TCON TRACON Pharmaceuticals Inc.

9.15
-0.2  -2%
Previous Close 9.35
Open 9.28
52 Week Low 0.95
52 Week High 10.65
Market Cap $125,215,490
Shares 13,684,753
Float 13,640,070
Enterprise Value $102,349,557
Volume 633,296
Av. Daily Volume 818,091
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Upcoming Catalysts

Drug Stage Catalyst Date
TJ4309
Solid tumors
Phase 1
Phase 1
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Envafolimab (ENVASARC)
Sarcomas
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
TRC102
Mesothelioma cancer
Phase 2
Phase 2
Phase 2 data presented at ASCO 2020.
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. SAN DIEGO, Nov. 23, 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 the publication of clinical data that provides molecular insight into TRC102's mechanism of action and patient populations most likely to respond to treatment. The article, entitled, "Molecular Features of Cancers Exhibiting Exceptional Responses to Treatment," highlights the clinical features and tumor biology of an exceptional responder patient…

    SAN DIEGO, Nov. 23, 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 the publication of clinical data that provides molecular insight into TRC102's mechanism of action and patient populations most likely to respond to treatment. The article, entitled, "Molecular Features of Cancers Exhibiting Exceptional Responses to Treatment," highlights the clinical features and tumor biology of an exceptional responder patient treated with TRC102 at the National Cancer Institute (NCI): https://www.traconpharma.com/wp-content/uploads/2020/11/Can_Cell_2020_Nov_Mol_Analysis_ER.pdf

    The patient was diagnosed with metastatic and highly refractory colorectal cancer and received temozolomide (Temodar®) and TRC102. Following treatment, the patient was considered an exceptional responder through the achievement of a near compete response lasting 45 months at the most recent follow-up. Detailed molecular analyses of the patient's tumor showed silencing of DNA repair pathways that may have resulted in sensitivity to the inhibition of DNA base excision repair pathway by TRC102. Specifically, MGMT expression was silenced by promoter methylation, and RAD50, a mediator of DNA double strand break repair, was silenced by genetic mutation and loss of heterozygosity. The publication authors hypothesized that the combination of Temodar and TRC102 was effective because all necessary DNA repair pathways were compromised genetically or through the activity of TRC102. MGMT expression was also assessed in biopsies from 11 colorectal patients who subsequently enrolled in an expansion cohort, one of which demonstrated a partial response. The tumor associated with the partial response did not express MGMT, whereas each of the 10 tumors that did not respond to therapy expressed this enzyme robustly.

    TRC102 is being studied in multiple Phase 1 and Phase 2 clinical trials sponsored by the NCI through a Cooperative Research and Development Agreement. TRC102 was also evaluated in a Phase 2 trial in combination with Temodar chemotherapy in 19 patients with progressive or recurrent glioblastoma who progressed following Temodar and external beam radiotherapy. Extended survival was observed in two patients for more than two years, both of whom demonstrated activation of the DNA base excision repair pathway and showed hyperactivation of DNA damage response genes prior to treatment with TRC102.

    "The Cancer Cell publication supports our belief that patients whose cancers are dependent on the DNA base excision repair pathway to repair DNA damage from chemotherapy may be particularly sensitive to the pharmacologic effects of TRC102," said James Freddo, M.D., Chief Medical Officer of TRACON. "The NCI data are also consistent with the results from the Phase 2 trial of Temodar and TRC102 in refractory glioblastoma. We remain committed to developing TRC102 in collaboration with the NCI and believe that the data generated to date provide strong rationale for studying TRC102 in combination with Temodar and radiotherapy in newly diagnosed patients with malignant glioma."

    About TRC102

    TRC102 (methoxyamine) is a novel, clinical-stage small molecule inhibitor of the DNA base excision repair pathway, which is a pathway that causes resistance to alkylating and antimetabolite chemotherapeutics. TRC102 is currently being studied in multiple Phase 1 and Phase 2 clinical trials sponsored by the National Cancer Institute through a Cooperative Research and Development Agreement (CRADA). TRC102 was granted orphan drug designation by the US FDA for the treatment of malignant glioma in 2020. For more information about the clinical trials, please visit TRACON's website at www.traconpharma.com/clinical-trials.

