Malignant Fibrous Histiocytoma

SAN DIEGO, March 05, 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 fourth quarter and year ended December 31, 2023. The Company will host a conference call and webcast today at 4:30 PM Eastern Time / 1:30 PM Pacific Time. “We are on track to complete enrollment of 80 patients treated with single agent envafolimab in the ongoing pivotal ENVASARC trial later this quarter. We expect to report updated response rate data shortly thereafter and before the end of this quarter, with final data anticipated in the second half of 2024,” said Charles Theuer, M.D., Ph.D., TRACON’s Chief Executive Officer. “We also expect to leverage 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.” Recent Corporate Highlights In December, we announced updated interim data from the ENVASARC Phase 2 pivotal trial in the initial 46 patients treated with single agent envafolimab. The objective response rate (ORR) was 15% by investigator review and 8.7% 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 80 patients (11.25%) treated with envafolimab and median duration of response of greater than six months is a key secondary endpoint. In November, we licensed our Product Development Platform (PDP) to a clinical stage biotech company for an upfront payment of $3.0 million. Expected Upcoming Milestones Complete accrual of the ENVASARC pivotal trial this quarter and report updated response rate data shortly thereafter and before the end of the quarter. Report final data from ENVASARC pivotal trial in the second half of 2024. Continue to leverage TRACON’s cost-efficient, CRO-independent PDP to generate non-dilutive capital. Fourth Quarter 2023 Financial Results Cash, cash equivalents and restricted cash were $8.6 million at December 31, 2023, compared to $17.5 million at December 31, 2022. License revenue for the fourth quarter of 2023 was $3.0 million and was due to the license of our PDP to a clinical stage biotech company. Research and development expenses for the fourth quarter of 2023 were $1.5 million, compared to $3.9 million for the fourth quarter of 2022. The decrease was primarily related to enrollment into only cohort C in the ongoing ENVASARC pivotal trial. General and administrative expenses for the fourth quarter of 2023 were $1.1 million, compared to $2.0 million for the fourth quarter of 2022. The decrease was primarily attributable to lower legal expenses. Net income for the fourth quarter of 2023 was $0.4 million, compared to a net loss of $7.0 million for the fourth quarter of 2022. 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 . 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 is enrolling patients in ENVARSAC 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 80 patients will receive treatment with single agent envafolimab at 600 mg every three weeks. The primary endpoint is objective response rate by central review 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 . 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 plans to further license out its platform; 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; and TRACON’s business development strategy and goals, including the ability to enter into additional collaborations. 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 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. 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, 2023 2022 2023 2022 Revenue $3,045 $ — $12,045 $ — Operating expenses: Research and development 1,494 3,875 12,277 13,888 General and administrative 1,144 1,957 6,666 14,006 Arbitration success fees — — 2,375 — Total operating expenses 2,638 5,832 21,318 27,894 Income (loss) from operations 407 (5,832) (9,273) (27,894) Total other income (expense) 32 (1,165) 5,685 (1,241) Net income (loss) $439 $(6,997) $(3,588) $(29,135) Earnings (loss) per share, basic and diluted $0.01 $(0.31) $(0.11) $(1.39) Weighted-average common shares outstanding, basic 40,195,856 22,293,735 32,745,708 20,919,118 Weighted-average common shares outstanding, diluted 40,206,186 22,293,735 32,745,708 20,919,118 TRACON Pharmaceuticals, Inc. Unaudited Condensed Consolidated Balance Sheets (in thousands) December 31, December 31, 2023 2022 Assets Current assets: Cash and cash equivalents $8,564 $17,433 Prepaid and other assets 526 795 Total current assets 9,090 18,228 Property and equipment, net 37 51 Restricted Cash 73 67 Other assets 905 1,123 Total assets $10,105 $19,469 Liabilities and Stockholders’ Deficit Current liabilities: Accounts payable and accrued expenses $9,755 $11,107 Accrued compensation and related expenses 427 1,457 Long-term debt, current portion — 9,807 Total current liabilities 10,182 22,371 Other long-term liabilities 732 969 Arbitration financing payable — 3,280 Commitments and contingencies Stockholders’ deficit: Common stock 44 23 Additional paid-in capital 239,646 229,737 Accumulated deficit (240,499) (236,911) Total stockholders’ deficit (809) (7,151) Total liabilities and stockholders’ deficit $10,105 $19,469 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

