Relay Therapeutics Reports Second Quarter 2024 Financial Results and Corporate Highlights
Relay Therapeutics (Nasdaq: RLAY) reported its Q2 2024 financial results and corporate highlights. The company announced three new programs focusing on genetic diseases and precision oncology.
Key updates include a global clinical trial collaboration with Pfizer for the combination development of RLY-2608 with fulvestrant and atirmociclib, targeting PI3Kα-mutated HR+/HER2- metastatic breast cancer, with clinical trials starting by end of 2024.
Relay has approximately $688 million in cash and investments, expected to fund operations into the second half of 2026. R&D expenses rose to $92 million, primarily due to the ReDiscover trial for RLY-2608, while G&A expenses remained steady at $20.1 million. The company posted a net loss of $92.2 million or $0.69 per share, compared to $98.5 million or $0.81 per share in Q2 2023.
Relay Therapeutics (Nasdaq: RLAY) ha riportato i risultati finanziari e i punti salienti aziendali del secondo trimestre del 2024. L'azienda ha annunciato tre nuovi programmi focalizzati su malattie genetiche e oncologia di precisione.
Le principali novità includono una collaborazione globale per studi clinici con Pfizer per lo sviluppo combinato di RLY-2608 con fulvestrant e atirmociclib, mirato al cancro al seno metastatico HR+/HER2- con mutazione del PI3Kα, con inizio degli studi clinici previsto entro la fine del 2024.
Relay dispone di circa 688 milioni di dollari in contante e investimenti, che si prevede finanzino le operazioni fino alla seconda metà del 2026. Le spese per la ricerca e sviluppo (R&D) sono aumentate a 92 milioni di dollari, principalmente a causa dello studio ReDiscover per RLY-2608, mentre le spese generali e amministrative (G&A) sono rimaste stabili a 20,1 milioni di dollari. L’azienda ha registrato una perdita netta di 92,2 milioni di dollari, ovvero 0,69 dollari per azione, rispetto ai 98,5 milioni di dollari, ovvero 0,81 dollari per azione, del secondo trimestre del 2023.
Relay Therapeutics (Nasdaq: RLAY) reportó sus resultados financieros y aspectos destacados corporativos del segundo trimestre de 2024. La compañía anunció tres nuevos programas centrados en enfermedades genéticas y oncología de precisión.
Las actualizaciones clave incluyen una colaboración global para ensayos clínicos con Pfizer para el desarrollo combinado de RLY-2608 con fulvestrant y atirmociclib, dirigido al cáncer de mama metastásico HR+/HER2- con mutaciones en PI3Kα, con ensayos clínicos que comenzarán a finales de 2024.
Relay cuenta con aproximadamente 688 millones de dólares en efectivo e inversiones, que se espera financien las operaciones hasta la segunda mitad de 2026. Los gastos de I+D aumentaron a 92 millones de dólares, principalmente debido al ensayo ReDiscover para RLY-2608, mientras que los gastos generales y administrativos (G&A) se mantuvieron estables en 20,1 millones de dólares. La empresa tuvo una pérdida neta de 92,2 millones de dólares, o 0,69 dólares por acción, en comparación con 98,5 millones de dólares, o 0,81 dólares por acción, en el segundo trimestre de 2023.
릴레이 테라퓨틱스 (Nasdaq: RLAY)는 2024년 2분기 재무 결과 및 기업 하이라이트를 보고했습니다. 이 회사는 유전 질환과 정밀 종양학에 중점을 둔 세 가지 새로운 프로그램을 발표했습니다.
주요 업데이트에는 PI3Kα 변이가 있는 HR+/HER2- 전이성 유방암을 목표로 RLY-2608과 풀베스트란트 및 아티르모시클립의 조합 개발을 위한 화이자와의 글로벌 임상 시험 협력이 포함되어 있으며, 임상 시험은 2024년 말까지 시작될 예정입니다.
릴레이는 약 6억 8800만 달러의 현금 및 투자를 보유하고 있으며, 이는 2026년 하반기까지 운영 자금을 지원할 것으로 예상됩니다. 연구개발(R&D) 비용은 RLY-2608에 대한 ReDiscover 시험으로 인해 9200만 달러로 증가했으며, 일반 및 관리(G&A) 비용은 2010만 달러로 안정세를 유지했습니다. 이 회사는 9220만 달러 또는 주당 0.69달러의 순손실을 기록했으며, 이는 2023년 2분기의 9850만 달러 또는 주당 0.81달러에 비해 감소한 수치입니다.
