Relay Therapeutics Reports First Quarter 2023 Financial Results and Corporate Highlights
Presented initial clinical data for RLY-2608 at
Initiated clinical trial for RLY-5836, a chemically-distinct PI3Kα pan-mutant inhibitor
“We have made important progress so far in 2023 by continuing to advance our clinical and pre-clinical programs,” said
Recent Corporate Highlights
RLY-4008 (FGFR2 inhibitor)
- Presented data at AACR Annual Meeting 2023, which showed that food and esomeprazole did not have a clinically relevant effect on the pharmacokinetics (PK) of RLY-4008
- Full dose escalation data from the ReFocus trial accepted for presentation at 2023
American Society of Clinical Oncology (ASCO) Annual Meeting,June 2-6, 2023
Breast Cancer Portfolio
- RLY-2608 (pan-mutant and isoform-selective PI3Kα inhibitor)
- Presented initial clinical data from the first-in-human ReDiscover trial at the AACR Annual Meeting, which support initial clinical proof of mechanism, demonstrating that RLY-2608 achieved selective target engagement at multiple predicted efficacious doses with a favorable initial safety and tolerability profile. The cut-off date for these data was
March 9, 2023 . Key highlights include:- Multiple doses achieved sustained target exposure of approximately 80 percent or greater mutant PI3Kα inhibition
- No Grade 3 hyperglycemia, rash or diarrhea observed at target exposures
- Favorable initial safety profile at target exposures with mostly low-grade adverse events that were manageable and reversible
- Partial response in breast cancer patient with 12 prior lines of therapy, which was confirmed subsequent to the data cut-off date
- Initial anti-tumor activity in breast cancer patients observed across a range of doses
- Median treatment duration among the 27 patients with breast cancer was approximately 4 months, with 70 percent (19/27) still on treatment as of the cut-off date
- Dose exploration is ongoing to determine the recommended dose(s) for the dose expansion cohorts, which
Relay Therapeutics anticipates initiating in the second half of 2023
- Presented initial clinical data from the first-in-human ReDiscover trial at the AACR Annual Meeting, which support initial clinical proof of mechanism, demonstrating that RLY-2608 achieved selective target engagement at multiple predicted efficacious doses with a favorable initial safety and tolerability profile. The cut-off date for these data was
- RLY-5836 (pan-mutant and isoform-selective PI3Kα inhibitor)
- In
April 2023 , initiated a first-in-human trial in patients with advanced solid tumors with a PIK3CA (PI3Kα) mutation
- In
- RLY-2139 (CDK2 inhibitor)
- Selected development candidate; anticipate early 2024 clinical start, pending regulatory authorization
Anticipated Upcoming Milestones
- RLY-4008
- Full dose escalation data to be presented at ASCO Annual Meeting
- Complete enrollment of pivotal cohort in the second half of 2023
- Data from non-CCA expansion cohorts in the second half of 2023
- Breast Cancer
- RLY-2608: initiation of expansion cohorts in the second half of 2023
- ERα degrader: development candidate nomination in 2023
- RLY-2139 (selective CDK2 inhibitor): clinical start in early 2024, pending regulatory authorization
First Quarter 2023 Financial Results
Cash, Cash Equivalents and Investments: As of
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, timing of enrollment completion, 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 RLY-4008, the initiation of expansion cohorts for RLY-2608, the clinical initiation of RLY-2139, and the nomination of a development candidate for Relay Therapeutics’ ERα degrader program; 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, or public health epidemics or outbreaks of an infectious disease, such as COVID-19, on countries or regions in which
Contact:
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| Condensed Consolidated Statements of Operations and Comprehensive Loss | ||||||||
| (In thousands, except share and per share data) | ||||||||
| (Unaudited) | ||||||||
| Three Months Ended |
||||||||
| 2023 | 2022 | |||||||
| Revenue: | ||||||||
| License and other revenue | $ | 226 | $ | 419 | ||||
| Total revenue | 226 | 419 | ||||||
| Operating expenses: | ||||||||
| Research and development expenses | $ | 82,827 | $ | 51,667 | ||||
| Change in fair value of contingent consideration liability | (1,003 | ) | (4,595 | ) | ||||
| General and administrative expenses | 19,579 | 16,068 | ||||||
| Total operating expenses | 101,403 | 63,140 | ||||||
| Loss from operations | (101,177 | ) | (62,721 | ) | ||||
| Other income: | ||||||||
| Interest income | 6,941 | 696 | ||||||
| Other expense | (3 | ) | (21 | ) | ||||
| Total other income, net | 6,938 | 675 | ||||||
| Net loss | $ | (94,239 | ) | $ | (62,046 | ) | ||
| Net loss per share, basic and diluted | $ | (0.78 | ) | $ | (0.57 | ) | ||
| Weighted average shares of common stock, basic and diluted | 121,320,865 | 108,293,251 | ||||||
| Other comprehensive loss: | ||||||||
| Unrealized holding gain (loss) | 4,618 | (8,130 | ) | |||||
| Total other comprehensive gain (loss) | 4,618 | (8,130 | ) | |||||
| Total comprehensive loss | $ | (89,621 | ) | $ | (70,176 | ) | ||
| Selected Condensed Consolidated Balance Sheet Data | ||||||||
| (In thousands) | ||||||||
| (Unaudited) | ||||||||
| 2023 | 2022 | |||||||
| Cash, cash equivalents and investments | $ | 937,804 | $ | 998,917 | ||||
| Working capital (1) | 887,921 | 955,796 | ||||||
| Total assets | 1,037,560 | 1,099,771 | ||||||
| Total liabilities | 154,148 | 149,553 | ||||||
| Total stockholders’ equity | 883,412 | 950,218 | ||||||
| Restricted cash | 2,578 | 2,578 | ||||||
(1) Working capital is defined as current assets less current liabilities.
Source: Relay Therapeutics, Inc.