Announcement • Dec 04
TRACON Pharmaceuticals, Inc. Common Stock to Be Deleted from OTC Equity TRACON Pharmaceuticals, Inc. Common Stock will be deleted from OTC Equity effective December 03, 2024, due to Charter Cancelled /Dissolution. Announcement • Nov 08
TRACON Pharmaceuticals Files Form 15 TRACON Pharmaceuticals, Inc. has announced that it has filed a Form 15 with the Securities and Exchange Commission to voluntarily deregister its Common Stock under the Securities Exchange Act of 1934, as amended. The par value of the company's Common Stock was $0.001 per share. Announcement • Nov 01
TRACON Pharmaceuticals, Inc. has withdrawn its Follow-on Equity Offering in the amount of $10 million. TRACON Pharmaceuticals, Inc. has withdrawn its Follow-on Equity Offering in the amount of $10 million.
Security Name: Common Stock
Security Type: Common Stock
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant Announcement • Jul 17
TRACON Pharmaceuticals Notifies Nasdaq of its Withdrawal of the Appeal As previously disclosed, on June 11, 2024, TRACON Pharmaceuticals, Inc. received a determination letter from Nasdaq stating that the Nasdaq Hearings Panel has determined to delist the Company’s common stock, par value $0.001 per share, from the Nasdaq Stock Market LLC, pending a request for a review of the Panel’s delisting determination. As a result, the Company began trading on OTCQB Venture Market as of June 28, 2024 and requested a review of the Panel’s decision. On July 10, 2024, the Company notified Nasdaq of its withdrawal of the appeal and has requested that Nasdaq file with the SEC a Notification of Removal from Listing and/or Registration on Form 25 to delist and deregister the Company’s common stock under Section 12(b) of the Securities Exchange Act of 1934, as amended. On July 12, 2024, Nasdaq notified the Company that it will delist the Company’s common stock on July 16, 2024 and will file a Form 25. The delisting of the common stock from Nasdaq will be effective 10 days after the filing of the Form 25. Announcement • Jul 01
TRACON Pharmaceuticals Announces Termination of Envasarc Trial and Will Explore Strategic Alternatives Leveraging Its In-House Product Development Platform TRACON Pharmaceuticals announced the objective response rate (ORR) by blinded independent central review (BICR) in the fully enrolled ENVASARC pivotal trial in the 82 evaluable patients is 5% (four responders), which is lower than the primary endpoint of the study of 11% ORR by BICR needed to support a biologics license application (BLA). As a result, the Company is terminating further development of envafolimab and is focusing entirely on exploring strategic alternatives in the near term that may include, but are not limited to, a merger, reverse merger, acquisition, other business combination, sales of assets, licensing or other strategic transactions involving the Company. In pursuit of any potential strategic transaction, TRACON plans to leverage its turnkey in-house Product Development Platform (PDP) utilizing integrated Veeva systems that has been used to conduct more than 15 Phase 1, 2 or 3 oncology trials at more than 120 sites in the U.S. and Europe across more than ten tumor types over 12 years, at a fully burdened cost of less than $100,000 per patient. TRACON offers cost-savings, time savings and enhanced quality of clinical trials using its PDP. There can be no assurance the exploration of strategic alternatives will result in any agreements or transactions, or, if completed, any agreements or transactions will be successful or on attractive terms. To the extent that it cannot complete a strategic transaction, there is no guarantee that the Company will continue as a going concern. TRACON does not expect to disclose developments with respect to this process until the evaluation of strategic alternatives has been completed or the Board of Directors has concluded disclosure is appropriate or legally required. Announcement • Jun 28
TRACON Pharmaceuticals, Inc.(OTCPK:TCON) dropped from NASDAQ Composite Index TRACON Pharmaceuticals, Inc. has been removed from NASDAQ Composite Index. Valuation Update With 7 Day Price Move • Jun 27
Investor sentiment improves as stock rises 16% After last week's 16% share price gain to US$1.43, the stock trades at a trailing P/E ratio of 2.2x. Average trailing P/E is 28x in the Biotechs industry in the US. Total loss to shareholders of 99% over the past three years. Announcement • Jun 15
The Nasdaq Hearings Panel Determines to Delist TRACON Pharmaceuticals' Common Stock from Nasdaq Due to Non-Compliance with Continued Listing Requirements by June 3, 2024 As previously disclosed by TRACON Pharmaceuticals, Inc. (the ‘Company’), pursuant to its Current Report on Form 8-K filed with the Securities and Exchange Commission (the ‘SEC’) on April 10, 2024, on March 20, 2024, the Nasdaq Hearings Panel (the ‘Panel’) granted the Company’s request for continued listing on The Nasdaq Capital Market (‘Nasdaq’), subject to the Company regaining compliance with all applicable continued listing requirements, including Nasdaq’s minimum bid price requirement set in Nasdaq Listing Rule 5550(a)(2) and the market value of listed securities requirement under Nasdaq Listing Rule 5550(b)(2) (or other applicable financial and liquidity standard), on or before June 3, 2024. On June 11, 2024, the Company received a determination letter (the ‘Delisting Notification’) from Nasdaq stating that the Panel has determined to delist the Company’s common stock, par value $0.001 per share (the ‘Common Stock’), from Nasdaq, and Nasdaq will accordingly suspend trading in the Company’s Common Stock, effective at the opening of business on June 13, 2024, because the Company did not demonstrate compliance with such continued listing requirements by June 3, 2024. Nasdaq will complete the delisting by filing a Form 25 Notification of Delisting with the SEC, after applicable appeal periods have lapsed, which will remove the Company’s securities from listing and registration on Nasdaq. Pursuant to the Delisting Notification, the Company has a period of 15 days from the date of the Delisting Notification to submit a written request for a review of the Panel’s delisting determination by the Nasdaq Listing and Hearing Review Council (the ‘Listing Council’). The Company intends to timely request a review by the Listing Council of the Panel’s delisting determination. Notwithstanding, the Company’s request for a review will not stay the decision of the Panel. Accordingly, the Company anticipates that, effective June 13, 2024, its Common Stock will commence trading on the OTCQB Venture Market under the symbol ‘TCON.’ The Company plans to continue to make all required SEC filings, including those on Forms 10-K, 10-Q and 8-K, and will remain subject to all SEC rules and regulations applicable to reporting companies under the Securities Exchange Act of 1934, as amended. Price Target Changed • May 16
Price target decreased by 19% to US$30.50 Down from US$37.50, the current price target is an average from 2 analysts. New target price is 1,893% above last closing price of US$1.53. Stock is down 88% over the past year. The company is forecast to post a net loss per share of US$3.28 next year compared to a net loss per share of US$2.19 last year. Breakeven Date Change • May 15
Forecast to breakeven in 2026 The 2 analysts covering TRACON Pharmaceuticals expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of US$3.45m in 2026. Average annual earnings growth of 54% is required to achieve expected profit on schedule. Announcement • May 09
TRACON Pharmaceuticals, Inc. to Report Q1, 2024 Results on May 14, 2024 TRACON Pharmaceuticals, Inc. announced that they will report Q1, 2024 results at 4:00 PM, US Eastern Standard Time on May 14, 2024 Announcement • Apr 14
TRACON Pharmaceuticals, Inc. has filed a Follow-on Equity Offering in the amount of $10 million. TRACON Pharmaceuticals, Inc. has filed a Follow-on Equity Offering in the amount of $10 million.