    About Malignant Glioma and GBM

    GBM (also called glioblastoma) is a fast-growing malignant glioma that develops from star-shaped glial cells (astrocytes and oligodendrocytes) that support the health of the nerve cells within the brain. GBM is the most invasive type of glial tumors, rapidly growing and commonly spreading into nearby brain tissue. The National Cancer Institute estimates that approximately 22,850 adults (12,630 men and 10,280 women) are diagnosed with brain and other nervous system cancer annually in the U.S. and approximately 15,320 of these diagnoses will result in death. GBM has an incidence of two to three per 100,000 adults per year in the U.S., and accounts for 52 percent of all primary brain tumors.

    About TRACON

    TRACON develops targeted therapies for cancer utilizing a capital efficient, CRO independent, 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 in a registrational trial in the U.S.; TRC253, a Phase 3 ready small molecule drug candidate for the treatment of prostate cancer; TRC102, a Phase 2 small molecule drug candidate in development for the treatment of lung cancer and glioblastoma; and TJ004309, a Phase 1 CD73 antibody in 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 and the National Cancer Institute's plans to further develop product candidates, expectations regarding clinical trials, development and regulatory plans, the potential benefits of TRC102, and TRACON's business development strategy and goals. 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 or other pandemics; 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, initiate additional trials or seek regulatory approval 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 WigginsBrian Ritchie
    Chief Business OfficerLifeSci Advisors LLC
    (858) 251-3492212-915-2578


      


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  2. SAN DIEGO, Nov. 16, 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 its corporate partners, Alphamab Oncology and 3D Medicines, have submitted a new drug application (NDA) for the approval of envafolimab (KN035) in the indication of MSI-H/dMMR cancer to the National Medical Products Administration (NMPA).

    "We congratulate our partners on the regulatory submission of data from the registration trial of envafolimab…

    SAN DIEGO, Nov. 16, 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 its corporate partners, Alphamab Oncology and 3D Medicines, have submitted a new drug application (NDA) for the approval of envafolimab (KN035) in the indication of MSI-H/dMMR cancer to the National Medical Products Administration (NMPA).

    "We congratulate our partners on the regulatory submission of data from the registration trial of envafolimab in MSI-H/dMMR advanced solid tumors including colorectal and gastric cancer, which marks an important milestone in the development and potential commercialization of the program," said Charles Theuer, M.D., Ph.D., TRACON Chief Executive Officer. "The submission for approval highlights the advanced status of envafolimab product development. Envafolimab is being studied in two additional registration trials, a randomized Phase 3 trial in biliary tract cancer in China being conducted by 3D Medicines and Alphamab, and TRACON's ENVASARC trial in sarcoma in the U.S., which recently opened multiple sites and expects to dose multiple patients prior to the end of the year."

    About Envafolimab (KN035)

    Envafolimab (KN035), a novel, single-domain antibody against PD-L1, is the first subcutaneously injected PD-(L)1 inhibitor to be studied in registration trials. Envafolimab is currently being studied in the ENVASARC Phase 2 registration trial in the U.S. sponsored by TRACON, as well as in a Phase 2 registration trial as a single agent in MSI-H/dMMR advanced solid tumor patients and a Phase 3 registration trial in combination with gemcitabine and oxaliplatin in advanced biliary tract cancer patients in China sponsored by TRACON's corporate partners, Alphamab Oncology and 3D Medicines. Alphamab Oncology and 3D Medicines have submitted an NDA to the NMPA in China for envafolimab in MSI-H/dMMR cancer. In the Phase 2 registration trial, the confirmed objective response rate (ORR) by blinded independent central review in MSI-H/dMMR colorectal cancer (CRC) patients treated with envafolimab who failed a fluoropyrimidine, oxaliplatin and irinotecan was 32%, which was similar to the 28% confirmed ORR reported in the Opdivo package insert in MSI-H/dMMR CRC patients who failed a fluoropyrimidine, oxaliplatin, and irinotecan and the 33% confirmed ORR reported for Keytruda in MSI-H/dMMR CRC patients who failed a fluoropyrimidine, oxaliplatin and irinotecan in cohort A of KEYNOTE-164.

