Soft Tissue Neoplasms

Dose escalation ongoing in four clinical-stage precision oncology programs; TNG908 phase 1/2 clinical data expected in 2024 First patient dosed in phase 1/2 clinical trial of TNG348 in patients with BRCA1/2-mutant and other HRD+ cancers FDA Orphan Drug Designation granted for TNG462 for the treatment of soft tissue sarcomas Strong cash position of $337 million as of December 31, 2023, combined with $42 million in proceeds from ATM in January 2024; cash runway into late 2026 expected to fund all clinical programs through proof-of-concept BOSTON--(BUSINESS WIRE)-- Tango Therapeutics, Inc. (NASDAQ: TNGX), a clinical-stage biotechnology company committed to discovering and delivering the next generation of precision cancer medicines, reported its financial results for the fourth quarter and full year ended December 31, 2023, and provided business highlights. “In 2023, we made meaningful progress developing precision oncology treatments and now have four ongoing phase 1/2 clinical trials. These treatments have the potential to reach people with a wide range of cancers, including those with MTAP-deleted solid tumors, STK11 loss-of-function mutations, BRCA 1/2 mutations and other DNA damage repair defects. To support the advancement of our broad clinical portfolio, we expanded our management team, adding members with expertise in regulatory affairs and clinical development,” said Barbara Weber, M.D., President and Chief Executive Officer of Tango Therapeutics. “We are off to a strong start in 2024, marked by dosing the first patient in the phase 1/2 clinical trial for TNG348, receiving Orphan Drug Designation from the U.S. FDA for TNG462 and strengthening our cash position. We remain on track to provide TNG908 clinical data this year." Recent Business Highlights Pipeline Update TNG908 phase 1 dose escalation ongoing Dose escalation and patient enrollment is ongoing in the phase 1/2 clinical trial evaluating TNG908, an MTA-cooperative PRMT5 inhibitor, in patients with MTAP-deleted solid tumors, including glioblastoma (GBM). To date, the safety, tolerability and pharmacokinetics profiles are favorable. MTAP deletions occur in approximately 10%-15% of all human cancers, including 40% of GBM. TNG462, a potentially best-in-class MTA-cooperative PRMT5 inhibitor The U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) to TNG462 in December 2023 for the treatment of soft tissue sarcomas. ODD is granted to investigational therapies addressing rare medical diseases or conditions that affect fewer than 200,000 people in the United States. This designation provides for a seven-year marketing exclusivity period upon regulatory approval, as well as certain incentives, including federal grants and tax credits. Dose escalation is ongoing in the TNG462 phase 1/2 clinical trial in patients with MTAP-deleted solid tumors except GBM, as TNG462 is not brain penetrant in preclinical models. To date, the preliminary safety, tolerability and pharmacokinetics profiles are favorable. TNG462 has the same mechanism of action as TNG908, but with enhanced potency and selectivity in MTAP-deleted cell lines and patient-derived xenografts. In preclinical studies, TNG462 is 45X selective for MTAP-deleted cancer cells versus normal cells and ~30X more potent than TNG908. TNG260, a first-in-class, highly selective CoREST complex inhibitor Dose escalation is ongoing in the TNG260 phase 1/2 clinical trial evaluating the safety, pharmacokinetics, pharmacodynamics and efficacy of TNG260 in combination with pembrolizumab in patients with locally advanced or metastatic solid tumors with an STK11 loss-of-function mutation. To date, the preliminary safety, tolerability and pharmacokinetics profiles are favorable. STK11 mutations occur in approximately 15% of NSCLC, 15% of cervical, 10% of carcinoma of unknown primary, 5% of breast and 3% of pancreatic cancers. TNG348, a novel USP1 inhibitor Dose escalation is ongoing in the TNG348 phase 1/2 clinical trial evaluating the safety, pharmacokinetics, pharmacodynamics and efficacy of TNG348 as a single agent and in combination with olaparib, a PARP inhibitor, in patients with BRCA1/2-mutant and other HRD+ (homologous recombination deficient) cancers. The first patient dosed was announced in January 2024. HRD+ cancers, including BRCA1/2 mutations, represent up to 50% of ovarian cancers, 25% of breast cancers, 10% of prostate cancers and 5% of pancreatic cancers. Upcoming Milestones Clinical data from the ongoing TNG908 phase 1/2 trial are expected in 2024. Scientific Presentations American Chemical Society (ACS) Spring 2024, March 17-21, 2024, New Orleans, LA In March 2024, an oral presentation of the discovery and preclinical characterization of TNG348 will be presented