Denali Therapeutics Reports Second Quarter 2024 Financial Results and Business Highlights
Denali Therapeutics (NASDAQ: DNLI) reported Q2 2024 financial results and business highlights. Key updates include:
1. Completed enrollment of 47 participants in Phase 1/2 study for tividenofusp alfa (DNL310) in MPS II.
2. FDA indicated openness to discussing accelerated approval pathway for tividenofusp alfa.
3. DNL126 selected for FDA's START Pilot Program for rare disease therapeutics.
4. Regained rights to ATV:Abeta program from Biogen for Alzheimer's disease.
5. Net loss of $99.0 million in Q2 2024, compared to net income of $183.4 million in Q2 2023.
6. No collaboration revenue in Q2 2024, down from $294.1 million in Q2 2023.
7. Cash, cash equivalents, and marketable securities of $1.35 billion as of June 30, 2024.
Denali Therapeutics (NASDAQ: DNLI) ha riportato i risultati finanziari e i principali aggiornamenti aziendali per il secondo trimestre del 2024. Le principali novità includono:
1. Completamento dell'arruolamento di 47 partecipanti nello studio di Fase 1/2 per tividenofusp alfa (DNL310) nella MPS II.
2. La FDA ha mostrato apertura nel discutere un percorso di approvazione accelerato per tividenofusp alfa.
3. DNL126 è stato selezionato per il Programma START della FDA per i terapeutici per malattie rare.
4. Ripresa dei diritti sul programma ATV:Abeta da Biogen per la malattia di Alzheimer.
5. Perdite nette di 99,0 milioni di dollari nel secondo trimestre del 2024, rispetto a un utile netto di 183,4 milioni di dollari nel secondo trimestre del 2023.
6. Nessun ricavo da collaborazione nel secondo trimestre del 2024, in calo rispetto a 294,1 milioni di dollari nel secondo trimestre del 2023.
7. Liquidità, equivalenti di liquidità e titoli negoziabili di 1,35 miliardi di dollari al 30 giugno 2024.
Denali Therapeutics (NASDAQ: DNLI) reportó resultados financieros y aspectos destacados del negocio para el segundo trimestre de 2024. Las actualizaciones clave incluyen:
1. Finalización de la inscripción de 47 participantes en el estudio de Fase 1/2 para tividenofusp alfa (DNL310) en MPS II.
2. La FDA mostró apertura para discutir una vía de aprobación acelerada para tividenofusp alfa.
3. DNL126 seleccionado para el Programa Piloto START de la FDA para terapias de enfermedades raras.
4. Recuperación de los derechos del programa ATV:Abeta de Biogen para la enfermedad de Alzheimer.
5. Pérdida neta de 99,0 millones de dólares en el segundo trimestre de 2024, en comparación con un ingreso neto de 183,4 millones de dólares en el segundo trimestre de 2023.
6. Sin ingresos por colaboración en el segundo trimestre de 2024, en comparación con 294,1 millones de dólares en el segundo trimestre de 2023.
7. Efectivo, equivalentes de efectivo y valores negociables de 1,35 mil millones de dólares al 30 de junio de 2024.
Denali Therapeutics (NASDAQ: DNLI)는 2024년 2분기 재무 결과 및 비즈니스 주요 사항을 보고했습니다. 주요 업데이트는 다음과 같습니다:
1. MPS II에 대한 tividenofusp alfa (DNL310) 임상 1/2상 연구에 47명의 참가자 등록 완료.
2. FDA는 tividenofusp alfa의 가속 승인 경로 논의에 열려 있음을 나타냈습니다.
3. DNL126이 FDA의 희귀 질환 치료제 START 파일럿 프로그램에 선정되었습니다.
4. 알츠하이머병에 대한 Biogen의 ATV:Abeta 프로그램 권리를 다시 가져왔습니다.
5. 2024년 2분기 순손실이 9,900만 달러로, 2023년 2분기 순이익 1억 8,340만 달러와 비교됩니다.
6. 2024년 2분기에 협력 수익이 없으며, 2023년 2분기에는 2억 9,410만 달러였습니다.
7. 2024년 6월 30일 기준으로 현금, 현금성 자산 및 매도가능 증권이 13억 5천만 달러입니다.
