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 SEPTEMBER 30, 2023 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 incorporation or organizati ...

Company Participants Joel Beatty - Robert W. Baird Edward White - H.C. Wainwright Now, I would like to turn the call over to Dr. Charles Theuer, President and CEO of TRACON Pharmaceuticals. Dr. Theuer? TRACON Pharmaceuticals, Inc. (NASDAQ:TCON) Q2 2023 Earnings Call August 14, 2023 4:30 PM ET Conference Call Participants Good day, ladies and gentlemen, and welcome to the TRACON PharmaceuticalsÂ' Second Quarter 2023 Earnings Conference Call. At this time, all callers are in a listen-only mode. After the spea ...

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 JUNE 30, 2023 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 incorporation or organization) 4 ...

Company Participants Operator TRACON Pharmaceuticals, Inc. (OTCQB:TCON) Q1 2023 Earnings Conference Call May 10, 2023 4:30 PM ET Conference Call Participants Good day, ladies and gentlemen, and welcome to TRACON Pharmaceuticals First Quarter 2023 Earnings Conference Call. [Operator Instructions]. During today's call, we will be making certain forward-looking statements, including statements regarding expected timing of clinical trials and results, regulatory activities, future expenses and cash runaway, our ...

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 Commission File Number 001-36818 TRACON Pharmaceuticals, Inc. (Exact name of registrant as specified in its charter) Delaware 34-2037594 San Diego CA 92122 (Address of principal executive offices) (Zip Code) (IRS Employer Identification No.) (858) 550-0780 (Registrant's telephone number, including area code) Securities registered pursuant ...

Financial Data and Key Metrics Changes - TRACON's research and development expenses increased to $3.9 million for Q4 2022 from $3.1 million in Q4 2021, and for the full year, expenses rose to $13.9 million from $11.1 million [3] - General and administrative expenses decreased to $2 million for Q4 2022 from $4.6 million in Q4 2021, and for the full year, they fell to $14 million from $17.5 million, attributed to lower legal expenses [3] - Cash and cash equivalents at December 31, 2022, totaled $17.4 million, down from $24.1 million at the end of 2021 [39] - The net loss for Q4 2022 was $7 million compared to $7.7 million in Q4 2021, and for the full year, the net loss was $29.1 million compared to $28.7 million in 2021 [60] Business Line Data and Key Metrics Changes - The ENVASARC trial has enrolled nearly 90 patients with refractory UPS or MFS, with an anticipated completion of enrollment of 160 patients by the end of 2023 [30] - The primary endpoint of the ENVASARC trial is the objective response rate, with a target of exceeding the 4% response rate of Votrient, the only approved treatment for these patients [31] - The trial's second interim efficacy analysis is expected in Q3 2023, requiring at least 3 responses in 46 patients to continue accrual [32][42] Market Data and Key Metrics Changes - The company is targeting a 15% response rate for single-agent ENVA and up to a 30% response rate for ENVA in combination with Yervoy [22] - The FDA has granted Fast Track designation for ENVA in specific sarcoma subtypes, which may expedite development and regulatory review [22] Company Strategy and Development Direction - TRACON aims to commercialize two in-licensed immuno-oncology therapies together in sarcoma, focusing on maximizing sales potential in this area [55] - The company plans to leverage its CRO-independent product development platform to secure nondilutive capital and enhance operational efficiency [17][36] - Future directions may include expanding the envafolimab license and exploring new molecules, including antibody-drug conjugates [51] Management's Comments on Operating Environment and Future Outlook - Management expects to report the arbitration panel's binding decision regarding legal disputes with I-Mab in the current quarter, which could significantly impact the company's financial position [61] - The company is preparing for potential capital influx from arbitration outcomes, which would support ongoing clinical trials and operational needs [58] Other Important Information - TRACON has secured up to $30 million in nondilutive, nonrecourse financing related to the arbitration award decision, with $3.5 million already funded [36] - The arbitration claims are complex, and the company cannot predict the outcome or the amount of recovery [25] Q&A Session Summary Question: What should be expected from the upcoming interim readout in the ENVASARC trial? - Management confirmed that the interim analysis will involve 90 patients and will assess the best overall response and continued response at that time point [5] Question: Can you elaborate on the arbitration and expected outcomes? - Management expressed confidence in receiving an award announcement this quarter but noted the confidentiality of the arbitration process [6] Question: What are the expectations for the Phase I trial of YH001? - The goal is to establish a recommended Phase II dose and demonstrate tolerability in patients with sarcoma [8] Question: How is TRACON preparing for potential bankruptcy from the arbitration? - Management clarified that they are focused on the potential benefits from the arbitration and do not foresee bankruptcy as a likely outcome [46] Question: What are the future directions for TRACON? - The company plans to continue focusing on oncology, particularly in unmet need populations, and may explore additional molecules based on available resources [71]

