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UNITY Biotechnology, Inc. Reports Second Quarter 2024 Financial Results and Business Updates

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UNITY Biotechnology (NASDAQ:UBX) reported its Q2 2024 financial results and provided business updates. Key highlights include:

Enrollment Success: The company exceeded its enrollment goal for the ASPIRE study, evaluating UBX1325 against aflibercept in diabetic macular edema (DME).

Financial Position: Cash, cash equivalents, and marketable securities totaled $34.0 million as of June 30, 2024. UNITY believes this is sufficient to fund operations into Q3 2025.

Reduced Net Loss: Q2 2024 net loss was $5.3 million, down from $15.5 million in Q2 2023.

Decreased Expenses: R&D expenses decreased to $3.5 million from $6.4 million, while G&A expenses reduced to $3.5 million from $5.4 million year-over-year.

Study Timeline: Topline 24-week primary endpoint data for the ASPIRE study is expected in Q1 2025, with 36-week data in Q2 2025.

UNITY Biotechnology (NASDAQ:UBX) ha riportato i risultati finanziari del secondo trimestre 2024 e fornito aggiornamenti aziendali. I punti salienti includono:

Successo nell'iscrizione: La società ha superato il suo obiettivo di iscrizione per lo studio ASPIRE, che valuta UBX1325 rispetto all'aflibercept nell'edema maculare diabetico (DME).

Posizione finanziaria: La liquidità, i mezzi equivalenti e i titoli negoziabili ammontano a 34,0 milioni di dollari al 30 giugno 2024. UNITY ritiene che questa somma sia sufficiente a finanziare le operazioni fino al terzo trimestre del 2025.

Riduzione della perdita netta: La perdita netta del secondo trimestre 2024 è stata di 5,3 milioni di dollari, in calo rispetto ai 15,5 milioni di dollari del secondo trimestre 2023.

Riduzione delle spese: Le spese di R&S sono diminuite a 3,5 milioni di dollari rispetto ai 6,4 milioni dell'anno precedente, mentre le spese generali e amministrative sono scese a 3,5 milioni rispetto ai 5,4 milioni dello scorso anno.

Tempistiche dello studio: Si prevede che i dati principali a 24 settimane per lo studio ASPIRE siano disponibili nel primo trimestre del 2025, con dati a 36 settimane nel secondo trimestre del 2025.

UNITY Biotechnology (NASDAQ:UBX) informó sobre sus resultados financieros del segundo trimestre de 2024 y proporcionó actualizaciones empresariales. Los puntos destacados incluyen:

Éxito en la inscripción: La compañía superó su objetivo de inscripción para el estudio ASPIRE, que evalúa UBX1325 frente a aflibercept en el edema macular diabetes (DME).

Posición financiera: El efectivo, los equivalentes de efectivo y los valores negociables totalizaron 34,0 millones de dólares al 30 de junio de 2024. UNITY cree que esta suma es suficiente para financiar las operaciones hasta el tercer trimestre de 2025.

Reducción de la pérdida neta: La pérdida neta del segundo trimestre de 2024 fue de 5,3 millones de dólares, una disminución con respecto a los 15,5 millones de dólares en el segundo trimestre de 2023.

Reducción de gastos: Los gastos de I+D se redujeron a 3,5 millones de dólares desde 6,4 millones, mientras que los gastos generales y administrativos disminuyeron a 3,5 millones desde 5,4 millones en comparación con el año anterior.

Cronograma del estudio: Se espera que los datos principales a 24 semanas para el estudio ASPIRE estén disponibles en el primer trimestre de 2025, con datos a 36 semanas en el segundo trimestre de 2025.

UNITY Biotechnology (NASDAQ:UBX)는 2024년 2분기 재무 결과와 사업 업데이트를 보고했습니다. 주요 내용은 다음과 같습니다:

등록 성공: 회사는 당뇨병성 황반부종(DME)에서 aflibercept와 비교하여 UBX1325를 평가하는 ASPIRE 연구의 등록 목표를 초과 달성했습니다.

재무 상태: 2024년 6월 30일 기준 현금, 현금성 자산 및 유가 증권 총액은 3,400만 달러입니다. UNITY는 이 금액이 2025년 3분기까지 운영 자금을 지원하기에 충분하다고 믿고 있습니다.

순 손실 감소: 2024년 2분기 순 손실은 530만 달러로, 2023년 2분기 1,550만 달러에서 감소했습니다.