at the ACS Spring Meeting, supporting the further development and ongoing phase 1/2 clinical trial of TNG348 as a single agent and in combination with olaparib. American Association of Cancer Research (AACR) Annual Meeting, April 5-10, 2024, San Diego, CA In April 2024, seven posters will be presented highlighting preclinical data from the Company’s clinical-stage precision oncology pipeline and synthetic lethality discovery platform. Ayushi Patel, Ph.D. from NYU Langone Health will present a minisymposium based on a Tango-NYU collaboration to study TNG260 in STK11 mutant non-small cell lung cancer in preclinical models. Leadership Updates: December 2023 Drew Sansone, M.S., was appointed Chief Regulatory Officer. Mr. Sansone brings over 25 years of pharmaceutical regulatory experience to this newly created role. He oversees the Company’s Regulatory Affairs team. Most recently, Mr. Sansone served as Vice President and Head, Global Regulatory Affairs, Regulatory and Quality, North America at Ipsen Pharmaceuticals. Heather DiBenedetto, M.S., was appointed Chief Development Operations Officer. Ms. DiBenedetto joined Tango in July 2020 as Head of Development Operations. She has over 25 years of drug development experience, focused in oncology. Doug Barry, J.D., was appointed Chief Legal Officer. Mr. Barry, who joined Tango in July 2021 as General Counsel, will continue to oversee the Company’s Legal, Compliance, Corporate Governance and Public Reporting functions as a publicly traded entity. Mr. Barry has practiced law for more than 20 years. Financial Results As of December 31, 2023, the Company held $336.9 million in cash, cash equivalents and marketable securities. Combined with $41.7 million in net proceeds from shares sold under the Company’s at-the-market (ATM) stock offering program in January 2024, the Company believes it is sufficiently capitalized to fund operations into late 2026. Collaboration revenue was $5.4 million for the three months ended December 31, 2023, compared to $6.4 million for the same period in 2022, and $31.5 million for the twelve months ended December 31, 2023 compared to $24.9 million for the same period in 2022. The amount of research costs spent under the collaboration directly affects the collaboration revenue that is recorded in the period. License revenue was $0.0 and $5.0 million for the three and twelve months ended December 31, 2023, respectively, compared to $0.0 for both the three and twelve months ended December 31, 2022. The increase is the result of out-licensing a program to Gilead for $5.0 million during the second quarter of 2023. Research and development expenses were $31.3 million for the three months ended December 31, 2023, compared to $29.1 million for the same period in 2022, and $115.2 million for the twelve months ended December 31, 2023 compared to $105.9 million for the same period in 2022. The change is primarily due to increased personnel-related costs to support our research and development activities. General and administrative expenses were $9.1 million for the three months ended December 31, 2023, compared to $7.9 million for the same period in 2022, and $35.5 million for the twelve months ended December 31, 2023 compared to $30.0 million for the same period in 2022. The change was primarily due to increases in personnel-related costs. Net loss for the three months ended December 31, 2023 was $30.8 million, or $0.32 per share, compared to a net loss of $29.1 million, or $0.33 per share, in the same period in 2022. Net loss for the twelve months ended December 31, 2023 was $101.7 million, or $1.08 per share, compared to a net loss of $108.2 million, or $1.23 per share, in the same period in 2022. About Tango Therapeutics Tango Therapeutics is a clinical-stage biotechnology company dedicated to discovering novel drug targets and delivering the next generation of precision medicine for the treatment of cancer. Using an approach that starts and ends with patients, Tango leverages the genetic principle of synthetic lethality to discover and develop therapies that take aim at critical targets in cancer. This includes expanding the universe of precision oncology targets into novel areas such as tumor suppressor gene loss and their contribution to the ability of cancer cells to evade immune cell killing. For more information, please visit . Forward-Looking Statements Certain statements in this press release may be considered forward-looking statements. Forward-looking statements generally relate to future events, Tango’s future operating performance and goals, the anticipated benefits of therapies and combination therapies (that include a Tango pipeline product), as well as the expectations, beliefs and development objectives for Tango’s