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Immunome Reports Second Quarter 2024 Financial Results and Provides Business Update

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Immunome (Nasdaq: IMNM) reported Q2 2024 financial results and provided a business update. Key highlights include:

- Pipeline Progress: Full enrollment completed for Phase 3 RINGSIDE Part B study of AL102 for desmoid tumors, with topline data expected in H2 2025. INDs for IM-1021 and IM-3050 anticipated in Q1 2025.

- Financial Position: Cash, cash equivalents, and marketable securities totaled $278.4 million as of June 30, 2024, with runway expected into 2026.

- Q2 2024 Results: R&D expenses were $29.1 million, in-process R&D expenses were $6.3 million, and G&A expenses were $7.0 million. Net loss reported at $36.1 million.

The company is focusing on developing a broad pipeline of oncology therapies, including ADCs and small molecules, supported by business development efforts and focused research.

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

- Progresso della Pipeline: Completamento dell'arruolamento totale per lo studio di Fase 3 RINGSIDE Parte B di AL102 per i tumori desmoidi, con dati preliminari attesi nella seconda metà del 2025. Le IND per IM-1021 e IM-3050 sono attese nel primo trimestre del 2025.

- Posizione Finanziaria: Liquidità, equivalenti di liquidità e titoli negoziabili sono ammontati a 278,4 milioni di dollari al 30 giugno 2024, con margine previsto fino al 2026.

- Risultati del Q2 2024: Le spese di R&D sono state pari a 29,1 milioni di dollari, le spese di R&D in corso sono state di 6,3 milioni di dollari, e le spese generali e amministrative sono state di 7,0 milioni di dollari. La perdita netta riportata è stata di 36,1 milioni di dollari.

L'azienda si sta concentrando sullo sviluppo di un'ampia gamma di terapie oncologiche, inclusi gli ADC e le piccole molecole, supportate da sforzi di sviluppo aziendale e ricerca mirata.

Immunome (Nasdaq: IMNM) reportó los resultados financieros del segundo trimestre de 2024 y proporcionó una actualización empresarial. Los puntos clave incluyen:

- Progreso del Pipeline: Se completó la inscripción total para el estudio de Fase 3 RINGSIDE Parte B de AL102 para tumores desmoides, con datos preliminares esperados para la segunda mitad de 2025. Se anticipan las IND para IM-1021 e IM-3050 en el primer trimestre de 2025.

- Posición Financiera: Efectivo, equivalentes de efectivo y valores negociables sumaron 278.4 millones de dólares al 30 de junio de 2024, con una proyección de recursos hasta 2026.

- Resultados del Q2 2024: Los gastos de I+D fueron de 29.1 millones de dólares, los gastos de I+D en proceso fueron de 6.3 millones de dólares, y los gastos generales y administrativos fueron de 7.0 millones de dólares. La pérdida neta reportada fue de 36.1 millones de dólares.

La empresa se enfoca en desarrollar una amplia cartera de terapias oncológicas, incluyendo ADCs y moléculas pequeñas, respaldadas por esfuerzos de desarrollo comercial e investigación enfocada.

Immunome (Nasdaq: IMNM)는 2024년 2분기 재무 결과를 발표하고 비즈니스 업데이트를 제공했습니다. 주요 하이라이트는 다음과 같습니다:

- 파이프라인 진행: AL102의 비대세포종에 대한 3상 RINGSIDE B 파트 연구에 대한 전체 모집이 완료되었으며, 최종 데이터는 2025년 하반기에 예상됩니다. IM-1021 및 IM-3050에 대한 IND는 2025년 1분기에 예상됩니다.

- 재무 상태: 현금, 현금 등가물 및 유가 증권의 총액은 2024년 6월 30일 기준으로 2억 7840만 달러에 달하며, 2026년까지 운영 자금이 예상됩니다.

- 2024년 2분기 결과: 연구개발 비용은 2910만 달러였으며, 진행 중인 연구개발 비용은 630만 달러, 일반 및 관리비용은 700만 달러였습니다. 보고된 순손실은 3610만 달러입니다.

회사는 ADC 및 소분자 약물을 포함한 광범위한 암 치료제 파이프라인 개발에 집중하고 있으며, 비즈니스 개발 노력과 집중 연구를 통해 지원받고 있습니다.