Relay Therapeutics (Nasdaq: RLAY) a annoncé ses résultats financiers et ses faits marquants pour le deuxième trimestre 2024. La société a annoncé trois nouveaux programmes axés sur les maladies génétiques et l'oncologie de précision.
Les mises à jour clés incluent une collaboration mondiale pour des essais cliniques avec Pfizer pour le développement combiné de RLY-2608 avec fulvestrant et atirmociclib, visant le cancer du sein métastatique HR+/HER2- avec mutation de PI3Kα, avec des essais cliniques commençant d'ici la fin de 2024.
Relay dispose d'environ 688 millions de dollars en liquidités et en investissements, qui devraient financer les opérations jusqu'à la seconde moitié de 2026. Les dépenses de R&D ont augmenté à 92 millions de dollars, principalement en raison de l'essai ReDiscover pour RLY-2608, tandis que les dépenses générales et administratives (G&A) sont restées stables à 20,1 millions de dollars. L'entreprise a affiché une perte nette de 92,2 millions de dollars, soit 0,69 dollar par action, par rapport à 98,5 millions de dollars, soit 0,81 dollar par action, au deuxième trimestre de 2023.
Relay Therapeutics (Nasdaq: RLAY) hat seine finanziellen Ergebnisse und Unternehmenshighlights für das zweite Quartal 2024 veröffentlicht. Das Unternehmen gab bekannt, dass es drei neue Programme zu genetischen Erkrankungen und präzisen Onkologie ins Leben ruft.
Wichtige Neuigkeiten beinhalten eine globale klinische Studienzusammenarbeit mit Pfizer zur kombinierten Entwicklung von RLY-2608 mit Fulvestrant und Atirmociclib, die auf PI3Kα-mutiertes HR+/HER2- metastatisches Brustkrebs abzielt, wobei klinische Studien bis Ende 2024 beginnen sollen.
Relay verfügt über etwa 688 Millionen Dollar an Bargeld und Investitionen, die voraussichtlich die Betriebe bis in die zweite Hälfte von 2026 finanzieren werden. Die F&E-Ausgaben (Forschung und Entwicklung) stiegen auf 92 Millionen Dollar, hauptsächlich aufgrund der ReDiscover-Studie für RLY-2608, während die allgemeinen und Verwaltungskosten (G&A) stabil bei 20,1 Millionen Dollar blieben. Das Unternehmen verzeichnete einen Nettoverlust von 92,2 Millionen Dollar oder 0,69 Dollar pro Aktie, verglichen mit 98,5 Millionen Dollar oder 0,81 Dollar pro Aktie im zweiten Quartal 2023.
- New global clinical trial collaboration with Pfizer to develop RLY-2608 combination therapy.
- Cash, cash equivalents, and investments of $688 million, expected to fund operations into the second half of 2026.
- Net loss per share reduced to $0.69 from $0.81 in Q2 2023.
- Net loss of $92.2 million for Q2 2024.
- R&D expenses increased to $92 million due to additional external costs for ReDiscover trial.
- Cash, cash equivalents, and investments decreased from $750.1 million at year-end 2023 to $688 million.
Relay Therapeutics' Q2 2024 results reveal a mixed financial picture. While R&D expenses increased to
The collaboration with Pfizer for RLY-2608 combination therapy could potentially accelerate development and share costs. However, the termination of the Genentech collaboration for migoprotafib is a setback, potentially impacting future revenue streams. The expansion into genetic diseases and NRAS inhibitors diversifies the pipeline but will require significant investment.
Overall, Relay's financial position remains stable, but investors should monitor the burn rate and progress of clinical programs for potential catalysts or risks.
Relay's RLY-2608 program shows promising developments in PI3Kα-mutant breast cancer. The planned data update with 100 patients in the safety database and 60 patients at the 600mg BID dose will provide important insights into efficacy and tolerability. The expansion into triplet combinations, particularly with Pfizer's selective CDK4 inhibitor, could potentially enhance treatment outcomes.
The partial responses observed in RLY-2608 monotherapy across multiple tumor types are encouraging, suggesting broader applicability. The NRAS-selective inhibitor program addresses an unmet need in RAS-driven cancers, potentially offering a more targeted approach than current pan-RAS inhibitors.
However, the termination of the migoprotafib program is a setback. Investors should closely monitor upcoming data readouts and regulatory interactions to gauge the potential clinical impact and market positioning of Relay's oncology pipeline.
Relay's expansion into genetic diseases with vascular malformations and Fabry disease programs represents a strategic diversification. The PI3Kα-targeted approach for vascular malformations addresses a significant unmet need, potentially benefiting 170,000 patients in the U.S. alone. The novel non-inhibitory chaperone for Fabry disease could offer a unique therapeutic approach for the estimated 8,000 U.S. patients.
