DURECT Corporation Reports Second Quarter 2024 Financial Results and Business Update
DURECT (Nasdaq: DRRX) reported Q2 2024 financial results and provided a business update. Key highlights include:
1. FDA granted Breakthrough Therapy Designation for larsucosterol in Alcohol-Associated Hepatitis (AH).
2. DURECT held a Type B meeting with FDA to discuss Phase 3 clinical trial design for larsucosterol in AH.
3. The company aims to initiate the Phase 3 trial in 2024, with topline results expected in 2H 2026, subject to sufficient funding.
4. Q2 2024 financial results: Total revenues were $2.2 million, net loss was $3.7 million. Cash, cash equivalents, and investments were $15.8 million as of June 30, 2024.
5. DURECT presented Phase 2b AHFIRM trial data at the EASL Congress 2024 in Milan, Italy.
DURECT (Nasdaq: DRRX) ha riportato i risultati finanziari del secondo trimestre 2024 e fornito un aggiornamento aziendale. I principali punti salienti includono:
1. La FDA ha concesso la Designazione di Terapia Innovativa per il larsucosterol in caso di epatite associata all'alcol (AH).
2. DURECT ha tenuto un incontro di Tipo B con la FDA per discutere il design della sperimentazione clinica di Fase 3 per il larsucosterol in AH.
3. L'azienda punta a avviare la sperimentazione di Fase 3 nel 2024, con risultati preliminari attesi nel secondo semestre del 2026, subordinati a un finanziamento sufficiente.
4. Risultati finanziari del secondo trimestre 2024: Le entrate totali sono state di 2,2 milioni di dollar, la perdita netta è stata di 3,7 milioni di dollar. La liquidità, equivalenti in cassa e investimenti ammontavano a 15,8 milioni di dollar al 30 giugno 2024.
5. DURECT ha presentato i dati della sperimentazione AHFIRM di Fase 2b al Congresso EASL 2024 a Milano, Italia.
DURECT (Nasdaq: DRRX) reportó los resultados financieros del segundo trimestre de 2024 y proporcionó una actualización del negocio. Los aspectos más destacados incluyen:
1. La FDA otorgó la Designación de Terapia Innovadora para el larsucosterol en Hepatitis Asociada al Alcohol (AH).
2. DURECT realizó una reunión de Tipo B con la FDA para discutir el diseño del ensayo clínico de Fase 3 para el larsucosterol en AH.
3. La compañía planea iniciar el ensayo de Fase 3 en 2024, con resultados preliminares esperados para la segunda mitad de 2026, sujeto a financiamiento suficiente.
4. Resultados financieros del segundo trimestre de 2024: Los ingresos totales fueron de 2,2 millones de dólares, y la pérdida neta fue de 3,7 millones de dólares. El efectivo, equivalentes de efectivo e inversiones fueron 15,8 millones de dólares al 30 de junio de 2024.
5. DURECT presentó los datos del ensayo AHFIRM de Fase 2b en el Congreso EASL 2024 en Milán, Italia.
DURECT (Nasdaq: DRRX)가 2024년 2분기 재무 결과를 발표하고 사업 업데이트를 제공했습니다. 주요 내용은 다음과 같습니다:
1. FDA는 알코올 연관 간염(AH) 치료를 위한 larsucosterol에 대해 획기적 치료제 지정을 부여했습니다.
2. DURECT는 AH에 대한 larsucosterol의 3상 임상 시험 설계를 논의하기 위해 FDA와 B 유형 회의를 개최했습니다.
3. 회사는 2024년 3상 시험을 시작할 계획이며, 결과는 2026년 하반기에 발표될 예정이며, 이는 충분한 자금 조달에 달려 있습니다.
4. 2024년 2분기 재무 결과: 총 수익은 220만 달러였고, 순손실은 370만 달러였습니다. 2024년 6월 30일 기준으로 현금과 현금성 자산 및 투자는 1580만 달러였습니다.