Immunome (Nasdaq: IMNM) a annoncé les résultats financiers du deuxième trimestre 2024 et a fourni une mise à jour sur l'entreprise. Les points clés incluent :

- Avancement du Pipeline : L'inscription complète a été réalisée pour l'étude de Phase 3 RINGSIDE Partie B d'AL102 pour les tumeurs desmoïdes, avec des données préliminaires attendues pour le second semestre 2025. Les IND pour IM-1021 et IM-3050 sont anticipées au premier trimestre 2025.

- Situation Financière : La trésorerie, les équivalents de trésorerie et les titres négociables totalisaient 278,4 millions de dollars au 30 juin 2024, avec une durée de financement prévue jusqu'en 2026.

- Résultats du Q2 2024 : Les dépenses de recherche et développement s'élevaient à 29,1 millions de dollars, les dépenses de R&D en cours à 6,3 millions de dollars, et les dépenses générales et administratives à 7,0 millions de dollars. La perte nette déclarée était de 36,1 millions de dollars.

L'entreprise se concentre sur le développement d'un large portefeuille de thérapies oncologiques, y compris des ADC et des petites molécules, soutenues par des efforts de développement commercial et une recherche ciblée.

Immunome (Nasdaq: IMNM) hat die finanziellen Ergebnisse des zweiten Quartals 2024 veröffentlicht und ein Unternehmensupdate bereitgestellt. Die wichtigsten Highlights sind:

- Fortschritt der Pipeline: Die vollständige Rekrutierung für die Phase-3-Studie RINGSIDE Teil B von AL102 bei desmoiden Tumoren ist abgeschlossen, wobei die ersten Daten für die zweite Hälfte von 2025 erwartet werden. INDs für IM-1021 und IM-3050 werden im ersten Quartal 2025 erwartet.

- Finanzielle Lage: Bargeld, Zahlungsmitteläquivalente und marktfähige Wertpapiere beliefen sich am 30. Juni 2024 auf insgesamt 278,4 Millionen US-Dollar, mit einer finanziellen Basis bis 2026.

- Ergebnisse Q2 2024: Die F&E-Ausgaben betrugen 29,1 Millionen US-Dollar, die in Bearbeitung befindlichen F&E-Ausgaben 6,3 Millionen US-Dollar und die allgemeinen und administrativen Ausgaben 7,0 Millionen US-Dollar. Der ausgewiesene Nettopro Verlust betrug 36,1 Millionen US-Dollar.

Das Unternehmen konzentriert sich auf die Entwicklung eines breiten Portfolios von Onkologie-Therapien, einschließlich ADCs und kleiner Moleküle, unterstützt durch Geschäftsentwicklungsmaßnahmen und fokussierte Forschung.

Positive
  • Completed full enrollment for Phase 3 RINGSIDE Part B study of AL102 for desmoid tumors
  • Strong cash position of $278.4 million, with runway expected into 2026
  • Advancing multiple promising ADC targets with first-in-class potential
  • Expanding pipeline through cost-effective business development efforts
Negative
  • Net loss of $36.1 million for Q2 2024
  • Significant R&D expenses of $29.1 million in Q2 2024
  • In-process R&D expenses of $6.3 million related to business development activity

Insights

Immunome's Q2 2024 results reveal a strong cash position of $278.4 million, extending their runway into 2026. This provides ample resources for advancing their pipeline. However, the net loss of $36.1 million is significant, primarily driven by R&D expenses of $29.1 million. The $6.3 million in-process R&D expense indicates active business development, which could potentially accelerate pipeline expansion but also increases cash burn. The G&A expenses of $7.0 million seem reasonable for a biotech of this size. Overall, while the company is well-funded, investors should monitor the burn rate and pipeline progress closely.

Immunome's focus on first-in-class and best-in-class targeted oncology therapies is promising. The completion of enrollment for the Phase 3 RINGSIDE Part B study of AL102 for desmoid tumors is a significant milestone. The expected topline data in H2 2025 will be important for the company's valuation. The planned IND submissions for IM-1021 and IM-3050 in Q1 2025 demonstrate pipeline progression. Their emphasis on next-generation ADCs aligns with current trends in oncology. The recent collaborations with Atreca, Nectin Therapeutics, Bluefin Biomedicine and OncoResponse could potentially enhance their ADC capabilities, but the outcomes remain to be seen.

BOTHELL, Wash.--(BUSINESS WIRE)-- Immunome, Inc. (Nasdaq: IMNM), a biotechnology company focused on the development of first-in-class and best-in-class targeted oncology therapies, today announced financial results for the second quarter ended June 30, 2024, and provided a business update.

