ALX Oncology Reports Second Quarter 2024 Financial Results and Provides Corporate Update
ALX Oncology (Nasdaq: ALXO) reported Q2 2024 financial results and provided a corporate update. Key highlights include:
1. Topline data from ASPEN-06 Phase 2 trial showed evorpacept improved tumor response in HER2-positive gastric/GEJ cancer patients.
2. Evorpacept combination with PADCEV demonstrated promising activity in urothelial cancer.
3. Phase 1/2 trial of evorpacept in B-cell non-Hodgkin lymphoma showed 94% ORR and 83% CRR.
4. Cash position of $186.2 million, sufficient to fund operations into Q1 2026.
5. Q2 2024 R&D expenses increased to $34.7 million, while G&A expenses decreased to $6.9 million.
6. GAAP net loss was $39.4 million ($0.76 per share) compared to $34.2 million ($0.84 per share) in Q2 2023.
ALX Oncology (Nasdaq: ALXO) ha riportato i risultati finanziari del secondo trimestre 2024 e fornito un aggiornamento aziendale. I punti salienti includono:
1. I dati preliminari della sperimentazione di fase 2 ASPEN-06 hanno mostrato che l'evorpacept ha migliorato la risposta tumorale nei pazienti con cancro gastrico/GEJ positivo per HER2.
2. La combinazione di evorpacept con PADCEV ha dimostrato un'attività promettente nel cancro uroteliale.
3. La sperimentazione di fase 1/2 di evorpacept nel linfoma non-Hodgkin a cellule B ha mostrato un tasso di risposta obiettiva del 94% e un tasso di risposta completa dell'83%.
4. La posizione di liquidità è di 186,2 milioni di dollari, sufficiente per finanziare le operazioni fino al primo trimestre del 2026.
5. Le spese per ricerca e sviluppo del secondo trimestre 2024 sono aumentate a 34,7 milioni di dollari, mentre le spese generali e amministrative sono diminuite a 6,9 milioni di dollari.
6. La perdita netta GAAP è stata di 39,4 milioni di dollari (0,76 dollari per azione) rispetto ai 34,2 milioni di dollari (0,84 dollari per azione) del secondo trimestre 2023.
ALX Oncology (Nasdaq: ALXO) informó los resultados financieros del segundo trimestre de 2024 y ofreció una actualización corporativa. Los aspectos más destacados incluyen:
1. Los datos preliminares del ensayo de fase 2 ASPEN-06 mostraron que el evorpacept mejoró la respuesta tumoral en pacientes con cáncer gástrico/GEJ positivo para HER2.
2. La combinación de evorpacept con PADCEV demostró una actividad prometedora en el cáncer urotelial.
3. El ensayo de fase 1/2 de evorpacept en linfoma no Hodgkin de células B mostró una tasa de respuesta objetiva del 94% y una tasa de respuesta completa del 83%.
4. La posición de efectivo es de 186,2 millones de dólares, suficiente para financiar operaciones hasta el primer trimestre de 2026.
5. Los gastos de I+D del segundo trimestre de 2024 aumentaron a 34,7 millones de dólares, mientras que los gastos generales y administrativos disminuyeron a 6,9 millones de dólares.
6. La pérdida neta según GAAP fue de 39,4 millones de dólares (0,76 dólares por acción) en comparación con 34,2 millones de dólares (0,84 dólares por acción) en el segundo trimestre de 2023.
ALX Oncology (Nasdaq: ALXO)는 2024년 2분기 재무 결과를 보고하고 기업 업데이트를 제공했습니다. 주요 내용은 다음과 같습니다:
1. ASPEN-06 2상 시험의 주요 데이터에 따르면, evorpacept가 HER2 양성 위/GEJ 암 환자에서 종양 반응을 개선했습니다.
2. evorpacept와 PADCEV의 조합은 요로 상피암에서 유망한 활성을 보였습니다.
