Relay Therapeutics Reports Third Quarter 2024 Financial Results and Corporate Highlights
Relay Therapeutics reported its third quarter 2024 financial results and corporate highlights. Key highlights include interim data for RLY-2608 + fulvestrant showing a 9.2-month median PFS in heavily pre-treated patients with PI3Kα-mutated, HR+/HER2- metastatic breast cancer. The company plans to initiate a pivotal trial in 2025.
Relay Therapeutics has $840 million in cash, expected to fund operations into the second half of 2027. Revenue for Q3 2024 was $0, down from $25.2 million in Q3 2023. R&D expenses decreased to $76.6 million, while G&A expenses increased to $19.8 million. The net loss was $88.1 million, or $0.63 per share.
Corporate highlights include a $230 million follow-on offering and a $50 million annual savings from streamlining the research organization. Looking ahead, the company plans several clinical trial initiations and expansions in 2024 and 2025.
Relay Therapeutics ha riportato i risultati finanziari del terzo trimestre 2024 e i principali eventi aziendali. Tra i punti salienti ci sono i dati intermedi per RLY-2608 + fulvestrant che mostrano una sopravvivenza libera da progressione (PFS) mediana di 9,2 mesi in pazienti ampiamente pretrattati con cancro al seno metastatico HR+/HER2- con mutazioni di PI3Kα. La società prevede di avviare uno studio clinico cruciale nel 2025.
Relay Therapeutics dispone di 840 milioni di dollari in contante, che si prevede possano finanziare le operazioni fino nella seconda metà del 2027. I ricavi per il terzo trimestre del 2024 sono stati pari a 0 dollari, in calo rispetto ai 25,2 milioni di dollari del terzo trimestre 2023. Le spese per ricerca e sviluppo sono diminuite a 76,6 milioni di dollari, mentre le spese generali e amministrative sono aumentate a 19,8 milioni di dollari. La perdita netta è stata di 88,1 milioni di dollari, ovvero 0,63 dollari per azione.
I punti salienti aziendali includono una offerta supplementare di 230 milioni di dollari e un risparmio annuale di 50 milioni di dollari grazie all'efficienza nella ricerca. Guardando al futuro, la società prevede di avviare diversi studi clinici e ampliamenti nel 2024 e nel 2025.
Relay Therapeutics reportó sus resultados financieros del tercer trimestre de 2024 y los aspectos destacados de la empresa. Los puntos clave incluyen datos interinos para RLY-2608 + fulvestrant que muestran una PFS mediana de 9.2 meses en pacientes con tratamiento previo extenso y cáncer de mama metastásico HR+/HER2- con mutaciones en PI3Kα. La compañía planea iniciar un ensayo pivotal en 2025.
Relay Therapeutics tiene 840 millones de dólares en efectivo, que se espera financien las operaciones hasta la segunda mitad de 2027. Los ingresos para el tercer trimestre de 2024 fueron de 0 dólares, en comparación con 25.2 millones de dólares en el tercer trimestre de 2023. Los gastos de I+D disminuyeron a 76.6 millones de dólares, mientras que los gastos generales y administrativos aumentaron a 19.8 millones de dólares. La pérdida neta fue de 88.1 millones de dólares, o 0.63 dólares por acción.
Los aspectos destacados de la empresa incluyen una oferta adicional de 230 millones de dólares y un ahorro anual de 50 millones de dólares al simplificar la organización de investigación. Mirando hacia adelante, la empresa planea iniciar y expandir varios ensayos clínicos en 2024 y 2025.
릴레이 테라퓨틱스는 2024년 3분기 재무 결과와 기업 하이라이트를 발표했습니다. 주요 하이라이트로는 PI3Kα 돌연변이, HR+/HER2- 전이성 유방암 환자에서 9.2개월의 중간 무진행 생존기간(PFS)을 보이는 RLY-2608 + 풀베스트란트의 중간 데이터가 있습니다. 이 회사는 2025년에 중대한 임상 시험을 시작할 계획입니다.
릴레이 테라퓨틱스는 8억 4천만 달러의 현금을 보유하고 있으며, 이는 2027년 하반기까지 운영 자금으로 사용될 것으로 예상됩니다. 2024년 3분기 수익은 0달러로, 2023년 3분기 2천 520만 달러에서 감소했습니다. 연구 및 개발(R&D) 비용은 7,660만 달러로 줄어들었고, 일반관리(G&A) 비용은 1,980만 달러로 증가했습니다. 순손실은 8,810만 달러, 주당 0.63달러였습니다.
