Vor Bio Reports Second Quarter 2024 Financial Results and Provides Company Update
Vor Bio (Nasdaq: VOR) reported second-quarter 2024 financial results and a corporate update. The company is advancing in its trem-cel + Mylotarg and VCAR33ALLO clinical trials. Trem-cel, aimed at AML and MDS patients, is progressing with 21 patients dosed, with the third dose level of Mylotarg at 2.0 mg/m2. Data updates, including engraftment, hematologic protection, and pharmacokinetic analyses, are expected in H2 2024. VCAR33ALLO is also advancing, with several patients dosed and initial data expected in H2 2024. Financially, Vor Bio ended Q2 2024 with $85.9 million in cash, projected to fund operations into H2 2025. R&D expenses decreased to $21.8 million from $23.9 million YoY, and G&A expenses decreased to $7.2 million from $8.3 million YoY. Net loss narrowed to $27.8 million from $30.0 million YoY.
Vor Bio (Nasdaq: VOR) ha riportato i risultati finanziari del secondo trimestre del 2024 e un aggiornamento aziendale. L'azienda sta avanzando nei suoi studi clinici su trem-cel + Mylotarg e VCAR33ALLO. Trem-cel, destinato a pazienti con AML e MDS, sta progredendo con 21 pazienti trattati, con il terzo livello di dosaggio di Mylotarg a 2,0 mg/m2. Aggiornamenti sui dati, inclusi il trapianto, la protezione ematologica e le analisi farmacocinetiche, sono attesi nella seconda metà del 2024. Anche VCAR33ALLO sta avanzando, con diversi pazienti trattati e dati iniziali attesi nella seconda metà del 2024. A livello finanziario, Vor Bio ha chiuso il secondo trimestre del 2024 con 85,9 milioni di dollari in cassa, previsti per finanziare le operazioni fino alla seconda metà del 2025. Le spese per R&S sono diminuite a 21,8 milioni di dollari da 23,9 milioni di dollari rispetto all'anno precedente, e le spese generali e amministrative sono diminuite a 7,2 milioni di dollari da 8,3 milioni di dollari rispetto all'anno precedente. La perdita netta si è ridotta a 27,8 milioni di dollari da 30,0 milioni di dollari rispetto all'anno precedente.
Vor Bio (Nasdaq: VOR) informó sobre los resultados financieros del segundo trimestre de 2024 y una actualización corporativa. La empresa avanza en sus ensayos clínicos de trem-cel + Mylotarg y VCAR33ALLO. Trem-cel, dirigido a pacientes con AML y MDS, está progresando con 21 pacientes tratados, con el tercer nivel de dosis de Mylotarg a 2.0 mg/m2. Se esperan actualizaciones de datos, que incluirán injertos, protección hematológica y análisis farmacocinéticos, para la segunda mitad de 2024. VCAR33ALLO también está avanzando, con varios pacientes tratados y datos iniciales esperados en la segunda mitad de 2024. Desde el punto de vista financiero, Vor Bio terminó el segundo trimestre de 2024 con 85.9 millones de dólares en efectivo, lo que se prevé que financie las operaciones hasta la segunda mitad de 2025. Los gastos de I+D disminuyeron a 21.8 millones de dólares desde 23.9 millones de dólares en comparación con el año anterior, y los gastos de G&A disminuyeron a 7.2 millones de dólares desde 8.3 millones de dólares en comparación con el año anterior. La pérdida neta se redujo a 27.8 millones de dólares desde 30.0 millones de dólares en comparación con el año anterior.
