Instil Bio Reports Third Quarter 2024 Financial Results and Provides Corporate Update
Instil Bio reported Q3 2024 financial results and corporate updates. The company licensed SYN-2510, a PD-L1xVEGF bispecific antibody, for global ex-China development. Cash position was $122.9M as of September 30, 2024, expected to fund operations beyond 2026. Q3 net loss per share was $3.54. Clinical updates include anticipated data from ImmuneOnco for SYN-2510 in 1H 2025, planned Phase 1b/2 studies in NSCLC and TNBC, and targeted U.S. clinical study initiation in 2H 2025.
Instil Bio ha riportato i risultati finanziari del terzo trimestre 2024 e aggiornamenti aziendali. La società ha concesso in licenza SYN-2510, un anticorpo bispecifico PD-L1xVEGF, per lo sviluppo globale al di fuori della Cina. La posizione di cassa era di 122,9 milioni di dollari al 30 settembre 2024, prevista per finanziare le operazioni oltre il 2026. La perdita netta per azione nel terzo trimestre è stata di 3,54 dollari. Gli aggiornamenti clinici includono dati attesi da ImmuneOnco per SYN-2510 nella prima metà del 2025, studi di Fase 1b/2 pianificati nel NSCLC e TNBC, e l'inizio di uno studio clinico mirato negli Stati Uniti nella seconda metà del 2025.
Instil Bio informó sobre los resultados financieros del tercer trimestre de 2024 y actualizaciones corporativas. La compañía licenció SYN-2510, un anticuerpo bispecífico PD-L1xVEGF, para el desarrollo global fuera de China. La posición de efectivo era de 122,9 millones de dólares al 30 de septiembre de 2024, lo que se espera que financie las operaciones más allá de 2026. La pérdida neta por acción en el tercer trimestre fue de 3,54 dólares. Las actualizaciones clínicas incluyen datos anticipados de ImmuneOnco para SYN-2510 en la primera mitad de 2025, estudios de Fase 1b/2 planificados en NSCLC y TNBC, y la iniciación de un estudio clínico dirigido en EE. UU. en la segunda mitad de 2025.
Instil Bio는 2024년 3분기 재무 실적 및 기업 업데이트를 보고했습니다. 이 회사는 SYN-2510, PD-L1xVEGF 이중 특이성 항체를 중국 외부에서 전 세계적으로 개발할 수 있도록 라이센스를 부여했습니다. 2024년 9월 30일 기준으로 현금 보유액은 1억 2천 290만 달러였으며, 이는 2026년 이후 운영을 지원할 것으로 예상됩니다. 3분기 주당 순손실은 3.54달러였습니다. 임상 업데이트에는 2025년 상반기에 ImmuneOnco의 SYN-2510에 대한 데이터 예상, NSCLC 및 TNBC에서 계획된 1b/2상 연구, 그리고 2025년 하반기에 미국에서의 임상 연구 시작이 포함됩니다.
Instil Bio a rapporté des résultats financiers pour le troisième trimestre 2024 et des mises à jour d'entreprise. La société a licencié SYN-2510, un anticorps bispécifique PD-L1xVEGF, pour le développement mondial en dehors de la Chine. La position de trésorerie était de 122,9 millions de dollars au 30 septembre 2024, et devrait financer les opérations au-delà de 2026. La perte nette par action au troisième trimestre était de 3,54 dollars. Les mises à jour cliniques incluent des données anticipées d'ImmuneOnco pour SYN-2510 au premier semestre 2025, des études de phase 1b/2 prévues dans le NSCLC et le TNBC, et le lancement d'une étude clinique ciblée aux États-Unis au second semestre 2025.
Instil Bio berichtete über die finanziellen Ergebnisse des dritten Quartals 2024 und Unternehmensaktualisierungen. Das Unternehmen lizenzierte SYN-2510, ein PD-L1xVEGF bispezifischer Antikörper, für die globale Entwicklung außerhalb von China. Die Liquiditätsposition betrug am 30. September 2024 122,9 Millionen US-Dollar und soll die Geschäfte über 2026 hinaus finanzieren. Der Nettoverlust pro Aktie im dritten Quartal betrug 3,54 US-Dollar. Zu den klinischen Aktualisierungen gehören erwartete Daten von ImmuneOnco für SYN-2510 in der ersten Jahreshälfte 2025, geplante Phase 1b/2 Studien bei NSCLC und TNBC sowie die Einleitung einer zielgerichteten klinischen Studie in den USA in der zweiten Jahreshälfte 2025.
