Apollomics Reports First Half 2024 Financial Results and Highlights Vebreltinib Clinical Progress
Apollomics Inc. (Nasdaq: APLM) reported its first half 2024 financial results and clinical progress for vebreltinib. Key highlights include:
1. Promising preliminary results from the vebreltinib program for tumors with Met dysregulation, including non-CNS MET fusion tumors and NSCLC with MET amplification.
2. Cash position of $25.9 million as of June 30, 2024, with runway into Q3 2025.
3. R&D expenses of $16.9 million and G&A expenses of $10.2 million for H1 2024.
4. Net loss of $(35.2) million, or $(0.38) per share, including a $10 million impairment loss for uproleselan.
5. Strategic focus on vebreltinib for NSCLC patients with Met Amplification.
6. Raised $5.8 million in a PIPE financing in May 2024.
Apollomics Inc. (Nasdaq: APLM) ha riportato i risultati finanziari del primo semestre 2024 e i progressi clinici per vebreltinib. I punti salienti includono:
1. Risultati preliminari promettenti dal programma di vebreltinib per tumori con disfunzione del Met, inclusi tumori fusioni MET non CNS e NSCLC con amplificazione MET.
2. Posizione di cassa di 25,9 milioni di dollari al 30 giugno 2024, con una disponibilità fino al terzo trimestre del 2025.
3. Spese per R&S di 16,9 milioni di dollari e spese generali e amministrative di 10,2 milioni di dollari per il primo semestre 2024.
4. Perdita netta di (35,2) milioni di dollari, ovvero $(0,38) per azione, inclusa una perdita da deprezzamento di 10 milioni di dollari per uproleselan.
5. Focalizzazione strategica su vebreltinib per i pazienti NSCLC con amplificazione del Met.
6. Raccolti 5,8 milioni di dollari in un finanziamento PIPE a maggio 2024.
Apollomics Inc. (Nasdaq: APLM) informó sus resultados financieros para la primera mitad de 2024 y los avances clínicos de vebreltinib. Los aspectos destacados incluyen:
1. Resultados preliminares prometedores del programa de vebreltinib para tumores con disfunción del Met, incluidos tumores fusionados MET no CNS y NSCLC con amplificación de MET.
2. Posición de efectivo de 25,9 millones de dólares al 30 de junio de 2024, con un margen hasta el tercer trimestre de 2025.
3. Gastos de I+D de 16,9 millones de dólares y gastos generales y administrativos de 10,2 millones de dólares para la primera mitad de 2024.
4. Pérdida neta de (35,2) millones de dólares, o $(0,38) por acción, incluyendo una pérdida por deterioro de 10 millones de dólares por uproleselan.
5. Enfoque estratégico en vebreltinib para pacientes de NSCLC con amplificación de Met.
6. Se recaudaron 5,8 millones de dólares en un financiamiento PIPE en mayo de 2024.
Apollomics Inc. (Nasdaq: APLM)는 2024년 상반기 재무 결과 및 vebreltinib의 임상 진행 상황을 보고했습니다. 주요 내용은 다음과 같습니다:
1. 유망한 초기 결과 vebreltinib 프로그램의 MET 이상 조절이 있는 종양에 대한 결과, 비중추신경계 MET 융합 종양 및 MET 증폭이 있는 NSCLC 포함.
2. 2024년 6월 30일 기준 2,590만 달러의 현금 보유, 2025년 3분기까지 운영 가능.
3. 2024년 상반기 R&D 비용 1,690만 달러 및 일반 관리 비용 1,020만 달러.
4. 순손실 (3,520만 달러), 주당 $(0.38)로 uproleselan의 $1,000만 감가상각 손실 포함.
5. MET 증폭 환자를 위한 NSCLC에 대한 vebreltinib의 전략적 집중.
6. 2024년 5월 PIPE 금융에서 580만 달러를 조달했습니다.
Apollomics Inc. (Nasdaq: APLM) a rapporté ses résultats financiers pour la première moitié de 2024 et les progrès cliniques concernant vebreltinib. Les points clés incluent :
1. Résultats préliminaires prometteurs du programme vebreltinib pour les tumeurs avec dérèglement du Met, y compris les tumeurs fusionnées MET non CNS et le NSCLC avec amplification du MET.
2. Position de trésorerie de 25,9 millions de dollars au 30 juin 2024, avec une réserve jusqu'au troisième trimestre 2025.