Clinical Trials and Efficacy - The ENVASARC Phase 2 pivotal trial is enrolling a total of 160 patients, with the primary objective to exceed the known 4% objective response rate (ORR) of Votrient® (pazopanib) for patients with refractory undifferentiated pleomorphic sarcoma (UPS) or myxofibrosarcoma (MFS) [17] - The trial aims to demonstrate at least 86% power to show that the lower bound of the 95% confidence interval is greater than 5% in each cohort, which is necessary for potential accelerated approval by the FDA [17] - The ENVASARC trial has shown a double-digit ORR in interim analyses, exceeding the prespecified futility rule, indicating promising efficacy for envafolimab monotherapy and in combination with Yervoy [19] - Envafolimab has been dosed in over 1,000 patients across more than 7 clinical trials, including pivotal trials in MSI-H/dMMR cancer patients [39] - The pivotal Phase 2 trial for Envafolimab in soft tissue sarcoma is expected to provide interim data in Q3 2023 and final data by mid-2024 [30] - Envafolimab demonstrated a 32% confirmed overall response rate (ORR) in 41 patients with MSI-H/dMMR colorectal cancer who failed prior treatments, comparable to 28% for Opdivo and 33% for Keytruda [64] - In the overall population of MSI-H/dMMR cancer patients (n=103), the ORR was 43%, with 92% of patients achieving a duration of response (DOR) of at least 12 months [64] - A Phase 2 trial of TRC102 in lung cancer aims to improve the one-year progression-free survival rate from 56% to 75% [24] - TRC102 has shown good tolerability and promising anti-tumor activity in initial clinical trials with over 100 patients, particularly in combination with Alimta® and Temodar® [24] - A Phase 1 trial of TRC102 in combination with chemoradiation for locally advanced non-squamous non-small cell lung cancer achieved a 100% objective response rate (ORR) among 15 patients, significantly higher than historical data [90] - In a Phase 2 trial for recurrent glioblastoma, 10.5% of patients showed clinical benefit, with two patients achieving PFS beyond 11 months [93] Regulatory and Market Considerations - The FDA granted fast track designation for envafolimab for patients with locally advanced, unresectable or metastatic UPS and MFS, with expectations to submit a biologics license application (BLA) in 2024 if positive data is obtained [20] - The FDA regulates the company's product candidates, requiring compliance with extensive regulations before marketing approval [152] - The FDA's goal is to review 90% of priority marketing applications within six months and 90% of standard applications within ten months [158] - The Orphan Drug Act provides a seven-year exclusive marketing period for drugs approved for rare diseases affecting fewer than 200,000 persons in the U.S. [163] - The U.S. provides a 12-year data exclusivity period for innovator biologic products from the date of first licensure [165] - The EU offers a data exclusivity period of 10 to 11 years for similar biological medicinal products, requiring the reference product to be authorized for at least 8 years [167] - Japan has a market exclusivity period of 8 years for new drug approvals, during which generic applications cannot be submitted [170] - The FDA's Fast Track program facilitates the development and review of drugs for serious conditions, potentially leading to priority review within 6 months [171] - Coverage and reimbursement for approved products depend on third-party payors, who may challenge prices and impose restrictions [175] - Governments are implementing cost-containment measures, including price controls, which could