Denali Therapeutics (NASDAQ: DNLI) a rapporté les résultats financiers et les points saillants de l'activité pour le deuxième trimestre de 2024. Les principales mises à jour comprennent :
1. Achèvement de l'inscription de 47 participants dans l'étude de Phase 1/2 pour tividenofusp alfa (DNL310) dans la MPS II.
2. La FDA a montré une ouverture à discuter d'une voie d'approbation accélérée pour tividenofusp alfa.
3. DNL126 sélectionné pour le programme pilote START de la FDA pour les thérapeutiques contre les maladies rares.
4. Récupération des droits du programme ATV:Abeta de Biogen pour la maladie d'Alzheimer.
5. Perte nette de 99,0 millions de dollars au deuxième trimestre 2024, comparativement à un bénéfice net de 183,4 millions de dollars au deuxième trimestre 2023.
6. Aucune recette de collaboration au deuxième trimestre 2024, en baisse par rapport à 294,1 millions de dollars au deuxième trimestre 2023.
7. Trésorerie, équivalents de trésorerie et titres négociables de 1,35 milliard de dollars au 30 juin 2024.
Denali Therapeutics (NASDAQ: DNLI) hat die finanziellen Ergebnisse und Geschäftshighlights für das zweite Quartal 2024 bekannt gegeben. Zu den wichtigsten Neuigkeiten gehören:
1. Abschluss der Rekrutierung von 47 Teilnehmern in der Phase 1/2-Studie für tividenofusp alfa (DNL310) bei MPS II.
2. Die FDA hat Bereitschaft signalisiert, den Weg zur beschleunigten Zulassung für tividenofusp alfa zu erörtern.
3. DNL126 wurde für das START-Pilotprogramm der FDA für Therapeutika gegen seltene Krankheiten ausgewählt.
4. Rückgewinnung der Rechte am ATV:Abeta-Programm von Biogen für die Alzheimer-Krankheit.
5. Nettverlust von 99,0 Millionen Dollar im zweiten Quartal 2024, verglichen mit einem Nettogewinn von 183,4 Millionen Dollar im zweiten Quartal 2023.
6. Im zweiten Quartal 2024 gab es keine Einnahmen aus Kooperationen, ein Rückgang von 294,1 Millionen Dollar im zweiten Quartal 2023.
7. Zahlungsmittel, Zahlungsmitteläquivalente und handelbare Wertpapiere in Höhe von 1,35 Milliarden Dollar zum 30. Juni 2024.
- Completed enrollment of 47 participants in Phase 1/2 study for tividenofusp alfa (DNL310) in MPS II
- FDA indicated openness to discussing accelerated approval pathway for tividenofusp alfa
- DNL126 selected for FDA's START Pilot Program for rare disease therapeutics
- Regained rights to ATV:Abeta program from Biogen for Alzheimer's disease
- Strong cash position of $1.35 billion as of June 30, 2024
- Net loss of $99.0 million in Q2 2024, compared to net income of $183.4 million in Q2 2023
- No collaboration revenue in Q2 2024, down from $294.1 million in Q2 2023
- Total research and development expenses of $91.4 million in Q2 2024
Insights
Denali Therapeutics' Q2 2024 financial results reveal a significant shift in the company's financial position. The company reported a net loss of
The lack of collaboration revenue is a critical point for investors to consider. It highlights the volatility of Denali's revenue stream, which is heavily dependent on milestone payments and partner activities. The
On the expense side, Denali has managed to slightly reduce its R&D expenses by
The company's cash position remains strong, with approximately
However, investors should note that without consistent revenue streams, the company's cash burn rate will be a critical metric to watch in coming quarters. The current financial position suggests Denali has several years of runway at current spending levels, but this could change rapidly if clinical programs advance and expenses increase.
Denali Therapeutics' Q2 2024 report showcases significant progress across its pipeline, particularly in its blood-brain barrier (BBB) crossing therapeutics. The company's Enzyme Transport Vehicle (ETV) franchise is gaining momentum, with two key developments:
- Tividenofusp alfa (DNL310) for MPS II: The FDA's openness to discussing an accelerated approval pathway using cerebrospinal fluid heparan sulfate as a surrogate biomarker is a potential game-changer. This could significantly expedite the path to market for this therapy.
