and TJ004309, a CD73 antibody in Phase 1 development for the treatment of advanced solid tumors. TRACON is actively seeking additional corporate partnerships whereby it leads U.S. regulatory and clinical development and shares in the cost and risk of clinical development and leads U.S. commercialization.  In these partnerships TRACON believes it can serve as a solution for companies without clinical and commercial capabilities in the U.S.  To learn more about TRACON and its product pipeline, 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 product candidates, expectations regarding the timing and scope of clinical trials, availability of clinical data and regulatory activities, expected development milestones and timing thereof, potential utility of product candidates, potential events, payments and actions under collaboration and license agreements, and TRACON's business development strategy and goals to enter into additional collaborations. Risks that could cause actual results to differ from those expressed in these forward‐looking statements include: risks associated with clinical development; whether TRACON or others will be able to complete or initiate clinical trials on TRACON's expected timelines, if at all, including due to risks associated with the COVID-19 pandemic; 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 third party collaborators complete on-going trials or initiate additional trials of TRACON's product candidates; the fact that TRACON's collaboration agreements are subject to early termination; whether TRACON will be able to enter into additional collaboration agreements on favorable terms or at all; 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.

    Company Contact: Investor Contact:
    Mark Wiggins Andrew McDonald
    Chief Business Officer LifeSci Advisors LLC
    (858) 251-3492 646-597-6987

     

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  4. Envafolimab Demonstrated a 30% Confirmed Objective Response Rate (ORR) by RECIST by Independent Central Review in Patients with Advanced Refractory MSI-H/dMMR Colorectal and Gastric Cancer

    ORR and Other Data will be Updated at ASCO

    TRACON Expects to Initiate its Pivotal ENVASARC Trial of Envafolimab in Sarcoma in Second Half of 2020

    SAN DIEGO, May 14, 2020 (GLOBE NEWSWIRE) -- TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted cancer therapeutics and utilizing a cost efficient, CRO-independent product development platform to partner with ex-U.S. companies to develop and commercialize innovative products in the U.S., today announced that positive…

    Envafolimab Demonstrated a 30% Confirmed Objective Response Rate (ORR) by RECIST by Independent Central Review in Patients with Advanced Refractory MSI-H/dMMR Colorectal and Gastric Cancer

    ORR and Other Data will be Updated at ASCO

    TRACON Expects to Initiate its Pivotal ENVASARC Trial of Envafolimab in Sarcoma in Second Half of 2020

    SAN DIEGO, May 14, 2020 (GLOBE NEWSWIRE) -- TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted cancer therapeutics and utilizing a cost efficient, CRO-independent product development platform to partner with ex-U.S. companies to develop and commercialize innovative products in the U.S., today announced that positive data from envafolimab in a pivotal trial in China for the treatment of MSI-H/dMMR cancer will be presented by the Company's corporate partners, 3D Medicines and Alphamab, at the American Society of Clinical Oncology (ASCO) 2020 Virtual Scientific Program.

    ASCO abstract #3021 entitled "Envafolimab (KN035) in Advanced Tumors with Mismatch-Repair Deficiency" reviewed data available on December 17, 2019 from the ongoing pivotal Phase 2 trial of envafolimab given by subcutaneous injection without an adjuvant in MSI-H/dMMR cancer. The trial enrolled 103 patients with MSI-H colorectal (CRC) or gastric cancer (GC) or with dMMR in other advanced solid tumors, in an open label format with efficacy endpoints, including the primary endpoint of confirmed objective response rate (ORR) determined by independent central review. MSI-H/dMMR status was assessed centrally for CRC and GC and locally for other tumors.