3. B세포 비호지킨 림프종에서 evorpacept의 1/2상 시험은 94%의 객관적 반응률과 83%의 완전 반응률을 보여주었습니다.
4. 현금 보유액은 1억8620만 달러로, 2026년 1분기까지 운영 자금을 충분히 지원할 수 있습니다.
5. 2024년 2분기 R&D 비용은 3470만 달러로 증가했으며, 일반 관리비는 690만 달러로 감소했습니다.
6. GAAP 기준의 순손실은 3940만 달러(주당 0.76 달러)로, 2023년 2분기의 3420만 달러(주당 0.84 달러)와 비교되었습니다.
ALX Oncology (Nasdaq: ALXO) a annoncé les résultats financiers du deuxième trimestre 2024 et a fourni une mise à jour de l'entreprise. Les points clés comprennent :
1. Les données préliminaires de l'essai de phase 2 ASPEN-06 ont montré qu'evorpacept améliorait la réponse tumorale chez les patients atteints de cancer gastrique/GEJ positif pour HER2.
2. La combinaison d'evorpacept avec PADCEV a démontré une activité prometteuse dans le cancer urothélial.
3. L'essai de phase 1/2 d'evorpacept dans le lymphome non-Hodgkin à cellules B a montré un taux de réponse objective de 94 % et un taux de réponse complète de 83 %.
4. La position de trésorerie s'élève à 186,2 millions de dollars, suffisante pour financer les opérations jusqu'au premier trimestre 2026.
5. Les dépenses de R&D du deuxième trimestre 2024 ont augmenté à 34,7 millions de dollars, tandis que les dépenses générales et administratives ont diminué à 6,9 millions de dollars.
6. La perte nette selon les normes GAAP était de 39,4 millions de dollars (0,76 dollar par action), contre 34,2 millions de dollars (0,84 dollar par action) au deuxième trimestre 2023.
ALX Oncology (Nasdaq: ALXO) hat die finanziellen Ergebnisse für das zweite Quartal 2024 bekannt gegeben und ein Unternehmensupdate bereitgestellt. Die wichtigsten Highlights sind:
1. Die wichtigsten Daten aus der ASPEN-06 Phase 2-Studie zeigten, dass evorpacept die Tumorreaktion bei HER2-positiven Magen-/GEJ-Krebs-Patienten verbesserte.
2. Die Kombination von evorpacept mit PADCEV zeigte vielversprechende Aktivität bei Urothelkarzinomen.
3. Die Phase 1/2-Studie von evorpacept bei B-Zellen Non-Hodgkin-Lymphom zeigte eine objektive Ansprechquote von 94 % und eine komplette Remissionsrate von 83 %.
4. Die Liquidität beträgt 186,2 Millionen US-Dollar, was ausreicht, um die Geschäftstätigkeit bis zum ersten Quartal 2026 zu finanzieren.
5. Die F&E-Ausgaben im 2. Quartal 2024 stiegen auf 34,7 Millionen US-Dollar, während die allgemeinen Verwaltungskosten auf 6,9 Millionen US-Dollar sanken.
6. Der GAAP-Nettoverlust betrug 39,4 Millionen US-Dollar (0,76 US-Dollar pro Aktie) im Vergleich zu 34,2 Millionen US-Dollar (0,84 US-Dollar pro Aktie) im 2. Quartal 2023.