5. DURECT는 2024 EASL Congress에서 이탈리아 밀라노에서 2b 단계 AHFIRM 시험 데이터를 발표했습니다.
DURECT (Nasdaq: DRRX) a publié ses résultats financiers pour le deuxième trimestre 2024 et a fourni une mise à jour sur l'entreprise. Les principaux points forts comprennent :
1. La FDA a accordé la Désignation de Thérapie Avancée pour le larsucosterol dans l'hépatite associée à l'alcool (AH).
2. DURECT a tenu une réunion de type B avec la FDA pour discuter du design de l'essai clinique de phase 3 pour le larsucosterol dans l'AH.
3. L'entreprise vise à lancer l'essai de phase 3 en 2024, avec des résultats préliminaires attendus au second semestre 2026, sous réserve d'un financement suffisant.
4. Résultats financiers du deuxième trimestre 2024 : Les revenus totaux s'élevaient à 2,2 millions de dollars, la perte nette était de 3,7 millions de dollars. Les liquidités, équivalents de liquidités et investissements s'élevaient à 15,8 millions de dollars au 30 juin 2024.
5. DURECT a présenté des données de l'essai AHFIRM de phase 2b lors du Congrès EASL 2024 à Milan, Italie.
DURECT (Nasdaq: DRRX) hat die Finanzzahlen für das zweite Quartal 2024 veröffentlicht und ein Unternehmensupdate bereitgestellt. Die wichtigsten Highlights sind:
1. Die FDA hat für larsucosterol die Breakthrough Therapy Designation bei alkoholassoziierter Hepatitis (AH) erteilt.
2. DURECT hat ein Typ-B-Meeting mit der FDA abgehalten, um das Design der Phase-3-Studie für larsucosterol bei AH zu besprechen.
3. Das Unternehmen plant, die Phase-3-Studie 2024 zu starten, mit ersten Ergebnissen, die für das zweite Halbjahr 2026 erwartet werden, vorbehaltlich ausreichender Finanzierung.
4. Finanzielle Ergebnisse für das zweite Quartal 2024: Die Gesamterträge betrugen 2,2 Millionen Dollar, der Nettoverlust betrug 3,7 Millionen Dollar. Zum 30. Juni 2024 beliefen sich Bargeld, Zahlungsmitteläquivalente und Investitionen auf 15,8 Millionen Dollar.
5. DURECT hat Daten zur Phase-2b-AHFIRM-Studie auf dem EASL-Kongress 2024 in Mailand, Italien, präsentiert.
- FDA granted Breakthrough Therapy Designation for larsucosterol in Alcohol-Associated Hepatitis
- Productive Type B meeting with FDA to discuss Phase 3 trial design
- Plans to initiate Phase 3 trial in 2024 with topline results expected in 2H 2026
- Potential to be the first FDA-approved treatment for Alcohol-Associated Hepatitis
- Phase 2b AHFIRM trial data presented at EASL Congress 2024
- Net loss of $3.7 million in Q2 2024
- Cash, cash equivalents, and investments decreased to $15.8 million from $29.8 million at the end of 2023
- Phase 3 trial initiation dependent on obtaining sufficient funding
Insights
DURECT's Q2 2024 results show a mixed financial picture. While revenues slightly increased to
The company's cash position has declined substantially, from
On a positive note, DURECT has reduced its debt from
The FDA's granting of Breakthrough Therapy Designation (BTD) for larsucosterol in Alcohol-Associated Hepatitis (AH) is a significant milestone. This designation could expedite the drug's development and review process, potentially bringing it to market faster if successful in Phase 3 trials.
The recent Type B meeting with the FDA to discuss Phase 3 trial design is crucial. The company's plan to initiate the Phase 3 study by end of 2024, with topline results expected in 2H 2026, provides a clear timeline for investors. However, it's important to note that this timeline is contingent on securing sufficient funding.
If successful, larsucosterol could become the first FDA-approved treatment for AH, addressing a significant unmet medical need. The presentation of Phase 2b AHFIRM trial data at the EASL Congress 2024 indicates growing scientific interest in this potential therapy. However, investors should remain cautious as Phase 3 results will be critical in determining the drug's future.