기업 하이라이트로는 2억 3천만 달러의 후속 공개 발행과 연구 조직의 효율성으로 인한 연간 5천만 달러 절감이 있습니다. 앞으로 이 회사는 2024년과 2025년에 여러 임상 시험 시작 및 확대를 계획하고 있습니다.
Relay Therapeutics a annoncé ses résultats financiers pour le troisième trimestre 2024 ainsi que les moments forts de l'entreprise. Les points clés incluent des données intermédiaires pour RLY-2608 + fulvestrant montrant une survie sans progression médiane (PFS) de 9,2 mois chez des patients fortement prétraités atteints d'un cancer du sein métastatique HR+/HER2- avec des mutations PI3Kα. L'entreprise prévoit de lancer un essai pivot en 2025.
Relay Therapeutics dispose de 840 millions de dollars en liquidités, ce qui devrait financer ses opérations jusqu'au second semestre 2027. Les revenus pour le troisième trimestre 2024 étaient de 0 dollar, en baisse par rapport à 25,2 millions de dollars au troisième trimestre 2023. Les dépenses en R&D ont diminué à 76,6 millions de dollars, tandis que les dépenses générales et administratives ont augmenté à 19,8 millions de dollars. La perte nette a été de 88,1 millions de dollars, soit 0,63 dollar par action.
Les moments forts de l'entreprise incluent une offre supplémentaire de 230 millions de dollars et des économies annuelles de 50 millions de dollars grâce à la rationalisation de l'organisation de recherche. En regardant vers l'avenir, l'entreprise prévoit plusieurs initiatives d'essais cliniques et expansions pour 2024 et 2025.
Relay Therapeutics hat die finanziellen Ergebnisse des dritten Quartals 2024 und die Unternehmenshighlights bekannt gegeben. Zu den wichtigen Highlights gehören interimistische Daten für RLY-2608 + Fulvestrant, die eine mediane progressionsfreie Überlebenszeit (PFS) von 9,2 Monaten bei stark vorgestellten Patienten mit PI3Kα-mutativen, HR+/HER2- metastasierten Brustkrebs zeigen. Das Unternehmen plant, 2025 eine entscheidende Studie zu beginnen.
Relay Therapeutics verfügt über 840 Millionen Dollar in bar, die voraussichtlich die Operationen bis in die zweite Hälfte 2027 finanzieren werden. Die Einnahmen für das dritte Quartal 2024 betrugen 0 Dollar, ein Rückgang von 25,2 Millionen Dollar im dritten Quartal 2023. Die F&E-Ausgaben sanken auf 76,6 Millionen Dollar, während die allgemeinen Verwaltungskosten auf 19,8 Millionen Dollar stiegen. Der Nettoverlust betrug 88,1 Millionen Dollar oder 0,63 Dollar pro Aktie.
Zu den Highlights des Unternehmens gehört ein Folgeangebot von 230 Millionen Dollar sowie eine jährliche Einsparung von 50 Millionen Dollar durch die Straffung der Forschungsorganisation. Ausblickend plant das Unternehmen mehrere klinische Studieninitiativen und Erweiterungen in 2024 und 2025.
- RLY-2608 + fulvestrant showed 9.2-month median PFS in heavily pre-treated patients.
- Plans to initiate pivotal trial in 2025.
- $840 million in cash, expected to fund operations into second half of 2027.
- $230 million raised in a follow-on offering.
- $50 million annual savings from streamlining research organization.
- Revenue dropped to $0 from $25.2 million in Q3 2023.
- Net loss increased to $88.1 million, or $0.63 per share.
- R&D expenses remain high at $76.6 million.
Insights
The Q3 results reveal a complex financial picture. While cash position strengthened to
Cost optimization efforts, including a
The RLY-2608 interim data shows promising clinical efficacy with a 9.2-month median PFS in heavily pre-treated breast cancer patients, particularly impressive in those with kinase mutations (10.3 months). The
The planned Phase 3 pivotal trial in 2L breast cancer and expansion into triplet combinations with CDK4/6 inhibitors represents a comprehensive development strategy. The additional exploration in vascular malformations and pipeline expansion demonstrates portfolio diversification beyond oncology.
Reported interim RLY-2608 data demonstrating 9.2-month median PFS in heavily pre-treated patients with PI3Kα-mutated, HR+/HER2- metastatic breast cancer at RP2D
Plan to initiate 2L pivotal trial of RLY-2608 + fulvestrant in 2025
Approximately
CAMBRIDGE, Mass., Nov. 06, 2024 (GLOBE NEWSWIRE) -- Relay Therapeutics, Inc. (Nasdaq: RLAY), a clinical-stage precision medicine company transforming the drug discovery process by combining leading-edge computational and experimental technologies, today reported third quarter 2024 financial results and recent corporate highlights.
