Prime Medicine Reports Second Quarter 2024 Financial Results and Provides Business Updates
Prime Medicine (Nasdaq: PRME) reported Q2 2024 financial results and provided business updates. Key highlights include:
1. FDA clearance for PM359, a Prime Editor for chronic granulomatous disease (CGD), to enter clinical trials.
2. Promotion of Dr. Mohammed Asmal to Chief Medical Officer.
3. Advancing multiple programs across core focus areas.
4. R&D expenses increased to $43.1 million from $34.6 million in Q2 2023.
5. Net loss widened to $55.3 million from $42.4 million in Q2 2023.
6. Cash position of $176.4 million as of June 30, 2024.
The company anticipates initial clinical data for PM359 in 2025 and plans to advance several programs in hematology, immunology, liver, ocular, and neuromuscular areas.
Prime Medicine (Nasdaq: PRME) ha riportato i risultati finanziari del Q2 2024 e fornito aggiornamenti aziendali. I punti salienti includono:
1. Approvazione della FDA per PM359, un Prime Editor per la malattia granulomatosa cronica (CGD), per entrare in sperimentazioni cliniche.
2. Promozione del Dr. Mohammed Asmal a Chief Medical Officer.
3. Sviluppo di molti programmi in aree di focus principali.
4. Le spese per R&D sono aumentate a 43,1 milioni di dollari rispetto ai 34,6 milioni di dollari del Q2 2023.
5. La perdita netta è aumentata a 55,3 milioni di dollari rispetto ai 42,4 milioni di dollari del Q2 2023.
6. Posizione di cassa di 176,4 milioni di dollari al 30 giugno 2024.
L'azienda prevede dati clinici iniziali per PM359 nel 2025 e ha in programma di sviluppare diversi programmi nelle aree di ematologia, immunologia, fegato, oculare e neuromuscolare.
Prime Medicine (Nasdaq: PRME) informó los resultados financieros del segundo trimestre de 2024 y proporcionó actualizaciones sobre su negocio. Los aspectos destacados incluyen:
1. Aprobación de la FDA para PM359, un Prime Editor para la enfermedad granulomatosa crónica (CGD), para entrar en ensayos clínicos.
2. Ascenso del Dr. Mohammed Asmal a Director Médico.
3. Avance de múltiples programas en áreas de enfoque clave.
4. Los gastos de I+D aumentaron a 43,1 millones de dólares desde 34,6 millones de dólares en el segundo trimestre de 2023.
5. La pérdida neta se amplió a 55,3 millones de dólares desde 42,4 millones de dólares en el segundo trimestre de 2023.
6. Posición de efectivo de 176,4 millones de dólares al 30 de junio de 2024.
La empresa espera datos clínicos iniciales para PM359 en 2025 y planea avanzar en varios programas en hematología, inmunología, hígado, ocular y áreas neuromusculares.
프라임 의학(나스닥: PRME)은 2024년 2분기 재무 결과를 보고하고 비즈니스 업데이트를 제공했습니다. 주요 하이라이트는 다음과 같습니다:
1. 만성 육아종 질환(CGD)을 위한 프라임 에디터 PM359에 대한 FDA 승인, 임상 시험에 들어갑니다.
2. 모하메드 아스말 박사가 최고 의학 책임자로 승진했습니다.
3. 핵심 집중 분야에서 여러 프로그램이 발전하고 있습니다.
4. 연구 개발 비용이 2023년 2분기 3,460만 달러에서 4,310만 달러로 증가했습니다.
5. 순손실이 2023년 2분기 4,240만 달러에서 5,530만 달러로 확대되었습니다.
6. 2024년 6월 30일 기준 현금 보유액은 1억 7,640만 달러입니다.
회사는 2025년 PM359의 초기 임상 데이터를 예상하고 있으며, 혈액학, 면역학, 간, 안구 및 신경근 분야에서 여러 프로그램을 개발할 계획입니다.
Prime Medicine (Nasdaq: PRME) a rapporté les résultats financiers du deuxième trimestre 2024 et a fourni des mises à jour sur l'entreprise. Les points clés comprennent :
1. Approbation de la FDA pour PM359, un Prime Editor pour la maladie granulomateuse chronique (CGD), afin d'entrer dans des essais cliniques.
2. Promotion du Dr. Mohammed Asmal au poste de directeur médical.
3. Avancement de plusieurs programmes dans des domaines clés de focalisation.
4. Les dépenses en R&D ont augmenté à 43,1 millions de dollars contre 34,6 millions de dollars au deuxième trimestre 2023.