- Evorpacept improved tumor response in HER2-positive gastric/GEJ cancer patients in ASPEN-06 Phase 2 trial
- Evorpacept combination with PADCEV showed promising activity in urothelial cancer
- Phase 1/2 trial of evorpacept in B-cell non-Hodgkin lymphoma achieved 94% ORR and 83% CRR
- Strong cash position of $186.2 million, sufficient to fund operations into Q1 2026
- Multiple upcoming clinical milestones across various oncology indications
- Increased R&D expenses of $34.7 million in Q2 2024, up from $29.5 million in Q2 2023
- GAAP net loss increased to $39.4 million in Q2 2024 from $34.2 million in Q2 2023
Insights
ALX Oncology's Q2 2024 results show a mixed financial picture. While R&D expenses increased by
The ASPEN-06 Phase 2 trial results for evorpacept in HER2-positive gastric/GEJ cancer are particularly noteworthy. The combination therapy (Evo-TRP) showed an improved ORR of
ALX Oncology's pipeline progress, particularly with evorpacept, positions the company well in the competitive oncology market. The positive data from multiple trials, including ASPEN-06 in gastric cancer and ASPEN-07 in urothelial cancer, demonstrate evorpacept's versatility across different cancer types and in combination with various therapies. This broad potential application could significantly expand ALX's market opportunity. The company's focus on combination therapies, especially with ADCs, aligns with current trends in oncology treatment. With multiple data readouts expected in 2025, including potential Phase 3 initiation, ALX Oncology has several near-term catalysts that could drive investor interest and potentially impact the stock price. However, investors should remain cautious as clinical trial outcomes remain uncertain.
SOUTH SAN FRANCISCO, Calif., Aug. 08, 2024 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., (“ALX Oncology” or “the Company”) (Nasdaq: ALXO), an immuno-oncology company developing therapies that block the CD47 immune checkpoint pathway, today reported financial results for the second quarter ended June 30, 2024, and provided a corporate update.
“Our team continues to make significant progress in the advancement of our evorpacept development pipeline across multiple oncology indications,” said Jason Lettmann, Chief Executive Officer of ALX Oncology. “Data readouts across our Phase 1 and 2 clinical trials highlight the potential of evorpacept as a disruptive therapy in combination with anti-cancer antibodies and ADCs. In particular, the recent ASPEN-06 Phase 2 clinical trial readout in patients with previously treated HER2-positive advanced gastric cancer is a significant growth milestone for the Company. We are well positioned to build on our second quarter achievements and continue to advance toward our anticipated milestones in the months ahead.”
Second Quarter 2024 Highlights and Recent Developments
Evorpacept Clinical Development Program
- On July 31, ALX Oncology reported topline data from the multi-center, international ASPEN-06 Phase 2 clinical trial evaluating evorpacept in combination with trastuzumab, CYRAMZA® (ramucirumab) and paclitaxel (“Evo-TRP”) against trastuzumab, CYRAMZA (ramucirumab) and paclitaxel (“TRP”) for the treatment of patients with HER2-positive gastric/gastroesophageal junction (“GEJ”) cancer, where all patients had received an anti-HER2 agent in prior lines of therapy (NCT05002127).
- Results demonstrated that evorpacept improved tumor response in patients with HER2-positive gastric/GEJ cancer, becoming the first CD47 blocker to show promising and durable response with a well-tolerated safety profile in a prospective randomized study.
- The primary endpoint was confirmed overall response rate (“ORR”) with key secondary endpoints being safety, median duration of response (“mDOR”), progression-free survival (“PFS”) and overall survival (“OS”). Primary study objectives were to compare confirmed ORR of Evo-TRP to an assumed ORR of
30% for CYRAMZA (ramucirumab) and paclitaxel (“RP”) with one-sided alpha error of 0.025, and to identify a clinically meaningful contribution of Evo to TRP in ORR (delta >10% ). - Evo-TRP achieved a confirmed ORR of
40.3% compared to26.6% for the TRP control arm and demonstrated a mDOR of 15.7 months compared to 7.6 months in the intent to treat population (“ITT”) (N=127). The primary analysis of the ITT compared Evo-TRP to an assumed RP control ORR of30% (p=0.095). When a comparison of Evo-TRP to the observed TRP control arm ORR of26.6% was explored using a similar testing procedure, a p-value of p=0.027 was observed. Secondary endpoints of PFS and OS were immature at the time of analysis. - Evo-TRP combination showed the greatest response with an ORR of
54.8% compared to23.1% in the TRP control arm in a pre-specified population of patients with fresh HER2-positive biopsies (n=48). In this population, Evo-TRP compared to an assumed RP control ORR of30% yielded a p-value of p=0.030 . When Evo-TRP compared to the observed TRP ORR of23.1% was explored using a similar testing procedure, a p-value of p=0.0038 was observed, suggesting HER2-expression strongly correlates with evorpacept efficacy and validating its mechanism of action.