    About ENVASARC (NCT04480502)

    The ENVASARC registration trial is a multi-center, open-label, randomized, non-comparative, parallel cohort study at approximately 25 top cancer centers in the United States. TRACON expects the trial to enroll 160 patients with UPS or MFS who have progressed following one or two lines of prior treatment and have not received an immune checkpoint inhibitor, with 80 patients enrolled into cohort A of treatment with single agent envafolimab and 80 patients enrolled in cohort B of treatment with envafolimab and Yervoy. The primary endpoint is ORR by blinded independent central review with duration of response a key secondary endpoint.

    About TRACON

    TRACON develops targeted therapies for cancer utilizing a capital efficient, CRO independent, product development platform. The Company's clinical-stage pipeline includes: Envafolimab, a subcutaneous PD-L1 single-domain antibody being developed in a registration trial for the treatment of sarcoma; TRC253, a small molecule drug candidate for the treatment of prostate cancer; TRC102, a Phase 2 small molecule drug candidate being developed for the treatment of lung cancer and glioblastoma; 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.

    About Alphamab Oncology

    Alphamab Oncology is a biopharmaceutical company focusing on innovative biologics medicine for oncology. On December 12, 2019, the Company was listed in the mainboard of Hong Kong Stock Exchange with stock code 9966. Alphamab has fully integrated proprietary biologics platforms in bi-specifics and protein engineering. Its pipeline includes eight anti-tumor drug candidates including mainly bi-specifics, and a Covid-19 multifunctional antibody. Four products have advanced into phase I-III clinical trials in China, the United States, and Japan. The Company also has state-of-the-art manufacturing capabilities designed and built to meet NMPA and EU/FDA's cGMP standards and a complete quality system which has passed the on-site inspection of a European Union qualified person. Alphamab Oncology is committed to building a global leading, multi-dimensional drug development and commercialization platform, focusing on multifunctional biological innovative drugs, and to benefit patients in China and around the world. Visit http://www.alphamabonc.com for more information.

    About 3D Medicines

    3D Medicines is a clinical-stage biopharmaceutical company focused on the development of differentiated next-generation immuno-oncology drugs for cancer patients. The world's first subcutaneous injection PD-L1 antibody Envafolimab (KN035), is currently under clinical development in the United States, China and Japan. 3D Medicines is building a pipeline targeting major indications through combination strategy, either with in-house assets or in collaboration with partners around the world. With a professional team in the China and US, 3D Medicines is capable of conducting global clinical development and registration.

    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 and regulatory milestones and timing thereof, 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 or other pandemics; 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, initiate additional trials or seek regulatory approval 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 WigginsBrian Ritchie
    Chief Business OfficerLifeSci Advisors LLC
    (858) 251-3492212-915-2578
     





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  3. SAN DIEGO, Nov. 10, 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 third quarter ended September 30, 2020. The Company will host a conference call and webcast today at 4:30 PM Eastern Time / 1:30 PM Pacific Time.

    "We made great progress during the quarter by securing capital from dedicated healthcare funds that extends our runway past expected ENVASARC registration trial interim data…

    SAN DIEGO, Nov. 10, 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 third quarter ended September 30, 2020. The Company will host a conference call and webcast today at 4:30 PM Eastern Time / 1:30 PM Pacific Time.

    "We made great progress during the quarter by securing capital from dedicated healthcare funds that extends our runway past expected ENVASARC registration trial interim data and into 2022. We expect to enroll patients at multiple sites in the ENVASARC trial this year and also expect our partners to submit envafolimab for approval in China before the end of the year," said Charles Theuer, M.D., Ph.D., President and CEO of TRACON. "We are focused on enrolling the ENVASARC trial expeditiously so we may deliver interim data in 2021, final data in 2022, and assuming positive clinical data and regulatory approval, potentially commercialize envafolimab in 2023 and thereby address a high unmet need within sarcoma."