“In the third quarter, we reported very encouraging interim data showing that RLY-2608 + fulvestrant led to clinically meaningful progression free survival in heavily pre-treated patients with PI3Kα-mutated, HR+, HER2- metastatic breast cancer,” said Sanjiv Patel, M.D., President and Chief Executive Officer of Relay Therapeutics. “Based on these data, we are preparing to initiate a pivotal trial in 2L breast cancer in 2025, which we expect to be able to fully fund through top-line readout with our existing cash on hand. We also continue to progress our pre-clinical programs and look forward to bringing new programs into the clinic in 2025.”
Recent Corporate Highlights
RLY-2608 (ReDiscover study)
- RLY-2608 doublet:
- Reported interim data for RLY-2608 + fulvestrant in patients with PI3Kα-mutated, HR+, HER2- metastatic breast cancer who had previously received at least one prior CDK4/6 inhibitor. The data demonstrated clinically meaningful progression free survival (PFS) at the company’s recommended Phase 2 dose (RP2D) of 600mg BID. The cut-off date for these data was August 12, 2024. Key highlights included:
- 9.2-month median PFS across all mutations & 10.3 months among patients with kinase mutations
33% objective response rate (ORR) across all patients &53% ORR in patients with kinase mutations at the RP2D- Favorable overall tolerability profile; at RP2D, only two patients discontinued treatment due to adverse events & only 1 patient experienced Grade 3 hyperglycemia
- RLY-2608 + fulvestrant data will be presented at the San Antonio Breast Cancer Symposium, taking place December 10-13, 2024. Details of the poster spotlight presentation are as follows:
- Abstract Title: PS7-01: Efficacy of RLY-2608, a mutant-selective PI3Kα inhibitor in patients with PIK3CA-mutant HR+HER2- advanced breast cancer: ReDiscover trial
- Abstract Number: SESS-2211
- Session: Concurrent Poster Spotlight Session 7: Targeting the ER and PI3K pathway: Novel drugs and combinations
- Date/Time: Wednesday, December 11, 8:00-9:30 a.m. ET (7:00-8:30 a.m. CT)
- Data support planned initiation of Phase 3 pivotal trial for RLY-2608 + fulvestrant in 2025
- Reported interim data for RLY-2608 + fulvestrant in patients with PI3Kα-mutated, HR+, HER2- metastatic breast cancer who had previously received at least one prior CDK4/6 inhibitor. The data demonstrated clinically meaningful progression free survival (PFS) at the company’s recommended Phase 2 dose (RP2D) of 600mg BID. The cut-off date for these data was August 12, 2024. Key highlights included:
- RLY-2608 triplet: Continued to progress two potential front-line triplet regimens in patients with PI3Kα-mutated, HR+, HER2- metastatic breast cancer who had previously received at least one prior CDK4/6 inhibitor, including:
- CDK4/6: RLY-2608 + ribociclib + fulvestrant dose escalation is currently testing biologically active doses of RLY-2608 and is on track to identify a dose of RLY-2608 that is combinable with full-dose ribociclib. Expansion cohorts are expected to initiate in the first half of 2025
- CDK4: RLY-2608 + atirmociclib + fulvestrant trial on track to initiate by the end of 2024
Lirafugratinib (RLY-4008)
- Presented updated FGFR2 fusion tumor agnostic data at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, October 23-25, 2024
- Provided regulatory update regarding lirafugratinib regulatory path in which the FDA suggested that the company first file a new drug application (NDA) in cholangiocarcinoma, followed by a tumor agnostic supplemental NDA for FGFR2 fusions with data from more patients and more follow up
- Disclosed plans to seek a global commercialization partner for lirafugratinib in order to maintain company’s focus on the remainder of the portfolio
Corporate Highlights
- Raised
$230 million of gross proceeds in an underwritten follow-on public offering in September 2024 - Completed series of changes to streamline the research organization, collectively resulting in an expected
$50 million in annual savings and workforce reduction of approximately15% . Changes are part of the company’s shift to becoming more development-focused in preparation for the upcoming RLY-2608 pivotal trial as well as new programs entering the clinic over the course of 2025
Anticipated Upcoming Milestones
- Breast Cancer
- RLY-2608 + fulvestrant + ribociclib initial safety data in the fourth quarter of 2024
- RLY-2608 + fulvestrant + atirmociclib clinical trial initiation by the end of 2024
- RLY-2608 + fulvestrant + ribociclib dose expansion initiation in the first half of 2025
- RLY-2608 + fulvestrant 2L Phase 3 trial initiation in 2025
- Pre-clinical
- Vascular malformations: RLY-2608 clinical trial initiation in the first quarter of 2025
- Fabry disease: clinical start in the second half of 2025
- NRAS: clinical start in the second half of 2025
Third Quarter 2024 Financial Results
Cash, Cash Equivalents and Investments: As of September 30, 2024, cash, cash equivalents and investments totaled
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 Relay Therapeutics
Relay Therapeutics is a clinical-stage precision medicine company transforming the drug discovery process by combining leading-edge computational and experimental technologies with the goal of bringing life-changing therapies to patients. As the first of a new breed of biotech created at the intersection of complementary techniques and technologies, Relay Therapeutics aims to push the boundaries of what’s possible in drug discovery. Its 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. Relay Therapeutics’ initial focus is on enhancing small molecule therapeutic discovery in targeted oncology and genetic disease indications. For more information, please visit www.relaytx.com or follow us on Twitter.