- FDA Granted Breakthrough Therapy Designation for Larsucosterol in Alcohol-Associated Hepatitis
- Held Type B Meeting with FDA to Discuss Phase 3 Clinical Trial Design
- Seeking to Initiate Phase 3 Trial in 2024 with Topline Results Expected in 2H 2026
- Webcast of Earnings Call Today, August 13th at 4:30 p.m. ET
"Our immediate priority is to finalize the design of our planned pivotal Phase 3 trial of larsucosterol in alcohol-associated hepatitis (AH)," stated James E. Brown, D.V.M., President and CEO of DURECT. "Recently we had a productive Type B meeting with the
Business Update:
- The FDA granted Breakthrough Therapy Designation to larsucosterol for the treatment of patients with AH. BTD is designed to expedite the development and review of therapies intended to treat a serious or life-threatening condition and whose preliminary clinical evidence indicates that the drug may demonstrate substantial improvement on one or more clinically significant endpoints over existing available therapies.
- In July 2024, DURECT held a Type B meeting with the FDA to discuss the design of its planned Phase 3 clinical trial of larsucosterol in AH that, if successful, could support a potential NDA filing. The Company plans to provide additional details of the Phase 3 trial design following receipt of the written minutes from this meeting. DURECT's goal is to initiate its Phase 3 trial in 2024, subject to obtaining sufficient funding, with topline results expected by the second half of 2026.
- Data from the Company's Phase 2b AHFIRM trial, which evaluated the safety and efficacy of larsucosterol as a treatment for patients with severe AH, were featured in a late-breaking oral presentation at the European Association for the Study of the Liver (EASL) Congress 2024 on June 8, 2024 in
Milan, Italy . This was the first presentation of the AHFIRM data at a medical meeting. Top line data from the study were previously announced in 2023.
Financial Highlights for Q2 2024:
- Total revenues were
$2.2 million $3.7 million $2.1 million $11.2 million - Cash, cash equivalents and investments were
$15.8 million $29.8 million $12.5 million $16.7 million
Earnings Conference Call
We will host a conference call and webcast today at 4:30 p.m. Eastern Time/1:30 p.m. Pacific Time to discuss the second quarter 2024 results and provide a corporate update:
Tuesday, August 13 @ 4:30 p.m. Eastern Time / 1:30 p.m. Pacific Time
Toll Free: | 1-877-407-0784 |
International: | 1-201-689-8560 |
Conference ID: | 13747506 |
Webcast: | https://viavid.webcasts.com/starthere.jsp?ei=1678530&tp_key=3a937134de |
Call me™: Participants can use Guest dial-in numbers above and be answered by an operator OR click the Call me™ link for instant telephone access to the event. The Call me™ link will be made active 15 minutes prior to the scheduled start time.
The live audio webcast of the presentation will be also available on DURECT's homepage at www.durect.com on the "Events" page, under the "Investors" section. If you are unable to participate during the live webcast, the call will be archived on DURECT's website under the same section, following the completion of the call.
About the AHFIRM Trial
AHFIRM was a Phase 2b randomized, double-blind, placebo-controlled, international, multi-center study conducted in subjects with severe alcohol-associated hepatitis (AH) to evaluate the saFety and effIcacy of laRsucosterol treatMent (AHFIRM). The study was comprised of three arms and enrolled 307 patients, with approximately 100 patients in each arm: (1) Placebo, which consists of standard of care, with or without methylprednisolone capsules at the investigators' discretion; (2) larsucosterol (30 mg); and (3) larsucosterol (90 mg). Patients in the larsucosterol arms received the same supportive care without steroids. The primary outcome measure was the 90-Day incidence of mortality or liver transplantation for patients treated with larsucosterol compared to those treated with placebo, and the key secondary endpoint was 90-Day survival. The Company enrolled patients at clinical trial sites across the
About Alcohol-associated Hepatitis (AH)
AH is an acute form of alcohol-associated liver disease (ALD) associated with long-term heavy alcohol intake, often following a recent period of increased consumption (i.e., a binge). AH is typically characterized by severe inflammation and liver cell damage, potentially leading to life-threatening complications including liver failure, acute kidney injury and multi-organ failure. There are no FDA approved therapies for AH, and a retrospective analysis of 77 studies published between 1971 and 2016, which included data from 8,184 patients, showed the overall mortality from AH was
About Larsucosterol
Larsucosterol is an endogenous sulfated oxysterol and an epigenetic modulator. Epigenetic regulators are compounds that regulate patterns of gene expression without modifying the DNA sequence. DNA hypermethylation, an example of epigenetic dysregulation, results in transcriptomic reprogramming and cellular dysfunction, and has been reported in many acute (e.g., AH) and chronic diseases (e.g., MASH). As an inhibitor of DNA methyltransferases (DNMT1, DNMT3a and 3b), larsucosterol inhibits DNA methylation, which subsequently modulates expression of genes that are involved in cell signaling pathways associated with stress responses, cell death and survival, and lipid biosynthesis. This may ultimately lead to improved cell survival, reduced inflammation, and decreased lipotoxicity. As an epigenetic modulator, the proposed mechanism of action provides further scientific rationale for developing larsucosterol for the treatment of acute organ injury and certain chronic diseases.