    Recent Corporate Highlights

    Envafolimab

    • In September, TRACON highlighted data from the registration trial of envafolimab in MSI-H/dMMR cancer that showed a 32% confirmed objective response rate (ORR) in patients (n=41) with MSI-H/dMMR colorectal cancer (CRC) who failed a fluoropyrimidine, oxaliplatin and irinotecan, and had at least two on-study tumor assessments. Twelve-month duration of response (DOR) was 75% and 12-month overall survival (OS) was 65%. The ORR in the overall population (n=103) was 43%, 12-month DOR was 92% and 12-month OS was 75%. Envafolimab demonstrated good tolerability and safety and there continued to be no infusion-related reactions. The 32% ORR is nearly identical to the 28% ORR reported for Opdivo and 33% ORR reported for Keytruda in separate trials of MSI-H/dMMR CRC patients who failed a fluoropyrimidine, oxaliplatin and irinotecan.

    TRC102

    • In October, TRACON announced orphan drug designation from the U.S. FDA for TRC102 in malignant glioma, including glioblastoma. TRC102 is a small molecule inhibitor of DNA base inhibitor repair being studied in Phase 1 and Phase 2 trials sponsored by the National Cancer Institute.

    Corporate

    • In August, TRACON announced financings of approximately $10.0 million in the aggregate with multiple healthcare focused institutional investors through private placements of its common stock and pre-funded warrants. The financings were completed at market price, and TRACON expects that the net proceeds will extend its cash runway into 2022.

    Expected Key Upcoming Milestones

    • Enroll patients at multiple sites into the ENVASARC registration trial during the fourth quarter of 2020.



    • Submission of envafolimab for approval in MSI-H/dMMR CRC to the National Medicinal Products Administration (NMPA) in China by our corporate partners 3D Medicines and Alphamab Oncology.



    • Independent Data Monitoring Committee review of ENVASARC safety data in 1H 2021.



    • FDA decision on orphan drug designation for envafolimab in sarcoma in 1H 2021.



    • Interim ENVASARC efficacy and safety data in mid-2021.



    Third Quarter 2020 Financial Results

    • Cash and cash equivalents were $26.5 million at September 30, 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 2022.



    • Research and development expenses for the third quarter of 2020 were $1.8 million, compared to $3.1 million for the third quarter of 2019.



    • General and administrative expenses for the third quarter of 2020 were $2.1 million, compared to $2.0 million for the third quarter of 2019.



    • Net loss for the third quarter of 2020 was $4.0 million, compared to $5.2 million for the third quarter of 2019.

    Conference Call Details

    Tuesday, November 10, at 4:30 PM Eastern Time / 1:30 PM Pacific Time
    Domestic:855-779-9066
    International:631-485-4859
    Conference ID:7399456

    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 (KN035), a novel, single-domain antibody against PD-L1, is the first subcutaneously injected PD-(L)1 inhibitor to be studied in registration trials. Envafolimab is currently dosing in a Phase 2 registration trial as a single agent in MSI-H/dMMR advanced solid tumor patients and a Phase 3 registration trial in combination with gemcitabine and oxaliplatin in advanced biliary tract cancer patients in China sponsored by TRACON's corporate partners, 3D Medicines and Alphamab Oncology. In the Phase 2 registration trial, the confirmed ORR in MSI-H/dMMR CRC patients treated with envafolimab who failed a fluoropyrimidine, oxaliplatin and irinotecan was 32%, which was similar to the 28% confirmed ORR reported in the Opdivo package insert in MSI-H/dMMR CRC patients who failed a fluoropyrimidine, oxaliplatin and irinotecan and the 33% confirmed ORR reported for Keytruda in MSI-H/dMMR CRC patients who failed a fluoropyrimidine, oxaliplatin and irinotecan in cohort A of KEYNOTE-164.

    About TRC102

    TRC102 (methoxyamine) is a novel, small molecule inhibitor of the DNA base excision repair pathway, which is a pathway that causes resistance to alkylating and antimetabolite chemotherapeutics. TRC102 is currently being studied in multiple Phase 1 and Phase 2 clinical trials sponsored by the National Cancer Institute through a Cooperative Research and Development Agreement (CRADA) and has orphan drug designation from the US FDA in malignant glioma, including glioblastoma.