limit net revenue and results for the company [176] Financial and Operational Risks - The company has incurred operating losses since inception and anticipates continued substantial losses, raising concerns about its ability to achieve profitability [15] - The company is heavily dependent on the success of envafolimab and requires substantial additional financing to continue its drug development efforts [15] - The ongoing military conflict between Ukraine and Russia, along with the COVID-19 pandemic, poses potential risks to the company's operations and financial condition [14] - The company faces intense competition and rapid technological change, which may adversely affect its financial condition and ability to commercialize its product candidates [15] Collaborations and Agreements - I-Mab's strategic partnership with Kalbe Genexine Biologics could yield up to $340 million in potential payments for TJ004309 [27] - The Envafolimab Collaboration Agreement allows the company to develop and commercialize envafolimab for sarcoma in North America, with tiered royalties on net sales ranging from the teens to mid-double digits [96][98] - The company has entered into a collaboration agreement with Eucure and Biocytogen for the development of YH001, a CTLA-4 antibody, with exclusive rights for commercialization in North America [102] - The company has collaboration agreements with I-Mab for the development of multiple immuno-oncology programs, including the CD73 antibody TJ004309 [108] - Under the TJ004309 Agreement, the company will bear the costs of filing an IND application and Phase 1 clinical trials, while sharing costs equally for Phase 2 trials [109] Intellectual Property and Patents - The company relies on a patenting strategy focused on protein and small molecule therapeutics, with patents for its candidates expected to expire between 2027 and 2030 [142] - The company holds an exclusive license for envafolimab's intellectual property rights in North America, with a non-exclusive license for clinical trials in the EU [145] - Eucure has an issued patent for YH001 in the U.S., expiring in 2037, allowing for the treatment of multiple human indications [146] - The company holds issued patents for TRC102 in multiple countries, with expiration expected in 2027 and 2031 for different combinations [147][148] - A non-exclusive license for TJ004309 in North America is held from I-Mab, which retains ownership of the related intellectual property rights [149] - The company relies on trade secrets, trademarks, and know-how to maintain its competitive position, protected by confidentiality agreements [151] Manufacturing and Development - Envafolimab is manufactured by AlphaMab in China, with fill finish performed by a U.S. contract manufacturer, at pre-negotiated prices [131] - The company utilizes a CRO-independent product development platform to enhance capital efficiency and expedite clinical trial processes [30] Employee and Corporate Information - As of December 31, 2022, the company had 18 full-time employees, with 12 involved in research, development, or manufacturing [184] - Access to the Annual Report on Form 10-K and quarterly reports on Form 10-Q is available through the investor section of the company's website without any charge [186] - The company does not assume any obligation to update forward-looking statements unless required by law [186] - The Annual Report contains references to trademarks, but does not imply endorsement or sponsorship by other companies [187] - There are no applicable quantitative and qualitative disclosures about market risk in the current report [475]