Security Name: Common Stock
Security Type: Common Stock
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant Announcement • Apr 03
TRACON Pharmaceuticals Provides Update on Ongoing ENVASARC Phase 2 Pivotal Trial Following Independent Data Monitoring Committee Recommendation to Continue the Trial as Planned TRACON Pharmaceuticals, Inc. announced the independent data monitoring committee (IDMC), following a review of ongoing safety and efficacy data on April 2, recommended the ENVASARC Phase 2 pivotal trial continue as planned. The ENVASARC Phase 2 pivotal trial completed enrollment in March 2024 with a total of 82 evaluable patients in cohort C of treatment with single agent envafolimab at 600 mg SQ every three weeks and final data are expected in the third quarter of 2024. The IDMC reviewed interim safety and efficacy data from 73 patients enrolled into cohort C who had the opportunity to complete two on-treatment scans (a minimum of 12 weeks of treatment). The objective response rate (ORR) is currently 11% by investigator review and the confirmed ORR by blinded independent central review (BICR) is currently 5.5% (four patients). Median duration of response by BICR is greater than six months. Envafolimab has been well tolerated without the development of a single drug-related serious adverse event of grade 3 or higher. The primary endpoint of the study is achievement of an objective response in nine of 82 patients (11%) treated with envafolimab by BICR and median duration of response of greater than six months is a key secondary endpoint. Board Change • Apr 01
Insufficient new directors There is 1 new director who has joined the board in the last 3 years. The company's board is composed of: 1 new director. 3 experienced directors. 5 highly experienced directors. Independent Director Carol Lam was the last director to join the board, commencing their role in 2021. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. New Risk • Mar 13
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 23% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (23% average weekly change). Negative equity (-US$809k). Shareholders have been substantially diluted in the past year (91% increase in shares outstanding). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$1.8m net loss in 3 years). Market cap is less than US$100m (US$17.7m market cap). New Risk • Mar 06
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 93% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Negative equity (-US$809k). Shareholders have been substantially diluted in the past year (93% increase in shares outstanding). Market cap is less than US$10m (US$8.53m market cap). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$11m net loss in 3 years). Share price has been volatile over the past 3 months (11% average weekly change). Announcement • Feb 29
TRACON Pharmaceuticals, Inc. to Report Q4, 2023 Results on Mar 05, 2024 TRACON Pharmaceuticals, Inc. announced that they will report Q4, 2023 results on Mar 05, 2024 Announcement • Dec 20
TRACON Pharmaceuticals, Inc. Provides Positive Update on Ongoing ENVASARC Pivotal Phase 2 Trial TRACON Pharmaceuticals announced that the ongoing pivotal Phase 2 ENVASARC trial has enrolled more than 70 of the 80 planned patients in Cohort C of single agent envafolimab treatment at a dose of 600 mg subQ every three weeks. Additional safety and efficacy data were reviewed for 46 patients enrolled into cohort C who were the subject of the September independent data monitoring committee (IDMC) review. At that time, patients had completed a minimum of 12 weeks of efficacy evaluations and the objective response rate (ORR) was 13% by investigator review and 8.7% by blinded independent central review (BICR). In December 2019, Alphamab Oncology, 3D Medicines and TRACON entered into a collaboration whereby TRACON has the right to develop and commercialize envafolimab in soft tissue sarcoma in North America. Envafolimab is currently being studied in the ENVASARC Phase 2 pivotal trial in the United States sponsored by TRACON and a Phase 3 pivotal trial in combination with gemcitabine and oaliplatin in advanced biliary tract cancer patients in China sponsored by TRACON's corporate partners, Alphamab Oncologist and 3D Medicines. TRACON has received orphan drug designation from the U.S. Food and Drug Administration for envafolimab for patients with soft tissue sarcoma and fast track designation from the FDA for envafolimab For patients with locally advanced, unresectable or metastatic undifferentiated pleomorphic sarcoma and myxofibrosarcoma who have progressed on one or two prior lines of chemotherapy. Major Estimate Revision • Nov 16
Consensus EPS estimates upgraded to US$0.45 loss The consensus outlook for fiscal year 2023 has been updated. 2023 losses forecast to reduce from -US$0.91 to -US$0.45 per share. Revenue forecast unchanged from US$9.00m at last update. Biotechs industry in the US expected to see average net income growth of 5.7% next year. Consensus price target down from US$6.50 to US$4.00. Share price rose 5.8% to US$0.17 over the past week. Announcement • Nov 01
TRACON Pharmaceuticals, Inc. to Report Q3, 2023 Results on Nov 09, 2023 TRACON Pharmaceuticals, Inc. announced that they will report Q3, 2023 results After-Market on Nov 09, 2023 New Risk • Oct 29
New major risk - Revenue and earnings growth Earnings have declined by 0.1% per year over the past 5 years. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are declining over an extended period, then in most cases the share price will decline over time unless the company can turn around its fortunes. A trend of falling earnings can be very difficult to turn around. If the company is well already established it may also be a sign the company has matured and is in decline. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$22m free cash flow). Share price has been highly volatile over the past 3 months (19% average weekly change). Negative equity (-US$16m). Earnings have declined by 0.1% per year over the past 5 years. Market cap is less than US$10m (US$4.97m market cap). Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (US$27m net loss in 2 years). Shareholders have been diluted in the past year (43% increase in shares outstanding). New Risk • Oct 11
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 14% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$22m free cash flow). Share price has been highly volatile over the past 3 months (14% average weekly change). Negative equity (-US$16m). Market cap is less than US$10m (US$4.06m market cap). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$21m net loss in 3 years). Shareholders have been diluted in the past year (43% increase in shares outstanding). Announcement • Sep 19
TRACON Pharmaceuticals Announces ENVASARC Phase 2 Pivotal Trial Exceeded Futility Threshold at Final Interim Analysis and Will Continue as Planned TRACON Pharmaceuticals announced that the ENVASARC Phase 2 pivotal trial more than satisfied the futility threshold of 3 responses out of 46 based on the results of the second and final mandated independent data monitoring committee (IDMC) efficacy review, and the trial will continue as planned. The IDMC reviewed interim safety and efficacy data from 46 patients enrolled into cohort C of treatment with single agent envafolimab who completed two on-treatment scans (a minimum of 12 weeks of efficacy evaluations). The objective response rate (ORR) in the initial 46 patients treated with single agent envafolimab was 13% by investigator review and 8.7% by blinded independent central review (BICR). The ORR assessed by BICR, all of which were confirmed responses, more than satisfied the prespecified futility rule and envafolimab monotherapy was generally well tolerated. Median duration of response by BICR was greater than six months. The primary endpoint of the study is achievement of an ORR in nine of 80 patients (11.25%) treated with envafolimab by BICR and median duration of response of greater than six months is a key secondary endpoint. The trial has enrolled more than 60 of the planned 80 patients and full accrual of the ENVASARC pivotal trial is expected in the fourth quarter of this year with final data anticipated in mid-2024. New Risk • Aug 19