- Strong cash position of $122.9M expected to fund operations beyond 2026
- Reduced net loss per share to $3.54 in Q3 2024 from $10.37 in Q3 2023
- Decreased R&D expenses to $0.6M in Q3 2024 from $8.5M in Q3 2023
- Lower restructuring charges of $2.4M in Q3 2024 compared to $46.3M in Q3 2023
- In-process R&D expenses increased to $10M in Q3 2024 from nil in Q3 2023
- Cash position decreased from $175.0M in December 2023 to $122.9M in September 2024
Insights
The Q3 2024 results reveal significant financial developments for Instil Bio. The company maintains a strong cash position of
Notable improvements in financial metrics include a substantial reduction in restructuring charges to
The licensing of SYN-2510, a PD-L1xVEGF bispecific antibody, represents a strategic pivot into a highly competitive oncology space. The preliminary dose optimization at 20 mg/kg Q2W and planned expansion into first-line NSCLC and TNBC trials demonstrates a well-structured clinical development strategy. The expanded patient enrollment in China, with 65 additional patients beyond the initial 33, will provide important efficacy and safety data in 1H 2025.
The dual-pronged approach of targeting both NSCLC and TNBC, particularly in first-line settings with chemotherapy combinations, positions the asset competitively in major market segments. The planned U.S. study initiation in 2H 2025 suggests a methodical global development strategy.
Licensed SYN-2510, a potential best-in-class PD-L1xVEGF bispecific antibody, for global ex-China development and commercialization
Clinical data update for SYN-2510/IMM2510 in China from ImmuneOnco anticipated in 1H 2025
Initiation of Phase 1b/2 SYN-2510/IMM2510 + chemotherapy combination in first-line non-small cell lung cancer (NSCLC) and triple negative breast cancer (TNBC) anticipated in late 2024 and 1H 2025, respectively, by ImmuneOnco in China
U.S. clinical study of SYN-2510/IMM2510 in NSCLC initiation targeted for 2H 2025
DALLAS, Nov. 13, 2024 (GLOBE NEWSWIRE) -- Instil Bio, Inc. (“Instil”) (Nasdaq: TIL), a clinical-stage biopharmaceutical company focused on developing a pipeline of novel cancer therapies, today reported its third quarter 2024 financial results and provided a corporate update.
“Our recent license of SYN-2510 is a significant milestone for Instil, positioning us with a potentially best-in-class asset in one of the most significant areas of interest in oncology,” said Bronson Crouch, CEO of Instil. “As we continue to build our internal team to operationalize the clinical development of SYN-2510, we are excited for the progress ImmuneOnco continues to make in advancing the program in its China trials.”
Recent Highlights:
- In-licensed SYN-2510/IMM2510 and SYN-27M/IMM27M: In August 2024, SyntBioTx, Inc., a wholly owned subsidiary of Instil, entered into a license and collaboration agreement with ImmuneOnco Biopharmaceuticals (Shanghai) Inc. (HKEX Code: 1541.HK, “ImmuneOnco”) to in-license global development and commercialization rights outside of Greater China for SYN-2510/IMM2510, a potential best-in-class PD-L1xVEGF bispecific antibody, and SYN-27M/IMM27M, a next-generation ADCC-enhanced CTLA-4 antibody. For SYN-2510/IMM2510, ImmuneOnco has identified a recommended Phase 2 monotherapy dose of 20 mg/kg Q2W, and is continuing patient enrollment in China to support dose optimization and dose expansion in multiple solid tumor cancers.
- Clinical data update for SYN-2510/IMM2510 in China anticipated in 1H 2025: ImmuneOnco expects to provide a clinical data update for SYN-2510/IMM2510 monotherapy in multiple solid tumors in China in the first half of 2025. Approximately 65 additional patients have been dosed with SYN-2510/IMM2510 monotherapy in addition to the initial 33 patients reported in ImmuneOnco’s ASCO 2024 publication.
- Initiation of Phase 1b/2 IMM2510/SYN-2510 studies expected in late 2024 and 1H 2025 in China by ImmuneOnco: Instil and ImmuneOnco announced in September 2024 that ImmuneOnco is accelerating clinical development of IMM2510/SYN-2510 into phase 1b/2 studies in China. IMM2510/SYN2510 will be administered in combination with chemotherapy in first-line NSCLC and TNBC, with anticipated start dates in late 2024 and 1H 2025, respectively.
