Company Contact: Verdolino & Lowey, P.C. 124 Washington Street, Suite 101 Foxboro, MA. 02035 Phone - 508-543-1720 Tracon@VLPC.com SAN DIEGO, July 30, 2024 (GLOBE NEWSWIRE) -- TRACON Pharmaceuticals (OTCQB: TCON) today announced that the Company has terminated its employees and will wind down its operations. This decision was made at a special meeting of the board of directors. The board of directors appointed Craig R. Jalbert, age 62, as the Company's CEO, President, Treasurer and Secretary, and sole member ...

Core Viewpoint - TRACON Pharmaceuticals has decided to terminate its employees and wind down operations following a special meeting of the board of directors [2]. Company Summary - The board of directors appointed Craig R. Jalbert as the Company's CEO, President, Treasurer, Secretary, and sole member of the board [4]. - Mr. Jalbert has extensive experience in managing distressed businesses and has been involved in wind-down phases for numerous firms [4].

Company will focus on exploring strategic alternatives, that may include a variety of strategic transactions such as a reverse merger, acquisition, sale of all assets, or other strategic transactions leveraging its in-house Product Development Platform of CRO-independent clinical trial execution SAN DIEGO, July 01, 2024 (GLOBE NEWSWIRE) -- TRACON Pharmaceuticals (NASDAQ:TCON) today announced the objective response rate (ORR) by blinded independent central review (BICR) in the fully enrolled ENVASARC pivotal ...

TRACON Pharmaceuticals, Inc. (NASDAQ:TCON) Q1 2024 Earnings Conference Call May 14, 2024 4:30 PM ET Conference Call Participants Good day, ladies and gentlemen, and welcome to TRACON Pharmaceuticals First Quarter 2024 Earnings Conference Call. At this time, all callers are in a listen-only mode. After the speakersÂ' prepared remarks, we will conduct a question-and-answer session and instructions will be given at that time. Now, I would like to turn the call over to Dr. Charles Theuer, President and CEO of T ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED MARCH 31, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number 001-36818 TRACON Pharmaceuticals, Inc. (Exact name of registrant as specified in its charter) | Delaware | 34-2037594 | | --- | --- | | (State or other jurisdiction of | (IRS Em ...

Exhibit 99.1 TRACON Pharmaceuticals Reports First Quarter 2024 Financial Results and Provides Corporate Update San Diego, CA – May 14, 2024 – TRACON Pharmaceuticals, Inc. (Nasdaq: TCON), a clinical stage biopharmaceutical company utilizing a cost-efficient, CRO-independent product development platform to advance its pipeline of novel targeted cancer therapeutics and to partner with other life science companies, today announced financial results for the first quarter ended March 31, 2024. The Company will ho ...

Company Participants Soumit Roy - Jones Research Steve Bersey - H.C. Wainwright During today's call, we will be making certain forward-looking statements, including statements regarding expected timing of clinical trials and results, regulatory activities, financing opportunities, our development plan and strategies, potential cost savings and other benefits deliverable through our product development platform or PDP, ability to enter into additional license agreements and expectations regarding envafolimab ...