“Immunome is focused on establishing and developing a broad pipeline of differentiated oncology therapies. We continue to advance work required to prepare AL102 for regulatory submissions, and we are moving towards submitting INDs for IM-1021 and IM-3050,” said Clay B. Siegall, Ph.D., President and Chief Executive Officer. “These programs are supported by an expanding team of drug developers, including leaders who previously contributed to the successful development and commercialization of ADCs and small molecules.”

Dr. Siegall continued, “In addition to our clinical pipeline, we have identified multiple promising ADC targets, all of which offer first-in-class potential. We believe that cost-effective business development efforts combined with focused research can accelerate the expansion of our pipeline and that rigorous science provides the foundation for transformative cancer therapies.”

Pipeline Highlights

Full enrollment for the Phase 3 RINGSIDE Part B study of AL102 for the treatment of desmoid tumors was completed in February 2024, and Immunome continues to expect to report topline data for RINGSIDE Part B in the second half of 2025. In parallel, Immunome is performing additional manufacturing and pharmacology work required to support a new drug application filing for AL102.

Immunome also anticipates submitting INDs for IM-1021 and IM-3050 in the first quarter of 2025, as previously disclosed.

These programs are complemented by robust discovery efforts centered on next-generation ADCs and active business development activity, including recent transactions with Atreca, Nectin Therapeutics, Bluefin Biomedicine, and OncoResponse intended to expand Immunome’s ADC toolbox.

Second Quarter 2024 Financial Results

  • As of June 30, 2024, cash, cash equivalents and marketable securities totaled $278.4 million. Immunome’s current cash runway is expected to extend into 2026.
  • Research and development expenses for the quarter ended June 30, 2024 were $29.1 million, including stock-based compensation costs of $1.0 million.
  • In-process research and development expenses for the quarter ended June 30th, 2024 were $6.3 million. These expenses were related to Immunome’s business development activity.
  • General and administrative expenses for the quarter ended June 30, 2024 were $7.0 million, including stock-based compensation expense of $2.2 million.
  • Immunome reported a net loss of $36.1 million for the quarter ended June 30, 2024.

About Immunome, Inc.

Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted therapies designed to improve outcomes for cancer patients. We are advancing an innovative portfolio of therapeutics, drawing on leadership that previously played key roles in the design, development and commercialization of cutting-edge targeted cancer therapies, including antibody-drug conjugates (ADCs). In addition to a portfolio of discovery-stage ADCs, our pipeline includes AL102, a gamma secretase inhibitor currently in a Phase 3 trial for treatment of desmoid tumors, as well as IM-1021, a ROR1 ADC, and IM-3050, a FAP-targeted radioligand, both of which are the subject of INDs expected to be submitted in the first quarter of 2025. For more information, visit www.immunome.com.

Cautionary Statement Regarding Forward-Looking Statements

Statements in this press release that are not purely historical in nature are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. We use words such as “believe,” “expected,” “look forward” and similar expressions to identify these forward-looking statements. These forward-looking statements include, but are not limited to, Immunome’s expected timing for filing an IND for IM-1021 and IM-3050; Immunome’s expected timing for providing topline data for the Phase 3 RINGSIDE Part B trial; Immunome’s expected cash runway; the potential of Immunome’s ADC targets to provide first-in-class potential; and other statements regarding management’s intentions, plans, beliefs, expectations or forecasts for the future. These forward-looking statements are based on Immunome’s current expectations and involve assumptions that may never materialize or may prove to be incorrect; consequently, actual results may differ materially from those expressed or implied in the statements due to a number of factors, including, but not limited to, the risk that Immunome will not be able to realize the benefits of its strategic transactions; the risk that regulatory approvals for Immunome’s programs and product candidates are not obtained, are delayed or are subject to unanticipated conditions; the risk that pre-clinical data may not be predictive of clinical data; the risk that Immunome’s product candidates and development candidates fail to achieve their intended endpoints; the reliance on Immunome’s management; the prior experience and successes of Immunome’s management team not being indicative of any future success; uncertainties related to Immunome’s capital requirements and Immunome’s expected cash runway; Immunome’s ability to grow and successfully execute on its business plan, including the development and commercialization of its pipeline and integration of newly acquired assets; and other risks and uncertainties indicated from time to time described in Immunome’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2024, filed with the SEC on May 14, 2024, in Immunome’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2024, being filed with the SEC today, and in Immunome’s other filings with the SEC. Except as required by law, Immunome assumes no obligation and does not intend to update any forward-looking statements included in this press release.