About DURECT Corporation
DURECT is a late-stage biopharmaceutical company pioneering the development of epigenetic therapies that target dysregulated DNA methylation to transform the treatment of serious and life-threatening conditions, including acute organ injury and cancer. Larsucosterol, DURECT's lead drug candidate, binds to and inhibits the activity of DNA methyltransferases (DNMTs), epigenetic enzymes that are elevated and associated with hypermethylation found in alcohol-associated hepatitis (AH) patients. Larsucosterol is in clinical development for the potential treatment of AH, for which the FDA has granted Fast Track and Breakthrough Therapy designation; metabolic dysfunction-associated steatohepatitis (MASH) is also being explored. In addition, POSIMIR® (bupivacaine solution) for infiltration use, a non-opioid analgesic utilizing the innovative SABER® platform technology, is FDA-approved and is exclusively licensed to Innocoll Pharmaceuticals for sale and distribution in the United States. For more information about DURECT, please visit www.durect.com and follow us on X (formerly Twitter) at https://x.com/DURECTCorp.
DURECT Forward-Looking Statements
This press release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, relating to: the Company's ability to commence a Phase 3 trial of larsucosterol in 2024 and report top-line data by the second half of 2026, the potential for a single Phase 3 trial of larsucosterol, if successful, to support an NDA filing, and the potential uses and benefits of laruscosterol in patients with AH and potentially other indications. Actual results may differ materially from those contained in the forward-looking statements contained in this press release, and reported results should not be considered as an indication of future performance. The potential risks and uncertainties that could cause actual results to differ from those projected include, among other things, the risks that the Company is unable to raise sufficient capital to commence the Phase 3 trial of larsucosterol in AH, trial enrollment or completion takes longer than anticipated, future clinical trials of larsucosterol are delayed or do not confirm the results from subset analyses of the AHFIRM trial, including geographic or other segmentation, or of earlier clinical or pre-clinical trials, or do not demonstrate the safety or efficacy of larsucosterol in a statistically significant manner; the risk that the FDA or other government agencies may require additional clinical trials for larsucosterol before approving larsucosterol for the treatment of AH, and that larsucosterol may never be approved; and risks related to the sufficiency of our cash resources, our anticipated capital requirements, our need or desire for additional financing, our ability to continue to meet the minimum bid price for continued listing on Nasdaq, our ability to obtain capital to fund our operations and expenses, and our ability to continue to operate as a going concern. Further information regarding these and other risks is included in DURECT's most recent Securities and Exchange Commission (SEC) filings, including its annual report on Form 10-K for the year ended December 31, 2023 and quarterly report on Form 10-Q for the quarter ended June 30, 2024, when filed, under the heading "Risk Factors." These reports are available on our website www.durect.com under the "Investors" tab and on the SEC's website at www.sec.gov. All information provided in this press release and in the attachments is based on information available to DURECT as of the date hereof, and DURECT assumes no obligation to update this information as a result of future events or developments, except as required by law.