Glenmark will be responsible for further developing, registering, and commercializing Envafolimab in India, Asia Pacific, Middle East and Africa, Russia, CIS, and Latin America. Jiangsu Alphamab and 3D Medicines will receive a low double digit Million US Dollar amount up to launch, additional triple digit Million US Dollar milestone payments based on sales performance across the length of the agreement, and a royalty fee of single-to-double-digits percentage according to the level of net sales. Jiangsu Alphamab will be responsible of manufacturing KN035 within and outside the Territory. 3D Medicines retains the right to develop and commercialize Envafolimab for any purpose outside the Territory. MUMBAI, India, Jan. 25, 2024 /PRNewswire/ -- Glenmark Specialty S.A. (GSSA), a subsidiary of Glenmark Pharmaceuticals Ltd. (Glenmark), today announced the signing of a license agreement with JIANGSU ALPHAMAB BIOPHARMACEUTICALS CO., LTD (Jiangsu Alphamab) and 3D MEDICINES INC. (3D Medicines), (together as the Licensors), for KN035 (Envafolimab) for India, Asia Pacific (except Singapore, Thailand, Malaysia), Middle East and Africa, Russia, CIS, and Latin America (the Territory). Under the terms of the agreement, GSSA will receive from Jiangsu Alphamab and 3D Medicines, an exclusive license to develop, register, commercialize, Envafolimab for the oncology indication in the Territory. Jiangsu Alphamab will be the exclusive supplier of the product. 3D Medicines retains the right to develop and commercialize Envafolimab for any purpose outside the Territory. The Licensors will receive a low double digit Million US Dollar amount up to launch, additional triple digit Million US Dollar milestone payments based on sales performance across the length of the agreement, and a royalty fee of single-to-double-digits percentage according to the level of net sales. The Licensors' respective entitlement to the payments (including the upfront payment, milestone payment and the royalty fees) under the License Agreement are subject to the agreements between 3D Medicines and Jiangsu Alphamab. "This is an important milestone for Glenmark, as through this transformational deal, we gain access to the first recombinant humanized single domain antibody against PD-L1 in a subcutaneous formulation for a wide territory globally. We are excited at the opportunity to take this innovative immuno-oncology product to cancer patients across the emerging markets and meaningfully contribute towards improving their access to potentially life-saving treatments," remarked Glenn Saldanha, Chairman & Managing Director, Glenmark Pharmaceuticals Ltd. Envafolimab, under the brand name ENWEIDA (恩維達®) has been approved in China by the National Medical Products Administration (Chinese NMPA) in November 2021 as the global-first subcutaneous injection PD-L1 inhibitor for the treatment of adult patients with previously treated microsatellite instability-high (MSI-H) or deficient MisMatch repair (dMMR) advanced solid tumor. Over 30,000 patients in China have already greatly benefited from this innovative treatment where, in December 2023, it has also been officially included in the 'List of Breakthrough Therapies' by the NMPA*. Overall, dMMR prevalence across 13 tumor types (based on 54 papers and 20,383 patients) was estimated at 16% (11%–22%)**, which makes it quite a widespread genetic signature among cancer patients. Envafolimab has the potential to provide an effective treatment for this population across Emerging Markets and beyond. Furthermore, Envafolimab is currently being developed in the USA by Tracon Pharma in a pivotal trial in soft tissue sarcoma (STS) subtypes including, Undifferentiated Pleomorphic Sarcoma (UPS) and the genetically related myxofibrosarcoma (MFS). Envafolimab has obtained two orphan drug designation from the U.S. FDA for advanced biliary tract cancer and soft tissue sarcoma (STS), and a Fast Track designation for STS. Additional indications such as biliary tract cancer and non-small cell lung cancer are currently in development. References: * Data on file **Epidemiology of Microsatellite Instability High (MSI-H) and Deficient Mismatch Repair (dMMR) in Solid Tumors: A Structured Literature Review (Maria Lorenzi et al.) Logo: SOURCE Glenmark Pharmaceuticals Ltd