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$22m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$22m free cash flow). Negative equity (-US$16m). Market cap is less than US$10m (US$6.52m market cap). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$21m net loss in 3 years). Share price has been volatile over the past 3 months (12% average weekly change). Shareholders have been diluted in the past year (32% increase in shares outstanding). Major Estimate Revision • Aug 17
Consensus revenue estimates increase by 50% The consensus outlook for revenues in fiscal year 2023 has improved. 2023 revenue forecast increased from US$6.00m to US$9.00m. Forecast losses expected to reduce from -US$0.733 to -US$0.723 per share. Biotechs industry in the US expected to see average net income decline 6.6% next year. Consensus price target down from US$7.33 to US$5.33. Share price fell 25% to US$0.25 over the past week. Announcement • Aug 03
TRACON Pharmaceuticals, Inc. to Report Q2, 2023 Results on Aug 14, 2023 TRACON Pharmaceuticals, Inc. announced that they will report Q2, 2023 results After-Market on Aug 14, 2023 Announcement • Jun 21
TRACON Pharmaceuticals Announces Positive Results Based on Ongoing Double-Digit Objective Response Rate for Single Agent Envafolimab in the ENVASARC Phase 2 Pivotal Trial TRACON Pharmaceuticals announced the positive results of a six-month independent data monitoring committee (IDMC) review for the ongoing ENVASARC Phase 2 pivotal trial. The IDMC reviewed interim safety and efficacy data from more than 80 patients equally randomized into cohort C of single agent envafolimab or cohort D of envafolimab given in combination with Yervoy. Enrollment of the separate trial of TRACON's CTLA-4 antibody YH001 with envafolimab and doxorubicin will continue, based on multiple responses seen in the Phase 1 portion of the trial to date using a higher dose of the CTLA-4 antibody. Phase 1 is designed to determine the optimal dose of YH001 in combination with envafolimaband doxorubicin, and the Company expects to report trial data at the Connective Tissue Oncology Society (CTOS) annual meeting in November. TRACON has received orphan drug designation from the U.S. Food and Drug Administration for envafolimab for patients with soft tissue sarcoma and fast track designation from the U.S., Food and Drug Administration for envAFolimab (KN035) for patients with locally advanced, unresectable or metastatic undifferentiated pleomorphic sarcoma (UPS) and myxofibrosarcoma (MFS) who have progressed on one or two prior lines of chemotherapy. Such statements include, but are not limited to, statements regarding TRACON's expectations for the timing and scope of its clinical trials as well as timely achievement of expected endpoints and goals, the availability and expected results of clinical data and the timing of future reviews of data by the Independent Data Monitoring Committee, continued timely accrual in the ENVASARC Phase 2 Phase 2 pivotal trial, the potential for envafolimab to become a treatment option and the expected cost and timing benefits to the ENVASARC phase 2 pivotal trial due to TRACON's termination of cohort D. 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 pharmaceutical product candidates; risks relating to cost variability of clinical trials. Announcement • Jun 12
TRACON Pharmaceuticals Receives Notice from Nasdaq Regarding Non-Compliance with the Market Value Rule and Minimum Bid Price Requirement On June 8, 2023, TRACON Pharmaceuticals, Inc. received letters (the ‘Notices’) from the Listing Qualifications staff (the ‘Staff’) of the Nasdaq Stock Market LLC (‘Nasdaq’) notifying the Company that (i) for 30 consecutive business days preceding the date of the Notices, the market value of the Company’s common stock was less than $35.0 million, which does not meet the requirement for continued listing on the Nasdaq Capital Market, as required by Nasdaq Listing Rule 5550(b)(2) (the ‘Market Value Rule’), and (ii) for 30 consecutive business days preceding the date of the Notices, the closing bid price of the Company’s common stock was below $1.00 per share, which is the minimum required closing bid price for continued listing on the Nasdaq Capital Market pursuant to Listing Rule 5550(a)(2) (the ‘Minimum Bid Price Requirement’). The Notices do not result in the delisting of the Company’s common stock at this time, and the Company’s common stock continues to trade on the Nasdaq Capital Market under the symbol ‘TCON.’ In accordance with Nasdaq Listing Rule 5810(c)(3)(C) and Nasdaq Listing Rule 5810(c)(3)(A), Nasdaq has provided the Company with 180 calendar days, or until December 5, 2023, to regain compliance with the Market Value Rule and the Minimum Bid Price Requirement in the manner described below. If the Company regains compliance with the Market Value Rule and the Minimum Bid Price Requirement, Nasdaq will provide written confirmation to the Company and close the matter. To regain compliance with the Market Value Rule, the market value of the Company’s common stock must meet or exceed $35.0 million for a minimum of ten consecutive business days during the 180-day grace period ending on or before December 5, 2023, unless the Staff exercises its discretion to extend this ten consecutive business day period pursuant to Nasdaq Listing Rule 5810(c)(3)(H). The Company could also regain compliance with Nasdaq’s alternative continued listing requirements by having stockholders’ equity of at least $2.5 million, or net income from continuing operations of $500,000 in the most recently completed fiscal year or in two of the three most recently completed fiscal years. In the event the Company does not regain compliance with the Market Value Rule prior to the expiration of the compliance period, it will receive written notification that its securities are subject to delisting. At that time, the Company may appeal the delisting determination to a Hearings Panel. To regain compliance with the Minimum Bid Price Requirement, the closing bid price of the Company’s common stock must be at least $1.00 per share for a minimum of ten consecutive business days during the 180-day grace period ending on or before December 5, 2023, unless the Staff exercises its discretion to extend this ten consecutive business day period pursuant to Nasdaq Listing Rule 5810(c)(3)(H). If the Company does not regain compliance by December 5, 2023, the Company may be eligible for an additional 180-day period to regain compliance if it meets the continued listing requirement under the Market Value Rule and all other initial listing standards, with the exception of the Minimum Bid Price Requirement, and provides written notice to Nasdaq of its intention to cure the deficiency during the second compliance period by effecting a reverse stock split, if necessary. However, if it appears to the Staff that the Company will not be able to cure the deficiency, or if the Company does not meet the other listing standards, Nasdaq could provide notice that the Company’s common stock will become subject to delisting. In the event the Company receives notice that its common stock is being delisted, Nasdaq rules permit the Company to appeal any delisting determination by the Nasdaq staff to a Hearings Panel. The Company is presently evaluating potential actions to regain compliance with all applicable requirements for continued listing on the Nasdaq Capital Market. There can be no assurance that the Company will be successful in maintaining its listing of its common stock on the Nasdaq Capital Market. Major Estimate Revision • May 17
