FDA BTD, trial advances and 2029 cash runway for Relay Therapeutics (Nasdaq: RLAY)
Rhea-AI Filing Summary
Relay Therapeutics reported first quarter 2026 results and highlighted major clinical progress for its lead PI3Kα inhibitor zovegalisib.
Revenue was $3.0 million for Q1 2026 versus $7.7 million a year earlier, while R&D expenses were $70.6 million and G&A expenses $11.0 million. Net loss narrowed to $73.3 million, or $0.41 per share, compared with a net loss of $77.1 million, or $0.46 per share, in Q1 2025.
Cash, cash equivalents and investments rose to $642.1 million as of March 31, 2026, helped by $137.1 million in at-the-market equity proceeds, and are expected to fund operations into 2029. Strategically, zovegalisib received FDA Breakthrough Therapy designation in advanced HR+/HER2- breast cancer, showed 11.1‑month median progression-free survival in a Phase 1/2 trial, and delivered a 44% objective response rate in a triplet regimen in heavily pre-treated patients. The company also initiated a Phase 1/2 trial for RLY‑8161, an NRAS-selective inhibitor, and plans a Phase 3 frontline breast cancer study in early 2027.
Positive
- FDA Breakthrough Therapy designation for zovegalisib in PIK3CA-mutant, HR+/HER2- advanced breast cancer, supported by 11.1-month median progression-free survival and a 44% objective response rate in heavily pre-treated patients.
- Strengthened balance sheet and extended runway, with cash, cash equivalents and investments rising to $642.1 million at March 31, 2026, and management expecting funding to cover operating and capital needs into 2029.
Negative
- Meaningful revenue decline, with Q1 2026 revenue of $3.0 million under the Elevar license agreement compared with $7.7 million in the prior-year quarter, while the company remains in a substantial net loss position.
Insights
BTD for zovegalisib and solid cash runway offset weaker near-term revenue.
Relay Therapeutics combined meaningful clinical milestones with a still-loss-making but better-controlled P&L. Zovegalisib secured FDA Breakthrough Therapy designation in PIK3CA‑mutant HR+/HER2- breast cancer, supported by Phase 1/2 data showing 11.1‑month median progression-free survival and a 44% objective response rate in heavily pre-treated, CDK4/6-experienced patients.
Financially, Q1 2026 revenue fell to $3.0M from $7.7M, but operating expenses declined as G&A dropped to $11.0M and R&D edged down to $70.6M. Net loss improved modestly to $73.3M. Cash, cash equivalents and investments increased to $642.1M, boosted by $137.1M from at-the-market offerings, and management expects this to fund operations into 2029.
Strategic risk now centers on execution of late-stage trials. The ongoing Phase 3 ReDiscover‑2 study in second-line breast cancer and the planned Phase 3 frontline trial expected to start in early 2027, together with the new Phase 1/2 trial for NRAS inhibitor RLY‑8161, will be key determinants of future value once results emerge in subsequent company disclosures.
8-K Event Classification
Key Figures
Key Terms
Breakthrough Therapy designation regulatory
progression-free survival medical
objective response rate medical
at-the-market offerings financial
NRAS-selective inhibitor medical
vascular anomalies medical
Earnings Snapshot
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations and Financial Condition.
On May 5, 2026, Relay Therapeutics, Inc. announced its financial results for the quarter ended March 31, 2026. A copy of the press release is being furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information in this Item 2.02, including Exhibit 99.1, of this Current Report on Form 8-K is intended to be furnished and shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
99.1 |
Press release issued by Relay Therapeutics, Inc. on May 5, 2026, furnished herewith. |
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Cover Page Interactive Data File (embedded within Inline XBRL document). |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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RELAY THERAPEUTICS, INC. |
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May 5, 2026 |
By: |
/s/ Soo-Yeun Lim |
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Soo-Yeun Lim |
Exhibit 99.1
Relay Therapeutics Reports First Quarter 2026 Financial Results and Corporate Updates
FDA Breakthrough Therapy designation granted to zovegalisib for PIK3CA-mutant, HR+/HER2- advanced breast cancer, the Phase 3 ReDiscover-2 trial population in 2L breast cancer
Presented zovegalisib doublet data at Phase 3 dose in CDK4/6-experienced patients at ESMO TAT, demonstrating 11.1-month median PFS with similar efficacy in kinase and non-kinase mutations
Selected zovegalisib plus atirmociclib as go-forward triplet regimen for 1L breast cancer; Phase 3 1L trial in endocrine-sensitive patients expected to initiate in early 2027
Initiated Phase 1/2 trial of RLY-8161, a NRAS-selective molecule, in patients with NRAS-mutant solid tumors
Initial vascular anomalies clinical data conference call planned for May 19 during the ISSVA World Congress 2026
Approximately $642 million in cash, cash equivalents and investments at end of Q1 2026
Cambridge, Mass. – May 5, 2026 – Relay Therapeutics, Inc. (Nasdaq: RLAY), a clinical-stage, small molecule precision medicine company developing potentially life-changing therapies for patients living with cancer and genetic disease, today reported first quarter 2026 financial results and corporate updates.