TRACON Pharmaceuticals, Inc. (OTCQB:TCON) Q3 2022 Earnings Conference Call November 14, 2022 4:30 PM ET Company Participants Charles Theuer - CEO, President & Director Scott Brown - CFO Conference Call Participants Joel Beatty - Robert W. Baird & Co. Edward White - H.C. Wainwright & Co. Soumit Roy - JonesTrading Robert Hazlett - BTIG Operator Good day, ladies and gentlemen, and welcome to the TRACON Pharmaceuticals Third Quarter 2020 Earnings Conference Call. [Operator Instructions]. During today's call, we ...

TRACON Pharmaceuticals, Inc. (OTCQB:TCON) Q2 2022 Earnings Conference Call August 10, 2022 4:30 PM ET Company Participants Charles Theuer - President and Chief Executive Officer Scott Brown - Chief Financial Officer Conference Call Participants Maury Raycroft - Jefferies Ed White - H.C. Wainwright Soumit Roy - Jones Research Nick Abbott - Wells Fargo Joel Beatty - Baird Operator Good day, ladies and gentlemen, and welcome to TRACON Pharmaceuticals Second Quarter 2022 Earnings Conference Call. At this time, ...

PART I [Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) The company reported increased net losses and decreased assets, raising substantial doubt about its ability to continue as a going concern Condensed Consolidated Balance Sheet Highlights (Unaudited) | (in thousands) | June 30, 2022 | December 31, 2021 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $13,580 | $24,072 | | Total current assets | $14,156 | $24,936 | | Total assets | $15,677 | $26,557 | | **Liabilities and Stockholders' Equity** | | | | Total current liabilities | $12,063 | $13,676 | | Total liabilities | $13,135 | $14,843 | | Total stockholders' equity | $2,542 | $11,714 | | Total liabilities and stockholders' equity | $15,677 | $26,557 | Condensed Consolidated Statements of Operations Highlights (Unaudited) | (in thousands, except per share data) | Three Months Ended June 30, 2022 | Six Months Ended June 30, 2022 | | :--- | :--- | :--- | | Collaboration revenue | $0 | $0 | | Research and development expenses | $2,923 | $5,916 | | General and administrative expenses | $3,316 | $9,769 | | Loss from operations | $(6,239) | $(15,685) | | Net loss | $(6,230) | $(15,703) | | Net loss per share, basic and diluted | $(0.31) | $(0.79) | Condensed Consolidated Statements of Cash Flows Highlights (Unaudited) | (in thousands) | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | $(14,759) | $(9,033) | | Net cash (used in) provided by investing activities | $(6) | $3,970 | | Net cash provided by (used in) financing activities | $4,273 | $(1,488) | | Change in cash and cash equivalents | $(10,492) | $(6,551) | | Cash and cash equivalents at end of period | $13,580 | $25,580 | - The company has incurred operating losses since inception, with an accumulated deficit of **$223.5 million** as of June 30, 2022[24](index=24&type=chunk) - Management has substantial doubt about the company's ability to continue as a going concern for the next 12 months, as existing cash of **$13.6 million** may not be sufficient to meet obligations[24](index=24&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=15&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) The biopharmaceutical company focuses on envafolimab development, with increased R&D and G&A expenses, and faces substantial doubt about its going concern status - TRACON is a biopharmaceutical company focused on developing and commercializing novel targeted cancer therapeutics[69](index=69&type=chunk) - Its lead product candidate is **envafolimab**, a PD-L1 antibody for treating sarcoma, currently in the ENVASARC Phase 2 pivotal trial[70](index=70&type=chunk) - The company is involved in a significant legal dispute with **I-Mab Biopharma** concerning collaboration agreements for TJ004309 and up to five bispecific antibodies[81](index=81&type=chunk)[117](index=117&type=chunk) - An arbitration tribunal decision is expected by September 30, 2022, with an unpredictable outcome that could materially impact the company[81](index=81&type=chunk)[117](index=117&type=chunk) Key Clinical Pipeline and Expected Data | Product Candidate | Indication | Phase | Data Expected | | :--- | :--- | :--- | :--- | | Envafolimab | Soft Tissue Sarcoma (UPS and MFS) | Pivotal Phase 2 | Interim Data - 2022 and 2023; Final Data – 2024 | | Envafolimab + YH001 | Multiple Soft Tissue Sarcoma Subtypes | Phase 1/2 (planned) | 2023 and 2024 | | TRC102 | Lung Cancer | Randomized Phase 2 | 2024 | - For the six months ended June 30, 2022, R&D expenses increased by **$0.6 million** to **$5.9 million** compared to the same period in 2021, driven by the ENVASARC trial[131](index=131&type=chunk) - G&A expenses increased by **$1.0 million** to **$9.8 million**, primarily due to legal expenses from the I-Mab arbitration[132](index=132&type=chunk) - The company has substantial doubt