0001564590-23-003308.txt : 20230308 0001564590-23-003308.hdr.sgml : 20230308 20230308160931 ACCESSION NUMBER: 0001564590-23-003308 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 14 CONFORMED PERIOD OF REPORT: 20230308 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20230308 DATE AS OF CHANGE: 20230308 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Tracon Pharmaceuticals, Inc. CENTRAL INDEX KEY: 0001394319 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 342037594 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-36818 FILM NUMBER: 23716220 BUSINESS ADDRESS: STREET 1: 4350 LA JOLLA VILLAGE DRIVE STREET 2: SUITE 800 CITY: San Diego STATE: CA ZIP: 92122 BUSINESS PHONE: 858-550-0780 MAIL ADDRESS: STREET 1: 4350 LA JOLLA VILLAGE DRIVE STREET 2: SUITE 800 CITY: San Diego STATE: CA ZIP: 92122 FORMER COMPANY: FORMER CONFORMED NAME: Tracon Pharmaceuticals Inc DATE OF NAME CHANGE: 20070324 8-K 1 tcon-8k_20230308.htm 8-K tcon-8k_20230308.htm
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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): March 8, 2023

 

TRACON Pharmaceuticals, Inc.

(Exact name of registrant as specified in its charter)

Delaware

001-36818

34-2037594

(State or other jurisdiction

(Commission File Number)

(IRS Employer Identification No.)

of incorporation)

 

 

 

 

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

____________________________________________________________________________

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:

☐ 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Securities 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. ☐


 

Item 2.02

Results of Operations and Financial Condition.

On March 8, 2023, TRACON Pharmaceuticals, Inc. (the “Company”) issued a press release announcing its financial results for the quarter and year ended December 31, 2022. A copy of this press release is furnished as Exhibit 99.1 hereto.

The information provided in this Item 2.02 of this Current Report on Form 8-K, including the exhibits, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any of the Company’s filings under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.

 

Item 9.01

Financial Statements and Exhibits.

 

(d)

Exhibits.

 

Exhibit No.

  

Description 

99.1 

 

 

Press release issued by TRACON Pharmaceuticals, Inc. on March 8, 2023 announcing its financial results for the quarter and year ended December 31, 2022.

104

 

Cover page Interactive Data File (embedded within the Inline XBRL document).

 


 

SIGNATURES

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

 

 

 

 

 

 

 

 

Date: March 8, 2023

 

 

 

TRACON Pharmaceuticals, Inc.

 

 

 

 

 

 

 

 

By:

 

/s/ Charles P. Theuer, M.D., Ph.D.

 

Name:

 

Charles P. Theuer, M.D., Ph.D.

 

 

 

President and Chief Executive Officer

 

 

 EX-99.1 2 tcon-ex991_24.htm EX-99.1 tcon-ex991_24.htm

 

Exhibit 99.1

 

 

TRACON Pharmaceuticals Reports Fourth Quarter and Year-End 2022 Financial Results and

Provides Corporate Update

 

San Diego, CA – March 8, 2023 – TRACON Pharmaceuticals, Inc. (Nasdaq: TCON), 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, today announced financial results for the fourth quarter and year ended December 31, 2022. The Company will host a conference call and webcast today at 4:30 PM Eastern Time / 1:30 PM Pacific Time.

 

“The significant progress we achieved in the fourth quarter sets up 2023 to be a potentially transformational year for TRACON,” said Charles Theuer, M.D., Ph.D., President and CEO of TRACON. “In December we announced interim efficacy results from the ongoing ENVASARC pivotal trial demonstrating that envafolimab achieved a double-digit objective response rate, both as a single agent and in combination with Yervoy, in 36 patients with refractory sarcoma. We also secured a non-dilutive non-recourse financing of up to $30 million related to the I-Mab arbitration award decision which we expect this month, of which $3.5 million was funded in December. Importantly, accrual in ENVASARC remains ahead of projections and we expect the second and final interim efficacy analysis of 92 patients in the third quarter, after each patient has had two on-study scans, and to complete accrual before year end, leading to final data in 2024.”