“We have made important progress so far in 2026, highlighted by promising data supporting further development for the zovegalisib plus atirmociclib triplet combination in frontline breast cancer,” said Sanjiv Patel, M.D., President and Chief Executive Officer of Relay Therapeutics. “With initial clinical data in vascular anomalies expected at ISSVA and preparations underway for our planned Phase 3 frontline study in endocrine-sensitive patients with metastatic breast cancer, we are entering a data-rich period for zovegalisib. Additionally, RLY-8161, our NRAS-selective molecule, has entered clinical development for patients with NRAS-mutant solid tumors. We remain focused on executing across these priorities to bring differentiated therapies to patients.”
Corporate Highlights
2L Breast Cancer
1L Breast Cancer
Vascular Anomalies
NRAS Selective Inhibitor: RLY-8161
First Quarter 2026 Financial Results
Cash, Cash Equivalents and Investments: As of March 31, 2026, cash, cash equivalents and investments totaled $642.1 million, as compared to $554.5 million as of December 31, 2025. The increase in cash was due to $137.1 million in net proceeds from "at-the-market" offerings under our sales agreement with TD Securities (USA) LLC during the quarter. This figure does not include an additional $22.1 million in net proceeds received from "at-the-market" offerings in April. The company expects its current cash, cash equivalents, and investments will be sufficient to fund its operating expenses and capital expenditure requirements into 2029.
Revenue: Revenue was $3.0 million for the first quarter of 2026, as compared to $7.7 million for the first quarter of 2025. The revenue recognized in each period was under the company's Exclusive License Agreement with Elevar Therapeutics, Inc.
R&D Expenses: Research and development expenses were $70.6 million for the first quarter of 2026, as compared to $73.8 million for the first quarter of 2025. The decrease was primarily due to the series of strategic choices made to streamline the research organization prior to 2026, offset by increases in costs related to the ReDiscover-2 trial.
G&A Expenses: General and administrative expenses were $11.0 million for the first quarter of 2026, as compared to $18.7 million for the first quarter of 2025. The decrease was primarily due to decreases in employee compensation costs, including stock compensation expense, and costs to obtain the Exclusive License Agreement with Elevar Therapeutics, Inc., which were expensed during the three months ended March 31, 2025.
Net Loss: Net loss was $73.3 million for the first quarter of 2026, or a net loss per share of $0.41, as compared to a net loss of $77.1 million for the first quarter of 2025, or a net loss per share of $0.46.
About Zovegalisib
Zovegalisib is the lead program in Relay Therapeutics’ efforts to discover and develop mutant-selective inhibitors of PI3Kα, the most frequently mutated kinase in all cancers and all vascular anomalies. Zovegalisib has the potential, if approved, to address a significant portion of the approximately 140,000 patients with HR+/HER2- breast cancer with a PI3Kα mutation and the estimated 170,000 patients with vascular anomalies driven by a PI3Kα mutation per year in the United States, one of the largest patient populations for a precision medicine.
Traditionally, the development of PI3Kα inhibitors has focused on the active, or orthosteric, site. The therapeutic index of orthosteric inhibitors is limited by the lack of clinically meaningful selectivity for mutant versus wild-type (WT) PI3Kα and off-isoform activity. Toxicity related to inhibition of WT PI3Kα and other PI3K isoforms results in sub-optimal inhibition of mutant PI3Kα with reductions in dose intensity and frequent discontinuation. The Dynamo® platform enabled the discovery of zovegalisib, the first known allosteric, pan-mutant, and isoform-selective PI3Kα inhibitor, designed to overcome these limitations. Relay Therapeutics solved the full-length cryo-EM structure of PI3Kα, performed computational long time-scale molecular dynamic simulations to elucidate conformational differences between WT and mutant PI3Kα, and leveraged these insights to support the design of zovegalisib. Zovegalisib is currently being evaluated in multiple metastatic breast cancer studies and a Phase 1/2 study designed to treat patients with PIK3CA (PI3Kα) mutation driven vascular anomalies. For more information on zovegalisib, please visit here.