- DNL126 for MPS IIIA: Its selection for the FDA's START program could accelerate development, potentially leading to faster market entry.
The regaining of rights to the ATV:Abeta program from Biogen is a double-edged sword. While it expands Denali's opportunities in Alzheimer's disease, it also means the loss of a major partner in this high-risk, high-reward area. The preclinical data showing potential for a wider therapeutic window and lower rates of ARIA is promising, but investors should remain cautious given the challenging nature of Alzheimer's drug development.
The advancement of multiple programs into later-stage clinical trials, including DNL343 for ALS and BIIB122/DNL151 for Parkinson's disease, demonstrates the breadth of Denali's pipeline. However, the voluntary pause of the TAK-594/DNL593 Phase 1/2 study highlights the inherent risks in drug development.
Denali's focus on BBB-crossing therapeutics positions it uniquely in the neurodegenerative disease space. The company's diverse approach, utilizing multiple technology platforms (ETV, PTV, OTV, ATV), provides multiple shots on goal but also increases complexity and resource requirements.
SOUTH SAN FRANCISCO, Calif., Aug. 01, 2024 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq: DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain barrier (BBB) for the treatment of neurodegenerative diseases and lysosomal storage diseases, today reported financial results for the second quarter ended June 30, 2024, and provided business highlights.
"In the second quarter, our Enzyme Transport Vehicle franchise gained additional momentum with continued engagement with the FDA on an accelerated approval pathway for tividenofusp alfa (DNL310, ETV:IDS) in MPS II and the FDA's selection of DNL126 (ETV:SGSH) in MPS IIIA for the START program," said Ryan Watts, Ph.D., Chief Executive Officer of Denali Therapeutics. “Today, we are also pleased to share that we have regained the rights to our TfR-based ATV:Abeta program from Biogen, thereby expanding our opportunities for addressing Alzheimer's disease with a potential best-in-class approach. We look forward to continuing to make significant progress as leaders in the promising and growing field of BBB-crossing therapeutics."
Second Quarter 2024 and Recent Program Updates
Late-stage and mid-stage clinical programs
Tividenofusp alfa (DNL310): Enzyme Transport Vehicle (ETV)-enabled, iduronate-2-sulfatase (IDS) replacement therapy in development for MPS II (Hunter syndrome)
- In April, completed enrollment of 47 participants with MPS II in the Phase 1/2 open-label study.
- COMPASS, the global Phase 2/3 study, is expected to complete enrollment in 2024.
- In July, Molecular Genetics and Metabolism published a review co-authored by Denali's Chief Medical Officer, Carole Ho, M.D., titled, "Community consensus for heparan sulfate as a biomarker to support accelerated approval in neuronopathic mucopolysaccharidoses", which summarizes many of the presentations at the Reagan-Udall Foundation workshop held in February 2024 and provides a perspective on the path forward for neuronopathic MPS disorders.
- Following the Reagan-Udall Foundation workshop, Denali received written communication from the Center for Drug Evaluation and Research (CDER) division of the FDA indicating openness to discussing an accelerated approval pathway for tividenofusp alfa in MPS II with cerebrospinal fluid heparan sulfate (CSF HS) as a surrogate biomarker. Denali looks forward to continued engagement with CDER regarding Denali’s intention to file for approval of tividenofusp alfa using the accelerated approval pathway. Denali will provide an update in 2H 2024.
DNL343: eIF2B activator in development for the treatment of amyotrophic lateral sclerosis (ALS)
- In May, the Sean M. Healey & AMG Center for ALS at Massachusetts General Hospital (MGH) in collaboration with the Northeast ALS Consortium (NEALS) announced that enrollment is complete in Regimen G (DNL343) of the Phase 2/3 HEALEY ALS Platform Trial.
SAR443820/DNL788: CNS-penetrant RIPK1 inhibitor in development for the treatment of multiple sclerosis (MS)
- Sanofi is evaluating SAR443820/DNL788 in a Phase 2 study in participants with MS, which is fully enrolled.
BIIB122/DNL151: LRRK2 inhibitor in development for the treatment of Parkinson’s disease (PD)
- Biogen is conducting the ongoing global Phase 2b LUMA study of BIIB122 in participants with early-stage Parkinson’s disease.
