– Clinical Trial Application (CTA) for TNG908, an MTA-cooperative PRMT5 inhibitor, approved by the
– TNG260 disclosed as a first-in-class CoREST complex inhibitor for treatment
of STK11-mutant cancers –
– TNG348 declared as a USP1 inhibitor development candidate for treatment
of BRCA1/2 mutant cancers –
–
“We have made significant progress advancing our pipeline of synthetic lethal therapies, including the recent expansion of clinical trial sites for TNG908, our lead PRMT5 program, to include
Recent Business Highlights
Pipeline Update
TNG908, a novel synthetic lethal PRMT5 inhibitor
- Enrollment is ongoing in the dose escalation phase of the TNG908 phase 1/2 trial.
- A CTA for TNG908 was approved by the ANSM in
France during the fourth quarter of 2022. - TNG908 is a synthetic lethal inhibitor of PRMT5 (protein arginine methyl transferase 5) that works selectively in cancer cells with MTAP (methylthioadenosine phosphorylase) deletion.
- MTAP deletions occur in approximately 10%-15% of all human cancers, including non-small cell lung cancer, mesothelioma, cholangiocarcinoma and glioblastoma.
TNG260, a first-in-class CoREST complex inhibitor
- The Company disclosed the target of TNG260 as the CoREST complex. The CoREST complex (Co-repressor of Repressor Element-1 Silencing Transcription) plays a major role in regulating the expression of immunomodulatory proteins.
- Inhibition of the CoREST complex by TNG260 reverses anti-PD1 resistance driven by STK11 mutations in preclinical models.
- The Company expects to file an Investigational New Drug (IND) application for this program in the first half of 2023.
- STK11 mutations occur in approximately 15% of non-small cell lung, 15% of cervical, 10% of carcinoma of unknown primary, 5% of breast and 3% of pancreatic cancers, among others.
TNG348, a novel USP1 inhibitor
- The Company declared TNG348 a development candidate for the USP1 program (ubiquitin-specific protease 1) in 4Q 2022, which is being developed for the treatment of BRCA1 and BRCA2-mutant cancers. The Company expects to file an IND for TNG348 in 2023.
- In vivo preclinical studies of USP1 inhibition have shown single agent efficacy in BRCA1 and BRCA2-mutant cell-line and patient derived xenografts, including those that are intrinsically resistant to PARP inhibition. These preclinical data further demonstrate that TNG348 is synergistic with PARP inhibition across a panel of human ovarian and breast cancer cell lines, including both PARP inhibitor resistant and sensitive lines.
- BRCA1/2 mutations are present in approximately 15% of ovarian, 10% of breast, 5% of endometrial and 5% of pancreatic cancers, among others.
Leadership Update
The Company strengthened its management team with the appointment of
Scientific Presentations
- The Company presented four posters and disclosed the target of TNG260, a first-in-class CoREST inhibitor for the treatment of STK11-mutant cancers. Preclinical data presented provide strong evidence that TNG260 reverses the immune evasion caused by STK11 mutations, with the combination of TNG260 and α-PD1 driving complete tumor regressions in STK11-mutant syngeneic xenografts.
- Additional posters highlighted the potential of the proprietary discovery platform to identify novel immune evasion targets for future development.
AACR-NCI-EORTC Molecular Targets and Cancer Therapeutics Symposium,
- The Company presented three preclinical posters on PRMT5 inhibitors, TNG908 and TNG462, highlighting the potential of this program to address the high unmet need in MTAP-deleted cancers.
Upcoming Milestones
- Initial safety and efficacy data is expected from the Phase 1/2 clinical trial of TNG908, a synthetic lethal PRMT5 inhibitor, in patients with MTAP-deleted solid tumors during the first half of 2023.
- The IND filing for TNG462, a next-generation MTA-cooperative PRMT5 inhibitor, is on track for the first half of 2023.
- The IND filing for TNG260, a first-in-class CoREST inhibitor, is on track for the first half of 2023.
- The IND filing for TNG348, a novel USP1 inhibitor that is being developed for treatment of BRCA1 and BRCA2-mutant cancers, is on track for 2023.