About Relay Therapeutics
Relay Therapeutics (Nasdaq: RLAY) is a clinical-stage, small molecule precision medicine company developing potentially life-changing therapies for patients living with cancer and genetic disease. Relay Therapeutics’ Dynamo® platform integrates an array of leading-edge computational and experimental approaches designed to drug protein targets that have previously been intractable or inadequately
addressed. The company’s lead clinical asset, zovegalisib, is the first pan-mutant selective PI3Kα inhibitor to enter clinical development and is currently in a Phase 3 clinical trial (ReDiscover-2) in HR+/HER2- metastatic breast cancer. Zovegalisib is also being investigated in a group of genetic disease indications called PI3Kα-driven vascular anomalies. Relay Therapeutics’ pipeline also includes programs for NRAS-driven solid tumors and Fabry disease. For more information, please visit www.relaytx.com or follow us on LinkedIn.
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 zovegalisib and RLY-8161; the timing of clinical data readouts and presentations for zovegalisib; the expected therapeutic benefits and potential efficacy and tolerability of zovegalisib, both as a monotherapy and in combination with other agents, and its other programs; the clinical data for zovegalisib; the interactions with regulatory authorities and any related approvals; the potential commercialization and market opportunity for zovegalisib; and the cash runway projection and the expectations regarding Relay Therapeutics’ use of capital and expenses. 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 Relay Therapeutics has operations or does business, as well as on the timing and anticipated results of its clinical trials, strategy, future operations and profitability; significant political, trade or regulatory developments, such as tariffs, beyond Relay Therapeutics’ control; the delay or pause of any current or planned clinical trials or the development of Relay Therapeutics’ drug candidates; the risk that the preliminary or interim results of its preclinical or clinical trials may not be predictive of future or final results in connection with future clinical trials of its product candidates and that interim and early clinical data may change as more patient data become available and are subject to audit and verification procedures; Relay Therapeutics’ ability to successfully demonstrate the safety and efficacy of its drug candidates; the timing and outcome of its planned interactions with regulatory authorities; and obtaining, maintaining and protecting its intellectual property. These and other risks and uncertainties are described in greater detail in the section entitled “Risk Factors” in Relay Therapeutics’ most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q, as well as any subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent Relay Therapeutics' views only as of today and should not be relied upon as representing its views as of any subsequent date. Relay Therapeutics explicitly disclaims any obligation to update any forward-looking statements. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements.
Contact:
Mitch Maisel
mmaisel@relaytx.com
Media:
Dan Budwick
1AB
973-271-6085
dan@1abmedia.com
Relay Therapeutics, Inc.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except share and per share data)
(Unaudited)
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Three Months Ended March 31, |
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2026 |
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2025 |
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Revenue: |
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License and other revenue |
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$ |
3,000 |
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$ |
7,679 |
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Total revenue |
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3,000 |
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7,679 |
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Operating expenses: |
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Research and development expenses |
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$ |
70,563 |
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$ |
73,809 |
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General and administrative expenses |
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11,027 |
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18,739 |
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Total operating expenses |
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81,590 |
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92,548 |
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Loss from operations |
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(78,590 |
) |
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(84,869 |
) |
Other income: |
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Interest income |
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5,352 |
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7,813 |
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Other expense |
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(53 |
) |
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(9 |
) |
Total other income, net |
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5,299 |
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7,804 |
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Net loss |
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$ |
(73,291 |
) |
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$ |
(77,065 |
) |
Net loss per share, basic and diluted |
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$ |
(0.41 |
) |
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$ |
(0.46 |
) |
Weighted average shares of common stock, basic and diluted |
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179,849,137 |
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169,233,155 |
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Other comprehensive (loss) income: |
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Unrealized holding (loss) gain |
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(172 |
) |
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1,029 |
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Total other comprehensive (loss) income |
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(172 |
) |
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1,029 |
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Total comprehensive loss |
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$ |
(73,463 |
) |
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$ |
(76,036 |
) |
Relay Therapeutics, Inc.
Selected Condensed Consolidated Balance Sheet Data
(In thousands)
(Unaudited)
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March 31, 2026 |
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December 31, 2025 |
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Cash, cash equivalents and investments |
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$ |
642,065 |
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$ |
554,518 |
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Working capital (1) |
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628,711 |
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552,701 |
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Total assets |
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699,613 |
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621,331 |
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Total liabilities |
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57,430 |
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54,271 |
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Total stockholders’ equity |
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642,183 |
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567,060 |
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Restricted cash |
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1,336 |
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1,336 |
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(1) Working capital is defined as current assets less current liabilities.