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 and clinical initiation of the programs across Relay Therapeutics’ portfolio; the progress toward bringing Relay Therapeutics’ pre-clinical programs to the clinic, including anticipated timing; the expected therapeutic benefits and potential efficacy and tolerability of RLY-2608, both as a monotherapy and in combination with other agents, and its other programs, including lirafugratinib; the timing and scope of clinical updates for RLY-2608; Relay Therapeutics’ plan to seek a global commercialization partner for lirafugratinib; the interactions with regulatory authorities and any related approvals; the potential market opportunity for RLY-2608; the cash runway projection and the expectations regarding Relay Therapeutics’ use of capital, expenses and potential cost savings. 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; 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:
Megan Goulart
617-545-5526
mgoulart@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) | ||||||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Revenue: | ||||||||||||||||
| License and other revenue | $ | — | $ | 25,202 | $ | 10,007 | $ | 25,547 | ||||||||
| Total revenue | — | 25,202 | 10,007 | 25,547 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development expenses | $ | 76,619 | $ | 81,494 | $ | 251,014 | $ | 252,522 | ||||||||
| Change in fair value of contingent consideration liability | — | (1,200 | ) | (13,206 | ) | (4,355 | ) | |||||||||
| General and administrative expenses | 19,750 | 18,485 | 59,688 | 58,184 | ||||||||||||
| Total operating expenses | 96,369 | 98,779 | 297,496 | 306,351 | ||||||||||||
| Loss from operations | (96,369 | ) | (73,577 | ) | (287,489 | ) | (280,804 | ) | ||||||||
| Other income: | ||||||||||||||||
| Interest income | 8,274 | 7,845 | 25,772 | 22,345 | ||||||||||||
| Other (expense) income | (10 | ) | (2 | ) | 13 | (19 | ) | |||||||||
| Total other income, net | 8,264 | 7,843 | 25,785 | 22,326 | ||||||||||||
| Net loss | $ | (88,105 | ) | $ | (65,734 | ) | $ | (261,704 | ) | $ | (258,478 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.63 | ) | $ | (0.54 | ) | $ | (1.94 | ) | $ | (2.12 | ) | ||||
| Weighted average shares of common stock, basic and diluted | 140,229,056 | 122,231,255 | 134,651,728 | 121,843,116 | ||||||||||||
| Other comprehensive income (loss): | ||||||||||||||||
| Unrealized holding gain | 3,849 | 2,695 | 2,705 | 7,034 | ||||||||||||
| Total other comprehensive income | 3,849 | 2,695 | 2,705 | 7,034 | ||||||||||||
| Total comprehensive loss | $ | (84,256 | ) | $ | (63,039 | ) | $ | (258,999 | ) | $ | (251,444 | ) | ||||
| Relay Therapeutics, Inc. Selected Condensed Consolidated Balance Sheet Data (In thousands) (Unaudited) | ||||||||
| September 30, 2024 | December 31, 2023 | |||||||
| Cash, cash equivalents and investments | $ | 839,609 | $ | 750,086 | ||||
| Working capital (1) | 818,161 | 739,834 | ||||||
| Total assets | 930,115 | 843,980 | ||||||
| Total liabilities | 91,254 | 91,977 | ||||||
| Total stockholders’ equity | 838,861 | 752,003 | ||||||
| Restricted cash | 2,119 | 2,707 | ||||||
(1) Working capital is defined as current assets less current liabilities.
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