Tango Therapeutics, Inc. annual report, FY2023

Tango Therapeutics, Inc. — FY2023 Form 10-K

Reporting period: Fiscal year ended December 31, 2023. This is an annual report, not a standalone fourth-quarter report. Tango is a clinical-stage precision oncology company with no approved products and no product-sales revenue. Its programs target genetically defined cancers using synthetic-lethality and immune-evasion approaches.

Financial and operating results

MetricFY2023FY2022Change
Collaboration revenue$31.5 million$24.9 million+$6.7 million
License revenue$5.0 million$0+$5.0 million
Total revenue$36.5 million$24.9 million+$11.7 million
Research and development expense$115.2 million$105.9 million+$9.3 million
General and administrative expense$35.5 million$30.0 million+$5.5 million
Operating loss$114.2 million$111.1 millionLoss increased $3.1 million
Net loss$101.7 million$108.2 millionLoss narrowed $6.4 million
Net loss per share$1.08$1.23Improved $0.15
Cash used in operations$118.0 million$109.1 millionOutflow increased $8.9 million

There are no meaningful product margins to assess because all revenue came from Gilead collaboration and license arrangements, not product sales. The net loss narrowed despite higher operating expenses, primarily because total other income rose to $12.6 million from $2.9 million, including $6.6 million of interest income and $5.9 million of other income, principally investment accretion.

At year-end, cash and cash equivalents were $66.4 million and marketable securities were $270.5 million, totaling $336.9 million; restricted cash was an additional $3.4 million. Total assets were $402.6 million and total liabilities were $149.5 million, including $38.9 million of operating lease liabilities and $92.4 million of deferred revenue. The filing does not report borrowings or other financial debt. Operating lease commitments totaled $55.5 million.

Management stated that year-end cash, cash equivalents and marketable securities, together with $41.7 million in net proceeds from January 2024 ATM sales, were expected to fund operations and capital needs into at least late 2026. This is an estimate dependent on assumptions and spending needs. The August 2023 private placement generated $79.8 million net proceeds and included common shares and pre-funded warrants. Common shares outstanding rose to 102.2 million at year-end from 88.2 million a year earlier; 106.7 million were outstanding as of March 12, 2024.

Business and pipeline developments

  • TNG908: Phase 1/2 trial of a brain-penetrant PRMT5 inhibitor for MTAP-deleted tumors, including glioblastoma. May 2023 biopsy data showed dose-dependent tumor SDMA reduction with minimal or no reduction in normal tissue, described as proof of mechanism. Management reported favorable early safety, tolerability and pharmacokinetics; clinical data were expected in 2024.
  • TNG462: Next-generation PRMT5 inhibitor for MTAP-deleted tumors, excluding glioblastoma because it is not expected to cross the blood-brain barrier. First patient dosed July 2023; early safety, tolerability and pharmacokinetics were described as favorable.
  • TNG260: CoREST inhibitor being tested with pembrolizumab in STK11-mutant solid tumors. First patient dosed July 2023; early safety, tolerability and pharmacokinetics were described as favorable.
  • TNG348: USP1 inhibitor for BRCA-mutant and other HRD-positive cancers. FDA cleared its IND in 2023; the first patient was dosed in January 2024, after the reporting period.

All four programs were in early clinical development; the filing reports no completed clinical trials or established clinical efficacy. The safety and activity claims for the programs are preliminary, while many efficacy claims cited are based on preclinical models.

Material changes, outlook and risks

  • Total revenue increased 47% year over year, including a $5.0 million Gilead program license fee. R&D spending increased 9%, with higher personnel and facility costs partly offset by lower discovery-program spending. G&A increased 18%, mainly due to personnel costs.
  • Gilead collaboration revenue recognized was $31.5 million in 2023. Gilead licensed a program for $5.0 million during the year; Tango reported three programs licensed and two option-extended under the collaboration. The research term runs through August 2027, and the agreement offers contingent milestones and royalties, not guaranteed future revenue.
  • Management expects significant ongoing losses and negative operating cash flow, with R&D expenses expected to increase as clinical programs advance. The company will need substantial additional funding; future equity financing could dilute shareholders, while debt or partnerships could impose restrictions or require relinquishing rights.
  • Key execution risks include early-stage clinical uncertainty, trial enrollment and biomarker-screening challenges, competition, regulatory approval, and reliance on CROs and a limited manufacturing base. One supplier is the sole source of active pharmaceutical ingredient and is affiliated with WuXi AppTec in China; the company noted proposed U.S. legislation could affect that relationship and said it was seeking an alternate source.
  • Other risks include dependence on third-party drug supply for combination trials, companion-diagnostic development, intellectual-property challenges, and reimbursement and drug-pricing pressures. The company reported no material pending legal proceedings. Its investments were primarily U.S. Treasury and government-agency securities, and management said a 1% interest-rate change would not materially affect their fair value.

Important facts for investors to verify

  • Review subsequent TNG908, TNG462 and TNG260 trial data, including confirmed efficacy, safety, dose selection, enrollment and timing; distinguish clinical evidence from preclinical results.
  • Check whether TNG348 enrollment and development progressed as planned after its first patient was dosed in January 2024.
  • Track cash burn, trial and manufacturing costs, and whether the stated late-2026 runway remains achievable; confirm any subsequent financing and dilution.
  • Monitor diversification of the active-pharmaceutical-ingredient supply chain and any regulatory or geopolitical developments affecting the China-based supplier.
  • Assess the quality and durability of collaboration revenue, including Gilead’s future option decisions, milestones and licensing activity, rather than treating contingent payments as assured.

Audit and controls: PricewaterhouseCoopers issued an unqualified opinion on the consolidated financial statements. Management concluded disclosure controls and internal control over financial reporting were effective as of December 31, 2023; no auditor attestation on internal controls was included because Tango qualified for the emerging-growth-company exemption.