Consensus revenue estimates increase by 100% The consensus outlook for revenues in fiscal year 2023 has improved. 2023 revenue forecast increased from US$3.00m to US$6.00m. Forecast losses expected to reduce from -US$0.773 to -US$0.733 per share. Biotechs industry in the US expected to see average net income decline 85% next year. Consensus price target down from US$9.33 to US$7.33. Share price fell 11% to US$0.63 over the past week. Price Target Changed • May 14
Price target decreased by 21% to US$7.33 Down from US$9.33, the current price target is an average from 3 analysts. New target price is 995% above last closing price of US$0.67. Stock is down 60% over the past year. The company is forecast to post a net loss per share of US$0.76 next year compared to a net loss per share of US$1.39 last year. Announcement • May 04
TRACON Pharmaceuticals, Inc. to Report Q1, 2023 Results on May 10, 2023 TRACON Pharmaceuticals, Inc. announced that they will report Q1, 2023 results After-Market on May 10, 2023 Price Target Changed • Apr 17
Price target decreased by 12% to US$9.33 Down from US$10.60, the current price target is an average from 3 analysts. New target price is 390% above last closing price of US$1.91. Stock is down 21% over the past year. The company is forecast to post a net loss per share of US$0.91 next year compared to a net loss per share of US$1.39 last year. Breakeven Date Change • Mar 10
No longer forecast to breakeven The 2 analysts covering TRACON Pharmaceuticals no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of US$27.1m in 2025. New consensus forecast suggests the company will make a loss of US$39.8m in 2025. Announcement • Jan 02
TRACON Pharmaceuticals Receives A Letter from Nasdaq Regarding Market Value Rule On December 30, 2022, TRACON Pharmaceuticals, Inc. ("the Company") received a letter ("the Notice") from the Listing Qualifications staff ("the Staff") of the Nasdaq Stock Market LLC ("Nasdaq") notifying the Company that for the last 30 consecutive business days prior to the date of the Notice, the market value of the Company's common stock was less than $35.0 million, which does not meet the requirement for continued listing on the Nasdaq Capital Market, as required by Nasdaq Listing Rule 5550(b)(2) (the Market Value Rule"). In accordance with Nasdaq Listing Rule 5810(c)(3)(C), Nasdaq has provided the Company with 180 calendar days, or until June 28, 2023, to regain compliance with the Market Value Rule. If the Company regains compliance with the Market Value Rule, Nasdaq will provide written confirmation to the Company and close the matter. The Notice does not result in the delisting of the Company's common stock from the Nasdaq Capital Market. To regain compliance with the Market Value Rule, the market value of the Company's common stock must meet or exceed $35.0 million for a minimum of ten consecutive business days during the 180-day grace period ending on or before June 28, 2023, unless the Staff exercises its discretion to extend this ten consecutive business day period pursuant to Nasdaq Listing Rule 5810(c)(3)(H). The Company could also regain compliance with Nasdaq's alternative continued listing requirements by having stockholders' equity of at least $2.5 million, or net income from continuing operations of $500,000 in the most recently completed fiscal year or in two of the three most recently completed fiscal years. In the event the Company does not regain compliance with the Market Value Rule prior to the expiration of the compliance period, it will receive written notification that its securities are subject to delisting. At that time, the Company may appeal the delisting determination to a Hearings Panel. The Company is presently evaluating potential actions to regain compliance with all applicable requirements for continued listing on the Nasdaq Capital Market. There can be no assurance that the Company will be successful in maintaining its listing of its common stock on the Nasdaq Capital Market. Announcement • Dec 16
TRACON Pharmaceuticals Announces Positive Results Based on Double-Digit Objective Response Rate in Each Cohort from the Ongoing ENVASARC Phase 2 Pivotal Trial TRACON Pharmaceuticals announced the IDMC for the ongoing ENVASARC Phase 2 pivotal trial recommended continued accrual as planned in both cohorts: single agent envafolimab and envafolimab in combination with Yervoy (ipilimumab). The IDMC reviewed interim safety and efficacy data from 18 patients enrolled into each cohort who completed a minimum of 12 weeks of efficacy evaluations (two on-treatment scans). The double-digit ORR assessed by blinded independent central review in each cohort more than satisfied the prespecified futility rule. Envafolimab monotherapy and in combination with Yervoy was well tolerated, with only a single related serious adverse event reported in 36 patients. Responses were noted in patients regardless of weight at the 600 mg dose of envafolimab that was instituted following the previous IDMC review of interim safety and efficacy data from patients in the ENVASARC trial treated at the 300 mg dose of envafolimab. Envafolimab (KN035), a single-domain antibody against PD-L1 invented by Alphamab Oncology and licensed by TRACON, is the first approved subcutaneously injected PD-(L)1 inhibitor. Envafolimab was approved by the Chinese NMPA in November 2021 in adult patients with MSI-H/dMMR advanced solid tumors who failed systemic treatment and have no satisfactory alternative treatment options. In December 2019, Alphamab Oncology, 3D Medicines and TRACON entered into a collaboration whereby TRACON has the right to develop and commercialize envafolimab in soft tissue sarcoma in North America. Envafolimab is currently being studied in the ENVASARC Phase 2 pivotal trial in the United States sponsored by TRACON and a Phase 3 pivotal 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. In September 2022, TRACON received fast track designation from the U.S. Food and Drug Administration for envafolimab (KN035) for patients with locally advanced, unresectable or metastatic undifferentiated pleomorphic sarcoma (UPS) and myxofibrosarcoma (MFS) who have progressed on one or two prior lines of chemotherapy. The ENVASARC pivotal trial is a multicenter, open label, randomized, non-comparative, parallel cohort study at 30 top cancer centers in the United States and the United Kingdom that began dosing in December 2020. TRACON expects the trial to enroll more than 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 a cohort of treatment with single agent envafolimab at 600 mg every three weeks and 80 patients enrolled into a cohort of treatment with envafolimab at 600 mg every three weeks with Yervoy®. The primary endpoint is objective response rate by central review with duration of response a key secondary endpoint. Announcement • Nov 22