The company's ability to leverage its computational platform across oncology and genetic diseases demonstrates versatility in drug discovery. The aggressive timeline to initiate clinical trials for these programs in 2025 is ambitious but could lead to rapid value creation if successful.
Investors should consider the potential market size of these rare disease indications and the competitive landscape. Success in these areas could significantly expand Relay's therapeutic reach and provide diversification from oncology-focused programs.
Announced 3 new programs, including genetic disease programs in vascular malformations, Fabry disease, as well as precision oncology program with NRAS-specific inhibitor
Initiated global clinical trial collaboration with Pfizer for combination development of RLY-2608 + fulvestrant + atirmociclib (CDK4i) in PI3Kα-mutated HR+/HER2- metastatic breast cancer, with clinical start planned by end of 2024
Approximately
CAMBRIDGE, Mass., Aug. 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 second quarter 2024 financial results and corporate highlights.
“In the second quarter, we made important progress continuing to advance our clinical programs, which we believe has positioned us well for multiple data readouts later this year. Additionally, we look forward to expanding the RLY-2608 development program, with the initiation of a new triplet combination with Pfizer's novel investigative selective-CDK4 inhibitor atirmociclib by the end of the year,” said Sanjiv Patel, M.D., President and Chief Executive Officer of Relay Therapeutics. “Looking further ahead, we are very excited by the pre-clinical programs we unveiled in June, including our first two genetic disease programs, which will be important in driving our continued growth and diversification.”
Recent Corporate Highlights
RLY-2608 (ReDiscover study)
- RLY-2608 doublet: continued to enroll patients with PI3Kα-mutant, HR+, HER2- locally advanced or metastatic breast cancer in dose expansion cohorts of RLY-2608 400mg BID and 600mg BID in combination with fulvestrant
- The next data update is expected in the fourth quarter of 2024 and will include approximately 100 patients across doses in the safety database and approximately 60 patients at the 600mg BID dose, including about 40 who have had the opportunity to be on RLY-2608 for at least 6 months
- RLY-2608 triplet:
- CDK4/6: continued enrollment of RLY-2608 + fulvestrant + ribociclib triplet combination in patients with PI3Kα-mutant, HR+, HER2- locally advanced or metastatic breast cancer
- CDK4: announced a clinical trial collaboration to evaluate atirmociclib, Pfizer’s investigative selective-CDK4 inhibitor, in combination with RLY-2608 and fulvestrant in patients with PI3Kα-mutant, HR+, HER2- metastatic breast cancer. The RLY-2608 + atirmociclib + fulvestrant triplet combination is planned to begin by the end of 2024
- RLY-2608 monotherapy: continued to enroll patients with unresectable or metastatic solid tumors with a PI3Kα mutation in dose escalation portion of RLY-2608 monotherapy arm and reported partial responses in multiple tumor types
Migoprotafib (GDC-1971)
- As previously disclosed, Genentech has terminated the collaboration agreement for the development and commercialization of migoprotafib
- The company will not continue development of migoprotafib
Pre-Clinical Programs
- Disclosed three new pre-clinical programs: vascular malformations, Fabry disease and NRAS
- Vascular Malformations
- PI3Kα is the most common driver mutation among specific types of vascular malformations, which are a series of rare syndromes that occur due to atypical development of lymphatic and/or blood vessels and can become life-threatening, depending on what vessel(s) are involved
- In the U.S., an estimated 170,000 people have one of the sub-types driven by a PI3Kα mutation, which include PIK3CA-related overgrowth spectrum, lymphatic malformations, venous malformations and cerebral cavernous malformations
- A mutant selective PI3Kα inhibitor provides the opportunity for greater target coverage, leading to the potential for improved efficacy and better chronic tolerability
- Relay Therapeutics plans to initiate clinical development of RLY-2608 in vascular malformations in the first quarter of 2025
- Fabry Disease
- In Fabry disease, harmful levels of Gb3 accumulate in blood cells and tissues throughout the body, due to insufficient αGal enzyme activity, which can lead to a range of symptoms, including potentially life-threatening ones such as kidney failure, heart failure and stroke. In the U.S., approximately 8,000 people have Fabry disease
- Relay Therapeutics has created the first investigational non-inhibitory chaperone for Fabry disease, which is designed to stabilize the αGal protein without inhibiting its activity, thus enabling greater Gb3 clearance across organs
