RCOR1

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, 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 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, Assets Current assets: Cash and cash equivalents 66,385 59,968 Marketable securities 270,500 306,165 Accounts receivable 2,000 Restricted cash 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 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 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 [email protected] Source: Tango Therapeutics, Inc. 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BOSTON, March 05, 2024 (GLOBE NEWSWIRE) -- Tango Therapeutics, Inc. (NASDAQ: TNGX), a clinical-stage biotechnology company committed to discovering and delivering the next generation of precision cancer medicines, today announced that one abstract has been selected for an oral minisymposium and seven abstracts have been accepted as poster presentations at the American Association for Cancer Research (AACR) Annual Meeting 2024, taking place April 5-10, 2024, in San Diego, California. Abstract accepted for oral minisymposium Title: TNG260, a small molecule CoREST inhibitor, sensitizes STK11-mutant NSCLC to anti-PD1 immunotherapyAbstract #: 3916Session Title: Immune Targets and Therapies Presenter: Ayushi Patel, Ph.D., NYU Langone Health Date and Time: Monday April 8, 2024, 2:30 – 4:30 p.m. PT Abstracts accepted for poster presentation Title: Genome-wide drug anchor screens identify CAAP1 and AKAP17A as regulators of PRMT5 inhibitor sensitivityAbstract #: 4636Presenter: Satoshi Yoda, M.D., Ph.D., Principal Scientist, Tango TherapeuticsDate and Time: April 9, 2024, 9:00 a.m. – 12:30 p.m. PT Title: Evaluation of the impact of homozygous MTAP truncations on the activity and selectivity of MTA-cooperative PRMT5 inhibitorsAbstract #: 4631Presenter: Kimberly Briggs, Ph.D., Director, Tango TherapeuticsDate and Time: April 9, 2024, 9:00 a.m. – 12:30 p.m. PT Title: TNG348 is synergistic with PARP inhibitors in tumor models with elevated replication stressAbstract #: 4527Presenter: Antoine Simoneau, Ph.D., Senior Scientist, Tango TherapeuticsDate and Time: April 9, 2024, 9:00 a.m. – 12:30 p.m. PT Title: TNG917 is a clinical-grade, potent and selective inhibitor of EHMT1/2 for the treatment of immune cold tumorsAbstract #: 3242Presenter: Yingnan Chen, Ph.D., Senior Director, Tango TherapeuticsDate and Time: April 8, 2024, 1:30 – 5:00 p.m. PT Title: Experimental ‘loss-of function’ annotation of STK11 mutations with prognostic and therapeutic implicationsAbstract #: 5584Presenters: Silvia Fenoglio, Ph.D., Principal Scientist, Tango Therapeutics and Brian Haines, Ph.D., Vice President, Tango Therapeutics Date and Time: April 9, 2024, 1:30 – 5:00 p.m. PT Title: LIG1 inactivation selectively inhibits growth of BRCA1 mutant cells in vitro and in vivoAbstract #: 3363Presenter: Hilary Nicholson, Ph.D., Principal Scientist, Tango TherapeuticsDate and Time: April 8, 2024, 1:30 – 5:00 p.m. PT Title: Stearoyl-CoA desaturase is a synthetic lethal target in SMAD4-deficient cancersAbstract #: 558Presenter: Alvin Lu, Ph.D., Principal Scientist, Tango TherapeuticsDate and Time: April 7, 2024, 1:30 – 5:00 p.m. PT 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 www.tangotx.com. 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), 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”, “committed” “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: the Company is committed to discovering and delivering the next generation of precision cancer medicines; 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 preliminary, interim and final clinical trial results; the expected therapeutic impact of the Company’s pre-clinical compounds; and the expected benefits of the Company's pre-clinical programs, pre-clinical compounds, 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 pre-clinical 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 and enrolling and dosing an adequate number of clinical trial participants) when expected, may not be able to continue dose escalation on anticipated timelines, and may not generate results (including final or initial safety, efficacy data and proof-of-mechanism and proof-of-concept) in the anticipated timeframe (or at all); Tango’s pipeline products and pre-clinical 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 file INDs 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; 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 product; 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; and delays and other impacts on product development and clinical trials from the COVID-19 pandemic. 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 presentation, 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. Investor Contact:Sam Martin/Andrew VulisArgot [email protected] Media Contact:Amanda Brown GalgaySVP, Corporate Communications, Tango [email protected]

