Refractory Soft Tissue Sarcoma

INT230-6, Intensity's lead drug candidate, advances into late-stage clinical programs in sarcoma and breast cancer Year-end cash and investments of $14.8 million expected to fund operations through the end of Q1 '25 Focusing on clinical operational and regulatory progress for a new technology to treat cancer Multiple clinical opportunities in cancer types having high unmet medical need Upcoming clinical milestones SHELTON, Conn., March 14, 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, announces full year 2023 financial results and provides a review of 2023 accomplishments and anticipated upcoming developments. 2023 and Other Recent Highlights Study May Proceed letter received from the U.S. Food and Drug Administration ("FDA") for the Company's Phase 3 protocol in soft tissue sarcoma using INT230-6 (the "INVINCIBLE-3" study) Completed IT-01 study, a 110-patient Phase 1/2 study using INT230-6 in refractory cancers Dosing completed in over 20 different cancers, with favorable safety and strong signals of efficacy shown with immune activation Completed dosing, database lock and tables, listings and figures for a 91-patient Phase 2 study using INT230-6 in pre-adjuvant breast cancer (the "INVINCIBLE-2" study) Presented INVINCIBLE-2 data at the San Antonio Breast Cancer Symposium ("SABCS") in an oral podium spotlight discussion session INT230-6 induced up to 95% necrosis in tumors following a single injection Favorable safety profile observed Increase in CD4 T-cells and NK cells observed within tumors Data presented at Connective Tissue Oncology Society ("CTOS") Annual Meeting showing INT230-6 extended survival in refractory soft tissue sarcoma subjects by 15 months compared to a synthetic control group with a 93% disease control rate when used as monotherapy Received Orphan Drug Designation for the three key ingredients in INT230-6 for the treatment of soft tissue sarcoma Presented two posters at the American Society of Clinical Oncology ("ASCO") Annual Meeting reporting anti-cancer immune activation in both breast cancer and sarcoma, which are cancers that are considered to be non-immunogenic Closed an up-sized initial public offering on the Nasdaq exchange with a full exercise of the underwriters' over-allotment option at the top of the range, raising over $22 million in gross proceeds Bolstered management team by adding Chief Financial Officer, Vice President of Clinical Operations, Vice President of Regulatory Affairs and manufacturing engineering staff "We had a pivotal year in 2023 culminating with the receipt of an FDA 'Study May Proceed' letter to enter into Phase 3 clinical trials for our lead drug candidate, INT230-6 for metastatic soft tissue sarcoma," said Lewis H. Bender, Founder, President and Chief Executive Officer. "Our selection this year by the review committees at ASCO, CTOS and SABCS, including oral podium presentations, validated our science and indicated interest by oncologists in our results. We are on track to initiate our Phase 3 sarcoma study in mid-2024. Following our IPO, our cash position remains strong, and we believe we have sufficient runway to meet near term milestones." In the INVINCIBLE-3 study, the Company plans to enroll 333 patients with an endpoint of overall survival. "Current U.S. standard-of-care drugs used for sarcoma after progression of the first line therapies require extensive safety monitoring. The standard-of-care ("SOC") medicines cause severe toxicities and provide median overall survival of only between 12 to 15 months depending on the drug and sarcoma subtype," stated Mr. Bender. "Our data suggests the potential for a significant survival increase with fewer and less severe toxicities. Sarcoma patients are in need of new and meaningful ways to treat their disease. A successful outcome of our Phase 3 survival study could be critical in treatment of other fatty, dense tumor types such as breast and pancreatic cancers." The Company also plans to initiate a Phase 2/3 program in presurgical breast cancer with the start of a Phase 2 randomized controlled trial testing two doses of INT230-6 prior to SOC compared to the SOC alone (the "INVINCIBLE-4" study). The endpoint for this portion of the study is the change in the pathological complete response rate for the combination, which is an accepted FDA endpoint for accelerated approval. The Company expects to initiate INVINCIBLE-4 in mid-2024, which will provide data to size the Phase 3 portion of the program. As Dr. Angel Arnout M.D., MSc., and the Principal Investigator from the INVINCIBLE-2 study stated in San Antonio, "the ability for INT230-6 to induce necrosis and noted immune effects prior to a patient's surgery, while maintaining a favorable safety profile, would be a major move forward for the treatment paradigm of breast cancer and potentially many other cancers." The Company will provide further updates on the progress of this study in the coming months. Anticipated Near-Term Milestones Initiate INVINCIBLE-3 Study in certain metastatic soft tissue sarcoma subtypes. The Company plans to enroll 333 patients with an endpoint of overall survival. The study will compare INT230-6 as a monotherapy treatment to the three current SOC drugs in 2nd and 3rd line soft tissue sarcoma subtypes. Initiate the Phase 2/3 program in presurgical breast cancer with the start of INVINCIBLE-4, a Phase 2 randomized controlled trial testing two doses of INT230-6 prior to SOC (immune-chemotherapy) compared to the SOC alone. The endpoint for this portion of the study is the change in the pathological complete response rate for the combination. The Company expects to initiate INVINCIBLE-4 in mid-2024, which will provide data to size the Phase 3 portion of the program. Year-End 2023 Financial Results Research and development expenses were $4.8 million for the year ended December 31, 2023, compared to $5.1 million for the same period in 2022. The decrease was primarily due to the completion of enrollment in the IT-01 study in mid-2022. This decrease was partially offset by higher 2023 expenses for start-up work on the INVINCIBLE-3 study and a new manufacturing batch of INT230-6. General and administrative expenses were $3.5 million for the year ended December 31, 2023, compared to $2.4 million for the same period in 2022. The increase was primarily due to salary and bonus increases, including the hiring of a new chief financial officer in the fourth quarter of 2023, higher stock-based compensation expense, and overall higher accounting fees, consulting, directors and officers insurance and other expenses as we transitioned into a publicly traded company. In 2023, the Company also recognized a non-cash $2.3 million loss on debt conversion at the time of the initial public offering, along with a non-cash preferred stock deemed dividend of $1.3 million, representing the value that was transferred to the Series B and C preferred stockholders upon triggering of anti-dilution provisions. Overall, net loss was $10.5 million for the year ended December 31, 2023, compared to $7.6 million for the year ended December 31, 2022. As of December 31, 2023, cash, cash equivalents and marketable debt securities totaled $14.8 million, which the Company expects will be sufficient to fund operations through the end of the first quarter in 2025. 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, 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, direct killing of the tumor by INT230-6 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 systemic 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 novel approach to cancer cell death that holds the potential to shift the treatment paradigm and turn many deadly cancers into chronic diseases. INT230-6 has completed enrollment of over 200 patients in a Phase 1/2 dose escalation trial (NCT03058289) and Phase 2 randomized control clinical trial in breast cancer (the INVINCIBLE 2 study) (NCT04781725). The Company is initiating a Phase 3 trial in soft tissue sarcoma (the INVINCIBLE 3 study) (NCT06263231), testing INT230-6 as second or third line monotherapy compared to the standard of care with overall survival as an endpoint. The Company is also planning a Phase 2/3 program in presurgical triple negative breast cancer testing INT230-6 in combination with standard of care compared to standard of care alone. For more information about the Company, including publications, papers and posters about its novel approach to cancer therapeutics, visit . 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: Justin Kulik [email protected] CORE IR (516) 222-2560 Media Contact: Jules Abraham CORE IR [email protected] SOURCE Intensity Therapeutics Inc.

