Methoxyamine Hydrochloride

Publication Highlights Activity of the Combination of TRC102 and Temodar (Temozolomide) in Patients who Progressed Following Initial Treatment with Surgical Resection, Temodar and External Beam Radiotherapy Consistent with the TRC102 Mechanism of Action, Extended Survival was Demonstrated in Patients with Activation of DNA Damage Response Pathways Prior to TRC102 Treatment SAN DIEGO, June 11, 2024 (GLOBE NEWSWIRE) -- TRACON Pharmaceuticals (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 the publication of Phase 2 clinical data of its DNA damage repair inhibitor drug candidate, TRC102, in patients with glioblastoma in Clinical Cancer Research. The article, entitled, “Evaluating the Base Excision Repair Inhibitor TRC102 and Temozolomide for patients with Recurrent Glioblastoma in the Phase 2 Adult Brain Tumor Consortium Trial BERT,” highlights the activity of TRC102 given in combination with Temodar chemotherapy in patients with recurrent glioblastoma: https://pubmed-ncbi-nlm-nih-gov.libproxy1.nus.edu.sg/38836759/ TRC102 was evaluated in a Phase 2 trial in combination with Temodar in 19 patients with progressive or recurrent glioblastoma following surgical resection, Temodar and external beam radiotherapy. Extended survival was observed in two patients (progression-free survival ≥ 17 months and overall survival > 32 months), both of whom demonstrated significantly enriched signatures of DNA damage response (DDR), chromosomal instability, and cellular proliferation by RNA sequencing prior to initiating treatment with Temodar and TRC102. The study was completed by the Adult Brain Tumor Consortium and led by Manmeet Alhuwalia, MD while he was Chair of Neuro-Oncology at Cleveland Clinic prior to his appointment as Chief of Medical Oncology, Chief Scientific Officer, and Deputy Director of the Miami Cancer Institute. The authors concluded the study findings confirm the safety and feasibility of TRC102 given with Temodar for recurrent glioblastoma patients and warrant further evaluation of combination therapy in biomarker-enriched trials enrolling glioblastoma patients with baseline hyperactivated DDR pathways. “We believe that the data generated to date provides a strong rationale for studying TRC102 in combination with Temodar and radiotherapy in newly diagnosed patients with malignant glioma,” said James Freddo, M.D., Chief Medical Officer of TRACON. “The Clinical Cancer Research publication supports prior data published in Cancer Cell (https://pubmed-ncbi-nlm-nih-gov.libproxy1.nus.edu.sg/33217343) that patients whose cancers demonstrate activation of DDR pathways may be particularly sensitive to the pharmacologic effects of TRC102.” Based on a 100% response rate (including a 20% complete response rate) in a Phase 1 clinical trial combining TRC102 with pemetrexed, cisplatin and radiation therapy in 15 patients with stage III non-squamous non-small cell lung cancer (https://pubmed-ncbi-nlm-nih-gov.libproxy1.nus.edu.sg/34740922), TRC102 is currently being studied in a randomized Phase 2 clinical trial in combination with chemotherapy (pemetrexed, cisplatin or carboplatin) and radiation therapy for stage III non-squamous non-small cell lung cancer (NCT05198830: https://clinicaltrials.gov/study/NCT05198830?intr=TRC102&rank=6). This trial is sponsored by the National Cancer Institute (NCI) through a Cooperative Research and Development Agreement (CRADA). Determination of the primary endpoint of progression free survival is expected in 2025. TRACON and the NCI have a longstanding history of partnership to develop TRC102, whereby the NCI has funded six Phase 1 or Phase 2 trials through the CRADA. About TRC102 TRC102 (methoxyamine) is a novel, clinical-stage 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 randomized Phase 2 clinical trial entitled Testing the Addition of an Anti-Cancer Drug, TRC102, to the Usual Chemotherapy Treatment (Pemetrexed, Cisplatin or Carboplatin) During Radiation Therapy for Stage III Non-Squamous Non-Small Cell Lung Cancer (NCT05198830) that is sponsored by the NCI through a CRADA. TRC102 was granted orphan drug designation by the US FDA for the treatment of malignant glioma in 2020. For more information about the clinical trials, please visit TRACON’s website at www.traconpharma.com/clinical-trials. About Malignant Glioma and Glioblastoma Glioblastoma (GBM) is a rapidly growing malignant glioma that develops from glial cells (astrocytes and oligodendrocytes) that support the health of the