- In June, ALX Oncology presented the first evorpacept combination data with an antibody-drug conjugate (“ADC”) from the Phase 1 ASPEN-07 clinical trial in patients with advanced urothelial cancer at the 2024 American Society of Cancer Oncology (“ASCO”) Annual Meeting.
- This open-label, single-arm, clinical trial of evorpacept in combination with an approved ADC, PADCEV® (enfortumab vedotin), demonstrated promising activity and was generally well tolerated in patients with locally advanced or metastatic urothelial cancer (NCT05524545).
- In April, ALX Oncology reported positive data from the ongoing Phase 1/2 investigator-sponsored clinical trial of evorpacept in combination with standard-of-care in patients with relapsed or refractory B-cell non-Hodgkin lymphoma (NCT05025800).
- The combination achieved promising initial activity with a best ORR of
94% and a complete response rate ("CRR") of83% in patients with indolent R/R B-NHL (compared to rituximab and lenalidomide historical CRR benchmark of34% ).
- The combination achieved promising initial activity with a best ORR of
- In April, ALX Oncology announced the initiation of a Phase 2 investigator-sponsored trial of neoadjuvant radiation and evorpacept in combination with KEYTRUDA® (pembrolizumab) in patients with previously untreated and early-stage locally advanced, resectable, human papillomavirus-mediated oropharyngeal cancer (NCT05787639).
Conference Presentations
- At the 2024 ASCO Annual Meeting, ALX Oncology presented the first evorpacept combination data with an ADC from the Phase 1 ASPEN-07 clinical trial in patients with locally advanced or metastatic urothelial cancer.
- In the open-label, single-arm, clinical trial of evorpacept in combination with an approved ADC, PADCEV® (enfortumab vedotin), demonstrated promising activity and was generally well tolerated in patients.
- The Company also presented results of an investigator-sponsored, Phase 2 study of evorpacept, cetuximab and pembrolizumab in patients with refractory microsatellite stable metastatic colorectal cancer.
- At the 2024 American Association of Cancer Research Annual Meeting, ALX Oncology presented two evorpacept clinical abstracts including:
- Phase 1 investigator-initiated trial of evorpacept, lenalidomide and rituximab for patients with relapsed or refractory B-cell non-Hodgkin lymphoma.
- Phase 1 study of azacitidine in combination with evorpacept for higher-risk myelodysplastic syndrome (MDS)
Board and Executive Appointments
- ALX Oncology strengthened the Company’s board and leadership team with the appointment of Alan Sandler, M.D., to its Board of Directors, and the addition of Allison Dillon, Ph.D., to its executive leadership team as Chief Business Officer.