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.

Objective Response Rate by investigator review increased to 15% since interim analysis in September Full ENVASARC enrollment expected in 1Q 2024 and final data anticipated during 3Q 2024 SAN DIEGO, Dec. 20, 2023 (GLOBE NEWSWIRE) -- TRACON Pharmaceuticals (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 that the ongoing pivotal Phase 2 ENVASARC trial has enrolled more than 70 of the 80 planned patients in Cohort C of single agent envafolimab treatment at a dose of 600 mg subQ every three weeks. Additional safety and efficacy data were reviewed for 46 patients enrolled into cohort C who were the subject of the September independent data monitoring committee (IDMC) review. At that time, patients had completed a minimum of 12 weeks of efficacy evaluations and the objective response rate (ORR) was 13% by investigator review and 8.7% by blinded independent central review (BICR). Since then, an additional patient has achieved an objective response by investigator review, which increased the ORR by investigator review to 15%. The most recent objective response has not yet been confirmed by BICR and the patient remains on treatment. Median duration of response by BICR remains greater than six months. In addition, envafolimab remains well tolerated and grade > 3 related toxicity has not been reported to date. “We continue to believe that these data position envafolimab to become a potentially compelling treatment option for patients with the refractory sarcoma subtypes of UPS and MFS based on the ORR and tolerability data to date,” said Charles Theuer, M.D., Ph.D., TRACON’s Chief Executive Officer. “ENVASARC enrollment continues to be brisk, reflecting the high unmet need that exists for these patients.” Updated safety and efficacy data are expected in 1Q 2024, including in the more than 20 patients enrolled following the September IDMC review who will have had a minimum of 12 weeks of efficacy evaluations (two CT scans) at that time. The primary endpoint of the ENVASARC study is achievement of an ORR in nine of 80 patients (11.25%) treated with envafolimab by BICR and median duration of response of greater than six months is a key secondary endpoint. 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 (FDA) for envafolimab for patients with soft tissue sarcoma and fast track designation from the FDA 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 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. ENVASARC is enrolling patients with UPS or MFS who have progressed following one or two lines of prior treatment and have not received an immune checkpoint inhibitor. In Cohort C, 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 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 expectations for the timing and scope of its ENVASARC Phase 2 pivotal trial as well as TRACON’s expectation for achievement of expected endpoints and goals, the availability and expected results of clinical data and the timing of future reviews of data by BICR, continued timely accrual in the ENVASARC Phase 2 pivotal trial, and the potential for envafolimab to become a treatment option. 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 pharmaceutical product candidates, including that the ENVASARC Phase 2 pivotal trial may not achieve its primary and secondary endpoints; risks relating to cost variability of clinical trials; whether other therapies are developed and compete with TRACON’s product candidates; whether TRACON or others will be able to complete (including the ENVASARC Phase 2 pivotal trial) or initiate clinical trials on TRACON’s expected timelines, if at all, including due to risks associated with clinical, macroeconomic and geopolitical events; the fact that future clinical results may not be consistent with preliminary results or results from prior studies; the fact that TRACON has limited control over whether or when third party collaborators complete on-going trials, initiate additional trials or seek regulatory approval 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 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