Financial Results
As of
Collaboration revenue was
There was no license revenue for the three and nine months ended
Research and development expenses were
General and administrative expenses were
Net loss for the three months ended
About
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”, “predict”, “potential” or “continue”, or the negatives of these terms or variations of them or similar terminology. For example, statements concerning the following include or constitute forward-looking statements: the Company believes its cash, cash equivalents and marketable securities are sufficient to fund operations into 2025; the Company expects to have initial safety and efficacy data in connection with the TNG908 Phase 1/2 clinical trial in the 1H 2023; TNG260 is a first-in-class, CoREST inhibitor that has reversed anti-PD1 resistance driven by STK11 mutations in preclinical models; the Company plans to file INDs for TNG462 and TNG260 in the first half of 2023; the Company expects to file an IND for TNG348 in 2023; the Company has the opportunity to potentially expand the benefits of precision oncology to additional genetically defined cancers, such as lung cancer and glioblastoma, where a significant need for new options remains; the potential of the Company’s proprietary discovery platform to identify synthetic lethal targets for future development; the potential of the Company’s PRMT5 therapies to address the high unmet need in MTAP-deleted cancers; the indications expected to be included in Company clinical trials; the potential applicability of synthetic lethal drugs targeting across a range of cancer types; the expected benefits of the Company's development candidates and other product candidates; 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 and final clinical trial results. 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: 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 and may not generate results (including final or initial safety and efficacy data) in the anticipated timeframe (or at all); benefits of product candidates seen in preclinical analyses may not be evident when tested in clinical trials or when used in broader patient populations (if approved for commercial sale); the benefits of Tango pipeline products, development candidates and potential combination therapies that are seen in pre-clinical experiments may not be present in clinical trials or in use commercially or 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; we 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 fast track designation (and such designation may not advance any anticipated approval timelines); 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; our products 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
Investor Contact:
tango@argotpartners.com
Media Contact:
tango@argotpartners.com
Consolidated Statements of Operations
(In thousands, except share and per share data)
Three Months Ended | Nine Months Ended | |||||||||||||||
2022 | 2021 | 2022 | 2021 | |||||||||||||
Collaboration revenue | $ | 6,920 | $ | 6,787 | $ | 18,449 | $ | 20,326 | ||||||||
License revenue | - | - | - | 11,000 | ||||||||||||
Total revenue | $ | 6,920 | $ | 6,787 | $ | 18,449 | $ | 31,326 | ||||||||
Operating expenses: | ||||||||||||||||
Research and development | 28,744 | 21,923 | 76,815 | 56,002 | ||||||||||||
General and administrative | 8,099 | 4,433 | 22,138 | 11,530 | ||||||||||||
Total operating expenses | 36,843 | 26,356 | 98,953 | 67,532 | ||||||||||||
Loss from operations | (29,923 | ) | (19,569 | ) | (80,504 | ) | (36,206 | ) | ||||||||
Other income (expense): | ||||||||||||||||
Interest income | 350 | 91 | 865 | 299 | ||||||||||||
Other income (expense), net | 523 | (50 | ) | 526 | (167 | ) | ||||||||||
Total other income, net | 873 | 41 | 1,391 | 132 | ||||||||||||
Loss before income taxes | (29,050 | ) | (19,528 | ) | (79,113 | ) | (36,074 | ) | ||||||||
Provision for income taxes | - | (62 | ) | (3 | ) | (115 | ) | |||||||||
Net loss | $ | (29,050 | ) | $ | (19,590 | ) | $ | (79,116 | ) | $ | (36,189 | ) | ||||
Net loss per common share – basic and diluted | $ | (0.33 | ) | $ | (0.28 | ) | $ | (0.90 | ) | $ | (0.68 | ) | ||||
Weighted average number of common shares outstanding – basic and diluted | 87,892,195 | 70,160,663 | 87,868,081 | 53,397,557 | ||||||||||||
Consolidated Balance Sheets
(In thousands)
2022 | 2021 | |||||||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 100,312 | $ | 142,745 | ||||
Marketable securities | 292,981 | 342,510 | ||||||
Accounts receivable | 2,000 | 2,000 | ||||||
Restricted cash | 567 | 567 | ||||||
Prepaid expenses and other current assets | 5,814 | 4,516 | ||||||
Total current assets | 401,674 | 492,338 | ||||||
Property and equipment, net | 11,296 | 4,832 | ||||||
Operating lease right-of-use assets | 47,757 | 1,254 | ||||||
Restricted cash, net of current portion | 3,423 | 1,712 | ||||||
Other assets | 6 | 19 | ||||||
Total assets | $ | 464,156 | $ | 500,155 | ||||
Liabilities and Stockholders' Equity | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 6,314 | $ | 3,226 | ||||
Accrued expenses and other current liabilities | 15,752 | 9,887 | ||||||
Operating lease liabilities | 781 | 1,503 | ||||||
Deferred revenue | 28,475 | 26,022 | ||||||
Income tax payable | — | 52 | ||||||
Total current liabilities | 51,322 | 40,690 | ||||||
Operating lease liability, net of current portion | 39,947 | — | ||||||
Deferred revenue, net of current portion | 99,815 | 114,718 | ||||||
Total liabilities | 191,084 | 155,408 | ||||||
Total stockholders’ equity | 273,072 | 344,747 | ||||||
Total liabilities and stockholders’ equity | $ | 464,156 | $ | 500,155 |
Source:
2022 GlobeNewswire, Inc., source