 

Recent Corporate Highlights

 

•

In November 2022, we announced dosing of the first patient in a Phase 1/2 trial that studies envafolimab with our proprietary CTLA-4 antibody YH001 in combination with doxorubicin in front line sarcoma.

 

•

In November 2022, we completed the Phase 1 study of the CD73 antibody TJ4309, triggering I-Mab’s right to reacquire the asset for a payment to TRACON of $9M.

 

•

In December 2022, we announced positive interim results in the ENVASARC Phase 2 pivotal trial based on a double-digit objective response rate (ORR) by central radiographic review in the cohort of single agent envafolimab (N=18) and the cohort of envafolimab given in combination with Yervoy (N=18). The primary endpoint of the pivotal ENVASARC trial is achievement of an 11.25% ORR by central radiographic review in either 80 patient cohort.

 

•

In December 2022, we announced a non-recourse non-dilutive financing of up to $30M related to the arbitration with I-Mab. We received $3.5M up front and the remainder will be available subject to the award exceeding a threshold and satisfaction of other conditions.

 

 

 

 

 

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

URL: www.traconpharma.com

 

 

Expected Upcoming Milestones

 

•

Report the binding decision of the International Chamber of Commerce Arbitration Panel on the ongoing arbitration involving the TJ4309 and bispecific antibody agreements with I-Mab Biopharma where we are seeking to recover over $200 million in damages, which we expect in the first quarter of 2023.

 

•

Report the second and final interim efficacy analysis from the ENVASARC pivotal trial following the review of more than 12 weeks of efficacy data (including two on-study CT scans) by the independent data monitoring committee from 46 patients who receive envafolimab as a single agent and 46 patients who receive envafolimab in combination with Yervoy®, which we expect in the third quarter of 2023.

 

•

Complete full accrual of the ENVASARC pivotal trial before the end of 2023.

 

•

Report Phase 1 data from the Phase 1/2 clinical trial of YH001 in combination with envafolimab and doxorubicin in patients with soft tissue sarcoma, which we expect in the second half of 2023.

 

 

Fourth Quarter 2022 Financial Results

 

•

Cash and cash equivalents were $17.4 million at December 31, 2022, compared to $24.1 million at December 31, 2021, and is expected to fund the company into mid-2023.

 

•

Research and development expenses for the fourth quarter of 2022 were $3.9 million, compared to $3.1 million for the fourth quarter of 2021.

 

•

General and administrative expenses for the fourth quarter of 2022 were $2.0 million, compared to $4.6 million for the fourth quarter of 2021. The decrease was primarily attributable to legal expenses incurred in the fourth quarter of 2021 in connection with the arbitration with I-Mab.

 

•

Net loss for the fourth quarter of 2022 was $7.0 million, compared to $7.7 million for the fourth quarter of 2021.

 

Conference Call Details

 

To access the call by phone, please register using this link and you will be provided with dial-in details.

 

A live webcast of the conference call will be available online from the Investor/Events and Presentation page of the Company’s website at www.traconpharma.com.

 

After the live webcast, a replay will remain available on TRACON’s website for 60 days.

 

 

 

About 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 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 as well as multiple Phase 1 and Phase 2 clinical trials in China sponsored by TRACON’s corporate partners, Alphamab Oncology 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 U.S. Food and Drug Administration for envafolimab 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.

 

About ENVASARC (NCT04480502)

 

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.