nerve cells within the brain. GBM is the most invasive type of glial tumors, rapidly growing and commonly invading into nearby brain tissue. The National Cancer Institute estimates that approximately 22,850 adults are diagnosed with brain and other nervous system cancers annually in the U.S. and approximately 15,320 of these diagnoses will result in death. GBM has an incidence of two to three per 100,000 adults per year in the U.S., and accounts for 52 percent of all primary brain tumors. About TRACON TRACON utilizes 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. TRACON believes it can serve as a solution for companies without clinical capabilities who wish to become CRO-independent. To learn more about TRACON, 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 TRACON’s and the NCI’s plans to further develop product candidates, expectations regarding clinical trials, development and regulatory plans, the potential benefits of TRC102, the potential for TRC102 to become a treatment option for patients with the glioblastoma or lung cancer, market estimates regarding annual diagnoses of brain and other nervous system cancer, and TRACON’s business development strategy and goals. Risks that could cause actual results to differ from those expressed in these forward‐looking statements include: risks associated with TRACON’s ability to remain listed on a national securities exchange, risks associated with clinical development and regulatory approval of pharmaceutical product candidates, including the results of clinical trials involving TRC102 and whether the results of earlier studies or trials will be consistent with or otherwise achieved in later trials; risks relating to TRACON’s ability to continue as a going concern; risks relating to other therapies that are being developed and compete with TRACON’s 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 macroeconomic and geopolitical events; 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 on favorable terms or at all; 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. Company Contact:Investor Contact:Charles TheuerBrian RitchieChief Executive OfficerLifeSci Advisors LLC(858) 550-0780(212) 915-2578ctheuer@traconpharma.combritchie@lifesciadvisors.com

SAN DIEGO, May 14, 2024 (GLOBE NEWSWIRE) -- 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 first quarter ended March 31, 2024. The Company will host a conference call and webcast today at 4:30 PM Eastern Time / 1:30 PM Pacific Time. “With ENVASARC fully enrolled we are focused on leveraging our Product Development Platform to generate non-dilutive capital through either an additional license or by replacing a CRO and executing clinical trials for partners at a lower cost compared to a CRO but still at a premium to our costs using a pay for performance model,” said Charles Theuer, M.D., Ph.D., President and CEO of TRACON. “We look forward to reporting the final response assessment data in all patients from the ENVASARC Phase 2 pivotal trial, which are expected in the third quarter.” Recent Corporate Highlights In April, we announced updated interim safety and efficacy data from the ENVASARC Phase 2 pivotal trial in 73 patients treated with single agent envafolimab. The objective response rate (ORR) was 11% by investigator review and 5.5% by blinded independent central review (BICR), all of which were confirmed responses. Envafolimab monotherapy was generally well tolerated and median duration of response by BICR was greater than six months. The primary endpoint of the study is achievement of an ORR by BICR in nine of 82 patients (11%) treated with envafolimab and median duration of response of greater than six months is a key secondary endpoint. In April, the Company announced that the Nasdaq Hearings Panel granted the Company’s request for an extension to demonstrate compliance with all applicable criteria for continued listing on The Nasdaq Capital Market, including the $1.00 bid price and $2.5 million stockholders’ equity requirements, through June 3, 2024, provided the Company execute a reverse stock split and file an S-1, both of which the Company executed in April. The Company continues to consider alternatives to address the $2.5 million stockholders’ equity requirement on or before June 3, 2024. Expected Upcoming Milestone Report the final response assessment data including duration of response in all patients from the ENVASARC Phase 2 pivotal trial, which are expected in the third quarter of 2024. First Quarter 2024 