Korro Reports Third Quarter 2024 Financial Results and Provides Business Updates
Korro Bio (Nasdaq: KRRO) reported its third quarter 2024 financial results and provided business updates. Significant milestones include the submission of a regulatory filing for the first-in-human clinical study of KRRO-110 for alpha-1 antitrypsin deficiency (AATD), the formation of a Clinical Advisory Board (CAB), and a partnership with Novo Nordisk to develop RNA editing therapies for cardiometabolic diseases. As of September 30, 2024, Korro's cash position was $169.1 million, providing a cash runway into the second half of 2026. R&D expenses increased to $16.0 million from $14.0 million in the same period in 2023, and G&A expenses rose to $7.3 million from $5.1 million. The net loss for the quarter was $21.0 million, compared to $18.5 million in the prior year.
Korro Bio (Nasdaq: KRRO) ha riportato i suoi risultati finanziari del terzo trimestre 2024 e fornito aggiornamenti sul business. Tra gli obiettivi significativi c'è stata la presentazione di una richiesta regolatoria per lo studio clinico di KRRO-110, il primo sull’uomo, per la carenza di alfa-1 antitripsina (AATD), la creazione di un Clinical Advisory Board (CAB) e una partnership con Novo Nordisk per sviluppare terapie di editing dell'RNA per malattie cardiometaboliche. Alla data del 30 settembre 2024, la posizione di cassa di Korro era di 169,1 milioni di dollari, garantendo un flusso di cassa fino alla seconda metà del 2026. Le spese di ricerca e sviluppo sono aumentate a 16,0 milioni di dollari rispetto ai 14,0 milioni dello stesso periodo del 2023, e le spese generali e amministrative sono salite a 7,3 milioni di dollari rispetto ai 5,1 milioni. La perdita netta per il trimestre è stata di 21,0 milioni di dollari, rispetto ai 18,5 milioni dell'anno precedente.
Korro Bio (Nasdaq: KRRO) reportó sus resultados financieros del tercer trimestre de 2024 y proporcionó actualizaciones sobre el negocio. Los hitos significativos incluyen la presentación de una solicitud regulatoria para el primer estudio clínico en humanos de KRRO-110 para la deficiencia de alfa-1 antitripsina (AATD), la formación de un Clinical Advisory Board (CAB) y una asociación con Novo Nordisk para desarrollar terapias de edición de ARN para enfermedades cardiometabólicas. Al 30 de septiembre de 2024, la posición de efectivo de Korro era de 169,1 millones de dólares, lo que proporciona un flujo de efectivo hasta la segunda mitad de 2026. Los gastos de I+D aumentaron a 16,0 millones de dólares desde 14,0 millones en el mismo periodo en 2023, y los gastos generales y administrativos subieron a 7,3 millones de dólares desde 5,1 millones. La pérdida neta para el trimestre fue de 21,0 millones de dólares, en comparación con los 18,5 millones del año anterior.
Korro Bio (Nasdaq: KRRO)는 2024년 3분기 재무 결과를 발표하고 사업 업데이트를 제공했습니다. 주요 이정표로는 KRRO-110의 인간 대상 임상 연구를 위한 규제 제출, 임상 자문 위원회(CAB) 구성, Novo Nordisk와의 파트너십을 통해 심혈관 대사 질환에 대한 RNA 편집 치료 개발이 포함됩니다. 2024년 9월 30일 현재 Korro의 현금 보유량은 1억 6,910만 달러로, 2026년 하반기까지의 현금 확보가 가능합니다. R&D 비용은 2023년 같은 기간의 1,400만 달러에서 1,600만 달러로 증가했으며, 일반 및 관리 비용은 510만 달러에서 730만 달러로 증가했습니다. 해당 분기의 순손실은 2,100만 달러로, 전년의 1,850만 달러와 비교됩니다.
Korro Bio (Nasdaq: KRRO) a annoncé ses résultats financiers pour le troisième trimestre de 2024 et a fourni des mises à jour sur ses activités. Parmi les jalons importants figurent la soumission d'une demande réglementaire pour l'étude clinique KRRO-110 sur l'homme pour la déficience en alpha-1 antitrypsine (AATD), la formation d'un Clinical Advisory Board (CAB), et un partenariat avec Novo Nordisk pour développer des thérapies d'édition de l'ARN pour les maladies cardiométaboliques. Au 30 septembre 2024, la position de trésorerie de Korro s'élevait à 169,1 millions de dollars, assurant une marge de trésorerie jusqu'à la seconde moitié de 2026. Les frais de R&D ont augmenté à 16,0 millions de dollars contre 14,0 millions au même période en 2023, et les frais généraux et administratifs ont augmenté à 7,3 millions de dollars contre 5,1 millions. La perte nette pour le trimestre s'élevait à 21,0 millions de dollars, par rapport à 18,5 millions de dollars l'année précédente.