Vor Bio (Nasdaq: VOR)는 2024년 2분기 재무 결과 및 기업 업데이트를 보고했습니다. 이 회사는 trem-cel + Mylotarg 및 VCAR33ALLO 임상 시험을 진행하고 있습니다. AML 및 MDS 환자를 대상으로 하는 trem-cel은 21명의 환자에게 투여되었으며, Mylotarg의 세 번째 용량 수준은 2.0 mg/m2입니다. 이식, 혈액학적 보호 및 약리학적 분석을 포함한 데이터 업데이트는 2024년 하반기에 예상됩니다. VCAR33ALLO 또한 여러 환자에게 투여되었으며, 초기 데이터가 2024년 하반기에 예상됩니다. 재무적으로 Vor Bio는 2024년 2분기를 8,590만 달러의 현금으로 마감했으며, 이는 2025년 하반기까지 운영을 지원할 것으로 예상됩니다. 연구개발 비용은 지난해 2,390만 달러에서 2,180만 달러로 감소했으며, 일반 관리 비용은 지난해 830만 달러에서 720만 달러로 감소했습니다. 순손실은 지난해 3,000만 달러에서 2,780만 달러로 좁혀졌습니다.
Vor Bio (Nasdaq: VOR) a publié ses résultats financiers du deuxième trimestre 2024 ainsi qu'une mise à jour de l'entreprise. La société avance dans ses essais cliniques avec trem-cel + Mylotarg et VCAR33ALLO. Trem-cel, destiné aux patients atteints d'AML et de MDS, suit son cours avec 21 patients traités, le troisième niveau de dose de Mylotarg étant de 2,0 mg/m2. Des mises à jour de données, incluant le greffage, la protection hématologique et les analyses pharmacocinétiques, sont attendues au second semestre 2024. VCAR33ALLO avance également, avec plusieurs patients traités et des données initiales attendues au second semestre 2024. Sur le plan financier, Vor Bio a terminé le deuxième trimestre 2024 avec 85,9 millions de dollars de liquidités, prévus pour financer les opérations jusqu'au second semestre 2025. Les dépenses de R&D ont diminué à 21,8 millions de dollars contre 23,9 millions de dollars l'année précédente, et les dépenses G&A ont diminué à 7,2 millions de dollars contre 8,3 millions de dollars l'année précédente. La perte nette s'est réduite à 27,8 millions de dollars contre 30,0 millions de dollars l'année précédente.
Vor Bio (Nasdaq: VOR) berichtete über die finanziellen Ergebnisse des zweiten Quartals 2024 sowie über ein Unternehmensupdate. Das Unternehmen macht Fortschritte bei seinen klinischen Studien mit trem-cel + Mylotarg und VCAR33ALLO. Trem-cel, das auf AML- und MDS-Patienten abzielt, verläuft gut mit 21 behandelten Patienten, wobei die dritte Dosisstufe von Mylotarg bei 2,0 mg/m2 liegt. Datenaktualisierungen, einschließlich Transplantation, hämatologischer Schutz und pharmakokinetischer Analysen, werden für die zweite Hälfte 2024 erwartet. VCAR33ALLO macht ebenfalls Fortschritte, mit mehreren behandelten Patienten und ersten Daten, die in der zweiten Hälfte 2024 erwartet werden. Finanziell schloss Vor Bio das zweite Quartal 2024 mit 85,9 Millionen US-Dollar in bar ab, was voraussichtlich die operativen Tätigkeiten bis zur zweiten Hälfte 2025 finanzieren wird. Die F&E-Ausgaben sind von 23,9 Millionen US-Dollar im Vorjahr auf 21,8 Millionen US-Dollar gesunken, und die V&V-Ausgaben verringerten sich von 8,3 Millionen US-Dollar auf 7,2 Millionen US-Dollar im Vergleich zum Vorjahr. Der Nettoverlust reduzierte sich auf 27,8 Millionen US-Dollar von 30,0 Millionen US-Dollar im Vorjahr.
- Cash position of $85.9 million projected to fund operations into H2 2025.
- R&D expenses decreased by $2.1 million YoY.
- Net loss decreased to $27.8 million from $30.0 million YoY.
- Net loss of $27.8 million for Q2 2024.
Vor Bio's Q2 2024 results show a mixed financial picture. The company's cash position of
R&D expenses decreased by
The burn rate remains high, with cash decreasing from
Vor Bio's clinical progress with trem-cel and VCAR33ALLO is encouraging. The enrollment of 21 patients in the trem-cel trial and the advancement to the third dose level of Mylotarg (2.0 mg/m2) suggests positive safety signals. The upcoming data update in H2 2024 will be crucial, particularly the engraftment and hematologic protection data.