about its ability to continue as a going concern[134](index=134&type=chunk)[146](index=146&type=chunk) - Cash and cash equivalents of **$13.6 million** as of June 30, 2022, are expected to fund operations into 2023, but not for a full 12 months from the report's issuance, necessitating additional funding[134](index=134&type=chunk)[146](index=146&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=27&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company has indicated that this section is not applicable - Not applicable[149](index=149&type=chunk) [Controls and Procedures](index=28&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the CEO and CFO, evaluated the company's disclosure controls and procedures and concluded they were effective as of June 30, 2022, with no material changes in internal control over financial reporting during the quarter - The company's management, including the Chief Executive Officer and Chief Financial Officer, concluded that disclosure controls and procedures were effective as of June 30, 2022[152](index=152&type=chunk) - There were no changes in the company's internal control over financial reporting during the quarter ended June 30, 2022, that have materially affected, or are reasonably likely to materially affect, its internal control over financial reporting[153](index=153&type=chunk) PART II OTHER INFORMATION [Legal Proceedings](index=29&type=section&id=Item%201.%20Legal%20Proceedings) The company is not party to any material legal proceedings, except for its ongoing arbitration with I-Mab Biopharma regarding collaboration agreements - The company is not currently a party to any material legal proceedings, except for the ongoing dispute and related arbitration with **I-Mab Biopharma**[156](index=156&type=chunk) [Risk Factors](index=29&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant financial, development, and operational risks, including going concern doubt, reliance on its lead candidate and third parties, and macroeconomic impacts - The company has a history of operating losses, an accumulated deficit of **$223.5 million**, and expects to incur substantial losses for the foreseeable future[160](index=160&type=chunk)[162](index=162&type=chunk) - There is substantial doubt about its ability to continue as a going concern without raising additional capital[160](index=160&type=chunk)[162](index=162&type=chunk) - The business is heavily dependent on the success of its lead product candidate, **envafolimab**[158](index=158&type=chunk) - Clinical development is lengthy, expensive, and uncertain, with a risk of failure at any stage[158](index=158&type=chunk) - The company relies on collaboration partners such as 3D Medicines, Alphamab, Eucure, and Biocytogen for critical development and manufacturing activities[215](index=215&type=chunk)[218](index=218&type=chunk) - The ongoing dispute with **I-Mab** over collaboration agreements creates significant uncertainty and could adversely affect business and financial results[215](index=215&type=chunk)[218](index=218&type=chunk) - The COVID-19 pandemic and adverse macroeconomic conditions, such as inflation and geopolitical conflicts (e.g., Ukraine-Russia), could continue to disrupt clinical trials, supply chains, and access to capital[289](index=289&type=chunk)[297](index=297&type=chunk) - The company faces risks related to protecting its intellectual property, potential infringement claims from third parties, and its reliance on licensors to maintain and enforce patents[226](index=226&type=chunk)[234](index=234&type=chunk)[236](index=236&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=61&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) There were no unregistered sales of equity securities during the period - None[336](index=336&type=chunk) [Defaults Upon Senior Securities](index=61&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) There were no defaults upon senior securities during the period - None[337](index=337&type=chunk) [Mine Safety Disclosures](index=61&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This section is not applicable to the company - Not applicable[338](index=338&type=chunk) [Other Information](index=61&type=section&id=Item%205.%20Other%20Information) There is no other information to report for the period - None[339](index=339&type=chunk) [Exhibits](index=62&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including corporate governance documents, securities purchase agreements, warrant forms, and officer certifications - The exhibits include corporate governance documents, securities purchase agreements from various dates, forms of warrants, and required officer certifications (Rule 13a-14(a) and Section 1350)[340](index=340&type=chunk) - Interactive data files (Inline XBRL) are also included as exhibits[340](index=340&type=chunk)