BEDMINSTER, N.J., Jan. 8, 2024 /PRNewswire/ -- Jubilant Therapeutics Inc., a clinical-stage biotechnology company pioneering the development of a first-in-class CoREST (Co-repressor of Repressor Element-1 Silencing Transcription) inhibitor JBI-802 with the dual activity on LSD1 and HDAC6, today announced preliminary safety, pharmacokinetic and initial efficacy results of the Phase I trial in advanced cancer patients. Furthermore, the study results provide a human proof of principle for expanding the development of JBI-802 in Essential Thrombocythemia (ET) and related Myeloproliferative Neoplasms (MPN/MDS) with thrombocytosis. The data from first 11 patients with advanced cancer revealed a dose-proportional increase in exposure across cohorts and a strong correlation between the exposure and the on-target effects of platelet decrease, indicating that pharmacological relevant level of LSD1 inhibition have been achieved. At the same time, platelet decrease is the only adverse event above grade 1 observed in these patients, which differentiates JBI-802 from LSD1-only inhibitors. Specifically, no AEs (Adverse Events) of anemia has been observed, which is potentially due to the positive benefit of inhibition of HDAC6 in erythrocytes. Also, there are no reports of Dysgeusia, an adverse event that has been observed with LSD1-only inhibitors. Among the 11 patients, two were NSCLC (Non-small Cell Lung Cancer) patients, both had progressed on doublet immunotherapy, nivolumab+ipilimumab as first line treatment and both showed anti-tumor activity. Both the patients were treated at lower dose level (10mg) where no relevant decrease of platelets is seen, suggesting that in patients with sensitive tumors this dose can be pharmacologically active with a desirable safety profile. Both NSCLC patients had failed first line treatment with doublet immunotherapy, nivoluman/ipilumab prior to enrolling in the JBI-802 study. The first patient had a STK11 mutation, known to decrease the effectiveness of immunotherapy, present in around 10% of NSCLC patients (higher frequency in lung adenocarcinoma). JBI-802 showed a confirmed partial response in this IO-refractory NSCLC patient with a 39% decrease in the target lung tumor mass. The tumor shrinkage outcome was accompanied by a complete resolution of pancoast syndrome (lung lesion affecting the nerves of brachial plexus). The response appears to be durable after nine cycles and the patient remains on JBI-802 therapy. The second patient had both lung lesion and liver metastasis, which are known to confer resistance to immunotherapy and lead to poor prognosis. Treatment with JBI-802 resulted in over 50% shrinkage of the patient's liver metastasis and a complete resolution of related portal hypertension, edema and improvement of quality of life. Dr. Alexander Starodub, The Christ Hospital - Cincinnati, treating physician for the above patients commented, "The anti-tumor activity seen in these two NSCLC patients is remarkable given the poor prognosis based on their genetic and metastatic pattern. The 10 mg dose of JBI-802 was well-tolerated without any clinically significant adverse effects and the initial clinical data suggest a good therapeutic index for JBI-802." Preclinical studies showed a synergistic anti-tumor effect by combining immunotherapy and JBI-802 in xenograft models. In addition, the CoREST inhibition was reported to sensitize immunotherapy resistant tumors, especially those with STK11 mutations. Taken together, the preliminary efficacy data from the JBI-802 Phase I study suggest the opportunity that a combination between immunotherapy and JBI-802 could bring a new therapy option to such patient populations with limited treatment options. In addition, the on-target dose/exposure-proportional decrease in platelet constitute a proof-of-principle that JBI-802 can be an active compound in hematological malignancies like Essential Thrombocythemia (ET) and other MPN/ MDS characterized by thrombocytosis. A follow up Phase I/II study in MPN/ET and MPN/MDS with thrombocytosis is being planned for early next year to investigate JBI-802 as potential novel treatment option. About Jubilant Therapeutics Inc.