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Prelude Therapeutics Reports Second Quarter 2024 Financial Results and Provides Corporate Update

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Prelude Therapeutics (NASDAQ: PRLD) reported its Q2 2024 financial results and provided a corporate update. Key highlights include:

  • Interim Phase 1 data for PRT3789, a first-in-class IV SMARCA2 degrader, selected for oral presentation at ESMO 2024
  • Received FDA IND authorization for PRT7732, a first-in-class oral SMARCA2 degrader
  • Announced clinical collaboration with Merck to evaluate PRT3789 with KEYTRUDA in SMARCA4-mutated cancers
  • CDK9 inhibitor PRT2527 on track to report interim Phase 1 data in Q4 2024
  • Cash runway into 2026 with $179.8 million as of June 30, 2024

Q2 2024 financials: R&D expenses increased to $29.5 million, G&A expenses rose to $7.7 million, and net loss was $34.7 million ($0.46 per share).

Prelude Therapeutics (NASDAQ: PRLD) ha riportato i risultati finanziari del secondo trimestre 2024 e fornito un aggiornamento aziendale. I principali punti salienti includono:

  • Dati intermedi della Fase 1 per PRT3789, un degrader IV SMARCA2 di prima classe, selezionato per presentazione orale all'ESMO 2024
  • Ricevuta l'autorizzazione IND dalla FDA per PRT7732, un degrader SMARCA2 orale di prima classe
  • Annunciata collaborazione clinica con Merck per valutare PRT3789 insieme a KEYTRUDA nei tumori mutati di SMARCA4
  • Inibitore CDK9 PRT2527 in programma per riportare dati intermedi della Fase 1 nel quarto trimestre del 2024
  • Liquidità fino al 2026 con $179,8 milioni al 30 giugno 2024

Finanziamenti del Q2 2024: le spese per ricerca e sviluppo sono aumentate a $29,5 milioni, le spese generali e amministrative sono salite a $7,7 milioni, e la perdita netta è stata di $34,7 milioni ($0,46 per azione).

Prelude Therapeutics (NASDAQ: PRLD) reportó sus resultados financieros del segundo trimestre de 2024 y ofreció una actualización corporativa. Los aspectos más destacados incluyen:

  • Datos interinos de Fase 1 para PRT3789, un degradador IV SMARCA2 de primera clase, seleccionado para presentación oral en ESMO 2024
  • Autorización IND de la FDA para PRT7732, un degradador SMARCA2 oral de primera clase
  • Anuncio de colaboración clínica con Merck para evaluar PRT3789 con KEYTRUDA en cánceres mutados por SMARCA4
  • El inhibidor de CDK9 PRT2527 está en camino de reportar datos interinos de Fase 1 en el cuarto trimestre de 2024
  • Disponibilidad de efectivo hasta 2026 con $179.8 millones al 30 de junio de 2024

Finanzas del Q2 2024: los gastos de I+D aumentaron a $29.5 millones, los gastos generales y administrativos subieron a $7.7 millones, y la pérdida neta fue de $34.7 millones ($0.46 por acción).

프렐루드 테라퓨틱스(나스닥: PRLD)가 2024년 2분기 재무 결과를 발표하고 회사 업데이트를 제공했습니다. 주요 하이라이트는 다음과 같습니다:

  • ESMO 2024에서 구두 발표를 위해 선정된 1상 간헐적 데이터 PRT3789, 1세대 IV SMARCA2 분해제
  • 1세대 경구 SMARCA2 분해제 PRT7732에 대한 FDA IND 승인 획득
  • MERCK와의 임상 협력 발표: SMARCA4 돌연변이 암에서 PRT3789와 KEYTRUDA 평가
  • CDK9 억제제 PRT2527: 2024년 4분기 중간 1상 데이터 보고 예정
  • 2024년 6월 30일 기준 1억 7천 9백 80만 달러로 2026년까지 현금 소진 가능

2024년 2분기 재정: R&D 비용은 2천 9백 50만 달러로 증가, G&A 비용은 770만 달러로 상승, 순손실은 3천 4백 70만 달러($0.46 주당)로 나타났습니다.