Korro Bio (Nasdaq: KRRO) hat seine Finanzergebnisse für das dritte Quartal 2024 veröffentlicht und Unternehmensupdates bereitgestellt. Zu den wichtigen Meilensteinen gehören die Einreichung einer behördlichen Anmeldung für die erste klinische Studie mit Menschen zu KRRO-110 bei Alpha-1-Antitrypsinmangel (AATD), die Gründung eines Clinical Advisory Board (CAB) sowie eine Partnerschaft mit Novo Nordisk, um RNA-Editing-Therapien für kardiometabolische Krankheiten zu entwickeln. Am 30. September 2024 betrug Korros Liquiditätsposition 169,1 Millionen US-Dollar, was einen finanziellen Spielraum bis zur zweiten Hälfte des Jahres 2026 bietet. Die Forschung und Entwicklungskosten stiegen von 14,0 Millionen auf 16,0 Millionen US-Dollar im Vergleich zum gleichen Zeitraum 2023, und die allgemeinen und Verwaltungskosten erhöhten sich von 5,1 Millionen auf 7,3 Millionen US-Dollar. Der Nettoverlust für das Quartal betrug 21,0 Millionen US-Dollar, verglichen mit 18,5 Millionen US-Dollar im Vorjahr.
- Regulatory filing submission for KRRO-110 Phase 1/2 clinical study.
- Partnership with Novo Nordisk to develop RNA editing therapies with potential milestones up to $530 million.
- Strong cash position of $169.1 million, providing a runway into the second half of 2026.
- Increased net loss to $21.0 million from $18.5 million in the same period in 2023.
- R&D expenses rose to $16.0 million from $14.0 million.
- G&A expenses increased to $7.3 million from $5.1 million.
Insights
The Q3 results showcase a solid financial position with
The Novo Nordisk partnership brings significant potential upside with up to
The regulatory filing for KRRO-110's first-in-human trial represents a important milestone in addressing alpha-1 antitrypsin deficiency (AATD). Preclinical data showing >60uM total AAT protein at week 13 suggests promising efficacy. The formation of a Clinical Advisory Board with lung and liver experts strengthens the development strategy.
The anticipated clinical timeline is well-structured with first patient dosing in Q1 2025, interim readout in H2 2025 and study completion in 2026. This methodical approach allows for proper safety monitoring and efficacy assessment of their RNA editing technology in treating this rare genetic disorder.
- Submitted regulatory filing for first-in-human clinical study of KRRO-110 in patients with alpha-1 antitrypsin deficiency (AATD)
- Formed Clinical Advisory Board (CAB) of leading lung and liver experts and strengthened leadership team
- Partnered with Novo Nordisk to develop up to two targets for cardiometabolic diseases leveraging Korro’s proprietary OPERATM platform
- Ended third quarter of 2024 with
- Cash runway into the second half of 2026 expected to fund KRRO-110 through completion of a Phase 1/2 clinical study and progress additional pipeline candidates
CAMBRIDGE, Mass., Nov. 12, 2024 (GLOBE NEWSWIRE) -- Korro Bio, Inc. (Korro) (Nasdaq: KRRO), a biopharmaceutical company focused on developing a new class of genetic medicines based on editing RNA for both rare and highly prevalent diseases, today reported financial results for the third quarter of 2024 and provided an update on its recent progress and anticipated milestones.
“Korro is delivering across key scientific, regulatory and business objectives, highlighted by our first regulatory filing submission, formation of a Clinical Advisory Board, and collaboration agreement with Novo Nordisk,” said Ram Aiyar, PhD, CEO and President of Korro. “Driven by the dedicated efforts of our employees and growing leadership team, our clinical efforts are well underway, and we expect to dose the first participant in our Phase 1/2 clinical study of KRRO-110 in the first quarter of 2025, pending regulatory approval. With a strong balance sheet and cash runway into the second half of 2026, we are well-positioned to execute multiple meaningful inflection points for KRRO-110 and to advance our wholly owned and partnered pipeline programs.”
Pipeline and Business Updates:
- Submitted regulatory filing for KRRO-110 Phase 1/2 clinical study in Australia. Korro submitted a regulatory filing with the Australian Bellberry Human Research Ethics Committee (HREC) to initiate a Phase 1/2 clinical study for KRRO-110 in AATD.