The VCAR33ALLO trial's progress is also noteworthy, with several patients dosed. This allogeneic CAR-T therapy could potentially address a significant unmet need in relapsed AML patients post-transplant. The initial data expected in H2 2024 will be critical in assessing its efficacy and safety profile.
Vor Bio's approach of shielded transplants is innovative, potentially allowing for safer and more effective post-transplant treatments. If successful, this could represent a paradigm shift in treating AML and MDS, addressing the high relapse rates in these aggressive hematological malignancies.
Vor Bio's market position in the AML and MDS treatment landscape is potentially disruptive. Their shielded transplant approach addresses a critical unmet need for patients who relapse post-transplant, a market segment with effective options.
The company's focus on both autologous (trem-cel) and allogeneic (VCAR33ALLO) therapies demonstrates a comprehensive strategy to tackle various patient scenarios. This dual approach could position Vor Bio favorably in the competitive cell therapy market.
However, investors should note the early stage of these therapies. While promising, significant hurdles remain before commercialization. The upcoming clinical updates in H2 2024 will be crucial inflection points for assessing the company's long-term potential and market impact.
Given the innovative nature of Vor Bio's approach, positive clinical data could attract partnership opportunities or make the company an attractive acquisition target for larger pharmaceutical companies looking to bolster their oncology pipelines.
- On-track for trem-cel + Mylotarg™ and VCAR33ALLO clinical updates in the second half of 2024
CAMBRIDGE, Mass., Aug. 08, 2024 (GLOBE NEWSWIRE) -- Vor Bio (Nasdaq: VOR), a clinical-stage cell and genome engineering company, today reported financial results for the three-month period ended June 30, 2024, and provided a corporate update.
“We are pleased with the progress we have made with enrollment of both the trem-cel + Mylotarg and VCAR33ALLO clinical trials during the quarter,” said Dr. Robert Ang, Vor Bio’s President and Chief Executive Officer. “Every year, thousands of patients with AML and MDS relapse post-transplant with no safe and effective treatment options. Our approach of shielded transplants may provide the first opportunity to deliver curative treatments post-transplant. We look forward to our next clinical update in the second half of this year.”
Corporate Updates
Trem-cel trial continues to enroll rapidly and patients are receiving Mylotarg at the third dose level
- 21 patients have been dosed with trem-cel and patients are now receiving the third dose level of Mylotarg at 2.0 mg/m2.
- The next data update is expected in the second half of 2024 and will include engraftment and hematologic protection data, and additional Mylotarg pharmacokinetic analyses. Several patients have been followed out for more than one year, and the Company also expects to provide a clinical update on these patients.
- Trem-cel is a shielded transplant in development for patients with acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS), in which healthy transplant donor cells are genetically engineered by removing CD33, with the potential to shield healthy cells and enable targeted therapies post-transplant such as Mylotarg and CAR-T therapy.
Continued progress with VCAR33ALLO
- Several patients have been dosed with VCAR33ALLO in the VBP301 study with enrollment continuing, and initial data is still expected in the second half of 2024.
- VBP301, a Phase 1/2, multicenter, open-label, first-in-human study of VCAR33ALLO, is a transplant donor-derived anti-CD33 CAR-T cell therapy for patients with AML who have relapsed following a standard-of-care or trem-cel transplant.
