TRACON Pharmaceuticals Reports Second Quarter 2020 Financial Results and Provides Corporate Update
Recent Corporate Highlights
- In July, TRACON filed the ENVASARC pivotal trial protocol with the
U.S. Food and Drug Administration(FDA) as part of an Investigational New Drug (IND) application. Following the 30 day FDA review period, TRACON expects to enroll the first patient in the ENVASARC trial evaluating the PD-L1 single domain antibody envafolimab in the soft tissue sarcoma subtypes of undifferentiated pleomorphic sarcoma (UPS) and myxofibrosarcoma (MFS) in the fourth quarter of 2020. Key elements of the ENVASARC pivotal trial include:
- Multi-center, open-label, randomized, non-comparative, parallel cohort study.
- Eligible patients will have undifferentiated pleomorphic sarcoma (UPS) or myxofibrosarcoma (MFS) and will have received one or two prior lines of cancer therapy, and no prior immune checkpoint inhibitor therapy.
- Planned total enrollment of 160 patients, 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.
- Primary endpoint of objective response rate (ORR) with duration of response a key secondary endpoint. Nine of 80 objective responses (11.25% ORR) are required to demonstrate an ORR that is statistically higher than the 4% ORR reported for Votrient, the only approved therapy for refractory
UPS/MFS, in its package insert.
- Open-label format with blinded independent central review of efficacy endpoint data.
- In May, TRACON announced positive results for envafolimab at the 2020
American Society of Clinical Oncology (ASCO) Virtual Scientific Programfrom the Company’s corporate partners, 3D Medicines and Alphamab Oncology, that showed 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), with 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 and the 27.9% confirmed ORR reported for Keytruda in MSI-H/dMMR CRC patients who failed a fluoropyrimidine, oxaliplatin and irinotecan in cohort A of KEYNOTE-164.
- In May, TRACON highlighted data at the 2020 ASCO Virtual Scientific Program from the
Alliance for Clinical Trialsin Oncology that showed a 29% confirmed ORR in patients (n=14) with highly refractory UPSwho received dual checkpoint inhibition with Opdivo in combination with Yervoy. For reference, cohort B of the ENVASARC pivotal trial will enroll UPS/MFS patients who will receive dual checkpoint inhibition with envafolimab with Yervoy.
- In May, positive data were presented from multiple TRC102 clinical trials at the 2020 ASCO Virtual Scientific Program. In a Phase 2 trial, two of 14 mesothelioma patients who progressed previously on Alimta had objective responses following treatment with Alimta and TRC102. In a Phase 1 trial, TRC102 in combination with chemo-radiation resulted in an objective response in all 15 patients with locally advanced non-squamous non-small cell lung cancer, including three patients who demonstrated a complete response to treatment. The 100% ORR indicates a significant improvement as compared to historical data of chemoradiation without TRC102 in advanced lung cancer.
“We were excited by the ASCO data presented by our corporate partners showing that envafolimab activity was comparable to the activity of the approved products Opdivo and Keytruda in separate trials of MSI-H/dMMR CRC. Moreover, we were encouraged by additional data presented at ASCO from the Alliance group which showed an impressive response rate for dual checkpoint inhibition with Opdivo and Yervoy in
Expected Upcoming Milestones
- Completion of the 30 day FDA review period for the ENVASARC protocol, a pivotal trial in the sarcoma subtypes of
UPSand MFS, that was submitted to the FDA on July 16, 2020.
- Enroll the first patient in ENVASARC during the fourth quarter of 2020.
- Submission of the envafolimab BLA with the
National Medical Products Associationin China(NMPA) by our partners, 3D Medicines and Alphamab Oncology.
- 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.
Second Quarter 2020 Financial Results
- Cash and cash equivalents were
$14.5 millionat June 30, 2020, compared to $16.4 millionat December 31, 2019. We expect our current cash and cash equivalents to fund operations into the second quarter of 2021. If the remaining $11.7 millionavailable under the Aspire Capitalagreement as of June 30, 2020were fully utilized, cash runway would extend late into the third quarter of 2021.
- Research and development expenses for the second quarter of 2020 were
$2.2 million, compared to $4.3 millionfor the second 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.
- General and administrative expenses for the second quarter of 2020 were
$2.1 million, compared to $1.9 millionfor the second quarter of 2019.
- Net loss for the second quarter of 2020 was
$4.5 million, compared to $6.3 millionfor the second quarter of 2019.
Conference Call Details
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.
Envafolimab (KN035), a novel, single-domain antibody against PD-L1, is the first subcutaneously injected PD-(L)1 inhibitor to be studied in registrational 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. 3D Medicines and Alphamab Oncology, TRACON’s corporate partners for this program, plan to submit a BLA to the NMPA in
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
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
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.
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 registrational trial in the
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, regulatory and commercial 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 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
Unaudited Condensed Consolidated Statements of Operations
(in thousands, except share and per share data)
|Three Months Ended
||Six Months Ended
|Research and development|
|General and administrative||2,096||1,893||3,982||3,842|
|Total operating expenses||4,314||6,240||8,198||13,403|
|Loss from operations||(4,314||)||(6,240||)||(8,198||)||(13,403||)|
|Total other income (expense)||(137||)||(86||)||(274||)||(136||)|
|Net loss per share, basic and diluted||$(0.70||)||$(2.11||)||$(1.47||)||$(4.53||)|
|Weighted‑average common shares outstanding, basic and diluted||6,385,562||2,992,936||5,778,456||2,991,079|
Condensed Consolidated Balance Sheets
|Cash and cash equivalents|
|Prepaid and other assets||503||848|
|Total current assets||14,956||17,260|
|Property and equipment, net||16||23|
|Liabilities and Stockholders’ Equity|
|Accounts payable and accrued expenses|
|Accrued compensation and related expenses||906||1,355|
|Long‑term debt, current portion||1,746||2,604|
|Total current liabilities||9,235||11,834|
|Other long-term liabilities||651||850|
|Long‑term debt, less current portion||2,761||2,739|
|Commitments and contingencies|
|Additional paid‑in capital||173,801||165,028|
|Total stockholders’ equity||3,003||2,698|
|Total liabilities and stockholders’ equity|
|Company Contact:||Investor Contact:|
|Chief Business Officer|
Source: TRACON Pharmaceuticals, Inc.