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]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 ☐ 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) (State or Other Jurisdiction of Incorporation or Organization) Delaware 34-2037594 (I.R.S. ...

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)