TCON TRACON Pharmaceuticals Inc

 

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): November 17, 2023

 

 

Tracon Pharmaceuticals, Inc.

(Exact name of Registrant as Specified in Its Charter)

 

 

Delaware			001-36818	34-2037594
(State or Other Jurisdiction of Incorporation)			(Commission File Number)	(IRS Employer Identification No.)
4350 La Jolla Village Drive, Suite 800
San Diego, California				92122
(Address of Principal Executive Offices)				(Zip Code)

 

Registrant’s Telephone Number, Including Area Code: (858) 550-0780

 

(Former Name or Former Address, if Changed Since Last Report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, par value $0.001 per share		TCON		The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

 

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Item 1.01 Entry into a Material Definitive Agreement.

On November 17, 2023 (the “Effective Date”), Tracon Pharmaceuticals, Inc. (the “Company”) entered into a License Agreement (the “Agreement”) with Inhibrx, Inc. (“Inhibrx”). Under the terms of the Agreement, the Company granted a non-exclusive and non-transferable license of its product development platform to Inhibrx for the design, conduct and administration of clinical trials and related research and development activities, including activities relating to regulatory filings, submissions and approvals (the “Tracon PDP License”). The Tracon PDP License will allow Inhibrx to use the Company’s configuration documentation with a widely used software package in addition to use of the Company’s validation and qualification of the software package, and the Company’s standard operation procedure documents, policies, work instructions, and clinical operation templates (the “Licensed Technology”). Upon Inhibrx’s request during the first six months after the Effective Date, the Company is obligated to provide up to 500 hours of training (“Technical Support”) to Inhibrx. Pursuant to the Agreement, Inhibrx will make an upfront payment of $3.0 million to the Company, plus a potential $0.2 million (i) upon the completion of the Technical Support by the Company, or (ii) six months following the Company’s delivery of the Licensed Technology, whichever is earlier.

 

The Agreement may be terminated at any time by mutual agreement of the parties. Either party may also terminate the Agreement in its entirety immediately upon notice of the other party’s material breach if such party fails to cure the breach in accordance with the terms of the Agreement. Either party may also terminate the Agreement in its entirety upon certain insolvency events involving the other party or upon a change of control in the Company.

 

The foregoing description of the Agreement is only a summary and is qualified in its entirety by reference to the Agreement, a copy of which the Company plans to file as an exhibit to its next Annual Report on Form 10-K.

Item 8.01 Other Events.

On November 20, 2023, the Company issued a press release announcing the Agreement, a copy of which is filed as Exhibit 99.1 to this Current Report on Form 8-K and incorporated herein by reference

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

 

Exhibit No.		Description
99.1		Press Release, dated November 20, 2023
104		Cover page Interactive Data File (embedded within the Inline XBRL document).

 

 

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

			TRACON Pharmaceuticals, Inc.
Date:	November 20, 2023	By:	/s/ Charles P. Theuer, M.D., Ph.D.
			Charles P. Theuer, M.D., Ph.D. President and Chief Executive Officer

 

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Exhibit 99.1

 

TRACON Pharmaceuticals Announces License of Product Development Platform for $3.0 Million Upfront Payment

 

San Diego, CA – November 20, 2023 – TRACON Pharmaceuticals, Inc. (Nasdaq: TCON), a clinical stage biopharmaceutical company utilizing a cost-efficient, CRO-independent product development platform (PDP) to advance its pipeline of novel targeted cancer therapeutics and to partner with other life science companies, today announced it has licensed its proprietary PDP of CRO-independent clinical research to a clinical stage biotech company for a $3.0 million upfront payment.

 

“We are excited to announce the first license of our PDP to a company that recognizes the value of internalizing its clinical operations to reap the benefits of CRO-independent clinical trial implementation that we enjoy at TRACON,” said Charles Theuer, M.D., Ph.D., TRACON’s Chief Executive Officer. “We are now in a position to widely license our PDP to allow clinical stage biotechnology and pharmaceutical companies to transform their clinical operations with the expectation of potentially dramatic cost reductions and shorter clinical trial timelines.”

 

Under the terms of the Agreement, TRACON granted a non-exclusive and non-transferable license of its PDP to the clinical stage biotech company for the design, conduct and administration of clinical trials and related research and development activities, including activities relating to regulatory filings, submissions and approvals. A licensee can integrate TRACON’s configuration documentation with a widely-used software package, enabling validation and qualification of the software package, in conjunction with TRACON’s standard operation procedure documents, policies, work instructions, and clinical operation templates.

 

About TRACON

 

TRACON is a clinical-stage biopharmaceutical company utilizing a cost-efficient, CRO-independent, product development platform to advance its pipeline of novel targeted cancer therapeutics and to partner with other life science companies. 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; and TRC102, a Phase 2 small molecule drug candidate for the treatment of lung cancer. TRACON is actively seeking additional corporate partnerships through a profit-share or revenue-share partnership, or through franchising TRACON’s product development platform. TRACON believes it can serve as a solution for companies without clinical and commercial capabilities in the United States or who wish to become CRO-independent. To learn more about TRACON, its product pipeline and its CRO-independent, product development platform, visit TRACON’s website at www.traconpharma.com.

 

 

 

4350 La Jolla Village Drive  Suite 800  San Diego, California 92122  P: 858.550.0780  F: 858.550.0786

URL: www.traconpharma.com

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Forward-Looking Statements

 

Statements made in this press release regarding matters that are not historical facts 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, TRACON’s and its collaboration partners’ plans to further develop product candidates; TRACON’s plans to further license out its platform, including the potential costs saving and other benefits related thereto; potential utility of product candidates; and TRACON’s business development strategy and goals, including the ability to enter into additional collaborations and licensing partnerships. Risks that could cause actual results to differ from those expressed in these forward‐looking statements include: the risk that TRACON’s cash runway will be less than currently anticipated; risks associated with clinical development and regulatory approval of novel pharmaceutical product candidates; 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 geopolitical and macroeconomic events; the fact that future preclinical studies and clinical trials may not be successful or otherwise consistent with results from prior studies; the fact that TRACON has limited control over whether or when third party collaborators complete on-going trials or initiate additional trials 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 or licensing partnerships 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.

 

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v3.23.3

Document And Entity Information	Nov. 17, 2023
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Nov. 17, 2023
Entity Registrant Name	Tracon Pharmaceuticals, Inc.
Entity Central Index Key	0001394319
Entity Emerging Growth Company	false
Securities Act File Number	001-36818
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	34-2037594
Entity Address, Address Line One	4350 La Jolla Village Drive, Suite 800
Entity Address, City or Town	San Diego
Entity Address, State or Province	CA
Entity Address, Postal Zip Code	92122
City Area Code	(858)
Local Phone Number	550-0780
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock, par value $0.001 per share
Trading Symbol	TCON
Security Exchange Name	NASDAQ

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