비용 감소: 연구개발 비용은 640만 달러에서 350만 달러로 줄어들었고, 일반 관리 비용은 전년 대비 540만 달러에서 350만 달러로 줄어들었습니다.

연구 일정: ASPIRE 연구의 24주 주요 결과 데이터는 2025년 1분기 중에 공개될 예정이며, 36주 데이터는 2025년 2분기에 발표될 예정입니다.

UNITY Biotechnology (NASDAQ:UBX) a publié ses résultats financiers pour le deuxième trimestre 2024 et a fourni des mises à jour commerciales. Les principaux points à retenir incluent :

Succès de l'inscription : L'entreprise a dépassé son objectif d'inscription pour l'étude ASPIRE, qui évalue UBX1325 par rapport à l'aflibercept dans l'œdème maculaire diabétique (DME).

Position financière : La trésorerie, les équivalents de trésorerie et les titres négociables totalisaient 34,0 millions de dollars au 30 juin 2024. UNITY estime que ce montant est suffisant pour financer ses opérations jusqu'au troisième trimestre 2025.

Réduction de la perte nette : La perte nette du deuxième trimestre 2024 s'élevait à 5,3 millions de dollars, contre 15,5 millions de dollars au deuxième trimestre 2023.

Réduction des dépenses : Les dépenses de R&D ont diminué à 3,5 millions de dollars, contre 6,4 millions de dollars, tandis que les dépenses générales et administratives ont été réduites à 3,5 millions de dollars, contre 5,4 millions de dollars d'une année sur l'autre.

Calendrier de l'étude : Les données de l'objectif principal à 24 semaines de l'étude ASPIRE devraient être disponibles au premier trimestre 2025, avec les données à 36 semaines au deuxième trimestre 2025.

UNITY Biotechnology (NASDAQ:UBX) hat die finanziellen Ergebnisse für das zweite Quartal 2024 veröffentlicht und Unternehmensupdates bereitgestellt. Zu den wichtigsten Punkten gehören:

Erfolgreiche Einschreibung: Das Unternehmen hat sein Einschreibungsziel für die ASPIRE-Studie übertroffen, in der UBX1325 im Vergleich zu Aflibercept bei der diabetischen Makulaödem (DME) bewertet wird.

Finanzposition: Die liquiden Mittel, liquiden Mitteläquivalente und marktgängigen Wertpapiere beliefen sich zum 30. Juni 2024 auf 34,0 Millionen USD. UNITY ist der Meinung, dass dieser Betrag ausreicht, um die Betriebe bis ins dritte Quartal 2025 zu finanzieren.

Reduzierter Nettoverlust: Der Nettoverlust im zweiten Quartal 2024 betrug 5,3 Millionen USD, ein Rückgang von 15,5 Millionen USD im zweiten Quartal 2023.

Verringerte Aufwendungen: Die F&E-Ausgaben sanken von 6,4 Millionen USD auf 3,5 Millionen USD, während die allgemeinen und Verwaltungskosten von 5,4 Millionen USD auf 3,5 Millionen USD im Jahresvergleich sanken.

Studienzeitplan: Die Ergebnisse zu den primären Endpunkten der 24-wöchigen ASPIRE-Studie werden im ersten Quartal 2025 erwartet, mit Daten nach 36 Wochen im zweiten Quartal 2025.

Positive
  • Exceeded enrollment goal for ASPIRE study in DME
  • Net loss decreased by 65.8% year-over-year to $5.3 million
  • R&D expenses reduced by 45.3% to $3.5 million
  • G&A expenses decreased by 35.2% to $3.5 million
  • Cash used in operations reduced by 56.3% to $9.8 million in H1 2024
Negative
  • Cash, cash equivalents and marketable securities decreased by 21.3% to $34.0 million since December 31, 2023

Insights

UNITY Biotechnology's Q2 2024 results show a significant improvement in financial health. The company's net loss decreased by $10.2 million year-over-year, from $15.5 million to $5.3 million. This 65.8% reduction in net loss is primarily attributed to decreased R&D and G&A expenses.

Cash burn has also improved substantially, with cash used in operations for H1 2024 at $9.8 million, compared to $22.4 million in H1 2023, a 56.3% reduction. This efficiency in cash management is crucial, extending the company's runway into Q3 2025.

However, investors should note the declining cash position, from $43.2 million at the end of 2023 to $34.0 million as of June 30, 2024. While the burn rate has improved, additional financing may be needed before the expected data readouts in 2025.