Clinical Trials and Results - The ENVASARC trial has enrolled more than 70 of the planned 80 patients, with an objective response rate (ORR) of 15% by investigator review[16]. - The primary endpoint of the ENVASARC trial is to achieve an ORR of 11.25% (9 of 80 patients) by blinded independent central review (BICR) to potentially support accelerated FDA approval[15]. - The ENVASARC trial is expected to complete full accrual by the end of Q1 2024, with final response assessment data anticipated in the second half of 2024[19]. - TRC102 has shown promising anti-tumor activity in initial clinical trials, with good tolerability in over 100 patients[22]. - The combination of envafolimab with Yervoy did not demonstrate synergy, leading to the termination of enrollment in cohort D of the ENVASARC trial[18]. - The Phase 1/2 trial of YH001 in combination with envafolimab and doxorubicin has been discontinued following a data review[25]. - Envafolimab has been dosed in over 1,000 patients across more than 7 ongoing or completed clinical trials in the US, China, and Japan as of December 31, 2023[37]. - In a Phase 1 trial in China, 15 out of 17 evaluable subjects achieved a confirmed partial response (PR) rate of 20% and a disease control rate (DCR) of 53.3%[44]. - The Phase 1 trial in the US reported a 38.9% overall response rate (CR+PR+SD) among 18 subjects, with 2 confirmed PRs[53]. - The Phase 1 trial in Japan enrolled 26 subjects, focusing on the safety and tolerability of envafolimab in previously treated advanced solid tumors[55]. - The Phase 2 trial of TRC102 in combination with chemotherapy for advanced gastric cancer reported a confirmed ORR of 60%[64]. - A Phase 1 trial of TRC102 combined with Alimta, 100% of patients demonstrated an objective response, significantly higher than historical data[72]. - A Phase 1 trial of TRC102 combined with chemoradiation achieved a 100% objective response rate in 15 evaluable patients with advanced localized lung cancer[76]. - YH001 has been dosed to over 41 patients in completed Phase 1 trials in China and Australia, demonstrating tolerability and activity in advanced solid tumors[79]. - In a Phase 1 trial in Australia, 4 out of 23 patients achieved partial response (PR) by RECIST, indicating efficacy of YH001[83]. Financials and Market Potential - The company estimates that marketing envafolimab in refractory UPS and MFS could generate peak annual sales of up to $200 million in the U.S.[20]. - For the year ended December 31, 2023, the company reported a net loss of $3.6 million, compared to a net loss of $29.1 million for the year ended December 31, 2022[169]. - As of December 31, 2023, the company had an accumulated deficit of $240.5 million[169]. - The company had cash and cash equivalents totaling $8.6 million as of December 31, 2023, which is expected to fund operations into mid-2024[172]. - The company has $41.5 million remaining available for sale under the Capital on Demand Sales Agreement as of December 31, 2023[174]. - The company has $25.0 million remaining available for sale under the LPC Purchase Agreement as of December 31, 2023[174]. - The company anticipates a decrease in research and development expenses in 2024 with the completion of enrollment of the ENVASARC trial in Q1 2024[171]. - The closing price of the company's common stock was $0.181 per share on February 29, 2024, presenting challenges for raising additional funds[178]. Regulatory and Approval Processes - The FDA may require additional data for the BLA submission of envafolimab, potentially delaying regulatory approval[186]. - The regulatory approval process is lengthy and unpredictable, with potential changes in requirements that could extend development timelines[192]. - The company has not previously submitted a marketing application to the FDA, and there is no certainty that any product candidates will receive regulatory approval[197]. - The FDA regulates the company's product candidates, requiring compliance with extensive regulations before marketing[131]. - The company must complete preclinical studies and clinical trials to establish safety and efficacy before FDA approval[138]. - The FDA aims to review 90% of priority marketing applications within six months and standard applications within ten months[139]. - The Biologics Price Competition and Innovation Act grants 12 years of exclusivity for original biological products before biosimilars can be approved[140]. - The Orphan Drug Act provides a seven-year exclusive marketing period in the U.S. for products that receive FDA approval for rare diseases affecting fewer than 200,000 persons[144]. - The company intends to seek breakthrough therapy designation for envafolimab, but this designation may not be granted or lead to expedited processes[209]. - The FDA may withdraw accelerated approval if confirmatory trials do not verify clinical benefits or if promotional materials are found misleading[202]. - Regulatory approval in one jurisdiction does not guarantee approval in others, and delays in one region can negatively impact approvals elsewhere[210]. - Changes in FDA policies or new government regulations could delay or prevent regulatory approval of product candidates[213]. Collaborations and Licensing - The company has licensed its product development platform to Inhibrx for a $3.0 million upfront fee, enhancing capital efficiency[27]. - A non-exclusive license agreement with Inhibrx was granted for $3.0 million, allowing them to utilize the company's clinical trial technology[90]. - The Envafolimab Collaboration Agreement allows the company to develop and commercialize envafolimab for sarcoma in North America, with tiered royalties on net sales[94]. - The YH001 Collaboration Agreement grants the company exclusive rights to develop and commercialize YH001 in North America for multiple indications, with escalating double-digit royalties owed to Eucure on net sales[110]. - The company is responsible for all regulatory submissions and clinical trials for YH001 in North America, while Eucure handles CMC activities[107]. Safety and Efficacy - Envafolimab demonstrated a favorable pharmacokinetic (PK) profile with a mean half-life of approximately 200 hours, indicating dose-dependent exposure across all dose levels[54]. - In pre-clinical studies, envafolimab showed stronger T-cell activation and higher anti-tumor efficacy compared to the approved PD-L1 inhibitor durvalumab, with maximum inhibition observed at a ten-fold lower dose[34][35]. - The safety profile in the Phase 1 trial in China indicated that 76.5% of subjects experienced treatment-related adverse events (TEAEs), with no dose-limiting toxicities (DLTs) reported[41]. - Envafolimab's subcutaneous administration allows for better patient compliance and relatively stable plasma-drug concentration, potentially reducing risks associated with treatment[33]. - The drug's smaller molecular size compared to typical monoclonal antibodies may enhance tumor penetration, as observed in pre-clinical experiments[33]. - Envafolimab's unique PK profile and administration method may lead to improved efficacy and reduced side effects compared to traditional PD-(L)1 inhibitors[32]. - The combination of TRC102 and Temodar showed a clinical benefit in 10.5% of patients, with two patients achieving progression-free survival (PFS) beyond 11 months[75]. Market Environment - The global PD-1 and PD-L1 inhibitors market was valued at over $30 billion in 2022, indicating significant competition for the company's oncology products[119]. - Coverage and reimbursement for approved products depend on third-party payors, which may challenge prices and limit coverage[155]. - Governments are implementing cost-containment measures, including price controls, which could limit net revenue and results for pharmaceutical products[156]. - Adverse macroeconomic and geopolitical developments have impacted clinical trials, causing delays in patient enrollment and compliance[187].