3. Dépenses de R&D de 16,9 millions de dollars et dépenses générales et administratives de 10,2 millions de dollars pour le premier semestre 2024.
4. Perte nette de (35,2) millions de dollars, soit $(0,38) par action, y compris une perte de valeur de 10 millions de dollars pour uproleselan.
5. Concentration stratégique sur vebreltinib pour les patients NSCLC avec amplification de Met.
6. Levée de fonds de 5,8 millions de dollars dans le cadre d'un financement PIPE en mai 2024.
Apollomics Inc. (Nasdaq: APLM) hat die finanziellen Ergebnisse für das erste Halbjahr 2024 und den klinischen Fortschritt von vebreltinib berichtet. Die Hauptpunkte sind:
1. Vielversprechende vorläufige Ergebnisse aus dem vebreltinib-Programm für Tumore mit Met-Dysregulation, einschließlich nicht-ZNS MET-Fusions-Tumoren und NSCLC mit MET-Amplifikation.
2. Bargeldposition von 25,9 Millionen Dollar zum 30. Juni 2024, mit einem finanzielle Spielraum bis ins dritte Quartal 2025.
3. F&E-Ausgaben von 16,9 Millionen Dollar und allgemeine Verwaltungskosten von 10,2 Millionen Dollar für das erste Halbjahr 2024.
4. Nettoverlust von (35,2) Millionen Dollar, oder $(0,38) pro Aktie, einschließlich eines Wertminderungsverlustes von 10 Millionen Dollar für uproleselan.
5. Strategischer Fokus auf vebreltinib für NSCLC-Patienten mit MET-Amplifikation.
6. Im Mai 2024 wurden 5,8 Millionen Dollar durch eine PIPE-Finanzierung beschafft.
- Vebreltinib achieved a 43% objective response rate in non-CNS MET fusion solid tumors
- 30% objective response rate in NSCLC patients with highest MET gene copy number
- 67% objective response rate in NSCLC patients with Met Exon 14 skipping mutations without c-Met amplification
- $5.8 million raised in PIPE financing
- Cash runway extended into Q3 2025
- Net loss increased to $35.2 million in H1 2024 from $150.7 million in H1 2023
- $10 million impairment loss on uproleselan intangible asset due to negative Phase 3 results
- Early closure of uproleselan Phase 3 bridging study in China
- Cash position decreased to $25.9 million from $37.8 million at end of 2023
- Increased R&D and G&A expenses compared to H1 2023
Apollomics' financial results reveal a concerning cash burn rate. With
The net loss of
Investors should closely monitor the company's cash position and potential future financing needs, as these could significantly impact stock performance in the coming quarters.
The clinical progress of vebreltinib shows promise, particularly in non-CNS MET fusion tumors with a
The decision to focus on NSCLC patients with MET amplification confirmed by central FISH testing is strategically sound, potentially improving future trial outcomes. The
The negative results from GlycoMimetics' uproleselan study and subsequent impairment of Apollomics' related asset is a significant setback. This narrows the company's pipeline and increases reliance on vebreltinib's success, elevating the overall risk profile for investors.
Apollomics' strategic shift to focus on vebreltinib for NSCLC patients with Met Amplification is a double-edged sword. While it allows for more efficient resource allocation, it also increases the company's dependence on a single asset. This concentration of risk could make the stock more volatile in response to future clinical updates.
The departure of key executives, including the co-founder and former CMO, may raise concerns about continuity and expertise retention. However, their transition to consulting roles could help maintain some institutional knowledge.
The company's ability to raise
- Continued clinical progress for the vebreltinib registration-enabling program, including new data in non-CNS MET fusion tumors and non-small cell lung cancer (NSCLC) with MET amplification
$25.9 million in cash and cash equivalents as of June 30, 2024; cash runway into the third quarter of 2025
FOSTER CITY, Calif., Aug. 14, 2024 (GLOBE NEWSWIRE) -- Apollomics Inc. (Nasdaq: APLM) (“Apollomics” or the “Company”), a late-stage clinical biopharmaceutical company developing multiple oncology drug candidates to address difficult-to-treat and treatment-resistant cancers, today announced financial results for the first half of 2024 ended June 30, 2024, and highlighted updates for its pipeline.