Upcoming Milestones
- Trem-cel clinical data update expected in the second half of 2024
- VCAR33ALLO clinical data update expected in the second half of 2024
Second Quarter 2024 Financial Results
- Cash Position: Cash, cash equivalents and marketable securities were
$85.9 million as of June 30, 2024, which is projected to fund operations into the second half of 2025. - Research & Development (R&D) Expenses: R&D expenses for the second quarter of 2024 were
$21.8 million , compared to$23.9 million for the second quarter of 2023. The decrease of$2.1 million was due to timing of purchases of manufacturing starting materials for our VCAR33ALLO program and a decrease in preclinical expenses, offset in part by an increase in clinical trial costs to support our trem-cel and VCAR33ALLO programs. - General & Administrative (G&A) Expenses: G&A expenses for the second quarter of 2024 were
$7.2 million , compared to$8.3 million for the second quarter of 2023. The decrease of$1.1 million was primarily due to a decrease in consulting and legal expenses, partially offset by an increase in personnel costs. - Net Loss: Net loss for the second quarter of 2024 was
$27.8 million , compared to$30.0 million for the second quarter of 2023.
| Condensed Consolidated Balance Sheet Data (Unaudited) | ||||||||
| (in thousands) | ||||||||
| June 30, | December 31, | |||||||
| 2024 | 2023 | |||||||
| Cash, cash equivalents and marketable securities | $ | 85,938 | $ | 137,175 | ||||
| Total assets | 141,588 | 198,126 | ||||||
| Total liabilities | 43,508 | 47,402 | ||||||
| Total stockholders' equity | 98,080 | 150,724 | ||||||
| Condensed Consolidated Statement of Operations (Unaudited) | ||||||||
| (in thousands, except share and per share data) | ||||||||
| Three Months Ended | ||||||||
| June 30, | ||||||||
| 2024 | 2023 | |||||||
| Operating expenses: | ||||||||
| Research and development | $ | 21,823 | $ | 23,897 | ||||
| General and administrative | 7,212 | 8,277 | ||||||
| Total operating expenses | $ | 29,035 | $ | 32,174 | ||||
| Loss from operations | $ | (29,035 | ) | $ | (32,174 | ) | ||
| Other income: | ||||||||
| Interest income | 1,196 | 2,195 | ||||||
| Total other income | 1,196 | 2,195 | ||||||
| Net loss | $ | (27,839 | ) | $ | (29,979 | ) | ||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.41 | ) | $ | (0.45 | ) | ||
| Weighted-average common shares outstanding, basic and diluted | 68,299,170 | 67,033,150 | ||||||
About Vor Bio
Vor Bio is a clinical-stage cell and genome engineering company that aims to change the standard of care for patients with blood cancers by engineering hematopoietic stem cells to enable targeted therapies post-transplant. For more information, visit: www.vorbio.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The words “aim,” “anticipate,” “can,” “continue,” “could,” “design,” “enable,” “expect,” “initiate,” “intend,” “may,” “on-track,” “ongoing,” “plan,” “potential,” “should,” “target,” “update,” “will,” “would,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements in this press release include Vor Bio’s statements regarding the potential of its product candidates to positively impact quality of life and alter the course of disease in the patients it seeks to treat, the timing and pace of patient enrollment and dosing in clinical trials and the availability of data therefrom, the expected safety profile of its product candidates, its intentions to use VCAR33ALLO in combination with trem-cel as a Treatment System, the potential of trem-cel to enable targeted therapies in the post-transplant setting including Mylotarg and CD33-targeted CAR-Ts, its potential upcoming milestones, its cash runway and expected capital requirements, and other statements that are not historical fact. Vor Bio may not actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors, including: uncertainties inherent in the initiation and completion of preclinical studies and clinical trials and clinical development of Vor Bio’s product candidates; availability and timing of results from preclinical studies and clinical trials; whether interim results from a clinical trial will be predictive of the final results of the trial or the results of future trials; uncertainties regarding regulatory approvals to conduct trials or to market products; the success of Vor Bio’s in-house manufacturing capabilities and efforts; and availability of funding sufficient for its foreseeable and unforeseeable operating expenses and capital expenditure requirements and Vor Bio’s ability to continue as a going concern. These and other risks are described in greater detail under the caption “Risk Factors” included in Vor Bio’s most recent annual or quarterly report and in other reports it has filed or may file with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Vor Bio expressly disclaims any obligation to update any forward-looking statements, whether because of new information, future events or otherwise, except as may be required by law.
Contact:
Investors & Media
Sarah Spencer
+1 857-242-6076
sspencer@vorbio.com
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