    Key highlights included:

    • The confirmed ORR in 50 patients with CRC who failed a fluoropyrimidine, oxaliplatin and irinotecan (n=39) plus those with advanced GC who failed at least one prior systemic treatment (n=11), with at least two on-study tumor assessments, was 30% (95% CI: 18%, 45%), of whom 80% were responding with median follow-up of 7.5 months at the time of the data cutoff.
    • The confirmed ORR in the overall population (n=103) was 34% (95% CI: 25%, 44%), of whom 86% were responding with median follow-up of 6.7 months at the time of the data cutoff.
    • The confirmed ORR in 24 patients with CRC who failed a fluoropyrimidine and oxaliplatin or irinotecan (n=24) was 54% (95% CI: 33%, 74%) of whom 85% were responding at the time of the data cutoff.
    • Envafolimab was well tolerated with a safety profile similar to that of approved PD-(L)1 checkpoint inhibitors but without infusion related reactions.

    "We are impressed by the confirmed ORR of envafolimab from its pivotal trial in Chinese patients with MSI-H/dMMR cancer, which is a genetically defined tumor type," said Charles Theuer, M.D., Ph.D., President and CEO. "We believe these data are important in assessing the potential of this novel subcutaneously administered product candidate in TRACON's initial indications in the U.S. of undifferentiated pleomorphic sarcoma (UPS) and myxofibrosarcoma (MFS), two soft tissue sarcoma subtypes which have responded to treatment with other checkpoint inhibitors. Moreover, these data indicate that envafolimab's activity in MSI-H cancer is similar to other checkpoint inhibitors, such as Keytruda or Opdivo but without infusion related reactions. We look forward to initiating our pivotal ENVASARC trial for envafolimab in UPS and MFS in the second half of 2020, for which we recently reached agreement on the key elements with the U.S. FDA."

    The complete abstract is available at: https://meetinglibrary.asco.org/record/189156/abstract

    About Envafolimab

    Envafolimab is a novel, single-domain antibody against PD-L1 that is administered by subcutaneous injection without the need for an adjuvant. Envafolimab is currently dosing in Phase 1 trials in the U.S. and Japan and is being studied in China in a Phase 2 registration trial as a single agent in MSI-H/dMMR tumor patients, and in combination with gemcitabine and oxaliplatin in a Phase 3 registration trial in biliary tract cancer. 3D Medicines plans to file a BLA in China for envafolimab in 2020 based on overall response rate and duration of response in MSI-H/dMMR patients. The filing would be based on the the ongoing pivotal phase 2 trial data of envafolimab in MSI-H/dMMR cancer. 

    About TRACON

    TRACON develops targeted therapies for cancer utilizing a capital efficient product development platform. The Company's clinical-stage pipeline includes: Envafolimab, a subcutaneous PD-L1 single-domain antibody being developed for the treatment of sarcoma with the goal of starting a registrational trial in the U.S. in the second half of 2020; TRC253, a small molecule drug candidate being developed of the treatment of prostate cancer; TRC102, a small molecule drug candidate being developed for the treatment of lung cancer; and TJ004309, a CD73 antibody in Phase 1 development for the treatment of advanced solid tumors. TRACON is actively seeking additional corporate partnerships whereby it leads U.S. regulatory and clinical development and shares in the cost and risk of clinical development and leads U.S. commercialization. In these partnerships TRACON believes it can serve as a solution for companies without clinical and commercial capabilities in the U.S. To learn more about TRACON and its product pipeline, 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 product candidates, expectations regarding the timing and scope of clinical trials, availability of clinical data and regulatory activities, expected development milestones and timing thereof, potential utility of product candidates, potential events, payments and actions under collaboration and license agreements, and TRACON's business development strategy and goals to enter into additional collaborations. Risks that could cause actual results to differ from those expressed in these forward‐looking statements include: risks associated with clinical development; whether TRACON or others will be able to complete or initiate clinical trials on TRACON's expected timelines, if at all, including due to risks associated with the COVID-19 pandemic; 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 third party collaborators complete on-going trials or initiate additional trials of TRACON's product candidates; the fact that TRACON's collaboration agreements are subject to early termination; whether TRACON will be able to enter into additional collaboration agreements on favorable terms or at all; 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.