 

About YH001

 

YH001 is an IgG1 antibody against CTLA-4 that has shown enhanced antibody dependent cellular cytotoxicity and complement dependent cytotoxicity in vitro. In preclinical studies YH001 demonstrated superior T cell activation and superior tumor growth inhibition activity compared to ipilimumab. YH001 also demonstrated superior activity compared to ipilimumab in human transgenic mouse tumor models when combined with a PD-(L)1 antibody. In these models, single agent YH001 depleted regulatory T cells and increased CD8+ T cells in tumor tissue. YH001 is being studied with envafolimab and doxorubicin in a Phase 1/2 clinical trial sponsored by TRACON (NCT05448820), and has been studied in multiple Phase 1 trials in China and Australia sponsored by TRACON’s corporate partner Eucure, a division of Biocytogen.

 

 

 

 

About TRC102

 

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 FDA in malignant glioma, including glioblastoma.

 

About TJ004309

 

TJ004309 is a novel, humanized antibody against CD73, an ecto-enzyme expressed on stromal cells and tumors that converts extracellular adenosine monophosphate to adenosine, which is highly immunosuppressive.  TJ004309 was studied in a Phase 1 trial sponsored by TRACON (NCT03835949) to assess safety and preliminary efficacy as a single agent and when combined with the PD-L1 checkpoint inhibitor Tecentriq® in patients with advanced solid tumors.

 

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 1/2 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 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 and its product pipeline, visit TRACON’s website at www.traconpharma.com.

 

 

 

 

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, statements regarding the timing of the final binding decision from the ICC Tribunal regarding the legal disputes involving the TJ004309 and bispecific antibody agreements with I-Mab Biopharma; whether the size of the award in the I-Mab arbitration will result in additional funding through our non-recourse financing relating to the arbitration; whether TRACON will recover any of the $200 million in damages it is seeking in its arbitration with I-Mab; the timing for TRACON’s completion of the TJ4309 Phase 1 trial and whether I-Mab will terminate the TJ4309 license and pay $9 million to TRACON; the initiation of dosing in TRACON’s Phase 1/2 clinical trial of envafolimab with YH001 and doxorubicin; TRACON’s expectations regarding the funding of its operations through its current cash and cash equivalents into mid-2023; TRACON’s and its collaboration partners’ plans to further develop product candidates; expectations regarding the timing and scope of clinical trials and availability of clinical data, including the timing and results of accrual and data from TRACON’s ENVASARC Phase 2 pivotal trial and a report of the IDMC on its second interim efficacy analysis; expected development, regulatory and commercial milestones and timing thereof; potential utility of product candidates; and TRACON’s business development strategy and goals to enter into additional collaborations. Risks that could cause actual results to differ from those expressed in these forward‐looking statements include: the inherent uncertainty regarding arbitrations and the risk that the ICC Tribunal delays the date by which it will render its decision or decides that TRACON is not entitled to recover any or only a portion of the damages that it is seeking; 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, such as the COVID-19 pandemic, the ongoing military conflict between Ukraine and Russia and related sanctions, and whether I-Mab will pay TRACON $9 million to terminate the TJ4309 license in connection with completion of the TJ4309 Phase 1 trial; 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 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.


 

 

TRACON Pharmaceuticals, Inc.

Unaudited Condensed Consolidated Statements of Operations

(in thousands, except share and per share data)

 

 

 

Three Months Ended
December 31,

 

Year Ended
December 31,

 

2022

 

2021

 

2022

 

2021

License revenue

$—

 

$—

 

$—

 

$346

Operating expenses:

 

 

 

 

 

 

 

Research and development

3,875

 

3,064

 

13,888

 

11,146

General and administrative

1,957

 

4,599

 

14,006

 

17,547

Total operating expenses

5,832

 

7,663

 

27,894

 

28,693

Loss from operations

(5,832)

 

(7,663)

 

(27,894)

 

(28,347)

Total other expense

(1,165)

 

(49)

 

(1,241)

 

(320)

Net loss

$(6,997)

 

$(7,712)

 

$(29,135)

 

$(28,667)

 

Net loss per share, basic and diluted

$(0.31)

 

$(0.40)

 

$(1.39)

 

$(1.66)

Weighted‑average common shares outstanding, basic and diluted

22,293,735

 

19,442,526

 

20,919,118

 

17,252,637

 

 

 

 

 

 


 

 

TRACON Pharmaceuticals, Inc.