- Denali plans to initiate a global Phase 2a study in 2024 to evaluate safety and biomarkers associated with BIIB122 in participants with Parkinson’s disease and confirmed pathogenic variants of LRRK2. This study is being funded under the Collaboration and Development Funding Agreement with a third party.
Eclitasertib (SAR443122/DNL758): Peripheral RIPK1 inhibitor in development for the treatment of ulcerative colitis (UC)
- Sanofi is conducting the ongoing Phase 2 study of SAR443122/DNL758 in participants with UC.
Early-stage clinical and preclinical programs
DNL126: ETV-enabled N-sulfoglucosamine sulfohydrolase (SGSH) replacement therapy in development for the treatment of MPS IIIA (Sanfilippo syndrome Type A)
- In June, Denali announced that the CDER selected DNL126 for participation in the FDA's Support for clinical Trials Advancing Rare disease Therapeutics (START) Pilot Program to further accelerate the development of novel drug and biological products for rare diseases. Participation in START is expected to facilitate and accelerate development of DNL126.
- Phase 1/2 biomarker and safety data are expected by the end of 2024.
TAK-594/DNL593: Protein Transport Vehicle (PTV)-enabled progranulin (PGRN) replacement therapy in development for the treatment of frontotemporal dementia-granulin (FTD-GRN)
- Denali has finalized the protocol amendment for the Phase 1/2 study and prescreening of participants for Cohort B2 is ongoing.
Oligonucleotide Transport Vehicle (OTV) platform
- Denali is advancing OTV:MAPT, targeting tau for Alzheimer’s disease, and OTV:SNCA, targeting alpha-synuclein for Parkinson’s disease, in the investigational new drug (IND)-enabling stage of development.
Antibody Transport Vehicle Amyloid beta (ATV:Abeta) program
- Today, Denali also announced that Biogen terminated its license to the ATV:Abeta program enabled by Denali’s TfR-targeting technology against amyloid beta for the potential treatment of Alzheimer's disease and granted Denali rights to data generated during the collaboration. As a result of the termination, all rights to develop, manufacture, perform medical affairs activities, and commercialize new TfR-targeting ATV:Abeta therapeutics reverted to Denali. Biogen licensed Denali's TfR-targeting ATV:Abeta program in April 2023 having exercised an option that was part of the 2020 collaboration agreement between the two companies. Biogen’s decision was not related to any efficacy or safety concerns with the Transport Vehicle platform.
- Denali is working to develop the next generation of anti-amyloid beta therapeutics with ATV:Abeta, which is designed to increase exposure of the therapeutic antibody and achieve broad biodistribution in the brain with the potential for improved efficacy and safety. Preclinical data demonstrated potential for a wider therapeutic window compared to a standard antibody, with superior plaque decoration and reduction and very low rates of amyloid related imaging abnormalities (ARIA). These data are included in a recent manuscript posted on bioRxiv.
- Denali plans to advance a TfR-targeting ATV:Abeta molecule as well as a CD98hc-targeting ATV:Abeta molecule into development for Alzheimer's disease.
Discovery programs
Denali applies its deep scientific expertise in neurodegeneration biology and the BBB to discover and develop medicines and platforms with the focus on programs enabled by the TV technology and targeting neurodegenerative disease, including Alzheimer’s and Parkinson’s, and lysosomal storage diseases.
- In July, Denali posted the manuscript titled, "Fc-engineered large molecules targeting the blood-brain barrier transferrin receptor and CD98hc have distinct central nervous system and peripheral biodistribution compared to standard antibodies" on bioRxiv. Using comprehensive and unbiased approaches, Denali scientists reveal distinct biodistribution of the TfR and CD98hc transport vehicle delivery platforms from the brain single-cell level all the way to the whole body.