Prelude Therapeutics (NASDAQ: PRLD) a annoncé ses résultats financiers pour le deuxième trimestre 2024 et a fourni une mise à jour de l'entreprise. Les faits saillants incluent :

  • Données intermédiaires de Phase 1 pour PRT3789, un dégradateur IV SMARCA2 de première classe, sélectionné pour une présentation orale à l'ESMO 2024
  • Obtention de l'autorisation IND de la FDA pour PRT7732, un dégradateur SMARCA2 oral de première classe
  • Annonce d'une collaboration clinique avec Merck pour évaluer PRT3789 avec KEYTRUDA dans les cancers mutés SMARCA4
  • Inhibiteur CDK9 PRT2527 à l'ordre du jour pour rapporter des données intermédiaires de la Phase 1 au quatrième trimestre 2024
  • Situation de liquidité jusqu'en 2026 avec 179,8 millions de dollars au 30 juin 2024

Finances du T2 2024 : Les dépenses en R&D ont augmenté à 29,5 millions de dollars, les dépenses générales et administratives ont augmenté à 7,7 millions de dollars, et la perte nette s'élevait à 34,7 millions de dollars (0,46 dollar par action).

Prelude Therapeutics (NASDAQ: PRLD) hat seine finanziellen Ergebnisse für das zweite Quartal 2024 veröffentlicht und ein Unternehmensupdate gegeben. Die wichtigsten Highlights sind:

  • Zwischenergebnisse der Phase 1 für PRT3789, einen erstklassigen IV SMARCA2-Degrader, der für eine mündliche Präsentation auf der ESMO 2024 ausgewählt wurde
  • Erhalt der FDA-IND-Genehmigung für PRT7732, einen erstklassigen oralen SMARCA2-Degrader
  • Ankündigung einer klinischen Zusammenarbeit mit Merck zur Bewertung von PRT3789 zusammen mit KEYTRUDA bei SMARCA4-mutierten Krebserkrankungen
  • CDK9-Inhibitor PRT2527 ist auf dem Weg, im vierten Quartal 2024 Zwischenergebnisse der Phase 1 zu berichten
  • Barmittel bis 2026 mit 179,8 Millionen USD zum 30. Juni 2024

Finanzen Q2 2024: F&E-Ausgaben stiegen auf 29,5 Millionen USD, G&A-Ausgaben erhöhten sich auf 7,7 Millionen USD und der Nettoverlust betrug 34,7 Millionen USD (0,46 USD pro Aktie).

Positive
  • Interim Phase 1 data for PRT3789 selected for oral presentation at ESMO 2024, indicating potential significance
  • Received FDA IND authorization for PRT7732, advancing the SMARCA2 degrader pipeline
  • Clinical collaboration with Merck to evaluate PRT3789 with KEYTRUDA, expanding potential applications
  • Cash runway extended into 2026 with $179.8 million on hand
  • PRT2527 on track to report interim Phase 1 data in Q4 2024, potentially demonstrating best-in-class safety profile
Negative
  • Increased R&D expenses to $29.5 million from $25.0 million in the prior year period
  • Higher G&A expenses of $7.7 million compared to $7.4 million in the prior year period
  • Net loss increased to $34.7 million from $30.4 million in the prior year period

Insights

Prelude Therapeutics' Q2 2024 results show a solid financial position with $179.8 million in cash and equivalents, extending runway into 2026. However, the company's net loss widened to $34.7 million ($0.46 per share) from $30.4 million in Q2 2023. R&D expenses increased to $29.5 million, reflecting investment in clinical programs.

The company's focus on first-in-class SMARCA2 degraders and CDK9 inhibitor shows promise, with upcoming data presentations potentially serving as catalysts. The collaboration with Merck for combination therapy could enhance market potential. However, investors should note that Prelude remains in early clinical stages with no approved products, presenting significant development risks.