- Formed Clinical Advisory Board (CAB) and appointed new Board and leadership members. Korro established a CAB comprised of esteemed lung and liver scientific experts to prepare for KRRO-110’s entry into the clinic and to guide KRRO-110’s development strategy. Additionally, Korro strengthened its leadership team with the appointment of Jeffrey Cerio as General Counsel and enhanced its Board of Directors with the appointment of Katharine Knobil, M.D. Dr. Knobil brings a wealth of clinical expertise and deep understanding of the regulatory landscape which will be invaluable as Korro prepares to advance KRRO-110 into the clinic and further build its pipeline of innovative programs.
- Presented preclinical data at Oligonucleotide Therapeutics Society (OTS) demonstrating the efficacy of the OPERA RNA editing platform. In September, Korro presented oral and poster presentations at OTS showcasing KRRO-110 preclinical data that demonstrated KRRO-110 achieved greater than 60uM total AAT protein at week 13 compared to control. Additional posters were presented that highlighted innovative research and developments derived from Korro’s proprietary RNA editing platform.
- Announced collaboration with Novo Nordisk to advance RNA editing therapies. In September, Korro formed a partnership with Novo Nordisk to advance the discovery and development of new genetic medicines, with the initial target to treat cardiometabolic diseases. Leveraging Korro’s proprietary OPERA platform combined with Novo Nordisk’s deep cardiometabolic disease understanding and drug development experience, the collaboration will develop RNA editing product candidates for up to two targets. Under the terms of the agreement, Korro is eligible to receive up to
$530 million in upfront, development and commercial milestone payments, in addition to tiered royalties and R&D funding.
Upcoming Milestones:
- First participant dosing of KRRO-110 expected in the first quarter of 2025.
- Interim Phase 1/2 clinical study readout for KRRO-110 in PiZZ patients anticipated in the second half of 2025.
- Completion of the Phase 1/2 clinical study for KRRO-110 expected in 2026.
Third Quarter 2024 Financial Results:
Cash Position: Cash, cash equivalents and marketable securities were
Research and Development (R&D) Expenses: R&D expenses were
General and Administration (G&A) Expenses: G&A expenses were
Net Loss: Korro’s net loss was
About Alpha-1 Antitrypsin Deficiency (AATD) and KRRO-110
AATD is a genetic disorder most commonly caused by a single missense mutation (G-to-A) in the SERPINA1 gene. Affected adult individuals experience pulmonary emphysema and/or hepatic cirrhosis, as well as end organ manifestations. KRRO-110 is the first RNA editing oligonucleotide product candidate from Korro’s proprietary RNA editing platform, Oligonucleotide Promoted Editing of RNA (OPERA™). KRRO-110 is designed to co-opt an endogenous enzyme, Adenosine Deaminase Acting on RNA’s (ADAR), to edit the “A” variant on SERPINA1 RNA, repair an amino acid codon, and restore secretion of normal AAT protein. This repair of the endogenous protein has the potential to clear protein aggregates from within liver cells to create a potentially clinically differentiated benefit for liver function and to preserve lung function by providing an adequate amount of normal AAT protein.
About Korro
Korro is a biopharmaceutical company focused on developing a new class of genetic medicines for both rare and highly prevalent diseases using its proprietary RNA editing platform. Korro is generating a portfolio of differentiated programs that are designed to harness the body’s natural RNA editing process to affect a precise yet transient single base edit. By editing RNA instead of DNA, Korro is expanding the reach of genetic medicines by delivering additional precision and tunability, which has the potential for increased specificity and improved long-term tolerability. Using an oligonucleotide-based approach, Korro expects to bring its medicines to patients by leveraging its proprietary platform with precedented delivery modalities, manufacturing know-how, and established regulatory pathways of approved oligonucleotide drugs. Korro is based in Cambridge, Massachusetts. For more information, visit korrobio.com.
Korro intends to use its Investor Relations website as a means of disclosing material nonpublic information and for complying with its disclosure obligations under Regulation FD. Accordingly, investors should monitor Korro’s Investor Relations website, in addition to following Korro’s press releases, SEC filings, public conference calls, presentations, and webcasts.
