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Instil Bio Reports Second Quarter 2024 Financial Results and Provides Corporate Update

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Instil Bio (Nasdaq: TIL) reported Q2 2024 financial results and provided a corporate update. Key highlights include:

1. In-licensed SYN-2510 and SYN-27M, potentially best-in-class therapeutics, from ImmuneOnco.

2. Executed a 15-year lease of cell therapy manufacturing facility to AstraZeneca, with initial base rent exceeding $7.5 million annually.

3. Cash, cash equivalents, marketable securities, and long-term investments totaled $152.6 million as of June 30, 2024.

4. Q2 2024 R&D expenses were $2.9 million, down from $8.5 million in Q2 2023.

5. Net loss per share for Q2 2024 was $2.29, improved from $2.87 in Q2 2023.

6. Cash runway expected to extend beyond 2026.

Instil Bio (Nasdaq: TIL) ha riportato i risultati finanziari del secondo trimestre 2024 e fornito un aggiornamento aziendale. I punti salienti includono:

1. Acquisizione in licenza di SYN-2510 e SYN-27M, potenzialmente terapeutiche di classe leader, da ImmuneOnco.

2. Firmato un contratto di locazione di 15 anni per un impianto di produzione di terapie cellulari con AstraZeneca, con un affitto base iniziale che supera i 7,5 milioni di dollari all'anno.

3. Liquidità, equivalenti di liquidità, titoli negoziabili e investimenti a lungo termine hanno totalizzato $152,6 milioni al 30 giugno 2024.

4. Le spese per R&D nel secondo trimestre 2024 sono state di 2,9 milioni di dollari, in calo rispetto agli 8,5 milioni di dollari nel secondo trimestre 2023.

5. La perdita netta per azione nel secondo trimestre 2024 è stata di 2,29 dollari, in miglioramento rispetto ai 2,87 dollari nel secondo trimestre 2023.

6. Si prevede che il capitale disponibile si estenda oltre il 2026.

Instil Bio (Nasdaq: TIL) reportó los resultados financieros del segundo trimestre de 2024 y proporcionó una actualización corporativa. Los aspectos más destacados incluyen:

1. Licencia adquirida para SYN-2510 y SYN-27M, potencialmente terapias líderes en su clase, de ImmuneOnco.

2. Se ejecutó un contrato de arrendamiento de 15 años para una instalación de fabricación de terapia celular con AstraZeneca, con un alquiler base inicial superior a 7.5 millones de dólares anuales.

3. Efectivo, equivalentes de efectivo, valores negociables e inversiones a largo plazo totalizaron $152.6 millones al 30 de junio de 2024.

4. Los gastos de I+D del segundo trimestre de 2024 fueron de 2.9 millones de dólares, disminuyendo desde 8.5 millones de dólares en el segundo trimestre de 2023.

5. La pérdida neta por acción para el segundo trimestre de 2024 fue de 2.29 dólares, mejorando desde 2.87 dólares en el segundo trimestre de 2023.

6. Se espera que la duración del capital se extienda más allá de 2026.

Instil Bio (나스닥: TIL)는 2024년 2분기 재무 결과를 발표하고 기업 업데이트를 제공했습니다. 주요 하이라이트는 다음과 같습니다:

1. ImmuneOnco로부터 잠재적으로 최고의 치료제인 SYN-2510SYN-27M의 라이센스를 인수하였습니다.

2. AstraZeneca와 세포 치료 제조 시설의 15년 임대 계약을 체결하였으며, 초기 기본 임대료는 연간 750만 달러를 초과합니다.

3. 2024년 6월 30일 기준으로 현금, 현금 등가물, 거래 가능한 증권 및 장기 투자는 총 $152.6 백만에 달했습니다.

4. 2024년 2분기 연구 개발(R&D) 비용은 290만 달러로, 2023년 2분기의 850만 달러에서 감소하였습니다.

5. 2024년 2분기 주당 순손실은 2.29달러로, 2023년 2분기의 2.87달러에서 개선되었습니다.

6. 현금 소진 기간이 2026년 이후로 연장될 것으로 예상됩니다.