Prelude's pipeline shows innovative approaches in precision oncology, particularly with SMARCA2 degraders. The selection of PRT3789 data for oral presentation at ESMO 2024 suggests promising early results. The focus on SMARCA4-mutated cancers addresses a high unmet need in oncology, as these patients often have poor prognoses.

The collaboration with Merck to combine PRT3789 with KEYTRUDA® is intriguing, as it could potentially enhance anti-tumor immunity. The development of oral SMARCA2 degrader PRT7732 and the potentially best-in-class CDK9 inhibitor PRT2527 further diversifies Prelude's approach. However, efficacy and safety data from ongoing trials will be important for assessing the true potential of these novel therapies.

Prelude's strategy of developing first-in-class therapies in precision oncology positions it well in a competitive biotech landscape. The company's focus on SMARCA2 degraders and CDK9 inhibitors demonstrates a targeted approach to addressing specific cancer pathways.

The collaboration with Merck and AbCellera highlights Prelude's ability to form strategic partnerships, potentially accelerating development and expanding market reach. However, as with many early-stage biotech companies, Prelude faces significant clinical and regulatory hurdles. The upcoming data presentations in Q3 and Q4 2024 will be critical for validating the company's technology and attracting further investor interest. Investors should closely monitor these events as potential inflection points for the stock.

Interim Phase 1 data for its first-in-class, highly selective IV SMARCA2 degrader, PRT3789, selected for an oral presentation at the European Society for Medical Oncology (ESMO) Congress 2024 in September

Received investigational new drug (IND) authorization for PRT7732, its first-in-class oral SMARCA2 degrader, from the U.S. Food and Drug Administration (FDA)

Announced clinical collaboration with Merck to evaluate PRT3789 in combination with Merck’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in patients with SMARCA4-mutated cancers

Potentially best-in-class CDK9 inhibitor, PRT2527, remains on track to report interim Phase 1 data in Q4 2024 

Current cash runway into 2026 with $179.8 million in cash, cash equivalents and marketable securities as of June 30, 2024 

WILMINGTON, Del., Aug. 12, 2024 (GLOBE NEWSWIRE) -- Prelude Therapeutics Incorporated (Nasdaq: PRLD), a clinical-stage precision oncology company, today reported its financial results for the second quarter ended June 30, 2024 and provided an update on its clinical development pipeline and other corporate developments.

“Our team continues to make solid progress towards the Company’s ambitious R&D objectives that we established for 2024 and beyond. We are focused on advancing our two lead clinical programs, including the first-in-class, highly selective SMARCA2 degrader, PRT3789 and a potent and selective CDK9 inhibitor, PRT2527, both on track to report initial clinical results this year,” stated Kris Vaddi, Ph.D., Chief Executive Officer of Prelude.

Dr. Vaddi continued, “We believe that targeting the SMARCA pathway has the potential to deliver a ‘pipeline in a program.’ We are building on our leadership position by advancing the industry’s first highly selective oral SMARCA2 degrader, PRT7732, into the clinic, and will initiate a study of PRT3789 in combination with KEYTRUDA in collaboration with Merck later this year. Additionally, in collaboration with AbCellera, we are developing precision ADCs with SMARCA payloads to extend the reach of our molecules to an even broader set of cancers without SMARCA4 mutations.”

“Regarding our clinical development programs, we are very pleased with the progress of both of our SMARCA2 degraders, PRT3789 and PRT7732,” added Jane Huang, M.D., President and Chief Medical Officer of Prelude. “We are looking forward to sharing the initial clinical data from the Phase 1 study of our highly selective SMARCA2 degrader which has been chosen as the subject of an oral presentation at the upcoming ESMO Congress in September.”  

Dr. Huang continued, “Additionally, based on the continued progress of PRT2527, our selective CDK9 inhibitor, we intend to present interim phase 1 clinical data, including a potential best-in-class safety profile in the fourth quarter of this year.”