UNITY's focus on UBX1325 (foselutoclax) for diabetic macular edema (DME) represents a potentially disruptive approach in ophthalmology. The senolytic mechanism of action, targeting upstream of VEGF inhibitors, could address key limitations of current treatments, particularly the high treatment burden.

The expansion of the ASPIRE study to 50 patients and 36 weeks demonstrates confidence in UBX1325's potential. Exceeding enrollment goals is a positive sign for investor confidence and could accelerate the timeline for data readouts.

However, it's important to note that while promising, the efficacy and durability of UBX1325 compared to aflibercept remain unproven. The upcoming topline 24-week and 36-week data in Q1 and Q2 2025, respectively, will be critical in determining the drug's potential market impact.

SOUTH SAN FRANCISCO, Calif., Aug. 06, 2024 (GLOBE NEWSWIRE) -- UNITY Biotechnology, Inc. (UNITY) [NASDAQ:UBX], a biotechnology company developing therapeutics to slow, halt, or reverse diseases of aging, today reported financial results for the second quarter ended June 30, 2024.

“Having expanded and extended our ASPIRE study to 50 patients and 36 weeks, respectively, to better assess the efficacy and durability of UBX1325 compared to aflibercept, we have been laser-focused on enrollment and execution this quarter,” said Anirvan Ghosh, Ph.D., chief executive officer of UNITY. “I’m pleased to report that due to the excellent performance of our clinical operations team and the enthusiasm and engagement of our investigators, we have not just met, but have exceeded our enrollment goal in this study."

UBX1325 (foselutoclax) is designed as a novel and durable therapeutic option in diabetic macular edema (DME) that acts via a senolytic mechanism of action upstream of VEGF inhibitors, with the potential to address shortcomings of the current standard of care, such as high treatment burden and sub-optimal response to treatment.

UNITY expects topline 24-week primary endpoint data in the first quarter of 2025 and 36-week data in the second quarter of 2025. The Phase 2b ASPIRE study in DME is a multi-center, randomized, double-masked, active-controlled study designed to evaluate the safety and efficacy of UBX1325 in a head-to-head comparison to aflibercept. More information about ASPIRE (NCT06011798) can be found here.

Second Quarter Financial Results

Cash, cash equivalents and marketable securities totaled $34.0 million as of June 30, 2024 compared with $43.2 million as of December 31, 2023. UNITY believes that current cash, cash equivalents and marketable securities are sufficient to fund operations into the third quarter of 2025.

Net loss for the three months ended June 30, 2024 was $5.3 million compared to $15.5 million for the three months ended June 30, 2023. Cash used in operations during the first and second quarters of 2024 was $9.8 million compared to $22.4 million during the first and second quarters of 2023.

Research and development expenses decreased by $3.0 million, to $3.5 million for three months ended June 30, 2024 from $6.4 million for the three months ended June 30, 2023. The decrease was primarily due to decreases of $2.0 million in personnel costs due to our reduced headcount related to our reduction in force, $0.7 million in direct research and development expenses mainly due to the completion of the Phase 2 BEHOLD study of UBX1325 in patients with DME and the Phase 2 ENVISION study of UBX1325 in patients with AMD, and $0.3 million in operating costs due to reduced fixed assets depreciation and reduced office space.

General and administrative expenses decreased by $1.9 million, to $3.5 million for the three months ended June 30, 2024 from $5.4 million for the three months ended June 30, 2023. The decrease was primarily due to decreases of $1.2 million in personnel-related expenses due to reduced headcount and the higher bonus and severance amounts paid in 2023, $0.4 million in professional fees and accounting service fees, and $0.3 million in operating costs mainly from the continuation of sublease income generated from the East Grand property.

About UNITY

UNITY is developing a new class of therapeutics to slow, halt, or reverse diseases of aging. UNITY’s current focus is on creating medicines to selectively eliminate or modulate senescent cells and thereby provide transformative benefit in age-related ophthalmologic and neurologic diseases. More information is available at www.unitybiotechnology.com or follow us on Twitter and LinkedIn.