TRACON Pharmaceuticals, Inc Announces Dosing of First Patient in Phase 1/2 Trial of YH001 in Combination with Envafolimab and Doxorubicin in Front Line Sarcoma TRACON Pharmaceuticals, Inc. announced dosing of the first patient in a Phase 1/2 trial evaluating the Company’s CTLA-4 antibody, YH001, in combination with its PD-L1 antibody envafolimab and with doxorubicin in front line therapy in patients with sarcoma (NCT 05448820). The Phase 1/2 trial will assess the safety and efficacy of the triplet combination of YH001, envafolimab and doxorubicin in the common sarcoma subtypes of leiomyosarcoma and dedifferentiated liposarcoma. In addition, the trial will assess the safety and efficacy of the doublet combination of YH001 and envafolimab in patients with the rare sarcoma subtypes of alveolar soft part sarcoma and chondrosarcoma. Price Target Changed • Nov 16
Price target decreased to US$10.20 Down from US$11.33, the current price target is an average from 5 analysts. New target price is 567% above last closing price of US$1.53. Stock is down 53% over the past year. The company is forecast to post a net loss per share of US$1.20 next year compared to a net loss per share of US$1.66 last year. Announcement • Nov 01
TRACON Pharmaceuticals, Inc. to Report Q3, 2022 Results on Nov 14, 2022 TRACON Pharmaceuticals, Inc. announced that they will report Q3, 2022 results at 4:00 PM, US Eastern Standard Time on Nov 14, 2022 Announcement • Oct 07
TRACON Pharmaceuticals, Inc. Announces Results of Independent Data Monitoring Committee Review of 12 Week Safety Data from Envasarc Phase 2 Pivotal Trial TRACON Pharmaceuticals, Inc. announced that the Independent Data Monitoring Committee for the ENVASARC Phase 2 pivotal trial has recommended that the trial proceed as planned following the review of 12 week safety data from patients enrolled into the trial as of June 30, 2022. The safety data reviewed included data from more than 10 patients enrolled into cohort C of treatment with single agent envafolimab at 600 mg administered subcutaneously every three weeks and more than 10 patients enrolled into cohort D of treatment with envafolimab at 600 mg administered subcutaneously every three weeks in combination with Yervoy (ipilimumab) given intravenously. Announcement • Sep 15
TRACON Pharmaceuticals Announces Fast Track Designation by the Food and Drug Administration for Envafolimab for the Treatment of the Soft Tissue Sarcoma Subtypes of UPS and MFS On September 14, 2022, TRACON Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted fast track designation for the development of envafolimab (KN035) for patients with locally advanced, unresectable or metastatic undifferentiated pleomorphic sarcoma (UPS) and myxofibrosarcoma (MFS) who have progressed on one or two prior lines of chemotherapy. The FDA designed the fast track process to facilitate the development and expedite the review of drugs to treat serious or life-threatening diseases or conditions and fill unmet medical needs. Fast track designation can confer important benefits, including the potential eligibility for priority review of a Biologics License Application, if relevant criteria are met. Envafolimab (KN035), a single-domain antibody against PD-L1 invented by Alphamab Oncology and licensed by TRACON, is the first approved subcutaneously injected PD-(L)1 inhibitor. Envafolimab was approved by the Chinese NMPA in November 2021 in adult patients with MSI-H/dMMR advanced solid tumors who failed systemic treatment and have no satisfactory alternative treatment options. In December 2019, Alphamab Oncology, 3D Medicines and TRACON entered into a collaboration whereby TRACON has the right to develop and commercialize envafolimab in soft tissue sarcoma in North America. Envafolimab is currently being studied in the pivotal ENVASARC Phase 2 trial in the United States sponsored by TRACON and a Phase 3 pivotal 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. Major Estimate Revision • Aug 17
Consensus forecasts updated The consensus outlook for 2022 has been updated. 2022 losses forecast to reduce from -US$1.39 to -US$1.18 per share. Revenue forecast unchanged from US$5.40m at last update. Biotechs industry in the US expected to see average net income decline 57% next year. Consensus price target of US$10.67 unchanged from last update. Share price rose 7.0% to US$2.22 over the past week. Announcement • Aug 11
TRACON Pharmaceuticals, Inc. Announces Results of Independent Data Monitoring Committee Review of Safety Data from ENVASARC Pivotal Trial TRACON Pharmaceuticals, Inc. announced that the Independent Data Monitoring Committee for the ENVASARC pivotal trial has recommended that the trial proceed as planned following the review of three week safety data from more than 20 patients enrolled into the trial as of June 30, 2022. The safety data reviewed included data from more than 10 patients enrolled into cohort A of treatment with single agent envafolimab at 600 mg administered subcutaneously every three weeks and more than 10 patients enrolled into cohort B of treatment with envafolimab at 600 mg administered subcutaneously every three weeks with Yervoy (ipilimumab) given intravenously. Envafolimab (KN035), a single-domain antibody against PD-L1 invented by Alphamab Oncology, is the first approved subcutaneously injected PD-(L)1 inhibitor. Envafolimab was approved by the Chinese NMPA in November 2021 in adult patients with MSI-H/dMMR advanced solid tumors who failed systemic treatment and have no satisfactory alternative treatment options. In December 2019, Alphamab Oncology, 3D Medicines and TRACON entered into a collaboration whereby TRACON has the right to develop and commercialize envafolimab in soft tissue sarcoma in North America. Envafolimab is currently being studied in the pivotal ENVASARC Phase 2 trial in the United States sponsored by TRACON and a Phase 3 pivotal 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. The ENVASARC pivotal trial is a multicenter, open label, randomized, non-comparative, parallel cohort study at 30 top cancer centers in the United States and the United Kingdom that began dosing in December 2020. TRACON expects the trial to enroll more than 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 a cohort of treatment with single agent envafolimab at 600 mg every three weeks and 80 patients enrolled into a cohort of treatment with envafolimab at 600 mg every three weeks with Yervoy®. The primary endpoint is objective response rate by central review with duration of response a key secondary endpoint. Announcement • Aug 09
TRACON Pharmaceuticals, Inc. Submits IND Application for CTLA-4 Antibody YH001 for the Treatment of Front-Line Sarcoma Patients in Combination with Envafolimab TRACON Pharmaceuticals, Inc. announced that the company submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for the initiation of a Phase 1/2 clinical study of YH001 in combination with envafolimab and doxorubicin for the treatment of sarcoma patients, including patients who have not received prior therapy. The Phase 1/2 trial will assess the safety and efficacy of YH001 and envafolimab with or without doxorubicin in patients with the rare sarcoma subtypes of alveolar soft part sarcoma and chondrosarcoma and in the common sarcoma subtypes of leiomyosarcoma and dedifferentiated liposarcoma. Announcement • Jul 28