Unaudited Condensed Consolidated Balance Sheets

(in thousands)

 

 

December 31,

 

December 31,

 

2022

 

2021

Assets

 

 

 

Current assets:

 

 

 

Cash and cash equivalents

$17,433

 

$24,072

Prepaid and other assets

795

 

864

Total current assets

18,228

 

24,936

Property and equipment, net

51

 

50

Restricted Cash

67

 

—

Other assets

1,123

 

1,571

Total assets

$19,469

 

$26,557

Liabilities and Stockholders’ Equity

 

 

 

Current liabilities:

 

 

 

Accounts payable and accrued expenses

$11,107

 

$10,753

Accrued compensation and related expenses

1,457

 

1,532

Long‑term debt, current portion

9,807

 

1,391

Total current liabilities

22,371

 

13,676

Other long-term liabilities

969

 

1,167

Arbitration financing payable

3,280

 

—

Commitments and contingencies

 

 

 

Stockholders’ equity:

 

 

 

Common stock

23

 

19

Additional paid‑in capital

229,737

 

219,471

    Accumulated deficit

(236,911)

 

(207,776)

Total stockholders’ equity

(7,151)

 

11,714

Total liabilities and stockholders’ equity

$19,469

 

$26,557

 

 

Company Contact:

Investor Contact:

Charles Theuer

Brian Ritchie

Chief Executive Officer

LifeSci Advisors LLC

(858) 550-0780

(212) 915-2578

ctheuer@traconpharma.com

britchie@lifesciadvisors.com

 

 

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end EX-101.SCH 4 tcon-20230308.xsd XBRL TAXONOMY EXTENSION SCHEMA 00000 - Document - Template Link link:presentationLink link:calculationLink link:definitionLink 100000 - Document - Document and Entity Information link:calculationLink link:presentationLink link:definitionLink EX-101.LAB 5 tcon-20230308_lab.xml XBRL TAXONOMY EXTENSION LABEL LINKBASE Entity Central Index Key Cover [Abstract] Document Type Document Type Amendment Flag Amendment Flag Document Period End Date Document Period End Date Entity Registrant Name Entity Registrant Name Entity Central Index Key Entity Emerging Growth Company Entity Emerging Growth Company Entity File Number Entity File Number Entity Incorporation, State or Country Code Entity Incorporation State Country Code Entity Tax Identification Number Entity Tax Identification Number Entity Address, Address Line One Entity Address Address Line1 Entity Address, Address Line Two Entity Address Address Line2 Entity Address, City or Town Entity Address City Or Town Entity Address, State or Province Entity Address State Or Province Entity Address, Postal Zip Code Entity Address Postal Zip Code City Area Code City Area Code Local Phone Number Local Phone Number Written Communications Written Communications Soliciting Material Soliciting Material Pre-commencement Tender Offer Pre Commencement Tender Offer Pre-commencement Issuer Tender Offer Pre Commencement Issuer Tender Offer Title of 12(b) Security Security12b Title Trading Symbol Trading Symbol Security Exchange Name Security Exchange Name EX-101.PRE 6 tcon-20230308_pre.xml XBRL TAXONOMY EXTENSION PRESENTATION LINKBASE XML 7 R1.htm IDEA: XBRL DOCUMENT v3.22.4
Document and Entity Information
Mar. 08, 2023
Cover [Abstract]  
Document Type 8-K
Amendment Flag false
Document Period End Date Mar. 08, 2023
Entity Registrant Name TRACON Pharmaceuticals, Inc.
Entity Central Index Key 0001394319
Entity Emerging Growth Company false
Entity 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
Entity Address, Address Line Two 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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