Forward-Looking Statements

This press release contains forward-looking statements including statements related to UNITY’s understanding of cellular senescence and the role it plays in diseases of aging, the potential for UNITY to develop therapeutics to slow, halt, or reverse diseases of aging, including for ophthalmologic and neurologic diseases, the potential for UNITY to successfully commence and complete clinical studies of UBX1325 for DME, AMD, and other ophthalmologic diseases, the expected timing of enrollment and results of the clinical trials in UBX1325, and UNITY’s expectations regarding the sufficiency of its cash runway. These statements involve substantial known and unknown risks, uncertainties, and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements, including risks related to delay or disruption in the enrollment of patients in clinical trials, risks relating to the uncertainties inherent in the drug development process, and risks relating to UNITY’s understanding of senescence biology. We may not actually achieve the plans, intentions, or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. The forward-looking statements in this press release represent our views as of the date of this release. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we have no current intention of doing so except to the extent required by applicable law. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this release. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the Company in general, see UNITY’s most recent Quarterly Report on Form 10-Q for the quarter ended June 30, 2024, filed with the Securities and Exchange Commission on August 6, 2024, as well as other documents that may be filed by UNITY from time to time with the Securities and Exchange Commission.


Unity Biotechnology, Inc.
Statements of Operations and Comprehensive Loss
(In thousands, except share and per share amounts)
       
  Three Months Ended  Six Months Ended 
  June 30,  June 30, 
  2024  2023  2024  2023 
  (Unaudited)  (Unaudited) 
Operating expenses:            
Research and development $3,463  $6,435  $7,184  $12,195 
General and administrative  3,516   5,413   7,394   10,212 
Total operating expenses  6,979   11,848   14,578   22,407 
Loss from operations  (6,979)  (11,848)  (14,578)  (22,407)
Interest income  515   805   1,028   1,660 
Interest expense     (883)     (1,885)
Gain (loss) on warrant liability  1,246   (3,461)  2,622   2,030 
Other income (expense), net  (61)  (69)  (141)  (133)
Net loss  (5,279)  (15,456)  (11,069)  (20,735)
Other comprehensive gain (loss)            
Unrealized gain (loss) on marketable debt securities  3   14   (11)  115 
Comprehensive loss $(5,276) $(15,442) $(11,080) $(20,620)
Net loss per share, basic and diluted $(0.31) $(1.07) $(0.66) $(1.44)
Weighted-average number of shares used in computing net loss per share, basic and diluted  16,815,387   14,425,775   16,800,238   14,369,643 
                 


Unity Biotechnology, Inc.
Condensed Balance Sheets
(In thousands)
       
  June 30,  December 31, 
  2024  2023 
  (Unaudited)    
Assets      
Current Assets:      
Cash and cash equivalents $7,584  $19,803 
Short-term marketable securities  26,400   23,398 
Prepaid expenses and other current assets  1,862   3,404 
Total current assets  35,846   46,605 
Property and equipment, net  4,630   5,082 
Operating lease right-of-use assets  11,900   12,981 
Long-term restricted cash  896   896 
Other long-term assets  250   126 
Total assets $53,522  $65,690 
Liabilities and Stockholders’ Equity      
Current liabilities:      
Accounts payable $1,456  $1,380 
Accrued compensation  1,385   1,841 
Accrued and other current liabilities  5,977   4,619 
Total current liabilities  8,818   7,840 
Operating lease liability, net of current portion  21,659   23,539 
Warrant liability  3,291   5,913 
Total liabilities  33,768   37,292 
Commitments and contingencies      
Stockholders’ equity:      
Common stock  2   2 
Additional paid-in capital  515,209   512,773 
Accumulated other comprehensive gain  (35)  (24)
Accumulated deficit  (495,422)  (484,353)
Total stockholders’ equity  19,754   28,398 
Total liabilities and stockholders’ equity $53,522  $65,690 


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Katherine Smith
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Joyce Allaire
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FAQ

What were UNITY Biotechnology's Q2 2024 financial results?

UNITY Biotechnology reported a net loss of $5.3 million for Q2 2024, compared to $15.5 million in Q2 2023. Cash, cash equivalents, and marketable securities totaled $34.0 million as of June 30, 2024.

When does UNITY Biotechnology expect topline data for the ASPIRE study of UBX1325?

UNITY expects topline 24-week primary endpoint data for the ASPIRE study in the first quarter of 2025 and 36-week data in the second quarter of 2025.

How much did UNITY Biotechnology's R&D expenses decrease in Q2 2024?

UNITY Biotechnology's R&D expenses decreased by $3.0 million, from $6.4 million in Q2 2023 to $3.5 million in Q2 2024, primarily due to reduced headcount and completion of previous studies.

What is the cash runway for UNITY Biotechnology (UBX) based on current resources?

UNITY Biotechnology believes that its current cash, cash equivalents, and marketable securities are sufficient to fund operations into the third quarter of 2025.

Unity Biotechnology, Inc.

NASDAQ:UBX

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Biotechnology
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SOUTH SAN FRANCISCO