5. La perte nette s'est élargie à 55,3 millions de dollars contre 42,4 millions de dollars au deuxième trimestre 2023.
6. Position de trésorerie de 176,4 millions de dollars au 30 juin 2024.
L'entreprise prévoit des données cliniques initiales pour PM359 en 2025 et prévoit de faire avancer plusieurs programmes dans les domaines de l'hématologie, de l'immunologie, du foie, de l'ocular et des domaines neuromusculaires.
Prime Medicine (Nasdaq: PRME) hat die finanziellen Ergebnisse für das 2. Quartal 2024 veröffentlicht und Unternehmensupdates bereitgestellt. Die wichtigsten Punkte sind:
1. FDA-Zulassung für PM359, einen Prime Editor für die chronische granulomatöse Erkrankung (CGD), um klinische Studien zu starten.
2. Beförderung von Dr. Mohammed Asmal zum Chief Medical Officer.
3. Fortschritte bei mehreren Programmen in den Kernbereichen.
4. Die F&E-Ausgaben sind von 34,6 Millionen Dollar im 2. Quartal 2023 auf 43,1 Millionen Dollar gestiegen.
5. Der Nettoverlust hat sich im Vergleich zu 42,4 Millionen Dollar im 2. Quartal 2023 auf 55,3 Millionen Dollar ausgeweitet.
6. Die Barposition beträgt zum 30. Juni 2024 176,4 Millionen Dollar.
Das Unternehmen erwartet erste klinische Daten für PM359 im Jahr 2025 und plant, mehrere Programme in den Bereichen Hämatologie, Immunologie, Leber, Augen und neuromuskuläre Bereiche voranzutreiben.
- FDA clearance for PM359 to enter clinical trials for chronic granulomatous disease
- Promotion of Dr. Mohammed Asmal to Chief Medical Officer
- Advancing multiple programs across core focus areas
- Cash position increased to $176.4 million from $135.2 million at the end of 2023
- R&D expenses increased to $43.1 million from $34.6 million in Q2 2023
- Net loss widened to $55.3 million from $42.4 million in Q2 2023
- G&A expenses increased to $12.6 million from $10.7 million in Q2 2023
Insights
Prime Medicine's Q2 2024 results reveal a significant increase in R&D expenses to
Prime Medicine's transition to a clinical-stage company with the FDA clearance for PM359 marks a significant milestone. The focus on chronic granulomatous disease (CGD) demonstrates a strategic approach to rare diseases. The company's diverse pipeline, including programs in hematology, immunology, liver, ocular and neuromuscular disorders, showcases the versatility of their Prime Editing platform. The advancement of proprietary technologies like Shielded HSC and Immunotherapy Pairs (SCIP) and Prime Assisted Site-Specific Integrase Gene Editing (PASSIGE) indicates potential for breakthrough therapies. However, investors should note that success in preclinical stages doesn't guarantee clinical efficacy. The company's ability to translate these innovative approaches into successful therapies will be important for long-term value creation.
The promotion of Dr. Mohammed Asmal to CMO is a positive development, given his role in shepherding PM359 to IND acceptance. His experience will be important as Prime Medicine navigates its first clinical trial. The company's ambitious timeline, promising initial clinical data for PM359 in 2025, sets high expectations. The diverse pipeline across multiple therapeutic areas demonstrates the potential breadth of Prime Editing technology. However, investors should be cautious as the company faces significant challenges in translating preclinical success to clinical outcomes. The emphasis on proprietary delivery capabilities and safety data in the coming months will be critical in validating the platform's potential. The modularity of the Prime Editing platform could be a game-changer if it truly accelerates development across the portfolio.
CAMBRIDGE, Mass., Aug. 08, 2024 (GLOBE NEWSWIRE) -- Prime Medicine, Inc. (Nasdaq: PRME), a biotechnology company committed to delivering a new class of differentiated one-time curative genetic therapies, today reported financial results for the second quarter ended June 30, 2024, and provided a business update.
“In the second quarter, we achieved a key milestone for Prime Medicine and our next-generation gene editing technology, securing clearance from the U.S. Food and Drug Administration (FDA) to advance PM359, our Prime Editor for the treatment of chronic granulomatous disease (CGD), into the clinic. We are now in the process of initiating our Phase 1/2 clinical trial, and we look forward to sharing initial clinical data in 2025,” said Keith Gottesdiener, M.D., President and Chief Executive Officer of Prime Medicine. “As we mature into a clinical-stage company, I am particularly excited to announce Dr. Mohammed Asmal’s promotion to Chief Medical Officer. Since joining Prime Medicine in 2022, Mohammed has been a valuable member of our leadership team, helping shepherd PM359 to an investigational new drug (IND) acceptance and Prime’s first clinical trial, and leading our clinical development strategy across our portfolio more broadly. I look forward to his continued contributions as we prepare to dose the first patient with a Prime Editor.”