“Thus far in 2024, we have announced promising preliminary results from our vebreltinib program for the treatment of various tumors with Met dysregulation. This includes new Apollomics data for the treatment of non-CNS solid tumors with Met fusions, an incremental data update for NSCLC with MET Exon 14 skipping earlier in the year and data for the treatment of NSCLC with MET Amplification shared in this announcement,” said Guo-Liang Yu, Ph.D., Chairman and Chief Executive Officer of Apollomics. “We are encouraged by these new data and remain focused on progressing the vebreltinib program to its first regulatory submission. We look forward to providing future data updates for this program.”
Pipeline Update
- Vebreltinib (APL-101) – a highly specific Met inhibitor for the treatment of NSCLC and other solid tumors with Met dysregulation
- In August 2024, the Company announced data from its SPARTA Phase 2 clinical trial for 14 patients with non-CNS MET fusion solid tumors, where a
43% objective response rate (ORR) was achieved by RECIST v1.1 criteria. This includes six confirmed responses out of 14 evaluable patients: one complete response in second-line metastatic NSCLC and five partial responses (three patients with NSCLC, one patient with pancreatic cancer, and one patient with intrahepatic bile duct cancer). Alongside the Avistone data for vebreltinib in the treatment of glioblastoma with PTPRZ1 MET fusions, vebreltinib has now demonstrated activity in a variety of tumors with MET fusions. - Apollomics has also recently completed an analysis of 38 patients in the SPARTA MET amplification cohorts. Testing method discordance (determination of MET amplification by status sequencing of blood, sequencing of tumor biopsies, and/or fluorescent in-situ hybridization (FISH), as well as the use of local versus central laboratory testing), has complicated the analysis. Of the patients with the highest MET gene copy number (GCN) as determined by central sequencing, an ORR of
30% (3/10) was achieved, as compared to13% (5/38) in the overall dataset. Going forward, Apollomics will only enroll NSCLC patients with MET amplification confirmed by central FISH testing. Apollomics believes that MET GCN ≥10 by sequencing may be comparable to GCN ≥6 by central FISH testing, which is the criteria to define MET amplification used in previous clinical trials of other MET inhibitors. - In March 2024, Apollomics announced an updated efficacy analysis by gene copy number (GCN) subgroup in the treatment of NSCLC patients with Met Exon 14 skipping mutations. The data show vebreltinib activity similar to previously announced. In the absence of overlapping c-Met amplification (GCN<4), in a pooled analysis of patients from SPARTA and KUNPENG an ORR of
67% was achieved (n=86).
- In August 2024, the Company announced data from its SPARTA Phase 2 clinical trial for 14 patients with non-CNS MET fusion solid tumors, where a
- Uproleselan (APL-106) – an E-selectin inhibitor as an adjunct to chemotherapy in acute myeloid leukemia (AML) treatment
- In May 2024, GlycoMimetics, our licensor of uproleselan in China, announced negative results from its pivotal Phase 3 study of uproleselan in relapsed or refractory acute myeloid leukemia. Apollomics is conducting a Phase 3 bridging study of uproleselan in China for the same indication. As positive results from the GlycoMimetics global study were likely necessary for approval of uproleselan in China for this indication, the Company has decided to close this study early and unblind after treatment for all patients is completed. As a result of these negative Phase 3 results from GlycoMimetics, the Company determined the recoverable amount was lower than the carrying value of the intangible asset and recorded an impairment loss of
$10.0 million to write down the full value of our intangible asset for this program.
- In May 2024, GlycoMimetics, our licensor of uproleselan in China, announced negative results from its pivotal Phase 3 study of uproleselan in relapsed or refractory acute myeloid leukemia. Apollomics is conducting a Phase 3 bridging study of uproleselan in China for the same indication. As positive results from the GlycoMimetics global study were likely necessary for approval of uproleselan in China for this indication, the Company has decided to close this study early and unblind after treatment for all patients is completed. As a result of these negative Phase 3 results from GlycoMimetics, the Company determined the recoverable amount was lower than the carrying value of the intangible asset and recorded an impairment loss of
Business Highlights
- Focus on vebreltinib: In July 2024, Apollomics announced a strategic prioritization for the treatment of NSCLC patients with Met Amplification. By focusing on the patient population with the greatest unmet medical need that can be addressed by MET inhibition with vebreltinib, Apollomics intends to apply its resources in the most efficient manner to generate additional clinical data for support of regulatory submissions.