Forward-Looking Statements
Certain statements in this press release may constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements include, but are not limited to, express or implied statements regarding expectations, hopes, beliefs, intentions or strategies of Korro regarding the future including, without limitation, express or implied statements regarding: Korro’s ability to develop up to two therapeutic candidates for cardiometabolic diseases under the collaboration with Novo Nordisk; Korro’s cash runway, including its ability to complete a Phase 1/2 clinical study of KRRO-110 for AATD; approval by the Australian Bellberry Human Research Ethics Committee of Korro’s regulatory filing to commence a Phase 1/2 clinical study of KRRO-110 for AATD; the timing of Korro dosing the first participant, interim data readout and completion of the Phase 1/2 clinical study; KRRO-110’s potential to provide a clinically differentiated benefit; Korro’s ability to advance its wholly owned and partnered pipeline programs and the strength of its balance sheet to support completion; and Korro’s ability to expand the reach of genetic medicines; among others. In addition, any statements that refer to projections, forecasts, or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “strive,” “would,” “aim,” “target,” “commit,” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that statement is not forward looking. Forward-looking statements are based on current expectations and assumptions that, while considered reasonable are inherently uncertain. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. Factors that may cause actual results to differ materially from current expectations include, but are not limited to, various factors beyond management’s control including risks inherent in biopharmaceutical development; risks associated with pre-clinical studies and clinical studies; and other risks associated with obtaining regulatory approvals and protecting intellectual property; as well as risks associated with general economic conditions; and other risks and uncertainties indicated from time to time in Korro’s filings with the SEC, including Part II Item 1A. “Risk Factors” in Korro’s Quarterly Report on Form 10-Q filed with the SEC on the date hereof, as such may be amended or supplemented by its other filings with the SEC. Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements in this press release, which speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein. Except as required by law, Korro does not undertake or accept any duty to release publicly any updates or revisions to any forward-looking statements to reflect any change in its expectations or in the events, conditions or circumstances on which any such statement is based. This press release does not purport to summarize all of the conditions, risks and other attributes of an investment in Korro.
Korro Bio Contact Information
Investor & Media Contact
Tim Palmer
IR@korrobio.com
| Korro Bio, Inc. Condensed Consolidated Statements of Operations (in thousands, except share and per share amounts) (unaudited) | ||||||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 15,964 | $ | 14,008 | $ | 46,674 | $ | 41,828 | ||||||||
| General and administrative | 7,328 | 5,140 | 22,196 | 15,813 | ||||||||||||
| Total operating expenses | 23,292 | 19,148 | 68,870 | 57,641 | ||||||||||||
| Loss from operations | (23,292 | ) | (19,148 | ) | (68,870 | ) | (57,641 | ) | ||||||||
| Other income: | ||||||||||||||||
| Other income, net | 2,284 | 656 | 6,526 | 1,922 | ||||||||||||
| Total other income, net | 2,284 | 656 | 6,526 | 1,922 | ||||||||||||
| Loss before provision for income taxes | (21,008 | ) | (18,492 | ) | (62,344 | ) | (55,719 | ) | ||||||||
| Provision for income taxes | 9 | — | (38 | ) | (27 | ) | ||||||||||
| Net loss | $ | (20,999 | ) | $ | (18,492 | ) | $ | (62,382 | ) | $ | (55,746 | ) | ||||
| Other comprehensive income: | ||||||||||||||||
| Unrealized gain on available-for-sale marketable securities | $ | 593 | $ | — | $ | 614 | $ | 5 | ||||||||
| Foreign currency translation adjustments, net | $ | (40 | ) | $ | — | $ | (40 | ) | $ | — | ||||||
| Comprehensive loss | $ | (20,446 | ) | $ | (18,492 | ) | $ | (61,808 | ) | $ | (55,741 | ) | ||||
| Net loss per share, basic and diluted | $ | (2.26 | ) | $ | (65.08 | ) | $ | (7.11 | ) | $ | (200.94 | ) | ||||
| Weighted-average shares used in computing net loss per share, basic and diluted | 9,303,218 | 284,156 | 8,771,743 | 277,433 | ||||||||||||
| Korro Bio, Inc. Selected Condensed Consolidated Balance Sheet Data (in thousands) (unaudited) | ||||||||
| September 30, 2024 | December 31, 2023 | |||||||
| Cash, cash equivalents and marketable securities | $ | 169,112 | $ | 166,150 | ||||
| Working capital(1) | 139,173 | 153,245 | ||||||
| Total assets | 243,543 | 221,663 | ||||||
| Total liabilities | 63,911 | 51,752 | ||||||
| Total stockholders' equity | 179,632 | 169,911 | ||||||
| (1) Working capital is defined as current assets less current liabilities. | ||||||||
FAQ
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