Participation in Upcoming Investor Conferences
- BTIG Virtual Biotechnology Conference, August 5-6
- 2024 Wedbush PacGrow Healthcare Conference, August 13-14
- Morgan Stanley 22nd Annual Global Healthcare Conference, September 4-6
- H.C. Wainwright 26th Annual Global Investment Conference, September 9-11
- 2024 Cantor Global Healthcare Conference, September 17-19
Second Quarter 2024 Financial Results
Net loss was
There was no collaboration revenue for the quarter ended June 30, 2024, compared to
Total research and development expenses were
General and administrative expenses were
Cash, cash equivalents, and marketable securities were approximately
About Denali Therapeutics
Denali Therapeutics is a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain barrier (BBB) for the treatment of neurodegenerative diseases and lysosomal storage diseases. Denali pursues new treatments by rigorously assessing genetically validated targets, engineering delivery across the BBB, and guiding development through biomarkers that demonstrate target and pathway engagement. Denali is based in South San Francisco. For additional information, please visit www.denalitherapeutics.com.
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. Forward-looking statements expressed or implied in this press release include, but are not limited to, statements regarding expectations regarding Denali’s TV technology platform; statements made by Denali’s Chief Executive Officer; plans, timelines, and expectations regarding DNL310 and the ongoing Phase 2/3 COMPASS and Phase 1/2 studies, the timing and likelihood of accelerated approval, and the timing and availability of program updates; plans and timelines regarding DNL343, including in Regimen G of the Phase 2/3 HEALEY ALS Platform Trial; plans, timelines, and expectations of both Denali and Sanofi regarding DNL788, including the Phase 2 study in MS; plans, timelines, and expectations regarding DNL151, including with respect to the ongoing LUMA study as well as enrollment and timing of the proposed Phase 2a study in PD patients with LRRK2 mutations; expectations regarding DNL758, including the ongoing Phase 2 study in patients with UC; plans, timelines, and expectations related to DNL126, including the timing and availability of data in the ongoing Phase 1/2 study and the impact on development of participation in START; plans, timelines, and expectations of both Denali and Takeda regarding DNL593 and the ongoing Phase 1/2 study; plans, timelines, and expectations regarding the advancement of OTV:MAPT and OTV:SNCA towards clinical development; plans, timelines, and expectations regarding the ATV:Abeta program, including its therapeutic potential and the clinical advancement of ATV:Abeta molecules; plans and expectations for Denali's preclinical programs; Denali's future operating expenses and anticipated cash runway; Denali's PIPE financing and its anticipated proceeds; and Denali's participation in upcoming investor conferences. Actual results are subject to risks and uncertainties and may differ materially from those indicated by these forward-looking statements as a result of these risks and uncertainties, including but not limited to, risks related to: any and all risks to Denali’s business and operations caused by adverse economic conditions; risk of the occurrence of any event, change, or other circumstance that could give rise to the termination of Denali’s agreements with Sanofi, Takeda, or Biogen, or any of Denali’s other collaboration agreements; Denali’s transition to a late-stage clinical drug development company; Denali’s and its collaborators’ ability to complete the development and, if approved, commercialization of its product candidates; Denali’s and its collaborators’ ability to enroll patients in its ongoing and future clinical trials; Denali’s reliance on third parties for the manufacture and supply of its product candidates for clinical trials; Denali’s dependence on successful development of its blood-brain barrier platform technology and its programs and product candidates; Denali’s and its collaborators' ability to conduct or complete clinical trials on expected timelines; the risk that preclinical profiles of Denali’s product candidates may not translate in clinical trials; the potential for clinical trials to differ from preclinical, early clinical, preliminary or expected results; the risk of significant adverse events, toxicities or other undesirable side effects; the uncertainty that product candidates will receive regulatory approval necessary to be commercialized; Denali’s ability to continue to create a pipeline of product candidates or develop commercially successful products; developments relating to Denali's competitors and its industry, including competing product candidates and therapies; Denali’s ability to obtain, maintain, or protect intellectual property rights related to its product candidates; implementation of Denali’s strategic plans for its business, product candidates, and blood-brain barrier platform technology; Denali's ability to obtain additional capital to finance its operations, as needed; Denali's ability to accurately forecast future financial results in the current environment; and other risks and uncertainties, including those described in Denali's most recent Annual and Quarterly Reports on Forms 10-K and 10-Q filed with the Securities and Exchange Commission (SEC) on February 28, 2024 and May 7, 2024, respectively, and Denali’s future reports to be filed with the SEC. Denali does not undertake any obligation to update or revise any forward-looking statements, to conform these statements to actual results, or to make changes in Denali’s expectations, except as required by law.
