TRACON Pharmaceuticals Reports Second Quarter 2021 Financial Results and Provides Corporate Update
“We remain on track to announce interim efficacy data from the pivotal ENVASARC trial by the end of this year and final data in 2022,” said
Recent Corporate Highlights
- In June, we received orphan drug designation for envafolimab in soft tissue sarcoma based on clinical data demonstrating confirmed objective partial responses by RECIST with duration of response in excess of six months, in two of five patients with refractory metastatic alveolar soft part sarcoma (ASPS) who received single agent envafolimab in Phase 1 clinical trials conducted by our partners, 3D Medicines and Alphamab Oncology.
August 6, the Independent Data Monitoring Committee (IDMC) recommended the ENVASARC trial proceed as planned following the review of more than three months of safety data from more than 20 patients enrolled in the trial as of May.
- In June, we presented the study design of the pivotal Phase 2 ENVASARC trial of single agent envafolimab and envafolimab given with Yervoy® (ipilimumab) at the 2021 ASCO virtual annual meeting.
- In July, we announced an underwritten public offering for gross proceeds of approximately
$15.0 million. We estimate that the proceeds will extend our cash runway into 2023, past expected final top-line data for ENVASARC.
- In the second quarter we enhanced our senior management team with multiple new hires, including a Head of Regulatory and Head of Biometrics, both of whom have BLA filing experience.
- In July, the book Unnecessary Expense: An Antidote to the Billion Dollar Drug Problem, authored by TRACON senior management to be published by ForbesBooks became available for preorder on Amazon. Publication is expected in September.
- In June, we presented preliminary Phase 1 data for the CD73 antibody uliledlimab (TJ4309) at the 2021 ASCO virtual annual meeting.
Expected Key Upcoming Milestones
- Interim ENVASARC efficacy data by end of 2021.
- Request FDA breakthrough therapy designation or fast track designation for envafolimab by end of 2021, assuming positive interim efficacy data.
- Decision on the envafolimab New Drug Application in MSI-H/dMMR cancer that is under priority review by the
Chinese National Medical Products Administration.
Second Quarter 2021 Financial Results
- Cash, cash equivalents and short-term investments were
$25.6 millionat June 30, 2021, compared to $36.1 millionat December 31, 2020. The cash balance at June 30, 2021, does not include the proceeds from the $15 millionunderwritten public offering in July, which extends the Company’s cash runway into 2023.
- Research and development expenses for the second quarter of 2021 were
$3.1 million, compared to $2.2 millionfor the second quarter of 2020.
- General and administrative expenses for the second quarter of 2021 were
$6.1 million, compared to $2.1 millionfor the second quarter of 2020. The increase was primarily attributable to legal expenses incurred with the now stayed lawsuit filed by I-Mabin the Delaware Court of Chanceryand ongoing arbitration on the TJ4309 and bispecific agreements. We expect the second quarter of 2021 to be the high point for general and administrative expenses this year.
- Net loss for the second quarter of 2021 was
$8.9 million, compared to $4.5 millionfor the second quarter of 2020.
Conference Call Details
A live webcast of the conference call will be available online from the Investor/Events and Presentations 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.
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
About ENVASARC (NCT04480502)
The ENVASARC pivotal trial is a multicenter, open label, randomized, non-comparative, parallel cohort study at approximately 25 top cancer centers in
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
TJ004309 is a novel, humanized antibody against CD73, an ecto-enzyme expressed on stromal cells and tumors that converts extracellular adenosine monophosphate (AMP) to adenosine, which is highly immunosuppressive. TJ004309 is currently being studied in an ongoing Phase 1 trial 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.
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; 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
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 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; expected development, regulatory and commercial milestones and timing thereof; estimated cash runway; 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: risks associated with clinical development and regulatory approval of novel pharmaceutical products; 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; 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
Unaudited Condensed Consolidated Statements of Operations
(in thousands, except share and per share data)
|Three Months Ended
||Six Months Ended
|Research and development||3,068||2,218||5,352||4,216|
|General and administrative||6,126||2,096||8,797||3,982|
|Total operating expenses||9,194||4,314||14,149||8,198|
|Loss from operations||(8,848||)||(4,314||)||(13,803||)||(8,198||)|
|Total other income (expense)||(91||)||(137||)||(200||)||(274||)|
Net loss per share, basic and diluted
|Weighted-average common shares outstanding, basic and diluted||15,497,315||6,385,562||15,488,359||5,778,456|
Unaudited Condensed Consolidated Balance Sheets
|Cash and cash equivalents||$||25,580||$||32,131|
|Prepaid and other assets||609||784|
|Total current assets||26,189||36,914|
|Property and equipment, net||40||16|
|Liabilities and Stockholders’ Equity|
|Accounts payable and accrued expenses||$||11,182||$||6,235|
|Accrued compensation and related expenses||945||1,590|
|Long-term debt, current portion||2,761||2,718|
|Total current liabilities||14,888||10,543|
|Other long-term liabilities||-||432|
|Long-term debt, less current portion||-||1,391|
|Commitments and contingencies|
|Additional paid-in capital||205,011||204,166|
|Total stockholders’ equity||11,915||25,072|
|Total liabilities and stockholders’ equity||$||26,803||$||37,438|
|Company Contact:||Investor Contact:|
|Chief Business Officer|
|(858) 251-3492||(212) 915-2578|
Source: TRACON Pharmaceuticals, Inc.