Financial Results Cash, cash equivalents and restricted cash were $8.0 million at March 31, 2024, compared to $8.6 million at December 31, 2023, which is expected to fund the Company late into the third quarter of 2024. Research and development expenses for the first quarter of 2024 were $1.9 million, compared to $5.0 million for the first quarter of 2023. The decrease was primarily related to completing enrollment of the ENVASARC Phase 2 pivotal trial in 2024. General and administrative expenses for the first quarter of 2024 were $1.4 million, compared to $2.3 million for the first quarter of 2023. Net loss for the first quarter of 2024 was $3.2 million, compared to $8.5 million for the first quarter of 2023. 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 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. 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. About ENVASARC (NCT04480502) The ENVASARC Phase 2 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 enrolled patients in ENVASARC with UPS or MFS who have progressed following one or two lines of prior treatment and have not received an immune checkpoint inhibitor. A total of 82 evaluable patients have received treatment with single agent envafolimab at 600 mg every three weeks. The primary endpoint is objective response rate by central review in nine of 82 patients (11%) with duration of response a key secondary endpoint. 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 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, TRACON’s plans to further develop product candidates; TRACON’s ability to regain compliance with Nasdaq continued listing standards and maintain the listing of its securities on a national securities exchange; TRACON’s plans to further license out its platform or replace CROs and generate non-dilutive capital; 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; expected development, regulatory and commercial milestones and timing thereof; potential utility of product candidates; TRACON’s cash runway; and TRACON’s business development strategy and goals, including the ability to enter into additional collaborations or licensing arrangements. Risks that could cause actual results to differ from those expressed in these forward‐looking statements include: the risk that TRACON needs substantial additional capital to continue as a going concern and to enroll or complete its ongoing clinical trials as currently planned, if at all; 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, including ENVARSAC, 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 arrangements or arrangements whereby TRACON replaces CROs 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; whether TRACON will experience unanticipated costs or other events that cause TRACON’s cash runway to not extend late into the third quarter of 2024; whether TRACON will remain listed on Nasdaq; 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. TRACON Pharmaceuticals, Inc.Unaudited Condensed Consolidated Statements of Operations(in thousands, except share and per share data) Three Months EndedMarch 31, 2024 2023 Revenue$100 $— Operating expenses: Research and development 1,878 4,969 General and administrative 1,434 2,344 Total operating expenses 3,312 7,313 Loss from operations (3,212) (7,313)Total other income (expense) 44 (1,191)Net loss$(3,168) $(8,504) Loss per share, basic and diluted$(1.33) $(6.76)Weighted-average common shares outstanding, basic and diluted 2,389,519 1,258,096 TRACON Pharmaceuticals, Inc.Unaudited Condensed Consolidated Balance Sheets(in thousands) March 31, December 31, 2024 2023 Assets Current assets: Cash and cash equivalents$7,891 $8,564 Prepaid and other assets 511 526 Total current assets 8,402 9,090 Property and equipment, net 33 37 Restricted Cash 73 73 Other assets 847 905 Total assets$9,355 $10,105 Liabilities and Stockholders’ Deficit Current liabilities: Accounts payable and accrued expenses$10,036 $9,755 Accrued compensation and related expenses 414 427 Total current liabilities 10,450 10,182 Other long-term liabilities 667 732 Commitments and contingencies Stockholders’ deficit: Common stock 3 2 Additional paid-in capital 241,902 239,688 Accumulated deficit (243,667) (240,499)Total stockholders’ deficit (1,762) (809)Total liabilities and stockholders’ deficit$9,355 $10,105 Company Contact:Investor Contact:Charles TheuerBrian RitchieChief Executive OfficerLifeSci Advisors LLC(858) 550-0780(212) 915-2578ctheuer@traconpharma.combritchie@lifesciadvisors.com