- The company expects its non-inhibitory chaperone to enter the clinic in the second half of 2025
- NRAS
- In the U.S., an estimated 28,000 people are diagnosed annually with mutated NRAS solid tumors, which are a known oncogene driver in the RAS family and can lead to a number of cancers, including melanoma, colorectal and non-small-cell lung
- Relay Therapeutics has created the first NRAS-selective inhibitor, which has been designed to address the liabilities of current pan-RAS inhibitors by only binding to NRAS, while sparing KRAS and HRAS
- The company expects to initiate clinical development of its NRAS-selective inhibitor in the second half of 2025
Anticipated Upcoming Milestones
- Breast Cancer
- RLY-2608 + fulvestrant data update in the fourth quarter of 2024
- 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 potential Phase 3 trial initiation in 2025
- Lirafugratinib: tumor agnostic data and regulatory update in the second half of 2024
- 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
Second Quarter 2024 Financial Results
Cash, Cash Equivalents and Investments: As of June 30, 2024, cash, cash equivalents and investments totaled
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 (Nasdaq: RLAY) 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 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 and progress of doublet and triplet combinations for RLY-2608, the timing and scope of clinical updates for RLY-2608, the timing of a clinical data and regulatory update for lirafugratinib; the timing of clinical initiation of Relay Therapeutics’ various programs, including a potential pivotal trial for RLY-2608, clinical development in vascular malformations, clinical development of Relay Therapeutics’ non-inhibitory chaperone, and clinical development of its NRAS-selective inhibitor; the potential of Relay Therapeutics’ product candidates to address a major unmet medical need; the cash runway projection; the competitive landscape and potential market opportunities for Relay Therapeutics’ product candidates; the expected strategic benefits under Relay Therapeutics’ collaborations; and expectations regarding Relay Therapeutics’ pipeline, operating plan, use of capital, expenses and other financial results. 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 results of its pre-clinical or clinical trials may not be predictive of future or final results in connection with future clinical trials of its product candidates; 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 June 30, | Six Months Ended June 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Revenue: | ||||||||||||||||
| License and other revenue | $ | — | $ | 119 | $ | 10,007 | $ | 345 | ||||||||
| Total revenue | — | 119 | 10,007 | 345 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development expenses | $ | 91,992 | $ | 88,201 | $ | 174,395 | $ | 171,028 | ||||||||
| Change in fair value of contingent consideration liability | (11,374 | ) | (2,152 | ) | (13,206 | ) | (3,155 | ) | ||||||||
| General and administrative expenses | 20,139 | 20,120 | 39,938 | 39,699 | ||||||||||||
| Total operating expenses | 100,757 | 106,169 | 201,127 | 207,572 | ||||||||||||
| Loss from operations | (100,757 | ) | (106,050 | ) | (191,120 | ) | (207,227 | ) | ||||||||
| Other income: | ||||||||||||||||
| Interest income | 8,547 | 7,559 | 17,498 | 14,500 | ||||||||||||
| Other (expense) income | (2 | ) | (14 | ) | 23 | (17 | ) | |||||||||
| Total other income, net | 8,545 | 7,545 | 17,521 | 14,483 | ||||||||||||
| Net loss | $ | (92,212 | ) | $ | (98,505 | ) | $ | (173,599 | ) | $ | (192,744 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.69 | ) | $ | (0.81 | ) | $ | (1.32 | ) | $ | (1.59 | ) | ||||
| Weighted average shares of common stock, basic and diluted | 132,821,826 | 121,680,844 | 131,832,420 | 121,501,849 | ||||||||||||
| Other comprehensive (loss) income: | ||||||||||||||||
| Unrealized holding (loss) gain | (182 | ) | (279 | ) | (1,144 | ) | 4,339 | |||||||||
| Total other comprehensive (loss) income | (182 | ) | (279 | ) | (1,144 | ) | 4,339 | |||||||||
| Total comprehensive loss | $ | (92,394 | ) | $ | (98,784 | ) | $ | (174,743 | ) | $ | (188,405 | ) | ||||
| Relay Therapeutics, Inc. Selected Condensed Consolidated Balance Sheet Data (In thousands) (Unaudited) | ||||||||
| June 30, 2024 | December 31, 2023 | |||||||
| Cash, cash equivalents and investments | $ | 688,415 | $ | 750,086 | ||||
| Working capital (1) | 659,227 | 739,834 | ||||||
| Total assets | 772,750 | 843,980 | ||||||
| Total liabilities | 90,806 | 91,977 | ||||||
| Total stockholders’ equity | 681,744 | 752,003 | ||||||
| Restricted cash | 2,707 | 2,707 | ||||||
(1) Working capital is defined as current assets less current liabilities.
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