FDA provides "Study May Proceed" letter for open-label, randomized phase 3 protocol in soft tissue sarcoma, and plans to initiate phase 3 study in first half of 2024 SHELTON, Conn., Jan. 3, 2024 /PRNewswire/ -- Intensity Therapeutics, Inc. ("Intensity" or the "Company") (Nasdaq: INTS), a late-stage clinical biotechnology company focused on the discovery and development of proprietary, novel immune-based intratumoral cancer therapies designed to kill tumors and increase immune system recognition of cancers, today announced a business update reflecting progress in its phase 3 sarcoma clinical program. IND Submission for Phase 3 In the fourth quarter of 2023, the Company submitted a new Investigational New Drug ("IND") to the Food and Drug Administration ("FDA"). The submission included the phase 3 protocol for a superiority trial of the Company's lead product INT230-6 used as monotherapy compared to the standard of care drugs in 2nd and 3rd line treatment for certain soft tissue sarcoma subtypes. The FDA provided the Company a "Study May Proceed" letter for phase 3 within the 30 day period following the IND submission. The study is an open-label, randomized phase 3 trial expected to enroll 333 patients. For every three patients enrolled, two will receive INT230-6 and one will receive standard of care drug(s) chosen by the investigators depending on the type of sarcoma. The Company is working with its contracted vendors to initiate the phase 3 trial in the first half of 2024. Manufacturing In the fourth quarter of 2023, the Company successfully developed the phase 3 quality analytical methods for measurement of the key INT230-6 components, validated those methods and manufactured a clinical batch of the drug product that met specifications. During the fourth quarter, the Company requested and was granted a meeting that was held with the FDA to review the INT230-6 chemical manufacturing and controls ("CMC") for INT230-6. The CMC discussion focused on the tasks necessary to initiate the phase 3 study and future product registration as part of a potential New Drug Application (NDA). During the meeting, the Company and FDA agreed upon a plan for the CMC set of activities for the active pharmaceutical ingredients and the drug product (INT230-6) necessary for the NDA. "The FDA's 'Study May Proceed' letter is another important milestone towards achieving our mission to develop a new, safer, and more effective way to treat cancer patients especially in the difficult to treat types such as sarcoma. A head-to-head comparison of INT230-6 as monotherapy locally delivered in metastatic sarcoma against the active, systemically-delivered standard-of-care drugs may be a first-of-its kind clinical trial," said Lewis H. Bender, President and Chief Executive Officer of Intensity. "Current standard-of-care drugs used for sarcoma after progression of the first line therapies require extensive safety monitoring. The standard of care drugs cause severe toxicities and provide median overall survival of only between 12 and 15 months depending on the drug and sarcoma subtype used. New and more effective ways to treat these patients are desperately needed." In November of 2023 at the annual Connective Tissue Oncology meeting held in Dublin, Christian Frederick Meyer, M.D., Ph.D., M.S., an Assistant Professor of Oncology at the Sidney Kimmel Cancer Center at Johns Hopkins University and an investigator for Intensity's Phase 1/2 clinical trial of INT230-6, presented that when compared to a synthetic control1, INT230-6 alone extended survival in refractory soft tissue sarcoma subjects by approximately 14.9 months. Dosing higher amounts of INT230-6 relative to a patient's presenting total tumor burden showed a potential further increase in survival when compared to the synthetic control. Median survival of the synthetic control for subjects failing a median of 3 lines of prior therapy was about 6.8 months. Median overall survival of INT230-6 monotherapy (n=15) was 21.5 months. The INT230-6 Disease Control Rate2 was 93% in subjects who received at least one dose of INT230-6 as monotherapy. Data on INT230-6 generated in metastatic patients indicated that INT230-6 has a favorable safety profile and is well tolerated with the majority of treatment-emergent adverse events (TEAEs) being grade 1 or 2 primarily localized pain, fatigue, and nausea. In September of 2023 the Company announced that the US FDA's Office of Orphan Products Development granted orphan-drug designation for the treatment of soft tissue sarcoma (STS) to the three active moieties comprising INT230-6, cisplatin, vinblastine sulfate, and the diffusion enhancer SHAO-FA (8-((2-hydroxybenzoyl) amino) octanoate). About Soft Tissue Sarcoma Soft tissue sarcoma is a broad term for cancers that start in soft tissues (muscle, tendons, fat, lymph and blood vessels, and nerves). These cancers can develop anywhere in the body but are found mostly in the arms, legs, chest, and abdomen. There are many types of sarcoma; however, the four most common are bone sarcoma (referred to as osteosarcoma), leiomyosarcoma, undifferentiated pleomorphic sarcoma (UPS) and liposarcoma. When sarcoma is metastatic prognosis is poor, even with chemotherapy. Each year, 12,000 people in the U.S. and 1,150 in Canada are diagnosed with soft tissue sarcomas. About 3,000 patients have bone