Instil Bio (Nasdaq: TIL) a rapporté les résultats financiers du deuxième trimestre 2024 et fourni une mise à jour de l'entreprise. Les points essentiels incluent :

1. Obtention sous licence de SYN-2510 et SYN-27M, potentiellement des traitements de premier plan, auprès d'ImmuneOnco.

2. Exécution d'un bail de 15 ans pour une installation de fabrication de thérapies cellulaires avec AstraZeneca, avec un loyer de base initial dépassant 7,5 millions de dollars par an.

3. La trésorerie, les équivalents de trésorerie, les valeurs mobilières et les investissements à long terme totalisaient 152,6 millions de dollars au 30 juin 2024.

4. Les dépenses de R&D pour le deuxième trimestre 2024 ont été de 2,9 millions de dollars, en baisse par rapport à 8,5 millions de dollars au deuxième trimestre 2023.

5. La perte nette par action pour le deuxième trimestre 2024 était de 2,29 dollars, en amélioration par rapport à 2,87 dollars au deuxième trimestre 2023.

6. La durée de la trésorerie est prévue pour s'étendre au-delà de 2026.

Instil Bio (Nasdaq: TIL) hat die finanziellen Ergebnisse des zweiten Quartals 2024 veröffentlicht und ein Unternehmensupdate bereitgestellt. Zu den wichtigsten Punkten gehören:

1. Lizenzierung von SYN-2510 und SYN-27M, potenziell Spitzenleistungen in der Therapie, von ImmuneOnco.

2. Ein 15-jähriger Mietvertrag für eine Zelltherapie-Herstellungsstätte wurde mit AstraZeneca abgeschlossen, wobei die anfängliche Grundmiete über 7,5 Millionen Dollar pro Jahr liegt.

3. Zum 30. Juni 2024 beliefen sich Bargeld, Zahlungsmitteläquivalente, handelbare Wertpapiere und langfristige Investitionen auf insgesamt 152,6 Millionen Dollar.

4. Die F&E-Ausgaben im zweiten Quartal 2024 betrugen 2,9 Millionen Dollar, ein Rückgang gegenüber 8,5 Millionen Dollar im zweiten Quartal 2023.

5. Der Nettoverlust pro Aktie für das zweite Quartal 2024 betrug 2,29 Dollar, eine Verbesserung gegenüber 2,87 Dollar im zweiten Quartal 2023.

6. Die Liquiditätsreserve wird voraussichtlich über 2026 hinausreichen.

Positive
  • In-licensed potentially best-in-class therapeutics SYN-2510 and SYN-27M
  • Executed 15-year lease of manufacturing facility to AstraZeneca, generating over $7.5 million annual base rent
  • Cash runway extended beyond 2026
  • Reduced R&D expenses from $8.5 million in Q2 2023 to $2.9 million in Q2 2024
  • Improved net loss per share from $2.87 in Q2 2023 to $2.29 in Q2 2024
Negative
  • Decrease in cash, cash equivalents, marketable securities, and long-term investments from $175.0 million (Dec 31, 2023) to $152.6 million (Jun 30, 2024)

Insights

Instil Bio's Q2 2024 results reveal a strategic shift and financial restructuring. The company's cash position of $152.6 million and extended runway beyond 2026 provide a solid financial foundation. However, the significant reduction in R&D expenses ($2.9 million in Q2 2024 vs $8.5 million in Q2 2023) suggests a scaling back of internal research activities.

The lease agreement with AstraZeneca for the cell therapy facility, generating over $7.5 million annually, is a smart move to monetize assets and bolster cash flow. This, combined with the in-licensing of SYN-2510 and SYN-27M, indicates a pivot towards a more capital-efficient model focused on clinical-stage assets. The reduction in net loss per share ($2.29 in Q2 2024 vs $2.87 in Q2 2023) is positive, but investors should monitor the impact of reduced R&D on long-term growth prospects.

The in-licensing of SYN-2510 and SYN-27M represents a significant strategic move for Instil Bio. SYN-2510, a PD-L1xVEGF bispecific antibody, targets two critical pathways in cancer: immune checkpoint inhibition and angiogenesis. This dual approach could potentially enhance efficacy across multiple solid tumor types. SYN-27M, an ADCC-enhanced CTLA-4 antibody, aims to improve upon existing CTLA-4 inhibitors by potentially reducing toxicity while maintaining or enhancing efficacy.