product pipeline and clinical trials. In some cases, you can identify forward-looking statements by terminology such as “may”, “should”, “expect”, “intend”, “will”, “goal”, “estimate”, “anticipate”, “believe”, “predict”, “designed,” “potential” or “continue”, or the negatives of these terms or variations of them or similar terminology. For example, implicit or explicit statements concerning the following include or constitute forward-looking statements: dose escalation is ongoing in all four of Tango’s clinical trials; company is actively enrolling patients in the company’s clinical trials; the objectives and endpoints of each of the clinical trials that are ongoing; data from the TNG908 clinical trial is expected in 2024; cash runway will last into late 2026, such amount expected to fund all clinical programs through proof-of-concept (the company is capitalized to fund operations into late-2026); Tango is committed to discovering and delivering the next generation of precision cancer medicines; each of the company’s four clinical stage assets have the potential to reach people with a wide range of cancers, including those with MTAP-deleted solid tumors, STK11 loss-of-function mutations, and BRCA 1/2 mutations and other DNA damage repair defects; Tango is well-positioned to deliver proof-of-concept data on its four clinical programs; TNG462 is a potentially best-in-class MTA-cooperative PRMT5 inhibitor; certain pre-clinical data support the ongoing phase 1/2 clinical trial of TNG348 as a single agent and in combination with olaparib; Orphan Drug Designation (ODD) to TNG462 for the treatment of soft tissue sarcomas and potential benefits resulting from such designation; and the expected timing of: (i) development candidate declaration for certain targets, (ii) initiating IND-enabling studies; (iii) filing INDs; (iv) clinical trial initiation and (v) disclosing initial, interim, additional and final clinical trial results; and the expected benefits of the Company's development candidates and other product candidates. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Tango and its management, are inherently uncertain. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. Factors that may cause actual results to differ materially from current expectations include, but are not limited to: benefits of product candidates seen in preclinical analyses may not be evident when tested in later preclinical studies or in clinical trials or when used in broader patient populations (if approved for commercial sale); Tango has limited experience conducting clinical trials (and will rely on a third party to operate its clinical trials) and may not be able to commence the clinical trial (including opening clinical trial sites, dosing the first patient, and continued enrollment and dosing of an adequate number of clinical trial participants) when expected, may not be able to continue dosing (and dose escalation) on anticipated timelines, and may not generate results (including final, initial or additional safety, efficacy data and proof-of-mechanism and proof-of-concept) in the anticipated timeframe (or at all); Tango’s pipeline products may not be safe and/or effective in humans; Tango has a limited operating history and has not generated any revenue to date from product sales, and may never become profitable; other companies may be able to identify and develop product candidates more quickly than the Company and commercially introduce the product prior to the Company; the Company’s proprietary discovery platform is novel and may not identify any synthetic lethal targets for future development; the Company may not be able to identify development candidates on the schedule it anticipates due to technical, financial or other reasons; the Company may not be able to for development candidates on time, or at all, due to technical or financial reasons or otherwise; the Company may utilize cash resources more quickly than anticipated; Tango will need to raise capital in the future and if we are unable to raise capital when needed or on attractive terms, we would be forced to delay, scale back or discontinue some of our development programs or future commercialization efforts (which may delay filing of INDs, dosing patients, reporting clinical trial results and filing new drug applications); Tango’s approach to the discovery and development of product candidates is novel and unproven, which makes it difficult to predict the time, cost of development, and likelihood of successfully developing any products; the Company may be unable to advance our preclinical development programs into and through the clinic for safety or efficacy reasons or commercialize our product candidates or we may experience significant