- Leadership team changes: As previously announced, as a result of the updated strategic focus, and aligned with the Company’s resource needs going forward, Sanjeev Redkar, Ph.D., Company co-founder and former President, and Peony Yu, M.D., former Chief Medical Officer, have departed their previous roles and are expected to transition to consulting roles in August. Dr. Redkar will remain on the Board of Directors.
- Raised
$5.8 million : In May 2024, the Company raised$5.8 million in a private placement in public equity (PIPE) financing, before transaction expenses.
First Half 2024 Financial Results
- Cash, cash equivalents, bank deposits and money market funds as of June 30, 2024 were
$25.9 million , compared to$37.8 million as of December 31, 2023. Based on current projections, the Company believes its cash position is sufficient to fund planned operations into the third quarter of 2025.
- Research and development (R&D) expenses were
$16.9 million , including share-based compensation of$3.7 million , for the first half of 2024, compared to$16.5 million , including share-based compensation of$2.8 million , for the first half of 2023.
- General and administrative (G&A) expenses were
$10.2 million , including share-based compensation of$4.5 million , for the first half of 2024, compared to$9.7 million , including share-based compensation of$2.4 million , for the first half of 2023.
- Net loss for the first half of 2024 was
$(35.2) million , or$(0.38) per basic and diluted share, compared with a net loss of$(150.7) million , or$(2.55) per basic and diluted share, for the first half of 2023. Net loss for the first half of 2024 includes an impairment loss of$10.0 million to write down the full value of the uproleselan intangible asset. Net loss for the first half of 2023 includes a non-cash expense for change in fair value of convertible preferred shares of$76.4 million and expenses related to capital markets activities of$45.5 million .
About Apollomics Inc.
Apollomics Inc. is an innovative clinical-stage biopharmaceutical company focused on the discovery and development of oncology therapies with the potential to be combined with other treatment options to harness the immune system and target specific molecular pathways to inhibit cancer. Apollomics’ lead programs include its core product, vebreltinib (APL-101), a potent, selective c-Met inhibitor for the treatment of non-small cell lung cancer and other advanced tumors with c-Met alterations, which is currently in a Phase 2 multicohort clinical trial in the United States, and uproleselan (APL-106), a specific E-selectin antagonist that has the potential to be used adjunctively with standard chemotherapy to treat acute myeloid leukemia and other hematologic cancers, which is currently in Phase 1 and Phase 3 clinical trials in China. For more information, please visit www.apollomicsinc.com.
Cautionary Statement Regarding Forward-Looking Statements
This press release includes statements that constitute “forward-looking statements” within the meaning of the federal securities laws, including Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). All statements, other than statements of present or historical fact included in this press release, regarding the Company’s strategy, prospects, plans and objectives are forward-looking statements. When used in this press release, the words “could,” “should,” “will,” “may,” “believe,” “anticipate,” “intend,” “estimate,” “expect,” “project,” the negative of such terms and other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain such identifying words. These forward-looking statements are based on management’s current expectations and assumptions about future events and are based on currently available information as to the outcome and timing of future events. Apollomics cautions you that these forward-looking statements are subject to numerous risks and uncertainties, most of which are difficult to predict and many of which are beyond the control of Apollomics. In addition, Apollomics cautions you that the forward-looking statements contained in this press release are subject to unknown risks, uncertainties and other factors, including: (i) the impact of any current or new government regulations in the United States and China affecting Apollomics’ operations and the continued listing of Apollomics’ securities; (ii) the inability to achieve successful clinical results or to obtain licensing of third-party intellectual property rights for future discovery and development of Apollomics’ oncology projects; (iii) the failure to commercialize product candidates and achieve market acceptance of such product candidates; (iv) the failure to protect Apollomics’ intellectual property; (v) breaches in data security; (vi) the risk that Apollomics may not be able to develop and maintain effective internal controls; (vii) unfavorable changes to the regulatory environment; and (viii) those risks and uncertainties discussed in the Annual Report on Form 20-F for the year ended December 31, 2023, filed by Apollomics Inc. with the U.S. Securities and Exchange Commission (“SEC”) under the heading “Risk Factors” and the other documents filed, or to be filed, by the Company with the SEC. Additional information concerning these and other factors that may impact the operations and projections discussed herein can be found in the reports that Apollomics has filed and will file from time to time with the SEC. These SEC filings are available publicly on the SEC’s website at www.sec.gov. Forward-looking statements speak only as of the date made by the Company. Apollomics undertakes no obligation to update publicly any of its forward-looking statements to reflect actual results, new information or future events, changes in assumptions or changes in other factors affecting forward-looking statements, except to the extent required by applicable law.
