TRACON Pharmaceuticals Announces $35 Million Non-Dilutive

SAN DIEGO, Sept. 06, 2022 (GLOBE NEWSWIRE) — TRACON Pharmaceuticals, Inc. (Nasdaq: TCON), a scientific stage biopharmaceutical firm using a cost-efficient, CRO-independent product growth platform to advance its pipeline of novel focused most cancers therapeutics and to companion with different life science firms, as we speak introduced entry right into a $35 million non-dilutive long-term debt facility with Runway Growth Capital LLC (Runway), a number one supplier of loans to enterprise and non-venture backed firms searching for non-dilutive capital.

“This non-dilutive financing extends our cash runway to support the robust accrual of the pivotal ENVASARC trial while we await completion of the Phase 1 TJ4309 clinical trial that triggers I-Mab’s license termination option for $9 million as well as the outcome of the binding arbitration with I-Mab, both of which are expected this quarter,” mentioned Charles Theuer, M.D., Ph.D., President and CEO of TRACON. “We are pleased to partner with Runway, which seeks long-term relationships with late-stage life science companies who will benefit from non-dilutive capital.”

“We are excited to enter into this facility with TRACON to help them achieve their goal of bringing envafolimab, the world’s first subcutaneous checkpoint inhibitor, to market in the underserved indication of sarcoma,” mentioned Igor DaCruz, Managing Director, Life Sciences at Runway.

$10 million of the $35 million mortgage was funded upon closing. The further $25 million out there below the ability could also be funded upon achievement of sure scientific milestones and at Runway’s discretion. The mortgage has a 24-month interest-only interval adopted by 24 month-to-month funds of principal and curiosity. In reference to the debt financing, TRACON issued Runway warrants to buy as much as 150,753 of its widespread inventory at an train worth of $1.99 per share.

Proceeds from the ability might be used to assist the continuing pivotal ENVASARC trial and for common company functions.

About Envafolimab

Envafolimab (KN035), a single-domain antibody in opposition to PD-L1 invented by Alphamab Oncology, is the primary authorised subcutaneously injected PD-(L)1 inhibitor. Envafolimab was authorised by the Chinese NMPA in November 2021 in grownup sufferers with MSI-H/dMMR superior stable tumors who failed systemic therapy and don’t have any passable various therapy choices. In December 2019, Alphamab Oncology, 3D Medicines and TRACON entered right into a collaboration whereby TRACON has the precise to develop and commercialize envafolimab in smooth tissue sarcoma in North America. Envafolimab is presently being studied within the pivotal ENVASARC Phase 2 trial within the United States sponsored by TRACON and a Phase 3 pivotal trial together with gemcitabine and oxaliplatin in superior biliary tract most cancers sufferers in China sponsored by TRACON’s company companions, Alphamab Oncology and 3D Medicines.

About ENVASARC (NCT04480502)

The ENVASARC pivotal trial is a multicenter, open label, randomized, non-comparative, parallel cohort research at 30 high most cancers facilities within the United States and the United Kingdom that started dosing in December 2020. TRACON expects the trial to enroll greater than 160 sufferers with UPS or MFS who’ve progressed following one or two traces of prior therapy and haven’t acquired an immune checkpoint inhibitor, with 80 sufferers enrolled right into a cohort of therapy with single agent envafolimab at 600 mg each three weeks and 80 sufferers enrolled right into a cohort of therapy with envafolimab at 600 mg each three weeks with Yervoy. The main endpoint is goal response fee by central overview with length of response a key secondary endpoint.

About TRACON

TRACON is a clinical-stage biopharmaceutical firm using a cost-efficient, CRO-independent, product growth platform to advance its pipeline of novel focused most cancers therapeutics and to companion with different life science firms. The Company’s clinical-stage pipeline contains: Envafolimab, a PD-L1 single-domain antibody given by fast subcutaneous injection that’s being studied within the pivotal ENVASARC trial for sarcoma; YH001, a possible best-in-class CTLA-4 antibody in Phase 1 growth; TRC102, a Phase 2 small molecule drug candidate for the therapy of lung most cancers; and TJ004309, a CD73 antibody in Phase 1 growth for the therapy of superior stable tumors. TRACON is actively searching for further company partnerships via a profit-share or revenue-share partnership, or via franchising TRACON’s product growth platform. TRACON believes it may possibly function an answer for firms with out scientific and business capabilities in the United States or who want to develop into CRO-independent. To be taught extra about TRACON and its product pipeline, go to TRACON’s web site at www.traconpharma.com.

Forward-Looking Statements

Statements made on this press launch relating to issues that aren’t historic information are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward‐looking statements. Such statements include, but are not limited to, statements regarding TRACON’s plans to further develop its product candidates, TRACON’s expected benefits from the partnership and financing with Runway and the expected cash runway resulting from the financing, TRACON’s expectations regarding the timing and success of clinical milestones, TRACON’s ability to obtain additional future funding, including achievement of the conditions necessary to obtain additional advances under the facility with Runway, and the outcome of the binding arbitration with I-Mab Biopharma. Risks that could cause actual results to differ from those expressed in these forward‐looking statements include: risks associated with clinical development and regulatory approval of novel pharmaceutical product candidates; increasing inflation and interest rates among other adverse market conditions; whether TRACON or others will be able to complete or initiate clinical trials on TRACON’s expected timelines, if at all, including due to risks associated with the COVID-19 pandemic and other geopolitical events; the fact that future clinical results may not be consistent with preliminary results or results from prior studies; the fact that TRACON has limited control over whether or when third party collaborators complete on-going trials, initiate additional trials or seek regulatory approval of TRACON’s product candidates; the fact that TRACON’s collaboration agreements are subject to early termination; whether TRACON will be able to enter into additional collaboration agreements on favorable terms or at all; potential changes in regulatory requirements in the United States and foreign countries; TRACON’s reliance on third parties for the development of its product candidates, including the conduct of its clinical trials and manufacture of its product candidates; whether TRACON will be able to obtain additional financing; and other risks described in TRACON’s filings with the Securities and Exchange Commission under the heading “Risk Factors”. All forward‐looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. TRACON undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made except as required by law.