Clinical Program Updates and Upcoming Milestones  

PRT3789 – A first-in-class, highly selective, intravenous SMARCA2 Degrader

PRT3789 is a first-in-class SMARCA2 degrader, highly selective for SMARCA2 and designed to treat patients with a SMARCA4 mutation. Cancer patients whose tumors have SMARCA4 mutations have a poor prognosis and as a result, this is an area of high unmet medical need.

PRT3789 is in Phase 1 clinical development in biomarker selected SMARCA4 mutant patients. Enrollment remains on track, and the Company expects to conclude monotherapy dose escalation in 2024 and identify a recommended Phase 2 dose. In addition, enrollment of patients into back-fill cohorts enriched for NSCLC and SMARCA4 loss-of-function mutations is ongoing, as is enrollment of the combination with docetaxel cohort.

Objectives for this first Phase 1 clinical trial are to establish the safety and tolerability profile of PRT3789 as both monotherapy and in combination with docetaxel, evaluate activity, pharmacokinetics and pharmacodynamics and determine a dose and potential indications for advancement into registrational clinical trial(s).

Prelude recently launched an educational video series focused on the science of SMARCA biology, the discovery of first-in-class, highly selective SMARCA2 degraders and the unmet medical need for patients with SMARCA4 mutated cancer. This series can be found on the Company’s website under Highly Selective SMARCA2 Degraders - Prelude Therapeutics (preludetx.com).

Interim Phase 1 data selected for an oral presentation at the ESMO Congress 2024

The abstract titled “First Clinical Results from a Phase 1 Trial of PRT3789, a First-in-Class Intravenous SMARCA2 Degrader, in Patients with Advanced Solid Tumors with a SMARCA4 Mutation,” will be presented by Robin Guo, M.D. from Memorial Sloan Kettering Cancer Center. The ESMO Congress 2024 Scientific Committee selected the abstract as an oral presentation.

The presentation is scheduled for September 13th, 2024, at 4:00 PM CEST (10:00 AM EST) in the Santander Auditorium (Hall 5) as part of the Developmental Therapeutics Session.

Abstracts are anticipated to be available on the ESMO website on September 9th, 2024 at 12:05 AM CEST (6:05 PM EST on September 8th).

Clinical collaboration announced with Merck to evaluate PRT3789 in combination with KEYTRUDA® in patients with SMARCA4-mutated cancers

In July 2024, Prelude announced a clinical collaboration with Merck to evaluate PRT3789 in combination with KEYTRUDA® in patients with SMARCA4-mutated cancers.

The mechanistic rationale and pre-clinical data to support the SMARCA2 and anti-PD-1 monoclonal antibody (mAb) combination was previously presented by the Company at the 2023 AACR International Conference on Molecular Targets and Cancer Therapeutics. In pre-clinical models, SMARCA2 degrader combined with an anti-PD-1 mAb in SMARCA4-mutated cancers enhanced anti-tumor immunity and demonstrated tumor regressions. Please see the Company’s website under Publications - Prelude Therapeutics (preludetx.com) for more information.

Under the terms of the Agreement, Merck will provide KEYTRUDA® to Prelude. Prelude will be the sponsor of the Phase 2 clinical combination trial, anticipated to initiate in the fourth quarter of 2024. Prelude and Merck each retain all commercial rights to their respective compounds, including as monotherapy or as combination therapies.

KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

PRT7732 – A potent, highly selective and orally bioavailable SMARCA2 Degrader

Prelude has identified a series of highly selective and orally bioavailable SMARCA2 degraders. The lead oral candidate, PRT7732, recently was granted IND authorization from the FDA and is expected to enter Phase 1 clinical development in the second half of 2024.

PRT2527 – A potent and highly selective CDK9 Inhibitor

PRT2527 is a potent and highly selective CDK9 inhibitor that has the potential to avoid off-target toxicities observed with other less selective CDK9 inhibitors. The Company is currently advancing PRT2527 as monotherapy in both lymphoid and myeloid hematological malignancies, and in combination with zanubrutinib in B-cell malignancies.