TRACON Pharmaceuticals, Inc. to Report Q2, 2022 Results on Aug 10, 2022 TRACON Pharmaceuticals, Inc. announced that they will report Q2, 2022 results at 4:00 PM, US Eastern Standard Time on Aug 10, 2022 Announcement • Jul 27
TRACON Pharmaceuticals Announces Dosing of 36Th Patient in Envasarc Pivotal Trial Triggering Initial Idmc Efficacy Review Expected in the Fourth Quarter TRACON Pharmaceuticals, Inc. announced the enrollment of the 36th patient in the ENVASARC pivotal trial at the 600 mg dose of envafolimab, which enables the initial independent data monitoring committee (IDMC) interim efficacy analysis to proceed. The interim analysis is expected to occur in the fourth quarter of this year. The initial IDMC interim efficacy analysis proceeds after the 36th patient has been enrolled for at least three months to permit two on study scans to determine the preliminary objective response rate. One objective response is required in each of the trial’s two cohorts to continue accrual in that cohort. The first cohort includes the initial 18 patients who receive single agent envafolimab and the second cohort includes 18 patients who receive envafolimab with ipilimumab. A second IDMC interim efficacy analysis is expected in 2023 following enrollment of the 92nd patient. Envafolimab (KN035), a single-domain antibody against PD-L1 invented by Alphamab Oncology, is the first approved subcutaneously injected PD-(L)1 inhibitor. Envafolimab was approved by the Chinese NMPA in November 2021 in adult patients with MSI-H/dMMR advanced solid tumors who failed systemic treatment and have no satisfactory alternative treatment options. In December 2019, Alphamab Oncology, 3D Medicines and TRACON entered into a collaboration whereby TRACON has the right to develop and commercialize envafolimab in soft tissue sarcoma in North America. Envafolimab is currently being studied in the pivotal ENVASARC Phase 2 trial in the United States sponsored by TRACON and a Phase 3 pivotal 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. The ENVASARC pivotal trial is a multicenter, open label, randomized, non-comparative, parallel cohort study at 30 top cancer centers in the United States and the United Kingdom that began dosing in December 2020. TRACON expects the trial to enroll more than 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 a cohort of treatment with single agent envafolimab at 600 mg every three weeks and 80 patients enrolled into a cohort of treatment with envafolimab at 600 mg every three weeks with Yervoy. The primary endpoint is objective response rate by central review with duration of response a key secondary endpoint. Major Estimate Revision • May 18
Consensus revenue estimates increase by 99% The consensus outlook for revenues in 2022 has improved. 2022 revenue forecast increased from US$1.82m to US$3.63m. Forecast losses expected to reduce from -US$1.47 to -US$1.39 per share. Biotechs industry in the US expected to see average net income decline 52% next year. Consensus price target of US$11.00 unchanged from last update. Share price rose 5.6% to US$1.88 over the past week. Announcement • May 05
TRACON Pharmaceuticals, Inc. to Report Q1, 2022 Results on May 11, 2022 TRACON Pharmaceuticals, Inc. announced that they will report Q1, 2022 results After-Market on May 11, 2022 Announcement • Apr 26
TRACON Pharmaceuticals, Inc., Annual General Meeting, Jun 14, 2022 TRACON Pharmaceuticals, Inc., Annual General Meeting, Jun 14, 2022, at 08:00 Pacific Standard Time. Location: 4350 La Jolla Village Drive Suite 800 San Diego California United States Agenda: To consider the election of two “Class I” directors named in the Company’s Proxy Statement to hold office until the Company’s 2025 Annual Meeting of Stockholders and until a successor is elected and qualified; to consider the approval, on an advisory basis, the compensation of the Company’s named executive officers; to indicate, on an advisory basis, the preferred frequency of future stockholder advisory votes on the compensation of the Company’s named executive officers; to ratify the selection of Ernst & Young LLP as the Company’s independent registered public accounting firm for the fiscal year ending December 31, 2022; and to transact such other business as may properly come before the meeting or any adjournments or postponements thereof. Breakeven Date Change • Apr 21
Forecast to breakeven in 2024 The 6 analysts covering TRACON Pharmaceuticals expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of US$14.9m in 2024. Average annual earnings growth of 54% is required to achieve expected profit on schedule. Announcement • Apr 20
TRACON Pharmaceuticals Announces Amended ENVASARC Protocol Approved and Open at all 30 Clinical Sites in the U.S. and U.K TRACON Pharmaceuticals announced that the amended ENVASARC protocol approved by the U.S. Food and Drug Administration (FDA) in February has now been approved by institutional review boards or ethics committees at all 30 clinical sites: 29 in the United States and one in the United Kingdom. In February, the FDA approved the amended ENVASARC protocol following the Independent Data Monitoring Committee (IDMC) recommendation based on the highly tolerable safety profile and the significantly higher objective response rate observed in lower weight patients in ENVASARC, to increase the dose of envafolimab to 600 mg every three weeks (Q3W), which is double the original envafolimab dose of 300 mg Q3W. Initial dosing under the amended protocol commenced in March, and more than 10 patients have been enrolled under the amended protocol at the 600 mg Q3W dose less than two months following FDA clearance. Each of the 29 U.S. cancer centers have approved the amended protocol and are open for accrual. An additional site in the United Kingdom, Royal Marsden Hospital, has also approved the amended protocol and is open for accrual. TRACON expects to report results of IDMC mandated interim safety reviews and the interim efficacy review in the second half of 2022. The ENVASARC pivotal trial is a multicenter, open label, randomized, non-comparative, parallel cohort study at 30 top cancer centers in the United States that began dosing in December 2020. TRACON expects the trial to enroll more than 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 a cohort of treatment with single agent envafolimab at 600 mg every three weeks and 80 patients enrolled into a cohort of treatment with envafolimab at 600 mg every three weeks with Yervoy. The primary endpoint is objective response rate by central review with duration of response a key secondary endpoint. 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; YH001, a potential best-in-class CTLA-4 antibody in Phase 1 development; 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 United States. Breakeven Date Change • Mar 18
No longer forecast to breakeven The 7 analysts covering TRACON Pharmaceuticals no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of US$1.33m in 2024. New consensus forecast suggests the company will make a loss of US$7.02m in 2024. Breakeven Date Change • Mar 16
No longer forecast to breakeven The 6 analysts covering TRACON Pharmaceuticals no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of US$1.33m in 2024. New consensus forecast suggests the company will make a loss of US$2.70m in 2024. Announcement • Mar 06
TRACON Pharmaceuticals, Inc. to Report Q4, 2021 Results on Mar 15, 2022 TRACON Pharmaceuticals, Inc. announced that they will report Q4, 2021 results After-Market on Mar 15, 2022 Announcement • Feb 03