Both assets have completed Phase 1a dose escalation, providing a faster path to later-stage clinical development. However, the true potential of these therapies will depend on forthcoming data from ongoing dose optimization and expansion studies. Investors should closely monitor clinical updates, as positive results could significantly boost Instil's oncology pipeline value.

Instil Bio's strategic pivot towards in-licensing clinical-stage assets aligns with current biotech market trends. This approach can potentially reduce R&D risks and accelerate time-to-market. The focus on "best-in-class" candidates like SYN-2510 and SYN-27M is particularly noteworthy in the highly competitive immuno-oncology space.

The company's exploration of further in-licensing opportunities suggests a continued focus on this strategy. This could lead to a diversified pipeline with multiple shots on goal, potentially reducing overall portfolio risk. However, success will depend on careful asset selection and effective clinical development execution. Investors should watch for additional deals and assess their potential impact on Instil's competitive positioning in the oncology market.

  • In-licensed SYN-2510/IMM2510, a potentially best-in-class PD-L1xVEGF bispecific antibody, and SYN-27M/IMM27M, a next-generation ADCC-enhanced anti-CTLA-4 antibody
  • Entered into a 15-year lease for our cell therapy manufacturing facility to AstraZeneca Pharmaceuticals LP

DALLAS, Aug. 13, 2024 (GLOBE NEWSWIRE) -- Instil Bio, Inc. (“Instil”) (Nasdaq: TIL), a clinical-stage biopharmaceutical company focused on developing a pipeline of novel therapies, today reported its second quarter 2024 financial results and provided a corporate update.

“We have expanded our pipeline with a pair of clinical-stage, potentially best-in-class therapeutics by in-licensing SYN-2510 and SYN-27M,” said Bronson Crouch, CEO of Instil. “By executing a 15-year lease of our Tarzana cell therapy manufacturing facility, we have strengthened our financial foundation to support Instil’s near-term clinical development of these assets.”

Recent Highlights:

  • In-licensed SYN-2510 and SYN-27M: In August 2024, SynBioTx, Inc., a wholly owned subsidiary of Instil, entered into a license and collaboration agreement with ImmuneOnco (HKEX:1541) for the exclusive global development and commercialization rights outside of Greater China of SYN-2510, a potentially best-in-class PD-L1xVEGF bispecific antibody, and SYN-27M, a next-generation ADCC-enhanced CTLA-4 antibody. SYN-2510 and SYN-27M have completed Phase 1a dose escalation studies in multiple solid tumor types in China, and ImmuneOnco is continuing patient enrollment in both programs to support dose optimization and dose expansion.
  • Executed lease of our cell therapy manufacturing facility to AstraZeneca Pharmaceuticals LP: In July 2024, Instil reported the execution of a lease of its U.S. cell therapy manufacturing facility to AstraZeneca Pharmaceuticals LP. Under the terms of the agreement, initial base rent is greater than $7.5 million annually, and escalates at 3% per annum, with the tenant also required to pay certain operating expenses and tax expenses, subject to certain rent abatement in the first year of the 15-year lease term.
  • Exploring further opportunities to in-license or acquire novel therapeutic candidates: Instil continues to explore further opportunities to in-license or otherwise acquire novel therapeutic candidates with first-in-class or best-in-class potential.
  • Cash runway expected beyond 2026.

Second Quarter 2024 Financial and Operating Results:

As of June 30, 2024, Instil had cash, cash equivalents, marketable securities and long-term investments of $152.6 million, which consisted of $6.8 million in cash and cash equivalents, $141.8 million in marketable securities, and $4.0 million in long-term investments, compared to $175.0 million in cash, cash equivalents, marketable securities and long-term investments as of December 31, 2023, consisting of $9.2 million in cash and cash equivalents, $1.5 million in restricted cash, $141.2 million in marketable securities, and $23.2 million in long-term investments. Instil expects that its cash, cash equivalents, marketable securities and long-term investments as of June 30, 2024 will enable it to fund its operating plan beyond 2026.

Research and development expenses were $2.9 million and $10.2 million for the three and six months ended June 30, 2024, respectively, compared to $8.5 million and $29.1 million for the three and six months ended June 30, 2023, respectively.