       
    Company Contact: Investor Contact:
    Mark Wiggins Andrew McDonald
    Chief Business Officer LifeSci Advisors LLC
    (858) 251-3492 646-597-6987

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  5. SAN DIEGO, May 13, 2020 (GLOBE NEWSWIRE) -- TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted cancer therapeutics and utilizing a cost efficient, CRO-independent product development platform to partner with ex-U.S. companies to develop and commercialize innovative products in the U.S., today announced financial results for the first quarter ended March 31, 2020.

    Recent Corporate Highlights

    • In May, TRACON completed a Type B meeting with the FDA to discuss the pivotal ENVASARC trial design for the potential registration of envafolimab in multiple soft tissue sarcoma subtypes. The FDA agreed with the trial design to enroll separate noncomparative…

    SAN DIEGO, May 13, 2020 (GLOBE NEWSWIRE) -- TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted cancer therapeutics and utilizing a cost efficient, CRO-independent product development platform to partner with ex-U.S. companies to develop and commercialize innovative products in the U.S., today announced financial results for the first quarter ended March 31, 2020.

    Recent Corporate Highlights

    • In May, TRACON completed a Type B meeting with the FDA to discuss the pivotal ENVASARC trial design for the potential registration of envafolimab in multiple soft tissue sarcoma subtypes. The FDA agreed with the trial design to enroll separate noncomparative cohorts of 80 patients each with undifferentiated pleomorphic sarcoma (UPS) or myxofibrosarcoma (MFS), with the first cohort receiving single-agent envafolimab and the second cohort receiving envafolimab plus Yervoy (ipilimumab), with the primary endpoint being objective response rate by RECIST by blinded independent radiographic review in each cohort. TRACON expects to initiate dosing of ENVASARC in the second half of 2020, provide interim clinical trial data in 2021, final clinical trial data in 2022, and provided the drug is approved by the US FDA, commercialize envafolimab in 2023.
       
    • In April, TRACON amended its agreement with Aspire Capital Fund, LLC (Aspire Capital) to lower the minimum price of shares sold to be considered at the market purchases for Nasdaq purposes to $1.89 per share.  Under the amended agreement, Aspire Capital is committed to purchase up to an aggregate of $15.0 million of shares of our common stock at our request from time to time until June 2022, $14.2 million of which remained available for sale as of March 31, 2020.
       
    • In April, TRACON retained global rights to TRC253 by virtue of Janssen Pharmaceutica N.V.'s decision not to exercise its option to reacquire global rights to TRC253 following a review of the Phase 2 data in prostate cancer patients with acquired resistance to Xtandi or Erleada. TRACON has initiated an out-licensing process to identify a corporate partner to develop and commercialize TRC253 in an earlier line of treatment in China, where the androgen receptor inhibitors Xtandi and Erleada are not widely accessible. 
       
    • In April, TRACON entered into a deferral agreement with Silicon Valley Bank to defer principal payments for six months, which is expected to extend TRACON's cash runway further into the first quarter of 2021.
       
    • In March, TRACON's licensee Santen announced the discontinuation of DE-122 development based on top-line data from the Phase 2a AVANTE clinical study that indicated the combination of DE-122 and Lucentis did not improve visual acuity when compared to single-agent Lucentis.

    "We are pleased the FDA agreed with our pivotal ENVASARC trial design and endpoints as we believe it can enable a fast to market strategy to provide envafolimab as expeditiously as possible to sarcoma patients in need of a new therapy," said Charles Theuer, M.D., Ph.D., President and CEO of TRACON. "We look forward to the presentation of envafolimab clinical data by our corporate partner, 3D Medicines, at ASCO, enrolling the first ENVASARC patient in the second half of this year, and potentially becoming a commercial stage company in three years."