Upcoming Clinical Milestones for Evorpacept’s Development Pipeline
- ALX Oncology is well-positioned to achieve numerous milestones across multiple oncology indications in its evorpacept clinical development program:
- Head and Neck Squamous Cell Carcinoma – Topline results from a Phase 2 randomized clinical trial of ASPEN-03 with KEYTRUDA (1H 2025)
- Head and Neck Squamous Cell Carcinoma – Topline results from a Phase 2 randomized clinical trial of ASPEN-04 with KEYTRUDA and chemotherapy (1H 2025)
- Gastric/GEJ Cancer – Updated results of ASPEN-06 Phase 2 clinical trial (1H 2025)
- Urothelial Cancer – Updated results from a Phase 1 clinical trial of ASPEN-07 in combination with PADCEV (1H 2025)
- Gastric/GEJ Cancer – Initiation of Phase 3 registrational randomized clinical trial for evorpacept (mid-2025)
- Breast Cancer – Topline results from a Phase 1b I-SPY TRIAL with ENHERTU® (fam-trastuzumab deruxtecan-nxki) (2H 2025)
Second Quarter 2024 Financial Results:
- Cash, Cash Equivalents and Investments: Cash, cash equivalents and investments as of June 30, 2024, were
$186.2 million . The Company believes its cash, cash equivalents and investments, which includes the proceeds from sales under its at-the-market (“ATM”) offering in the first half of 2024 are sufficient to fund planned operations well into Q1 2026. - Research and Development (“R&D”) Expenses: R&D expenses consist primarily of pre-clinical, clinical and manufacturing expenses related to the development of the Company’s current lead product candidate, evorpacept, and R&D employee-related expenses. These expenses for the three months ended June 30, 2024, were
$34.7 million , compared to$29.5 million for the prior-year period. R&D expenses increased by$5.2 million during the three months ended June 30, 2024, compared to the three months ended June 30, 2023. The increase was primarily attributable to an increase of$1.7 million in preclinical costs for development of new targets, an increase of$1.2 million in personnel and related costs primarily driven by headcount growth, an increase of$1.8 million in stock-based compensation expense and an increase of$0.7 million in other research costs primarily due to absence of VAT refunds in the current quarter compared to prior year quarter. - General and Administrative (“G&A”) Expenses: G&A expenses consist primarily of administrative employee-related expenses, legal and other professional fees, patent filing and maintenance fees, and insurance. These expenses for the three months ended June 30, 2024, were
$6.9 million , compared to$7.3 million for the prior year period. G&A expenses decreased by$0.4 million during the three months ended June 30, 2024, compared to the three months ended June 30, 2023. The decrease was primarily attributable to a decrease of$0.8 million in stock-based compensation expense primarily due to a change in classification from the comparative periods of stock-based compensation from G&A to R&D as described above under R&D expenses, offset by an increase of$0.3 million in other G&A costs from accounting consulting and personnel costs driven by headcount growth. - Net loss: GAAP net loss was
$39.4 million for the three months ended June 30, 2024, or ($0.76) per basic and diluted share, as compared to a GAAP net loss of$34.2 million for the three months ended June 30, 2023, or ($0.84) per basic and diluted share. Non-GAAP net loss was$32.1 million for the three months ended June 30, 2024, as compared to a non-GAAP net loss of$27.9 million for the three months ended June 30, 2023. A reconciliation of GAAP to non-GAAP financial results can be found at the end of this news release.
About ALX Oncology
ALX Oncology is a publicly traded, clinical-stage immuno-oncology company focused on helping patients fight cancer by developing therapies that block the CD47 immune checkpoint inhibitor and bridge the innate and adaptive immune system. ALX Oncology’s lead product candidate, evorpacept, is a CD47 blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated, proprietary Fc domain. To date, evorpacept has been dosed in over 500 subjects and has demonstrated promising activity and favorable tolerability profile across a range of hematologic and solid malignancies in combination with various leading anti-cancer antibodies. ALX Oncology is currently focusing on combining evorpacept with anti-cancer antibodies, ADCs, and PD-1/PD-L1 immune checkpoint inhibitors.