Immunome, Inc.
Consolidated Balance Sheets
(Unaudited; In thousands, except share and per share amounts)
 
June 30, 2024 December 31, 2023
Assets
Current assets:
Cash and cash equivalents $

165,332

 

$

98,679

 

Marketable securities

113,021

 

39,463

 

Prepaid expenses and other current assets

5,931

 

6,561

 

Total current assets

284,284

 

144,703

 

Property and equipment, net

6,096

 

2,073

 

Operating right-of-use assets

2,523

 

1,564

 

Restricted cash

100

 

100

 

Other long-term assets

3,212

 

100

 

Total assets $

296,215

 

$

148,540

 

Liabilities and stockholders’ equity
Current liabilities:
Accounts payable $

7,047

 

$

3,311

 

Accrued expenses and other current liabilities

20,264

 

8,025

 

Deferred revenue, current

12,589

 

10,493

 

Total current liabilities

39,900

 

21,829

 

Deferred revenue, non-current

 

5,489

 

Operating lease liabilities, net of current portion

2,477

 

1,340

 

Total liabilities

42,377

 

28,658

 

Stockholders’ equity:
Preferred stock

 

 

Common stock

6

 

4

 

Additional paid-in capital

642,251

 

342,663

 

Accumulated other comprehensive income

2

 

22

 

Accumulated deficit

(388,421

)

(222,807

)

Total stockholders’ equity

253,838

 

119,882

 

Total liabilities and stockholders’ equity $

296,215

 

$

148,540

 

 
 
Immunome, Inc.
Consolidated Statements of Operations
(Unaudited; In thousands, except share and per share amounts)
 
Three Months Ended June 30, Six Months Ended June 30,

2024

2023

2024

2023

Collaboration revenue $

2,364

 

$

4,263

 

$

3,393

 

$

6,627

 

Operating expenses:
In-process research and development

6,312

 

 

118,266

 

 

Research and development

29,083

 

5,716

 

44,452

 

9,629

 

General and administrative

6,978

 

4,320

 

12,983

 

7,242

 

Total operating expenses

42,373

 

10,036

 

175,701

 

16,871

 

Loss from operations

(40,009

)

(5,773

)

(172,308

)

(10,244

)

Interest income

3,887

 

216

 

6,694

 

417

 

Net loss $

(36,122

)

$

(5,557

)

$

(165,614

)

$

(9,827

)

Net loss per share, basic and diluted $

(0.60

)

$

(0.46

)

$

(2.97

)

$

(0.81

)

Weighted-average shares outstanding, basic and diluted

59,936,703

 

12,197,801

 

55,740,543

 

12,190,182

 

Comprehensive loss
Net loss $

(36,122

)

$

(5,557

)

$

(165,614

)

$

(9,827

)

Unrealized loss on marketable securities

(2

)

 

(20

)

 

Comprehensive loss $

(36,124

)

$

(5,557

)

$

(165,634

)

$

(9,827

)

 
(1) Amounts include non-cash stock based compensation as follows (in thousands):
 
Three Months Ended June 30, Six Months Ended June 30,

2024

2023

2024

2023

Research and development $

1,041

 

$

427

 

$

1,424

 

$

857

 

General and administrative

2,186

 

606

 

3,962

 

1,400

 

Total share-based compensation expense $

3,227

 

$

1,033

 

$

5,386

 

$

2,257

 

 

 

Investor Contact:

Max Rosett

Chief Financial Officer

investors@immunome.com

Source: Immunome, Inc.

FAQ

When does Immunome (IMNM) expect to report topline data for the RINGSIDE Part B study?

Immunome expects to report topline data for the RINGSIDE Part B study of AL102 for desmoid tumors in the second half of 2025.

What is Immunome's (IMNM) cash runway as of Q2 2024?

Immunome's current cash runway is expected to extend into 2026, based on their cash, cash equivalents, and marketable securities totaling $278.4 million as of June 30, 2024.

When does Immunome (IMNM) plan to submit INDs for IM-1021 and IM-3050?

Immunome anticipates submitting INDs for IM-1021 and IM-3050 in the first quarter of 2025.

What was Immunome's (IMNM) net loss for Q2 2024?

Immunome reported a net loss of $36.1 million for the quarter ended June 30, 2024.

Immunome, Inc.

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