PRT2527 is expected to complete monotherapy dose escalation in B-cell malignancies this year. Initiation of dose escalation in myeloid malignancies occurred in the first half of 2024. Interim Phase 1 data is on track for presentation in the fourth quarter of 2024. 

Second Quarter 2024 Financial Results  

Cash, Cash Equivalents, and Marketable securities:  
Cash, cash equivalents and marketable securities as of June 30, 2024 were $179.8 million. The Company anticipates that its existing cash, cash equivalents and marketable securities will fund Prelude’s operations into 2026.  

Research and Development (R&D) Expenses:  
For the second quarter of 2024, R&D expense increased to $29.5 million from $25.0 million for the prior year period. Research and development expenses increased primarily due to an increase in our chemistry, manufacturing, and controls (CMC) expense to support our pre-clinical and clinical research programs. We expect our R&D expenses to vary from quarter to quarter, primarily due to the timing of our clinical development activities.   

General and Administrative (G&A) Expenses:  
For the second quarter of 2024, G&A expenses increased to $7.7 million from $7.4 million for the prior year period. The increase is primarily due to an increase in professional fees incurred as we expand our operations to support our research and development efforts.

Net Loss:  
For the three months ended June 30, 2024, net loss was $34.7 million, or $0.46 per share compared to $30.4 million, or $0.54 per share, for the prior year period. Included in the net loss for the quarter ended June 30, 2024, was $6.1 million of non-cash expenses related to the impact of expensing share-based payments, including employee stock options, as compared to $6.7 million for the same period in 2023.  

About Prelude Therapeutics 

Prelude Therapeutics is a leading precision oncology company developing innovative medicines in areas of high unmet need for cancer patients. Our pipeline is comprised of several novel drug candidates including first-in-class, highly selective IV and oral SMARCA2 degraders, and a potentially best-in-class CDK9 inhibitor. We are also leveraging our expertise in targeted protein degradation to discover, develop and commercialize next generation degrader antibody conjugates (“Precision ADCs”) with partners. We are on a mission to extend the promise of precision medicine to every cancer patient in need. For more information, visit preludetx.com.

Cautionary Note Regarding Forward-Looking Statements 

This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, anticipated discovery, preclinical and clinical development activities for Prelude’s product candidates, the potential safety, efficacy, benefits and addressable market for Prelude’s product candidates, the expected timeline for initial proof-of-concept data and clinical trial results for Prelude’s product candidates, and the sufficiency of Prelude’s cash runway into 2026. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The words “believes,” “anticipates,” “estimates,” “plans,” “expects,” “intends,” “may,” “could,” “should,” “potential,” “likely,” “projects,” “continue,” “will,” “schedule,” and “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements are predictions based on the Company’s current expectations and projections about future events and various assumptions. Although Prelude believes that the expectations reflected in such forward-looking statements are reasonable, Prelude cannot guarantee future events, results, actions, levels of activity, performance or achievements, and the timing and results of biotechnology development and potential regulatory approval is inherently uncertain. Forward-looking statements are subject to risks and uncertainties that may cause Prelude's actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties related to Prelude's ability to advance its product candidates, the receipt and timing of potential regulatory designations, approvals and commercialization of product candidates, clinical trial sites and our ability to enroll eligible patients, supply chain and manufacturing facilities, Prelude’s ability to maintain and recognize the benefits of certain designations received by product candidates, the timing and results of preclinical and clinical trials, Prelude's ability to fund development activities and achieve development goals, Prelude's ability to protect intellectual property, and other risks and uncertainties described under the heading "Risk Factors" in Prelude’s Annual Report on Form 10-K for the year ended December 31, 2023, its Quarterly Reports on Form 10-Q and other documents that Prelude files from time to time with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this press release, and Prelude undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof, except as may be required by law.  