Dr. Gottesdiener continued, “In addition, we are advancing multiple programs across our core areas of focus, and we look forward to sharing new preclinical data showcasing our proprietary delivery capabilities, as well as the safety and potential of our Prime Editing technology across target tissues in the coming months. Importantly, we believe the modularity of our Prime Editing platform will allow us to apply learnings from these efforts across our portfolio, accelerating and de-risking our ongoing work and longer-term, enabling us to more efficiently execute our clinical development plans with the hope of rapidly impacting millions of people.”
Recent Business Updates
Corporate
- Today, Prime Medicine announced the promotion of Mohammed Asmal, M.D, Ph.D. to Chief Medical Officer, effective immediately. Dr. Asmal has served as Senior Vice President, Head of Clinical at Prime Medicine since 2022.
Anticipated Upcoming Milestones
Prime Medicine expects the following activities and next steps to drive Prime Medicine forward and support the Company’s maturation into a clinical-stage company:
Hematology and Immunology:
- Announce initial clinical data from the Phase 1/2 clinical trial of PM359 in CGD in 2025.
- Advance Shielded Hematopoietic Stem Cell (HSC) and Immunotherapy Pairs (SCIP) technology, establish proof-of-concept in HSC and immunotherapy and identify first clinical program(s) with this approach in 2024.
- Advance differentiated CAR-T program, using Prime Assisted Site-Specific Integrase Gene Editing (PASSIGE) technology, into lead optimization.
Liver:
- Continue to advance preclinical studies for three liver programs and initiate IND-enabling activities for at least one in 2024, leading to an IND and/or clinical trial application (CTA) in the second half of 2025 or first half of 2026.
Ocular:
- Nominate development candidate for Retinitis Pigmentosa/Rhodopsin (RHO-RP) program and initiate IND-enabling activities in 2024.
Neuromuscular:
- Continue to advance Friedreich’s Ataxia and advance one other program into lead optimization in 2024.
- In large animal studies, establish adeno-associated virus (AAV) delivery platform and route of administration for neuromuscular programs in 2024.
Second Quarter 2024 Financial Results
- Research and Development (R&D) Expenses: R&D expenses were
$43.1 million for the three months ended June 30, 2024, as compared to$34.6 million for the three months ended June 30, 2023. The increase in R&D expenses was driven by expenses related to the advancement of the Company’s pipeline and platform. - General and Administrative (G&A) Expenses: G&A expenses were
$12.6 million for the three months ended June 30, 2024, as compared to$10.7 million for the three months ended June 30, 2023. - Net Loss: Net loss was
$55.3 million for the three months ended June 30, 2024, as compared to$42.4 million for the three months ended June 30, 2023. - Cash Position: As of June 30, 2024, cash, cash equivalents, investments, and restricted cash were
$176.4 million , as compared to$135.2 million as of December 31, 2023.
About Prime Medicine
Prime Medicine is a leading biotechnology company dedicated to creating and delivering the next generation of gene editing therapies to patients. The Company is deploying its proprietary Prime Editing platform, a versatile, precise and efficient gene editing technology, to develop a new class of differentiated one-time curative genetic therapies. Designed to make only the right edit at the right position within a gene while minimizing unwanted DNA modifications, Prime Editors have the potential to repair almost all types of genetic mutations and work in many different tissues, organs and cell types. Taken together, Prime Editing’s versatile gene editing capabilities could unlock opportunities across thousands of potential indications.
Prime Medicine is currently progressing a diversified portfolio of investigational therapeutic programs organized around core areas of focus: hematology and immunology, liver, lung, ocular and neuromuscular. Across each core area, Prime Medicine’s initial focus is on genetic diseases with a fast, direct path to treating patients, and those with high unmet need not currently addressable using other gene editing approaches. Over time, the Company intends to maximize Prime Editing’s broad and versatile therapeutic potential to expand beyond the genetic diseases in its initial pipeline, potentially including immunological diseases, cancers, infectious diseases, and targeting genetic risk factors in common diseases, which collectively impact millions of people. For more information, please visit www.primemedicine.com.
© 2024 Prime Medicine, Inc. All rights reserved. PRIME MEDICINE, the Prime Medicine logos, and PASSIGE are trademarks of Prime Medicine, Inc. All other trademarks referred to herein are the property of their respective owners.