Financial Performance - Cash, cash equivalents, and restricted cash were $8.6 million at December 31, 2023, down from $17.5 million at December 31, 2022[9] - License revenue for Q4 2023 was $3.0 million, attributed to the licensing of the Product Development Platform to a clinical stage biotech company[9] - Research and development expenses for Q4 2023 were $1.5 million, a decrease of 61% from $3.9 million in Q4 2022[9] - General and administrative expenses for Q4 2023 were $1.1 million, down from $2.0 million in Q4 2022, primarily due to lower legal expenses[9] - Net income for Q4 2023 was $0.4 million, compared to a net loss of $7.0 million in Q4 2022[9] - Total operating expenses for Q4 2023 were $2.6 million, down from $5.8 million in Q4 2022[14] - TRACON's total assets decreased to $10.1 million at December 31, 2023, from $19.5 million at December 31, 2022[16] Clinical Trials - The objective response rate (ORR) in the ENVASARC trial was 15% by investigator review and 8.7% by blinded independent central review, with a median duration of response greater than six months[5] - TRACON expects to complete enrollment of 80 patients in the ENVASARC trial later this quarter and report updated response rate data shortly thereafter[2] - The primary endpoint of the ENVASARC study is achieving an ORR by BICR in nine of 80 patients (11.25%) treated with envafolimab[5]

Company Participants Good day, ladies and gentlemen, and welcome to TRACON Pharmaceuticals Third Quarter 2023 Earnings Conference Call. [Operator Instructions] Now, I'd like to turn the call over to Dr. Charles Theuer, President and CEO of TRACON Pharmaceuticals. Dr. Theuer? Good afternoon, and thank you for joining TRACON's Third Quarter 2023 Financial Results and Business Update Call. I will begin with an update on our pipeline and then review our recent activities. Following that, Scott Brown, our Chief ...