- U.S. clinical study of SYN-2510 in NSCLC targeted initiation in 2H 2025: Instil is targeting initiation of a U.S. study of SYN-2510 in NSCLC in 2H 2025.
- Clinical update for SYN-27M/IMM27M in breast cancer from ImmuneOnco: Today, ImmuneOnco announced initial clinical results for patients with estrogen receptor positive (ER+) advanced breast cancer treated in the Phase 1 dose escalation of SYN-27M/IMM27M and the initiation of a Phase 2 clinical trial of SYN-27M/IMM27M for patients with ER+ breast cancer that failed after endocrine therapy or have recurred. Additionally, patient enrollment continues in the dose escalation study of the combination of SYN-27M/IMM27M and SYN-2510/IMM2510.
Third Quarter 2024 Financial and Operating Results:
As of September 30, 2024, Instil had cash, cash equivalents, marketable securities and long-term investments of
In-process research and development expenses were
Research and development expenses were
General and administrative expenses were
Restructuring and impairment charges were
Net loss per share, basic and diluted were
Note Regarding Use of Non-GAAP Financial Measures
In this press release, Instil has presented certain financial information that has not been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”). These non-GAAP financial measures include non-GAAP net loss and non-GAAP net loss per share, which are defined as net loss and net loss per share, respectively, excluding non-cash stock-based compensation expense and restructuring and impairment charges. Instil believes that these non-GAAP financial measures, when considered together with the GAAP figures, can enhance an overall understanding of Instil’s financial performance. The non-GAAP financial measures are included with the intent of providing investors with a more complete understanding of Instil’s operating results. In addition, these non-GAAP financial measures are among the indicators Instil’s management uses for planning purposes and to measure Instil’s performance. These non-GAAP financial measures should be considered in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP. The non-GAAP financial measures used by Instil may be calculated differently from, and therefore may not be comparable to, non-GAAP financial measures used by other companies. Please refer to the below reconciliation of these non-GAAP financial measures to the comparable GAAP financial measures.
About Instil Bio
Instil Bio is a clinical-stage biopharmaceutical company focused on developing a pipeline of novel therapies. Instil’s lead asset, SYN-2510, is a novel and differentiated PD-L1xVEGF bispecific antibody in development for the treatment of multiple solid tumor cancers. For more information visit www.instilbio.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “anticipates,” “believes,” “expects,” “expected,” “exploring,” “future,” “intends,” “may,” “plans,” “potential,” “projects,” “targets” and “will” or similar expressions are intended to identify forward-looking statements. Forward-looking statements include express or implied statements regarding our expectations with respect to the license and collaboration agreement with ImmuneOnco, the therapeutic potential of SYN-2510 and SYN-27M, clinical development of SYN-2510 and SYN-27M, including the initiation of clinical trials for SYN-2510 and SYN-27M and the generation of clinical data for SYN-2510 and SYN-27M; concerning or implying our ability to in-license or acquire and develop additional product candidates; our research, development and regulatory plans for our product candidates; our expectations regarding our capital position, resources, and balance sheet and the expected impact of the lease of our U.S. manufacturing facility with respect thereto, and the potential impact thereof on the development of any product candidates; and other statements that are not historical fact. Forward-looking statements are based on management's current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements, including risks and uncertainties associated with acquiring additional product candidates, the costly and time-consuming drug product development process and the uncertainty of clinical success; the risks inherent in relying on collaborators and other third parties, including for manufacturing and generating clinical data, and the ability to rely on any such data from clinical trials in China in regulatory filings submitted to regulatory authorities outside of China; the risks and uncertainties related to successfully making regulatory submissions and initiating, enrolling, completing and reporting data from clinical studies, particularly collaborator-led clinical trials, as well as the risks that results obtained in any clinical trials to date may not be indicative of results obtained in ongoing or future trials and that our product candidates may otherwise not be effective treatments in their planned indications; risks related to macroeconomic conditions, including as a result of international conflicts and U.S.-China trade and political tensions, as well as interest rates, inflation, and other factors, which could materially and adversely affect our business and operations; the risks and uncertainties associated with the time-consuming and uncertain regulatory approval process and the sufficiency of our cash resources; and other risks and uncertainties affecting us and our plans and development programs, including those discussed in the section titled “Risk Factors” in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2024 to be filed with the SEC, as well as our other filings with the SEC. Additional information will be made available in other filings that we make from time to time with the SEC. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. These forward-looking statements speak only as the date hereof, and we disclaim any obligation to update these statements except as may be required by law.