Investor Contact:
Eric Ribner
LifeSci Advisors, LLC
(646) 751-4363
eric@lifesciadvisors.com
APOLLOMICS INC. CONDENSED CONSOLIDATED INTERIM STATEMENTS OF FINANCIAL POSITION (All amounts in thousands of $) | ||||||||
As of June 30, 2024 (Unaudited) | As of December 31, 2023 | |||||||
Non-current assets | ||||||||
Plant and equipment, net | $ | 124 | $ | 161 | ||||
Right-of-use assets | 1,177 | 425 | ||||||
Intangible assets, net | 4,747 | 14,757 | ||||||
Rental deposits | 113 | 119 | ||||||
Total non-current assets | 6,161 | 15,462 | ||||||
Current assets | ||||||||
Deposits, prepayments and deferred expenses | 2,483 | 2,108 | ||||||
Financial assets at fair value through profit and loss (“FVTPL”) | — | 5,761 | ||||||
Cash and cash equivalents | 25,929 | 32,056 | ||||||
Total current assets | 28,412 | 39,925 | ||||||
Total assets | 34,573 | 55,387 | ||||||
Current liabilities | ||||||||
Other payables and accruals | 8,877 | 9,162 | ||||||
Short term bank loans | 3,508 | 4,236 | ||||||
Lease liabilities, current portion | 264 | 158 | ||||||
Total current liabilities | 12,649 | 13,556 | ||||||
Net current assets | 15,763 | 26,369 | ||||||
Total assets less current liabilities | 21,924 | 41,831 | ||||||
Non-current liabilities | ||||||||
Lease liabilities, non-current portion | 951 | 267 | ||||||
Warrant liabilities at FVTPL | 166 | 330 | ||||||
Total non-current liabilities | 1,117 | 597 | ||||||
Net assets | 20,807 | 41,234 | ||||||
Equity | ||||||||
Share capital | 11 | 9 | ||||||
Share premium | 666,521 | 661,474 | ||||||
Reserves | 36,446 | 26,716 | ||||||
Accumulated losses | (682,171 | ) | (646,965 | ) | ||||
Total equity | $ | 20,807 | $ | 41,234 | ||||
APOLLOMICS INC. CONDENSED CONSOLIDATED INTERIM STATEMENTS OF LOSS AND COMPREHENSIVE LOSS (UNAUDITED) (All amounts in thousands of $, except for per share data) | ||||||||
Six Months Ended June 30, | ||||||||
2024 | 2023 | |||||||
Other income | $ | 1,737 | $ | 401 | ||||
Foreign exchange losses | (2 | ) | (2,104 | ) | ||||
Fair value change of financial assets at FVTPL | 198 | 460 | ||||||
Fair value change of financial liabilities at FVTPL | 164 | 676 | ||||||
Fair value change of convertible preferred shares | — | (76,430 | ) | |||||
Research and development expenses | (16,926 | ) | (16,518 | ) | ||||
Administrative expenses | (10,153 | ) | (9,652 | ) | ||||
Impairment of an intangible asset | (10,000 | ) | — | |||||
Finance costs | (134 | ) | (60 | ) | ||||
Other expense | (90 | ) | (47,457 | ) | ||||
Loss before taxation | (35,206 | ) | (150,684 | ) | ||||
Income tax expenses | — | (10 | ) | |||||
Loss and total comprehensive loss for the period, net of taxation, attributable to owners of the Company | $ | (35,206 | ) | $ | (150,694 | ) | ||
Loss per share | ||||||||
Basic loss per common share | $ | (0.38 | ) | $ | (2.55 | ) | ||
Diluted loss per common share | $ | (0.38 | ) | $ | (2.55 | ) | ||
Weighted average number of common shares outstanding – Basic and Diluted | 93,740 | 59,000 | ||||||
![](https://ml.globenewswire.com/media/ZWQ1ZjRkMjgtNWVlMS00ODczLWEyNTMtNjljYmFjMjEyMWM2LTExMzQzMzE=/tiny/Apollomics-Inc-.png)
FAQ
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