    Expected Upcoming Milestones

    • Receive orphan drug designation for envafolimab in soft tissue sarcoma in the second half of 2020.
       
    • Enroll the first patient in ENVASARC, a pivotal trial in the sarcoma subtypes of UPS and MFS, during the second half of 2020.
       
    • Report top-line data from the Phase 1 dose escalation study of TJ4309, a CD73 antibody, as a single agent and in combination with Tecentriq (a PD-L1 antibody being supplied by Roche), in the second half of 2020.

    First Quarter 2020 Financial Results

    • Cash and cash equivalents were $14.1 million at March 31, 2020, compared to $16.4 million at December 31, 2019.  We expect our current cash and cash equivalents to fund operations into the first quarter of 2021. We believe our cash runway could extend into the third quarter of 2021 if we were to fully utilize the $14.2 million that remains available under the Aspire Capital agreement.
       
    • Research and development expenses for the first quarter of 2020 were $2.0 million, compared to $5.2 million for the first quarter of 2019. The decrease was primarily attributable to lower manufacturing expenses and clinical trial expenses due to the discontinuation of the Phase 3 TRC105 program and lower manufacturing expenses for TRC253.
       
    • General and administrative expenses for the first quarter of 2020 and 2019 were $1.9 million.
       
    • Net loss for the first quarter of 2020 was $4.0 million, compared to $7.2 million for the first quarter of 2019.

    Investor Conference Call

    The Company will hold a conference call today at 4:30 p.m. EDT / 1:30 p.m. PDT to provide an update on corporate activities and to discuss the financial results of its first quarter 2020. The dial-in numbers are (855) 779‑9066 for domestic callers and (631) 485-4859 for international callers. Please use passcode 6453397. 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 Envafolimab

    Envafolimab is a novel, single-domain antibody against PD-L1 that is administered by subcutaneous injection without the need for an adjuvant.   Envafolimab is currently dosing in Phase 1 trials in the U.S. and Japan and is being studied in China in a Phase 2 registration trial as a single agent in MSI-H tumor patients, and in combination with gemcitabine and oxaliplatin in a Phase 3 registration trial in biliary tract cancer.  Subject to positive data from the MSI-H registrational trial, 3D Medicines plans to file a BLA in China for envafolimab in 2020 based on overall response rate in MSI-H patients.  The filing would be based on the principle that the response rate required for approval in China is similar to the response rates seen with Keytruda and Opdivo in MSI-H patients from separate clinical trials per the U.S. product package inserts.

    About TRC253

    TRC253 is a novel, orally bioavailable small molecule drug that is a potent, high affinity competitive inhibitor of the androgen receptor (AR) and AR mutations, including the F877L mutation.  The AR F877L mutation results in an alteration in the AR ligand binding domain that confers resistance to therapies for prostate cancer. Therapies targeting the AR have demonstrated clinical efficacy by extending time to disease progression, and in some cases, the survival of patients with metastatic castration-resistant prostate cancer. However, resistance to these agents is often observed and several molecular mechanisms of resistance have been identified, including gene amplification, overexpression, alternative splicing, and point mutation of the AR. TRC253 recently completed a Phase 1/2 clinical trial in prostate cancer conducted by TRACON.  TRACON believes TRC253 can be developed and commercialized successfully in China and is actively seeking a strategic collaboration.

    About TJ004309

    TJ004309 is a novel, humanized antibody against CD73, an ecto-enzyme expressed on stromal cells and tumors that converts extracellular adenosine monophosphate (AMP) to adenosine, which is highly immunosuppressive.   TJ004309 is currently being studied in a Phase 1 trial to assess safety and preliminary efficacy as a single agent and when combined with the PD-L1 checkpoint inhibitor Tecentriq in patients with advanced solid tumors.