delays in doing so as a result of factors beyond Tango’s control; the Company may not be able to realize the benefits of ODD or Fast Track designation (and such designations may not advance any anticipated approval timelines); Tango may not identify or discover additional product candidates or may expend limited resources to pursue a particular product candidate or indication and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success; the Company’s product candidates may cause adverse or other undesirable side effects (or may not show requisite efficacy) that could, among other things, delay or prevent regulatory approval; our dependence on third parties for conducting clinical trials and producing drug substance and drug product; and our ability to obtain and maintain patent and other intellectual property protection for our technology and product candidates or the scope of intellectual property protection obtained is not sufficiently broad. Additional information concerning risks, uncertainties and assumptions can be found in Tango’s filings with the SEC, including the risk factors referenced in Tango’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022, as supplemented and/or modified by its most recent Quarterly Report on Form 10-Q. You should not place undue reliance on forward-looking statements in this press release, which speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein. Tango specifically disclaims any duty to update these forward-looking statements. 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 Collaboration revenue $ 5,431 $ 6,411 $ 31,527 $ 24,860 License revenue — — 5,000 — Total revenue 5,431 6,411 36,527 24,860 Operating expenses: Research and development 31,339 29,091 115,198 105,906 General and administrative 9,105 7,887 35,502 30,025 Total operating expenses 40,444 36,978 150,700 135,931 Loss from operations (35,013 ) (30,567 ) (114,173 ) (111,071 ) Other income, net 4,297 1,558 12,563 2,949 Loss before income taxes (30,716 ) (29,009 ) (101,610 ) (108,122 ) Provision for income taxes (47 ) (51 ) (134 ) (54 ) Net loss $ (30,763 ) $ (29,060 ) $ (101,744 ) $ (108,176 ) Net loss per common share – basic and diluted $ (0.32 ) $ (0.33 ) $ (1.08 ) $ (1.23 ) Weighted average number of common shares outstanding – basic and diluted 97,223,183 87,971,485 94,572,448 87,820,037 Consolidated Balance Sheets (In thousands) December 31, 2023 2022 Assets Current assets: Cash and cash equivalents $ 66,385 $ 59,968 Marketable securities 270,500 306,165 Accounts receivable — 2,000 Restricted cash 856 567 Prepaid expenses and other current assets 8,797 6,572 Total current assets 346,538 375,272 Property and equipment, net 9,908 10,884 Operating lease right-of-use assets 43,508 46,886 Restricted cash, net of current portion 2,567 3,423 Other assets 46 5 Total assets $ 402,567 $ 436,470 Liabilities and Stockholders' Equity Current liabilities: Accounts payable $ 2,785 $ 4,453 Accrued expenses and other current liabilities 15,401 17,495 Operating lease liabilities 2,082 1,770 Deferred revenue 25,670 31,792 Income tax payable — 35 Total current liabilities 45,938 55,545 Operating lease liabilities, net of current portion 36,838 39,361 Deferred revenue, net of current portion 66,683 92,088 Total liabilities 149,459 186,994 Total stockholders’ equity 253,108 249,476 Total liabilities and stockholders’ equity $ 402,567 $ 436,470 View source version on businesswire.com: Contacts Investor Contact: Sam Martin/Andrew Vulis Argot Partners tango@argotpartners.com Source: Tango Therapeutics, Inc. 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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.

SHELTON, Conn., March 14, 2024 /PRNewswire/ -- Intensity Therapeutics, Inc. (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 that Lewis H. Bender, Founder, President and Chief Executive Officer, will participate in a fireside chat with Roth Managing Director and Senior Analyst, Jonathan Aschoff, Ph.D. at the 36th Annual Roth Conference in Orange County, CA on Tuesday, March 19, at 12:30PM PDT at the Ritz Carlton in Laguana Nigel, CA in the Healthcare Suite 2022. A live webcast of the presentation will be available on the "Events" section of Intensity's website at: An archived replay will be available on the company's website for a period of 90 days after the conference. Mr. Bender will be available for one-on-one meetings during the conference. To schedule a one-on-one meeting, please contact your Roth representative or Justin Kulik at [email protected]. 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 INVINCIBLE3 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] (585) 230 6401 Media Contact: Jules Abraham CORE IR [email protected] SOURCE Intensity Therapeutics Inc.