sarcomas . About INT230-6 INT230-6, Intensity's lead proprietary investigational product candidate, is designed for direct intratumoral injection. INT230-6 was discovered using Intensity's proprietary DfuseRx℠ technology platform. The drug is composed of two proven, potent anti-cancer agents, cisplatin and vinblastine sulfate, and a penetration enhancer molecule (SHAO) that helps disperse potent cytotoxic drugs throughout tumors for diffusion into cancer cells. These agents remain in the tumor resulting in a favorable safety profile. In addition to local disease control i.e. direct killing of the tumor by INT230-6, the dying tumor releases a bolus of neoantigens specific to the patient's malignancy, leading to engagement of the immune system and systemic anti-tumor effects. Importantly, these effects are mediated without immunosuppression that so often occurs with systemically delivered chemotherapy. About Intensity Therapeutics Intensity Therapeutics is a late-stage clinical biotechnology company that applies novel engineered chemistry to turn "cold" tumors "hot" by enabling its aqueous cytotoxic-containing drug product, INT230-6, to mix and saturate the dense, high-fat pressurized environment of the tumor. As a result of the saturation, Intensity's clinical trials have demonstrated the ability of INT230-6 to kill tumors and elicit an adaptive immune response within days of injection, representing a truly novel approach to cancer cell death that holds the potential to shift the treatment paradigm and turn many deadly cancers into chronic diseases. For more information about the Company, including publications, papers and posters about its novel approach to cancer therapeutics, visit . INT230-6 has completed enrollment of over 200 patients in two phase 2 and phase 1 dose escalation clinical trials (NCT03058289 and NCT04781725) with various advanced solid tumors; IT-01 in metastatic disease, and IT-02 (the INVINCIBLE study) in presurgical breast cancer. The Company partnered with Merck Sharpe & Dohme (Merck) to evaluate the combination of INT230-6, Intensity's lead product candidate, and KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 (programmed death receptor-1) therapy, in patients with advanced malignancies. The Company also partnered with Bristol-Myers Squibb to evaluate the combination of INT230-6 with Bristol-Myers Squibb's anti-CTLA-4 antibody, ipilimumab, in patients with advanced cancers. The Company also executed agreements with the Ottawa Hospital Research Institute (OHRI) and the Ontario Institute of Cancer Research (OICR) to study INT230-6 in the INVINCIBLE study, a randomized controlled neoadjuvant phase 2 study in women with early-stage breast cancer. Forward-Looking Statements Certain statements in this press release may constitute "forward-looking statements" within the meaning of the United States Private Securities Litigation Reform Act of 1995, as amended to date. These statements include, but are not limited to, statements relating to the expected future plans, development activities, projected milestones, business activities or results. We have based these forward-looking statements on our current expectations and projections about future events, nevertheless, actual results or events could differ materially from the plans, intentions and expectations disclosed in, or implied by, the forward-looking statements we make. These risks and uncertainties, many of which are beyond our control, include: the risk that the anticipated milestones may be delayed or not occur or be changed, as well as other risks described in the section entitled "Risk Factors" in the Company's SEC filings, which can be obtained on the SEC website at . Readers are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date on which they are made and reflect management's current estimates, projections, expectations and beliefs. The Company does not plan to update any such forward-looking statements and expressly disclaims any duty to update the information contained in this press release except as required by law. Investor Relations Contact: Argot Partners Jonathan Nugent [email protected] 205-566-3026 Media Contact: Argot Partners David Rosen [email protected] 212-600-1902 1 A synthetic control is a construction of a weighted combination of reported data to which the treatment group is compared. This comparison is used to estimate what would have happened to the treatment group if it had not received the treatment. The synthetic control developed to predict survival of the enrolled IT-01 sarcoma population was based on the presenting biomarker data and used the Royal Marsden Hospital Index method for survival prediction. 2 The disease control rate measures the percentage of patients with advanced or metastatic cancer who have achieved had stable disease, partial response or complete response while on a therapy. SOURCE Intensity Therapeutics Inc.