Relay Therapeutics Reports Third Quarter 2023 Financial Results and Corporate Highlights
Reported initial RLY-4008 (lirafugratinib) data demonstrating durable responses across multiple FGFR2-altered solid tumors
Announced plans to initiate RLY-2608 + fulvestrant + CDK4/6 triplet combinations in HR+/HER2- breast cancer by YE 2023
Updated pipeline to extend cash runway by approximately 1 year
Approximately
“We have made important progress expanding the number of patients we have the potential to help with our clinical programs,” said
Recent Corporate Highlights
RLY-4008 (lirafugratinib)
- Presented initial clinical data in patients with FGFR2-altered solid tumors at the 2023
AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics , which demonstrated activity across several sub-groups, including in patients with FGFR2-fusion tumors and in patients with FGFR2-altered HR+/HER2- breast cancer. The cut-off date for these data wasAugust 23, 2023 . Key highlights include:- FGFR2 fusions: Nine of 26 patients experienced a confirmed partial response (PR) (35% overall response rate (ORR)), with 63 percent of responders experiencing a duration of response of at least 6 months
- HR+/HER2- breast cancer, all FGFR2 alterations: Four of 10 patients achieved PRs (40% ORR), with all responders having a duration of response of at least 6 months, and the longest duration of response 72 weeks and ongoing as of the data cut-off
- Patients were very heavily pre-treated (median of 6 prior lines of therapy) with prior targeted therapies (100%), prior chemotherapy/ADC (93%), prior endocrine therapy (79%) and prior CDK4/6 (71%)
- FGFR2 amplifications: Eight of 34 patients experienced a PR (24% ORR), with 43 percent of responders experiencing a duration of response of at least 6 months
- Completed enrollment in the pivotal expansion cohort in patients with FGFR2-fusion cholangiocarcinoma (CCA) who have not previously received an FGFR inhibitor
- Paused near-term commercial readiness activities for CCA to align with the broader tumor agnostic opportunity being pursued
RLY-2608
- Announced plans to initiate RLY-2608 + fulvestrant + CDK4/6 triplet combinations in patients with PI3Kα-mutant, HR+, HER2- locally advanced or metastatic breast cancer by the end of 2023
Pre-Clinical
- Paused further development efforts on RLY-2139 (CDK2 inhibitor)
Anticipated Upcoming Milestones
- Lirafugratinib: report additional tumor agnostic clinical data and regulatory update in 2024
- PI3Kα: next data update expected in 2024
- Pre-clinical: disclose new program(s) in 2024
Third Quarter 2023 Financial Results
Cash, Cash Equivalents and Investments: As of
Revenue: Revenue was
R&D Expenses: Research and development expenses were
G&A Expenses: General and administrative expenses were
Net Loss: Net loss was
About
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and express statements regarding Relay Therapeutics’ strategy, business plans and focus; the progress and timing of the clinical development of the programs across Relay Therapeutics’ portfolio, including the expected therapeutic benefits of its programs, potential efficacy and tolerability, and the timing and success of interactions with and approval of regulatory authorities; the timing of a clinical data update for the PI3Kα franchise, the initiation of triplet combinations for RLY-2608, the timing of a clinical data and regulatory update for lirafugratinib, and the timing of disclosure of additional pre-clinical programs; expectations regarding Relay Therapeutics’ pipeline, operating plan, use of capital, expenses and other financial results; and Relay Therapeutics’ cash runway projection. The words “may,” “might,” “will,” “could,” “would,” “should,” “plan,” “anticipate,” “intend,” “believe,” “expect,” “estimate,” “seek,” “predict,” “future,” “project,” “potential,” “continue,” “target” and similar words or expressions, or the negative thereof, are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.
Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, risks associated with: the impact of global economic uncertainty, geopolitical instability and conflicts, or public health epidemics or outbreaks of an infectious disease on countries or regions in which
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Condensed Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except share and per share data)
(Unaudited)
Three Months Ended |
Nine Months Ended |
|||||||||||||||
2023 | 2022 | 2023 | 2022 | |||||||||||||
Revenue: | ||||||||||||||||
License and other revenue | $ | 25,202 | $ | 344 | $ | 25,547 | $ | 1,128 | ||||||||
Total revenue | 25,202 | 344 | 25,547 | 1,128 | ||||||||||||
Operating expenses: | ||||||||||||||||
Research and development expenses | $ | 81,494 | $ | 66,900 | $ | 252,522 | $ | 179,078 | ||||||||
Change in fair value of contingent consideration liability | (1,200 | ) | 3,262 | (4,355 | ) | (1,133 | ) | |||||||||
General and administrative expenses | 18,485 | 16,074 | 58,184 | 49,607 | ||||||||||||
Total operating expenses | 98,779 | 86,236 | 306,351 | 227,552 | ||||||||||||
Loss from operations | (73,577 | ) | (85,892 | ) | (280,804 | ) | (226,424 | ) | ||||||||
Other income: | ||||||||||||||||
Interest income | 7,845 | 1,713 | 22,345 | 3,414 | ||||||||||||
Other (expense) income | (2 | ) | 7 | (19 | ) | 4 | ||||||||||
Total other income, net | 7,843 | 1,720 | 22,326 | 3,418 | ||||||||||||
Net loss | $ | (65,734 | ) | $ | (84,172 | ) | $ | (258,478 | ) | $ | (223,006 | ) | ||||
Net loss per share, basic and diluted | $ | (0.54 | ) | $ | (0.76 | ) | $ | (2.12 | ) | $ | (2.04 | ) | ||||
Weighted average shares of common stock, basic and diluted | 122,231,255 | 110,905,940 | 121,843,116 | 109,290,743 | ||||||||||||
Other comprehensive loss: | ||||||||||||||||
Unrealized holding gain (loss) | 2,695 | (1,483 | ) | 7,034 | (12,301 | ) | ||||||||||
Total other comprehensive gain (loss) | 2,695 | (1,483 | ) | 7,034 | (12,301 | ) | ||||||||||
Total comprehensive loss | $ | (63,039 | ) | $ | (85,655 | ) | $ | (251,444 | ) | $ | (235,307 | ) | ||||
Selected Condensed Consolidated Balance Sheet Data
(In thousands)
(Unaudited)
2023 |
2022 |
|||||||
Cash, cash equivalents and investments | $ | 810,615 | $ | 998,917 | ||||
Working capital (1) | 781,050 | 955,796 | ||||||
Total assets | 906,959 | 1,099,771 | ||||||
Total liabilities | 128,586 | 149,553 | ||||||
Total stockholders’ equity | 778,373 | 950,218 | ||||||
Restricted cash | 2,707 | 2,578 |
(1) Working capital is defined as current assets less current liabilities.
Source: Relay Therapeutics, Inc.