    About TRC253

    TRC253 is a Phase 3 ready 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, CRO independent, product development platform. The Company's clinical-stage pipeline includes: Envafolimab, a PD-L1 single-domain antibody given by rapid subcutaneous injection that is being studied in the pivotal ENVASARC trial for sarcoma; TRC253, a Phase 3 ready small molecule drug candidate for the treatment of prostate cancer; TRC102, a Phase 2 small molecule drug candidate 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 and its collaboration partners' plans to further develop product candidates, expectations regarding the timing and scope of clinical trials and availability of clinical data, expected development, regulatory and commercial milestones and timing thereof, estimated cash runway, potential utility of product candidates, potential events 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 and regulatory approval of novel pharmaceutical products; 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,; 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

    September 30,
     Nine Months Ended

    September 30,


      2020  2019  2020  2019 
    Operating expenses:    
    Research and development$1,785 $3,056 $6,001 $12,617 
    General and administrative 2,063  2,025  6,045  5,867 
    Total operating expenses 3,848  5,081  12,046  18,484 
    Loss from operations (3,848) (5,081) (12,046) (18,484)
    Total other expense (144) (118) (418) (254)
    Net loss $(3,992) $(5,199) $(12,464) $(18,738)


    Net loss per share, basic and diluted
     $(0.38) $(1.74) $(1.69) $(6.26)
    Weightedaverage common shares outstanding, basic and diluted 10,509,220  2,993,746  7,366,888  2,991,978 
         



    TRACON Pharmaceuticals, Inc.

    Condensed Consolidated Balance Sheets

    (in thousands)

     September 30, December 31,
      2020   2019 
    Assets(Unaudited)  
    Current assets:   
    Cash and cash equivalents$26,451  $16,412 
    Prepaid and other assets 1,002   848 
    Total current assets 27,453   17,260 
    Property and equipment, net 13   23 
    Other assets 595   838 
    Total assets $28,061   $18,121 
    Liabilities and Stockholders' Equity   
    Current liabilities:   
    Accounts payable and accrued expenses$6,409  $7,875 
    Accrued compensation and related expenses 1,080   1,355 
    Longterm debt, current portion 2,464   2,604 
    Total current liabilities 9,953   11,834 
    Other long-term liabilities 543   850 
    Longterm debt, less current portion 2,079   2,739 
    Commitments and contingencies   
    Stockholders' equity:   
    Common stock 14   4 
    Additional paidin capital 190,270   165,028 
    Accumulated deficit (174,798)  (162,334)
    Total stockholders' equity 15,486   2,698 
    Total liabilities and stockholders' equity $28,061   $18,121 
            



    Company Contact:Investor Contact:
    Mark WigginsBrian Ritchie
    Chief Business OfficerLifeSci Advisors LLC
    (858) 251-3492212-915-2578
    b

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  4. SAN DIEGO, Nov. 03, 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 it will report its third quarter 2020 financial and operating results after the close of U.S. financial markets on Tuesday, November 10, 2020. In addition, management will host a conference call to provide an update on corporate activities and discuss the quarterly financial results.

    Conference call and webcast:
    Date:November 10, 2020
    Time:4:30

    SAN DIEGO, Nov. 03, 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 it will report its third quarter 2020 financial and operating results after the close of U.S. financial markets on Tuesday, November 10, 2020. In addition, management will host a conference call to provide an update on corporate activities and discuss the quarterly financial results.

    Conference call and webcast:
    Date:November 10, 2020
    Time:4:30 pm Eastern Time (1:30 pm Pacific Time)
    Dial-in:(855) 779-9066 (Domestic) or (631) 485-4859 (International)
    Passcode:7399456
    Via web:www.traconpharma.com; "Events and Presentations" section within the "Investors" section

    A replay of the webcast will be available for 60 days on the website.

    About TRACON

    TRACON develops targeted therapies for cancer utilizing a capital efficient, CRO independent, 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 initiating a pivotal trial in the U.S. in the second half of 2020; TRC253, a small molecule drug candidate for the treatment of prostate cancer; TRC102, a Phase 2 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 WigginsBrian Ritchie
    Chief Business OfficerLifeSci Advisors LLC
    (858) 251-3492212-915-2578

     

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  5. SAN DIEGO, Oct. 26, 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 the U.S. Food and Drug Administration (FDA) granted TRC102 orphan drug designation for the treatment of patients with malignant glioma, including glioblastoma (GBM). TRC102 is a small molecule inhibitor of the DNA base excision repair pathway.