PRELUDE THERAPEUTICS INCORPORATED
 
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(UNAUDITED)
 
  Three Months Ended June 30,
(in thousands, except share and per share data) 2024
 2023
Operating expenses:      
Research and development $29,509  $24,966 
General and administrative  7,655   7,432 
Total operating expenses  37,164   32,398 
Loss from operations  (37,164)  (32,398)
Other income, net  2,424   1,967 
Net loss $(34,740) $(30,431)
Per share information:      
Net loss per share of common stock, basic and diluted $(0.46) $(0.54)
Weighted average common shares outstanding, basic and diluted  75,762,152   56,240,491 
Comprehensive loss:      
Net loss $(34,740) $(30,431)
Unrealized (loss) gain on marketable securities, net of tax  (55)  (313)
Comprehensive loss $(34,795) $(30,744)


PRELUDE THERAPEUTICS INCORPORATED
 
BALANCE SHEETS
 
(in thousands, except share data) June 30,
2024
  December 31,
2023
Assets (unaudited)     
Current assets:       
Cash and cash equivalents $27,828   $25,291 
Marketable securities  152,016    207,644 
Prepaid expenses and other current assets  2,870    2,654 
Total current assets  182,714    235,589 
Restricted cash  4,044    4,044 
Property and equipment, net  7,554    7,325 
Operating lease right-of-use asset  29,574    30,412 
Other assets  405    295 
Total assets $224,291   $277,665 
Liabilities and stockholders’ equity       
Current liabilities:       
Accounts payable $6,170   $4,580 
Accrued expenses and other current liabilities  11,426    15,768 
Deferred revenue  3,000     
Operating lease liability  2,232    1,481 
Finance lease liability  507     
Total current liabilities  23,335    21,829 
Other liabilities  3,215    3,339 
Operating lease liability  15,465    15,407 
Total liabilities  42,015    40,575 
Commitments       
Stockholders’ equity:       
Voting common stock, $0.0001 par value: 487,149,741 shares authorized; 42,158,224 and 42,063,995 shares issued and outstanding at June 30, 2024 and December 31, 2023, respectively  4    4 
Non-voting common stock, $0.0001 par value: 12,850,259 shares authorized; 12,850,259 shares issued and outstanding at both June 30, 2024 and December 31, 2023  1    1 
Additional paid-in capital  705,122    693,252 
Accumulated other comprehensive (loss) income  (290)   223 
Accumulated deficit  (522,561)   (456,390)
Total stockholders’ equity  182,276    237,090 
Total liabilities and stockholders’ equity $224,291   $277,665 
          

Investor Contact: 
Robert A. Doody, Jr.
Senior Vice President, Investor Relations
Prelude Therapeutics Incorporated 
484.639.7235
rdoody@preludetx.com


FAQ

What were Prelude Therapeutics' (PRLD) key financial results for Q2 2024?

Prelude Therapeutics reported a net loss of $34.7 million ($0.46 per share), R&D expenses of $29.5 million, and G&A expenses of $7.7 million for Q2 2024. The company had $179.8 million in cash, cash equivalents, and marketable securities as of June 30, 2024.

What are the upcoming milestones for Prelude Therapeutics' (PRLD) drug candidates?

Prelude Therapeutics expects to present interim Phase 1 data for PRT3789 at ESMO in September 2024, initiate a Phase 2 clinical trial for PRT3789 in combination with KEYTRUDA in Q4 2024, begin Phase 1 clinical development for PRT7732 in H2 2024, and report interim Phase 1 data for PRT2527 in Q4 2024.

What is the significance of Prelude Therapeutics' (PRLD) collaboration with Merck announced in July 2024?

The collaboration with Merck will evaluate Prelude's PRT3789 in combination with Merck's KEYTRUDA in patients with SMARCA4-mutated cancers. This partnership expands the potential applications of PRT3789 and leverages preclinical data showing enhanced anti-tumor immunity in combination therapy.

How long is Prelude Therapeutics' (PRLD) current cash expected to fund operations?

Prelude Therapeutics anticipates that its existing cash, cash equivalents, and marketable securities of $179.8 million as of June 30, 2024, will fund the company's operations into 2026.

Prelude Therapeutics Incorporated

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