NOTE: POSIMIR® is a trademark of Innocoll Pharmaceuticals, Ltd. in the
DURECT CORPORATION | |||||||||
CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS | |||||||||
(in thousands, except per share amounts) | |||||||||
(unaudited) | |||||||||
Three months ended | Six months ended | ||||||||
June 30 | June 30 | ||||||||
2024 | 2023 | 2024 | 2023 | ||||||
Collaborative research and development and other revenue | $ 606 | $ 508 | $ 1,102 | $ 1,151 | |||||
Product revenue, net | 1,565 | 1,573 | 2,896 | 2,984 | |||||
Total revenues | 2,171 | 2,081 | 3,998 | 4,135 | |||||
Operating expenses: | |||||||||
Cost of product revenues | 356 | 359 | 645 | 747 | |||||
Research and development | 2,247 | 7,946 | 6,366 | 16,539 | |||||
Selling, general and administrative | 2,972 | 3,827 | 6,108 | 7,922 | |||||
Total operating expenses | 5,575 | 12,132 | 13,119 | 25,208 | |||||
Loss from operations | (3,404) | (10,051) | (9,121) | (21,073) | |||||
Other income (expense): | |||||||||
Interest and other income | 227 | 511 | 548 | 1,028 | |||||
Interest and other expenses | (445) | (749) | (974) | (1,475) | |||||
Change in fair value of warrant liabilities | (78) | (892) | (1,796) | 1,585 | |||||
Issuance cost for warrants | - | - | - | (1,200) | |||||
Loss on issuance of warrants | - | - | - | (2,033) | |||||
Other income (expense), net | (296) | (1,130) | (2,222) | (2,095) | |||||
Net loss | $ (3,700) | $ (11,181) | $ (11,343) | $ (23,168) | |||||
Net change in unrealized loss on available-for-sale securities, net of reclassification adjustments and taxes | $ 3 | $ 1 | $ 7 | $ 7 | |||||
Total comprehensive loss | $ (3,697) | $ (11,180) | $ (11,336) | $ (23,161) | |||||
Net loss per share | |||||||||
Basic | $ (0.12) | $ (0.46) | $ (0.37) | $ (0.96) | |||||
Diluted | $ (0.12) | $ (0.46) | $ (0.37) | $ (0.96) | |||||
Weighted-average shares used in computing net loss per share | |||||||||
Basic | 31,038 | 24,508 | 30,838 | 24,140 | |||||
Diluted | 31,038 | 24,508 | 30,838 | 24,377 | |||||
DURECT CORPORATION | ||||
CONDENSED BALANCE SHEETS | ||||
(in thousands) | ||||
As of | As of | |||
June 30, 2024 | December 31, 2023 (1) | |||
(unaudited) | ||||
ASSETS | ||||
Current assets: | ||||
Cash and cash equivalents | $ 15,646 | $ 28,400 | ||
Short-term Investments | - | 1,280 | ||
Accounts receivable, net | 1,012 | 1,261 | ||
Inventories, net | 2,474 | 2,219 | ||
Prepaid expenses and other current assets | 818 | 1,511 | ||
Total current assets | 19,950 | 34,671 | ||
Property and equipment, net | 67 | 91 | ||
Operating lease right-of-use assets | 3,390 | 3,980 | ||
Goodwill | 6,169 | 6,169 | ||
Long-term restricted Investments | 150 | 150 | ||
Other long-term assets | 128 | 128 | ||
Total assets | $ 29,854 | $ 45,189 | ||
LIABILITIES AND STOCKHOLDERS' EQUITY | ||||
Current liabilities: | ||||
Accounts payable | $ 394 | $ 1,777 | ||
Accrued liabilities | 4,670 | 5,966 | ||
Term loan, current portion, net | 12,545 | 16,663 | ||
Operating lease liabilities, current portion | 1,299 | 1,381 | ||
Warrant liabilities | 3,020 | 1,224 | ||
Total current liabilities | 21,928 | 27,011 | ||
Operating lease liabilities, noncurrent portion | 2,220 | 2,702 | ||
Other long-term liabilities | 669 | 693 | ||
Stockholders' equity | 5,037 | 14,783 | ||
Total liabilities and stockholders' equity | $ 29,854 | $ 45,189 | ||
(1) Derived from audited financial statements. | ||||
View original content to download multimedia:https://www.prnewswire.com/news-releases/durect-corporation-reports-second-quarter-2024-financial-results-and-business-update-302221386.html
SOURCE DURECT Corporation
FAQ
What is the status of larsucosterol's development for Alcohol-Associated Hepatitis (DRRX)?
What were DURECT 's (DRRX) financial results for Q2 2024?
When does DURECT (DRRX) expect topline results from the planned Phase 3 trial of larsucosterol?
Where did DURECT (DRRX) present its Phase 2b AHFIRM trial data in June 2024?