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 about Prime Medicine’s beliefs and expectations regarding: the potential of PM359 to correct the causative mutation of CGD; the anticipated maturation into a clinical-stage company by bringing PM359 into clinical development in 2024 with initial clinical data from the planned Phase 1/2 clinical trial of PM359 expected in 2025; the initiation, timing, progress, and results of its research and development programs, preclinical studies and future clinical trials, and the release of data related thereto; the potential for Prime Editors to repair genetic mutations and offer curative genetic therapies for a wide spectrum of diseases; the potential of Prime Editors to reproducibly correct disease-causing genetic mutations across different tissues, organs and cell types, and the capacity of its PASSIGE technology to edit CAR-T cells for the treatment of certain cancers and immune diseases; certain activities and next steps to support the Company’s maturation into a clinical-stage company, including opening an IND and/or CTA application, clinical data expectations, establishing proof-of-concept, advancing programs into lead optimization, advancing preclinical studies and initiating IND-enabling activities, nominating development candidate, and establishing AAV delivery platform and route of administration for neuromuscular programs; the expansion of Prime Editing’s therapeutic potential and the creation of value through strategic business development to extend the reach and impact of Prime Editing to areas beyond Prime Medicine’s current core areas of focus; exploring business development opportunities that could accelerate existing work and the benefits thereof; the modularity of the Prime Editing platform and the benefits thereof; its expectations regarding the breadth of Prime Editing technology and the implementation of its strategic plans for its business, programs, and technology; and the potential of Prime Editing to unlock opportunities across thousands of potential indications. The words “may,” “might,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “expect,” “estimate,” “seek,” “predict,” “future,” “project,” “potential,” “continue,” “target” and similar words or expressions 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: uncertainties related to Prime Medicine’s product candidates entering clinical trials; the authorization, initiation, and conduct of preclinical and IND-enabling studies and other development requirements for potential product candidates, including uncertainties related to opening INDs and obtaining regulatory approvals; risks related to the development and optimization of new technologies, the results of preclinical studies, or clinical studies not being predictive of future results in connection with future studies; the scope of protection Prime Medicine is able to establish and maintain for intellectual property rights covering its Prime Editing technology; Prime Medicine’s ability to identify and enter into future license agreements and collaborations; the effect of unfavorable macroeconomic conditions or market volatility resulting from general economic, industry and market conditions, including rising interest rates, inflation, and adverse developments affecting the financial services industry; and Prime Medicine’s accumulated deficit and the expectation for continued operating losses and negative operating cash flows for the foreseeable future, including its expectations regarding the anticipated timeline of its cash runway and future financial performance. These and other risks and uncertainties are described in greater detail in the section entitled “Risk Factors” in Prime Medicine’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q for the quarter ended June 30, 2024, as well as any subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent Prime Medicine’s views only as of today and should not be relied upon as representing its views as of any subsequent date. Prime Medicine explicitly disclaims any obligation to update any forward-looking statements subject to any obligations under applicable law. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements.
Investor Contact
Hannah Deresiewicz
Precision AQ
212-362-1200
hannah.deresiewicz@precisionaq.com
Media Contact
Dan Budwick, 1AB
dan@1ABmedia.com
| Condensed Consolidated Balance Sheet Data | ||||
| (unaudited) | ||||
| (in thousands) | June 30, 2024 | December 31, 2023 | ||
| Cash, cash equivalents, and investments | 162,868 | 121,665 | ||
| Total assets | 259,705 | 193,851 | ||
| Total liabilities | 63,116 | 60,780 | ||
| Total stockholders’ equity | 196,589 | 133,071 | ||
| Condensed Consolidated Statement of Operations | ||||||||
| (unaudited) | ||||||||
| Three Months Ended June 30, | ||||||||
| (in thousands, except share and per share amounts) | 2024 | 2023 | ||||||
| Operating expenses: | ||||||||
| Research and development | $ | 43,071 | $ | 34,599 | ||||
| General and administrative | 12,601 | 10,658 | ||||||
| Total operating expenses | 55,672 | 45,257 | ||||||
| Loss from operations | (55,672 | ) | (45,257 | ) | ||||
| Other income: | ||||||||
| Change in fair value of short-term investment — related party | (1,925 | ) | 263 | |||||
| Other income, net | 2,136 | 2,640 | ||||||
| Total other income, net | 211 | 2,903 | ||||||
| Net loss before income taxes | (55,461 | ) | (42,354 | ) | ||||
| (Provision for) benefit from income taxes | 134 | (31 | ) | |||||
| Net loss attributable to common stockholders | $ | (55,327 | ) | $ | (42,385 | ) | ||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.46 | ) | $ | (0.47 | ) | ||
| Weighted-average common shares outstanding, basic and diluted | 119,188,866 | 90,467,298 | ||||||
FAQ
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