Denali Therapeutics Inc.
Condensed Consolidated Statements of Operations
(Unaudited)
(In thousands, except share and per share amounts)
| Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||
| 2024 | 2023 | 2024 | 2023 | ||||||||||||
| Collaboration revenue: | |||||||||||||||
| Collaboration revenue from customers(1) | $ | — | $ | 294,123 | $ | — | $ | 329,264 | |||||||
| Total collaboration revenue | — | 294,123 | — | 329,264 | |||||||||||
| Operating expenses: | |||||||||||||||
| Research and development(2) | 91,399 | 97,520 | 198,415 | 226,336 | |||||||||||
| General and administrative | 25,194 | 26,120 | 50,430 | 53,260 | |||||||||||
| Total operating expenses | 116,593 | 123,640 | 248,845 | 279,596 | |||||||||||
| Gain from divestiture of small molecule programs | — | — | 14,537 | — | |||||||||||
| Income (loss) from operations | (116,593 | ) | 170,483 | (234,308 | ) | 49,668 | |||||||||
| Interest and other income, net | 17,567 | 12,900 | 33,480 | 23,934 | |||||||||||
| Net income (loss) | $ | (99,026 | ) | $ | 183,383 | $ | (200,828 | ) | $ | 73,602 | |||||
| Net income (loss) per share: | |||||||||||||||
| Net income (loss) per share, basic | $ | (0.59 | ) | $ | 1.34 | $ | (1.26 | ) | $ | 0.54 | |||||
| Net income (loss) per share, diluted | $ | (0.59 | ) | $ | 1.30 | $ | (1.26 | ) | $ | 0.52 | |||||
| Weighted-average shares used in calculating: | |||||||||||||||
| Net income (loss) per share, diluted | 168,831,329 | 137,047,227 | 159,117,759 | 136,787,321 | |||||||||||
| Weighted average number of shares outstanding, basic and diluted | 168,831,329 | 140,930,625 | 159,117,759 | 140,550,226 | |||||||||||
| __________________________________________________ | ||
| (1) | Includes related-party collaboration revenue from customers of | |
| (2) | Includes expenses for cost sharing payments due to a related party of | |
Denali Therapeutics Inc.
Condensed Consolidated Balance Sheets
(Unaudited)
(In thousands)
| June 30, 2024 | December 31, 2023 | ||||||
| Assets | |||||||
| Current assets: | |||||||
| Cash and cash equivalents | $ | 74,679 | $ | 127,106 | |||
| Short-term marketable securities | 821,365 | 907,405 | |||||
| Prepaid expenses and other current assets | 32,339 | 29,626 | |||||
| Total current assets | 928,383 | 1,064,137 | |||||
| Long-term marketable securities | 450,994 | — | |||||
| Property and equipment, net | 48,077 | 45,589 | |||||
| Operating lease right-of-use asset | 24,533 | 26,048 | |||||
| Other non-current assets | 50,578 | 18,143 | |||||
| Total assets | $ | 1,502,565 | $ | 1,153,917 | |||
| Liabilities and stockholders' equity | |||||||
| Current liabilities: | |||||||
| Accounts payable | $ | 13,936 | $ | 9,483 | |||
| Accrued clinical and other research & development costs | 19,915 | 19,035 | |||||
| Accrued manufacturing costs | 7,111 | 15,462 | |||||
| Other accrued costs and current liabilities | 6,013 | 5,152 | |||||
| Accrued compensation | 9,555 | 21,590 | |||||
| Operating lease liability, current | 7,771 | 7,260 | |||||
| Deferred research funding liability | 10,232 | — | |||||
| Total current liabilities | 74,533 | 77,982 | |||||
| Operating lease liability, less current portion | 40,981 | 44,981 | |||||
| Total liabilities | 115,514 | 122,963 | |||||
| Total stockholders' equity | 1,387,051 | 1,030,954 | |||||
| Total liabilities and stockholders’ equity | $ | 1,502,565 | $ | 1,153,917 | |||
Investor and Media Contact:
Laura Hansen, Ph.D.
Vice President, Investor Relations
(650) 452-2747
hansen@dnli.com
FAQ
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