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. Forward-looking statements include statements regarding future results of operations and financial position, business strategy, product candidates, planned preclinical studies and clinical trials, results of clinical trials, research and development costs, regulatory approvals, timing and likelihood of success, plans and objects of management for future operations, as well as statements regarding industry trends. Such forward-looking statements are based on ALX Oncology’s beliefs and assumptions and on information currently available to it on the date of this press release. Forward-looking statements may involve known and unknown risks, uncertainties and other factors that may cause ALX Oncology’s actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. These and other risks are described more fully in ALX Oncology’s filings with the Securities and Exchange Commission (“SEC”), including ALX Oncology’s Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and other documents ALX Oncology files with the SEC from time to time. Except to the extent required by law, ALX Oncology undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
| ALX ONCOLOGY HOLDINGS INC. Condensed Consolidated Statements of Operations (unaudited) (in thousands, except share and per share amounts) | |||||||||||||||
| Three Months Ended | Six Months Ended | ||||||||||||||
| June 30, | June 30, | ||||||||||||||
| 2024 | 2023 | 2024 | 2023 | ||||||||||||
| Operating expenses: | |||||||||||||||
| Research and development | $ | 34,653 | $ | 29,482 | $ | 66,370 | $ | 54,245 | |||||||
| General and administrative | 6,872 | 7,295 | 12,917 | 14,735 | |||||||||||
| Total operating expenses | 41,525 | 36,777 | 79,287 | 68,980 | |||||||||||
| Loss from operations | (41,525 | ) | (36,777 | ) | (79,287 | ) | (68,980 | ) | |||||||
| Interest income | 2,563 | 2,666 | 5,185 | 4,977 | |||||||||||
| Interest expense | (429 | ) | (372 | ) | (856 | ) | (759 | ) | |||||||
| Other (expense) income, net | (8 | ) | 324 | (22 | ) | 419 | |||||||||
| Net loss | $ | (39,399 | ) | $ | (34,159 | ) | $ | (74,980 | ) | $ | (64,343 | ) | |||
| Net loss per share, basic and diluted | $ | (0.76 | ) | $ | (0.84 | ) | $ | (1.47 | ) | $ | (1.57 | ) | |||
| Weighted-average shares of common stock used to compute net loss per shares, basic and diluted | 51,831,157 | 40,875,457 | 50,969,089 | 40,869,021 | |||||||||||
| Condensed Consolidated Balance Sheet Data (in thousands) | |||||||
| June 30, | December 31, | ||||||
| 2024 | 2023 | ||||||
| Cash, cash equivalents and investments | $ | 186,198 | $ | 218,147 | |||
| Total assets | $ | 214,618 | $ | 242,553 | |||
| Total liabilities | $ | 55,301 | $ | 52,841 | |||
| Accumulated deficit | $ | (561,252 | ) | $ | (486,272 | ) | |
| Total stockholders’ equity | $ | 159,317 | $ | 189,712 | |||
| GAAP to Non-GAAP Reconciliation (unaudited) (in thousands) | |||||||||||||||
| Three Months Ended | Six Months Ended | ||||||||||||||
| June 30, | June 30, | ||||||||||||||
| 2024 | 2023 | 2024 | 2023 | ||||||||||||
| GAAP net loss, as reported | $ | (39,399 | ) | $ | (34,159 | ) | $ | (74,980 | ) | $ | (64,343 | ) | |||
| Adjustments: | |||||||||||||||
| Stock-based compensation expense | 7,252 | 6,237 | 14,283 | 12,588 | |||||||||||
| Accretion of term loan discount and issuance costs | 66 | 62 | 130 | 123 | |||||||||||
| Total adjustments | 7,318 | 6,299 | 14,413 | 12,711 | |||||||||||
| Non-GAAP net loss | $ | (32,081 | ) | $ | (27,860 | ) | $ | (60,567 | ) | $ | (51,632 | ) | |||
Use of Non-GAAP Financial Measures
We supplement our consolidated financial statements presented on a GAAP basis by providing additional measures which may be considered “non-GAAP” financial measures under applicable SEC rules. We believe that the disclosure of these non-GAAP financial measures provides our investors with additional information that reflects the amounts and financial basis upon which our management assesses and operates our business. These non-GAAP financial measures are not in accordance with generally accepted accounting principles and should not be viewed in isolation or as a substitute for reported, or GAAP, net loss, and are not a substitute for, or superior to, measures of financial performance performed in conformity with GAAP.
“Non-GAAP net loss” is not based on any standardized methodology prescribed by GAAP and represents GAAP net loss adjusted to exclude stock-based compensation expense and accretion of term loan discount and issuance costs. Non-GAAP financial measures used by ALX Oncology may be calculated differently from, and therefore may not be comparable to, non-GAAP measures used by other companies.
FAQ
What were ALX Oncology's (ALXO) key financial results for Q2 2024?
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