TRACON Pharmaceuticals Announces Initiation of Randomized Phase 2 Trial of TRC102 in Lung Cancer Sponsored by the National Cancer Institute TRACON Pharmaceuticals announced that the National Cancer Institute (NCI) has initiated a randomized Phase 2 trial of TRC102 in combination with chemoradiation in patients with stage III non-squamous non-small cell lung cancer. The open-label two arm trial will enroll 78 patients and assess the benefit of adding TRC102 to current standard of care treatment of pemetrexed, cisplatin, and radiation therapy followed by consolidative durvalumab. The primary endpoint of the trial is progression free survival (PFS) and the trial is designed to detect an improvement in PFS at one year from 56% to 75%. Enrollment is expected to begin in June 2022 and results are expected in 2024. The randomized trial builds upon positive data from a Phase 1 trial of TRC102 in combination with chemoradiation presented at ASCO 2020 that demonstrated a 100% response rate in 15 patients with Stage IIIA or Stage IV non-squamous non-small cell lung cancer, including three patients who had a complete response to treatment. These data compared favorably to historical data of the same combination of chemoradiation without TRC102 in advanced lung cancer from the PROCLAIM and the PACIFIC clinical trials. 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 U.S. FDA in malignant glioma, including glioblastoma. Announcement • Dec 28
TRACON Pharmaceuticals Announces Positive Results from the Independent Data Monitoring Committee Review of Interim Safety and Efficacy Data from the Ongoing ENVASARC Pivotal Trial TRACON Pharmaceuticals, Inc. announced the Independent Data Monitoring Committee (IDMC) for the ongoing ENVASARC pivotal trial recommended continued accrual as planned in both cohort A of single agent envafolimab and cohort B of envafolimab given with Yervoy (ipilimumab). The IDMC reviewed interim safety and efficacy data from 18 patients enrolled into each cohort who completed a minimum of 12 weeks of efficacy evaluations (two on-treatment scans). The ORR by BICR in each cohort satisfied the prespecified futility rule. Envafolimab was well tolerated, with only a single Grade 3 related adverse event reported in 36 patients. Based on the highly tolerable safety profile and the significantly higher ORR observed in lower weight patients, the IDMC recommended increasing the envafolimab dose to 600 mg Q3W, which is twice the current envafolimab dose of 300 mg Q3W. Given the robust activity demonstrated by higher doses of envafolimab in completed studies, including in the pivotal trial in MSI-H/dMMR cancer that was the basis for approval in China, TRACON agrees with the IDMC guidance and will recommend this dose to the U.S. Food and Drug Administration (FDA) through a protocol amendment. Announcement • Dec 01
TRACON Pharmaceuticals, Inc. Reports Regulatory Approval of Envafolimab in China TRACON Pharmaceuticals, Inc. reported that its partners Alphamab Oncology and 3D Medicines (Beijing) Co. Ltd. announced that envafolimab (KN035), the world's first single-domain PD-L1 antibody formulated for subcutaneous injection received marketing authorization from the Chinese National Medical Products Administration (NMPA). Envafolimab was approved for adult patients with microsatellite instability-high (MSI-H) or deficient MisMatch Repair (dMMR) advanced solid tumors, including those patients with advanced colorectal cancer who have experienced disease progression following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan, as well as patients with other advanced solid tumors who have experienced disease progression following prior systemic treatment and have no satisfactory alternative treatment options. Prior to this approval, all marketed PD-1 and PD-L1 antibody drugs required intravenous infusions. As a subcutaneously administered PD-L1 antibody, envafolimab can be administered within 30 seconds in the physician’s office—thereby increasing convenience, shortening treatment time and sparing patients from the risk of infusion reactions. In a pivotal phase 2 clinical study in patients with advanced dMMR/MSI-H tumors who received one or more lines of treatment, envafolimab demonstrated an objective response rate (ORR) by blinded independent radiographic review (BIRR) of 44.7%, including 12 (11.7%) cases of complete response. Responses were durable, with duration of response at 12 months in responding patients with advanced colorectal cancer (CRC), advanced gastric cancer, other advanced solid tumors, and all responding patients of 89%, 100%, 100%, and 93%, respectively. Median progression-free survival was 11.1 months and the 12-month overall survival rate was 73.6%. The confirmed ORR by BIRR 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 treatment and the 33% confirmed ORR reported for KEYTRUDA® in MSI-H/dMMR CRC patients who failed a fluoropyrimidine, oxaliplatin and irinotecan treatment in cohort A of the phase 2 KEYNOTE-164 trial. Envafolimab was well tolerated in this study and no cases of immune-related pneumonitis, immune-related colitis, or immune-related nephritis were reported. Announcement • Jul 24
TRACON Pharmaceuticals, Inc. has completed a Follow-on Equity Offering in the amount of $15.000002 million. TRACON Pharmaceuticals, Inc. has completed a Follow-on Equity Offering in the amount of $15.000002 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 3,926,702
Price\Range: $3.82
Discount Per Security: $0.29 Announcement • Jun 05
TRACON Pharmaceuticals Presents Data from a Phase 1 Study of Uliledlimab (TJ004309) and Tecentriq® (Atezolizumab) at the American Society of Clinical Oncology Virtual Annual Meeting TRACON Pharmaceuticals presented updated data from the Company’s Phase 1 study of TJ004309 and Tecentriq® (atezolizumab) at the American Society of Clinical Oncology (ASCO) virtual annual meeting. In poster presentation 2511 entitled, “The safety, pharmacokinetics (PK), pharmacodynamics (PD) and clinical efficacy of uliledlimab (TJ004309), a differentiated CD73 antibody, in combination with atezolizumab in patients with advanced cancer,” data were presented from 20 refractory cancer patients with advanced or metastatic solid tumors treated with the combination of uliledlimab and atezolizumab. Higher tumor CD73 and PD-L1 co-expression were found in responders compared to non-responders. Announcement • Jun 02
TRACON Pharmaceuticals Announces Results of Independent Data Monitoring Committee Review of Safety Data from ENVASARC Pivotal Trial TRACON Pharmaceuticals announced that the Independent Data Monitoring Committee for the ENVASARC pivotal trial has recommended that the trial will proceed as planned following the review of safety data from more than 20 patients enrolled into the trial to date. The safety data reviewed included data from more than 10 patients enrolled into cohort A of treatment with single agent envafolimab and more than 10 patients enrolled into cohort B of treatment with envafolimab and Yervoy (ipilimumab). Envafolimab (KN035), a novel, single-domain antibody against PD-L1, is the first subcutaneously injected PD-(L)1 inhibitor to be studied in pivotal trials. Envafolimab is currently being studied in the ENVASARC Phase 2 pivotal trial in the U.S. sponsored by TRACON, has been studied in a completed Phase 2 pivotal trial as a single agent in MSI-H/dMMR advanced solid tumor patients in China and is being studied in an ongoing Phase 3 pivotal trial in combination with gemcitabine and oxaliplatin in advanced biliary tract cancer patients in China, with both Chinese trials sponsored by TRACON’s corporate partners, Alphamab Oncology and 3D Medicines. Alphamab Oncology and 3D Medicines submitted an NDA to the NMPA in China for envafolimab in MSI-H/dMMR cancer that was accepted for review in December 2020 and granted priority review in January 2021. The ENVASARC pivotal trial is a multi-center, open label, randomized, non-comparative, parallel cohort study at approximately 25 top cancer centers in the United States that began dosing in December 2020. 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. Announcement • Mar 10