    About TRACON

    TRACON develops targeted therapies for cancer utilizing a capital efficient product development platform. The Company's clinical-stage pipeline includes: Envafolimab, a subcutaneous PD-L1 single-domain antibody being developed for the treatment of sarcoma with the goal of starting a registrational trial in the U.S. in the second half of 2020; TRC253, a small molecule drug candidate being developed of the treatment of prostate cancer; TRC102, a small molecule drug candidate being developed for the treatment of lung cancer; and TJ004309, a CD73 antibody in Phase 1 development for the treatment of advanced solid tumors. TRACON is actively seeking additional corporate partnerships whereby it leads U.S. regulatory and clinical development and shares in the cost and risk of clinical development and leads U.S. commercialization.  In these partnerships TRACON believes it can serve as a solution for companies without clinical and commercial capabilities in the U.S.  To learn more about TRACON and its product pipeline, 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 product candidates, expectations regarding the timing and scope of clinical trials and availability of clinical data, expected development milestones and timing thereof, estimated cash runway, potential access to future capital, potential utility of product candidates, potential events, payments and actions under collaboration and license agreements, and TRACON's business development strategy and goals to enter into additional collaborations. Risks that could cause actual results to differ from those expressed in these forward‐looking statements include: risks associated with clinical development; whether TRACON or others will be able to complete or initiate clinical trials on TRACON's expected timelines, if at all, including due to risks associated with the COVID-19 pandemic; 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 third party collaborators complete on-going trials or initiate additional trials of TRACON's product candidates; the fact that TRACON's collaboration agreements are subject to early termination; whether TRACON will be able to enter into additional collaboration agreements on favorable terms or at all; whether and when any bispecific antibodies are developed under TRACON's collaboration with I-Mab; uncertainty with respect to the outcome of TRACON's disputes with I-Mab; 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, including being able to meet the conditions for sales of common stock under TRACON's agreement with Aspire Capital; the possibility of unexpected expenses or other uses of TRACON's cash resources; 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.
    Unaudited Condensed Consolidated Statements of Operations
    (in thousands, except share and per share data)
      Three Months Ended
    March 31,
        2020       2019  
         
         
    Operating expenses:    
    Research and development   $1,998       $5,214  
    General and administrative   1,886       1,949  
    Total operating expenses   3,884       7,163  
    Loss from operations   (3,884 )     (7,163 )
    Total other income (expense)   (137 )     (50 )
    Net loss   $(4,021 )     $(7,213 )

    Net loss per share, basic and diluted
      $(0.78 )     $(2.41 )
    Weighted‑average common shares outstanding, basic and diluted   5,171,351       2,989,251  
       
       



    TRACON Pharmaceuticals, Inc.
    Condensed Consolidated Balance Sheets
    (in thousands)
      March 31,   December 31,
        2020       2019  
    Assets (Unaudited)    
    Current assets:      
    Cash and cash equivalents   $14,134       $16,412  
    Prepaid and other assets   835       848  
    Total current assets   14,969       17,260  
    Property and equipment, net   19       23  
    Other assets   760       838  
    Total assets   $15,748       $18,121  
    Liabilities and Stockholders' Equity      
    Current liabilities:      
    Accounts payable and accrued expenses   $6,911       $7,875  
    Accrued compensation and related expenses   594       1,355  
    Long‑term debt, current portion   1,267       2,604  
    Total current liabilities   8,772       11,834  
    Other long-term liabilities   754       850  
    Long‑term debt, less current portion   3,438       2,739  
    Commitments and contingencies      
    Stockholders' equity:      
    Common stock   5       4  
    Additional paid‑in capital   169,134       165,028  
    Accumulated deficit   (166,355 )     (162,334 )
    Total stockholders' equity   2,784       2,698  
    Total liabilities and stockholders' equity   $15,748       $18,121  
                   


    Company Contact: Investor Contact:
    Mark Wiggins Andrew McDonald
    Chief Business Officer LifeSci Advisors LLC
    (858) 251-3492 646-597-6987

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