Contacts:
Investor Relations:
1-972-499-3350
investorrelations@instilbio.com
www.instilbio.com
| INSTIL BIO, INC. SELECTED FINANCIAL DATA (Unaudited; in thousands, except share and per share amounts) Selected Condensed Consolidated Balance Sheet Data | ||||||
| September 30, 2024 | December 31, 2023 | |||||
| Cash, cash equivalents, restricted cash, marketable securities and long-term investments | $ | 122,910 | $ | 175,018 | ||
| Total assets | $ | 272,562 | $ | 325,630 | ||
| Total liabilities | $ | 96,230 | $ | 99,801 | ||
| Total stockholders’ equity | $ | 176,332 | $ | 225,829 | ||
| Condensed Consolidated Statements of Operations | ||||||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| In-process research and development | $ | 10,000 | $ | — | $ | 10,000 | $ | — | ||||||||
| Research and development | 562 | 8,492 | 10,739 | 37,621 | ||||||||||||
| General and administrative | 10,707 | 11,941 | 33,837 | 36,681 | ||||||||||||
| Restructuring and impairment charges | 2,362 | 46,283 | 7,146 | 71,847 | ||||||||||||
| Total operating expenses | 23,631 | 66,716 | 61,722 | 146,149 | ||||||||||||
| Loss from operations | (23,631 | ) | (66,716 | ) | (61,722 | ) | (146,149 | ) | ||||||||
| Interest income | 1,654 | 2,313 | 5,635 | 6,671 | ||||||||||||
| Interest expense | (2,007 | ) | (2,003 | ) | (5,988 | ) | (3,229 | ) | ||||||||
| Other rental income | 1,493 | — | 1,493 | — | ||||||||||||
| Other expense, net | (530 | ) | (1,026 | ) | (1,658 | ) | (455 | ) | ||||||||
| Net loss | $ | (23,021 | ) | $ | (67,432 | ) | $ | (62,240 | ) | $ | (143,162 | ) | ||||
| Net loss per share, basic and diluted | $ | (3.54 | ) | $ | (10.37 | ) | $ | (9.57 | ) | $ | (22.01 | ) | ||||
| Weighted-average shares used in computing net loss per share, basic and diluted | 6,506,681 | 6,503,913 | 6,504,842 | 6,503,913 | ||||||||||||
| INSTIL BIO, INC. Reconciliation of GAAP to Non-GAAP Net Loss and Net Loss per Share (Unaudited; in thousands, except share and per share amounts) | ||||||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Net loss | $ | (23,021 | ) | $ | (67,432 | ) | $ | (62,240 | ) | $ | (143,162 | ) | ||||
| Adjustments: | ||||||||||||||||
| Non-cash stock-based compensation expense | 4,068 | 4,670 | 12,756 | 13,613 | ||||||||||||
| Restructuring and impairment charges | 2,362 | 46,283 | 7,146 | 71,847 | ||||||||||||
| Non-GAAP net loss | $ | (16,591 | ) | $ | (16,479 | ) | $ | (42,338 | ) | $ | (57,702 | ) | ||||
| Net loss per share, basic and diluted | $ | (3.54 | ) | $ | (10.37 | ) | $ | (9.57 | ) | $ | (22.01 | ) | ||||
| Adjustments: | ||||||||||||||||
| Non-cash stock-based compensation expense per share | 0.63 | 0.72 | 1.96 | 2.09 | ||||||||||||
| Restructuring and impairment charges per share | 0.36 | 7.12 | 1.10 | 11.05 | ||||||||||||
| Non-GAAP net loss per share, basic and diluted* | $ | (2.55 | ) | $ | (2.53 | ) | $ | (6.51 | ) | $ | (8.87 | ) | ||||
| Weighted-average shares outstanding, basic and diluted | 6,506,681 | 6,503,913 | 6,504,842 | 6,503,913 | ||||||||||||
| * Non-GAAP net loss per share, basic and diluted may not total due to rounding. | ||||||||||||||||
FAQ
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