TRACON Pharmaceuticals, Inc. Announces Appointment of Lisa Johnson-Pratt to its Board of Directors TRACON Pharmaceuticals announced the appointment of Lisa Johnson-Pratt, M.D., Senior Vice President, New Product Planning at Ionis Pharmaceuticals, Inc., to its Board of Directors. Dr. Johnson-Pratt brings more than two decades of broad business and commercialization leadership experience to TRACON. Dr. Johnson Pratt currently serves as Sr. Vice President, New Product Planning at Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) which is focused on discovering, developing and commercializing RNA-targeted therapeutics for a broad range of diseases. Dr. Johnson-Pratt joined Ionis following its acquisition of Akcea Therapeutics, where she was an Executive Council Member and led an integrated medical team responsible for the commercialization strategy of two novel late stage antisense assets. Prior to that, Dr. Johnson-Pratt was Head of Global Pharma Commercial Operations at GSK. During her time at GSK, she also served as Head of Early Pipeline Commercial Strategy supporting assets in early-stage development across multiple therapeutic areas, including oncology. Announcement • Feb 19
TRACON Pharmaceuticals, Inc. to Report Q4, 2020 Results on Feb 25, 2021 TRACON Pharmaceuticals, Inc. announced that they will report Q4, 2020 results After-Market on Feb 25, 2021 Announcement • Dec 11
TRACON Pharmaceuticals, Inc. Announces Dosing of First Patient in ENVASARC Pivotal Trial TRACON Pharmaceuticals announced dosing of the first patient in the ENVASARC registration trial. Key elements of the ENVASARC registration trial include: Multi-center, open-label, randomized, non-comparative, parallel cohort study at approximately 25 top cancer centers in the United States. Eligible patients will have undifferentiated pleomorphic sarcoma (UPS) or myxofibrosarcoma (MFS) and received one or two prior cancer therapies, but 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. Open-label format with blinded independent central review of efficacy endpoint data. Announcement • Nov 25
TRACON Pharmaceuticals, Inc. Announces Publication in Cancer Cell of Clinical Data That Provides Molecular Insight into the Mechanism of Action of Trc102 and Patient Populations Most Likely to Respond to Treatment TRACON Pharmaceuticals, Inc. 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). 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. Announcement • Nov 18
TRACON Pharmaceuticals Announces Submission for Approval of Envafolimab (KN035) with the NMPA in China by its Corporate Partners Alphamab Oncology and 3D Medicines TRACON Pharmaceuticals 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). 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. 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. Announcement • Nov 05
TRACON Pharmaceuticals, Inc. to Report Q3, 2020 Results on Nov 10, 2020 TRACON Pharmaceuticals, Inc. announced that they will report Q3, 2020 results on Nov 10, 2020 Announcement • Sep 22
Tracon Pharmaceuticals Highlights Updated Envafolimab Clinical Results in MSI-H/dMMR Colorectal Cancer TRACON Pharmaceuticals highlighted updated clinical data from the pivotal trial of envafolimab in MSI-H/dMMR cancer patients that were recently presented by the Company’s corporate partners, 3D Medicines and Alphamab Oncology. In a presentation highlighting updated clinical results at the Chinese Society of Clinical Oncology (CSCO) 2020 Virtual Scientific Program entitled, “Subcutaneous Injection of PD-L1 Antibody Envafolimab (KN035) in Advanced Tumors with Mismatch-Repair Deficiency,” single agent envafolimab was shown to have a 32% confirmed objective response rate (ORR) by central radiographic review of 41 patients with MSI-H/dMMR colorectal cancer (CRC) who failed a fluoropyrimidine, oxaliplatin and irinotecan, and had at least two on-study tumor assessments. Duration of response (DOR) was greater than or equal to 12 months in 75% of patients and overall survival (OS) was greater than or equal to 12 months in 65% of patients. The ORR in the overall population (N=103) was 43%, DOR was greater than or equal to 12 months in 92% of patients and OS was greater than or equal to 12 months in 75% of patients. Envafolimab demonstrated good tolerability and safety and there continued to be no infusion-related reactions. Earlier data from this trial were presented by 3D Medicines and Alphamab Oncology at ASCO 2020, in a presentation entitled, “Envafolimab (KN035) in Advanced Tumors with Mismatch-Repair Deficiency,” at which time single agent envafolimab was shown to have a 28% confirmed ORR by central radiographic review in 39 patients with MSI-H/dMMR CRC who failed a fluoropyrimidine, oxaliplatin and irinotecan, and had at least two on-study tumor assessments. The trial enrolled 103 patients with MSI-H CRC, GC or with dMMR in other advanced solid tumors at clinical sites in China, in an open label format with efficacy endpoints, including the primary endpoint of confirmed ORR determined by independent central review. MSI-H/dMMR status was assessed centrally for CRC and GC and locally for other tumors. The confirmed ORR in MSI-H/dMMR colorectal cancer patients treated with envafolimab who failed a fluoropyrimidine, oxaliplatin and irinotecan reported at CSCO 2020 of 32% is similar to the 28% confirmed ORR reported in the Opdivo package insert in MSI-H/dMMR colorectal cancer 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 seen in cohort A of the pivotal KEYNOTE-164 trial. Announcement • Aug 28
TRACON Pharmaceuticals, Inc. announced that it expects to receive $4.999998 million in funding from Opaleye Management Inc. TRACON Pharmaceuticals, Inc. (NasdaqCM:TCON) announced that it has entered into a securities purchase agreement with an accredited investor, Opaleye L.P, a fund managed by Opaleye Management Inc. for a private placement of 1,170,788 common shares of the company’s common stock, par value $0.001 per share, at a price of $1.64 per share and pre-funded warrants at a price of the share purchase price minus $0.01 per pre-funded warrant to purchase an aggregate of 1,889,513 shares of common stock for gross proceeds of approximately $4,999,998 on August 26, 2020. The transaction is expected to close on or about August 27, 2020. The pre-funded warrants have a per share exercise price of $0.01. The pre-funded warrants are exercisable for a period of seven years from the date of issuance. Each pre-funded warrant also provides that the holder thereof may not exercise such pre-funded warrant if the exercise would result in the holder beneficially owning more than 19.99% of the company’s outstanding common stock. The company will issue securities on the private placement exemption from registration provided by Section 4(a)(2) of the Securities Act and by Rule 506 of Registration D, promulgated by the SEC, and on similar exemptions under applicable state laws.