General and administrative expenses were $10.7 million and $23.1 million for the three and six months ended June 30, 2024, respectively, compared to $11.5 million and $24.7 million for the three and six months ended June 30, 2023, respectively.

Restructuring and impairment charges were $0.5 million and $4.8 million for the three and six months ended June 30, 2024, respectively, compared to $1.0 million and $25.6 million for three and six months ended June 30, 2023, respectively.

Net loss per share, basic and diluted were $2.29 and $6.03 for the three and six months ended June 30, 2024, respectively, compared to $2.87 and $11.64 for the three and six months ended June 30, 2023, respectively. Non-GAAP net loss per share, basic and diluted, were $1.57 and $3.95 for the three and six months ended June 30, 2024, respectively, compared to $2.03 and $6.33 for the three and six months ended June 30, 2023, respectively.

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,” 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 and the generation of clinical data for SYN-2510 and SYN-27M; concerning or implying our ability to 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 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 June 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
 
 June 30, 2024 December 31, 2023
Cash, cash equivalents, restricted cash, marketable securities and long-term investments$152,578 $175,018
Total assets$294,316 $325,630
Total liabilities$99,297 $99,801
Total stockholders’ equity$195,019 $225,829


Condensed Consolidated Statements of Operations
 
 Three Months Ended Six Months Ended
 June 30, June 30,
  2024   2023   2024   2023 
Operating expenses:       
Research and development$2,921  $8,459  $10,177  $29,129 
General and administrative 10,706   11,518   23,130   24,740 
Restructuring and impairment charges 508   1,010   4,783   25,564 
Total operating expenses 14,135   20,987   38,090   79,433 
Loss from operations (14,135)  (20,987)  (38,090)  (79,433)
Interest income 1,919   2,287   3,981   4,358 
Interest expense (1,999)  (590)  (3,980)  (1,226)
Other (expense) income, net (702)  628   (1,130)  571 
Net loss$(14,917) $(18,662) $(39,219) $(75,730)
Net loss per share, basic and diluted$(2.29) $(2.87) $(6.03) $(11.64)
Weighted-average shares used in computing net loss per share, basic and diluted 6,503,913   6,503,913   6,503,913   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 Six Months Ended
 June 30, June 30,
  2024   2023   2024   2023 
Net loss$(14,917) $(18,662) $(39,219) $(75,730)
Adjustments:       
Non-cash stock-based compensation expense 4,173   4,413   8,688   8,943 
Restructuring and impairment charges 508   1,010   4,783   25,564 
Non-GAAP net loss$(10,236) $(13,239) $(25,748) $(41,223)
Net loss per share, basic and diluted$(2.29) $(2.87) $(6.03) $(11.64)
Adjustments:       
Non-cash stock-based compensation expense per share 0.64   0.68   1.34   1.38 
Restructuring and impairment charges per share 0.08   0.16   0.74   3.93 
Non-GAAP net loss per share, basic and diluted*$(1.57) $(2.03) $(3.95) $(6.33)
Weighted-average shares outstanding, basic and diluted 6,503,913   6,503,913   6,503,913   6,503,913 

* Non-GAAP net loss per share, basic and diluted may not total due to rounding.


FAQ

What were Instil Bio's (TIL) key financial results for Q2 2024?

Instil Bio reported cash, cash equivalents, marketable securities, and long-term investments of $152.6 million as of June 30, 2024. R&D expenses were $2.9 million, and net loss per share was $2.29 for Q2 2024.

What significant deals did Instil Bio (TIL) announce in Q2 2024?

Instil Bio in-licensed SYN-2510 and SYN-27M from ImmuneOnco, and executed a 15-year lease of its cell therapy manufacturing facility to AstraZeneca Pharmaceuticals LP.

How long is Instil Bio's (TIL) cash runway expected to last?

Instil Bio expects its current cash, cash equivalents, marketable securities, and long-term investments to fund its operating plan beyond 2026.

What is the annual base rent for Instil Bio's (TIL) manufacturing facility lease to AstraZeneca?

The initial base rent for the manufacturing facility lease to AstraZeneca is greater than $7.5 million annually, with a 3% annual escalation.

Instil Bio, Inc.

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