    TRC102 is being studied in multiple Phase 1 and Phase 2 clinical trials sponsored by the National…

    SAN DIEGO, Oct. 26, 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 the U.S. Food and Drug Administration (FDA) granted TRC102 orphan drug designation for the treatment of patients with malignant glioma, including glioblastoma (GBM). TRC102 is a small molecule inhibitor of the DNA base excision repair pathway.

    TRC102 is being studied in multiple Phase 1 and Phase 2 clinical trials sponsored by the National Cancer Institute through a Cooperative Research and Development Agreement (CRADA). TRC102 was evaluated in a Phase 2 trial in combination with Temodar chemotherapy in 19 patients with progressive or recurrent GBM who progressed following Temodar and external beam radiotherapy. Extended survival was observed in two patients for more than two years, both of whom demonstrated activation of the DNA base excision repair pathway and demonstrated hyperactivation of DNA damage response genes. TRC102 was also evaluated in combination with chemotherapy and external beam radiotherapy in a separate Phase 1 study of 15 patients with newly diagnosed non-squamous cell non-small cell lung cancer that resulted in a response by the Radiographic Evaluation Criteria in Solid Tumors (RECIST) in all patients, including three patients who had a complete response to treatment.

    "Orphan drug designation for TRC102 underscores the high level of unmet medical need in patients with malignant glioma and supports its potential in this indication based on the previously reported data demonstrating prolonged survival in patients retreated with Temodar combined with TRC102," said James Freddo, M.D, Chief Medical Officer of TRACON. "We remain committed to developing TRC102 in collaboration with the National Cancer Institute and believe that the data generated to date provide a rationale to study TRC102 in combination with Temodar and radiotherapy in newly diagnosed patients with malignant glioma."

    The FDA's Orphan Drug Designation program provides orphan status to drugs and biologics that are being developed to address rare diseases or disorders that affect fewer than 200,000 people in the U.S. With orphan designation, TRACON qualifies for various incentives with respect to TRC102 for the treatment of glioblastoma, including tax credits for qualified clinical trials and seven years of market exclusivity upon receipt of regulatory approval.

    About TRC102

    TRC102 (methoxyamine) is a novel, clinical-stage small molecule inhibitor of the DNA base excision repair pathway, which is a pathway that causes resistance to alkylating and antimetabolite chemotherapeutics. TRC102 is currently being studied in multiple Phase 1 and Phase 2 clinical trials sponsored by the National Cancer Institute through a Cooperative Research and Development Agreement (CRADA). For more information about the clinical trials, please visit TRACON's website at www.traconpharma.com/clinical-trials.php.

    About Malignant Glioma and GBM

    GBM (also called glioblastoma) is a fast-growing malignant glioma that develops from star-shaped glial cells (astrocytes and oligodendrocytes) that support the health of the nerve cells within the brain. GBM is the most invasive type of glial tumors, rapidly growing and commonly spreading into nearby brain tissue. The National Cancer Institute estimates that approximately 22,850 adults (12,630 men and 10,280 women) are diagnosed with brain and other nervous system cancer annually in the U.S. and approximately 15,320 of these diagnoses will result in death. GBM has an incidence of two to three per 100,000 adults per year in the U.S., and accounts for 52 percent of all primary brain tumors.

    About TRACON

    TRACON develops targeted therapies for cancer utilizing a capital efficient, CRO independent, 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 in a registrational trial in the U.S.; TRC253, a Phase 3 ready small molecule drug candidate for the treatment of prostate cancer; TRC102, a Phase 2 small molecule drug candidate in development for the treatment of lung cancer and glioblastoma; and TJ004309, a Phase 1 CD73 antibody in 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 and the National Cancer Institute's plans to further develop product candidates, the potential benefits of orphan drug designation for TRC102, expectations regarding clinical trials, development and regulatory plans, the potential benefits of TRC102, and TRACON's business development strategy and goals. 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 or other pandemics; 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, initiate additional trials or seek regulatory approval 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 the expected benefits of orphan drug designation will ultimately be realized, including due to potential loss of orphan drug designation or the development of competing products; 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 WigginsBrian Ritchie
    Chief Business OfficerLifeSci Advisors LLC
    (858) 251-3492212-915-2578




     

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