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ALX Oncology Reports Third Quarter 2024 Financial Results and Provides Corporate Update

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ALX Oncology (NASDAQ: ALXO) reported Q3 2024 financial results and clinical progress. The company's lead candidate evorpacept showed promising results in the ASPEN-06 Phase 2 trial, achieving a 40.3% overall response rate compared to 26.6% in the control arm for HER2-positive gastric cancer treatment.

Financial highlights include cash position of $162.6 million, sufficient until Q1 2026. Q3 net loss was $30.7 million ($0.58 per share), improved from $51.0 million loss year-over-year. R&D expenses decreased to $26.5 million from $45.8 million, while G&A expenses reduced to $6.1 million from $7.5 million.

ALX Oncology (NASDAQ: ALXO) ha riportato i risultati finanziari e i progressi clinici per il terzo trimestre del 2024. Il candidato principale dell'azienda, evorpacept, ha mostrato risultati promettenti nello studio di fase 2 ASPEN-06, raggiungendo un tasso di risposta complessivo del 40,3% rispetto al 26,6% del gruppo di controllo nel trattamento del cancro gastrico HER2-positivo.

I punti salienti finanziari includono una posizione di cassa di $162,6 milioni, sufficiente fino al primo trimestre del 2026. La perdita netta del terzo trimestre è stata di $30,7 milioni ($0,58 per azione), migliorata rispetto alla perdita di $51,0 milioni dell'anno precedente. Le spese per R&S sono diminuite a $26,5 milioni rispetto ai $45,8 milioni, mentre le spese generali e amministrative sono scese a $6,1 milioni da $7,5 milioni.

ALX Oncology (NASDAQ: ALXO) reportó los resultados financieros del tercer trimestre de 2024 y los avances clínicos. El principal candidato de la empresa, evorpacept, mostró resultados prometedores en el ensayo de fase 2 ASPEN-06, alcanzando una tasa de respuesta general del 40,3% en comparación con el 26,6% en el grupo de control para el tratamiento del cáncer gástrico HER2-positivo.

Los aspectos financieros destacados incluyen una posición de efectivo de $162,6 millones, suficiente hasta el primer trimestre de 2026. La pérdida neta en el tercer trimestre fue de $30,7 millones ($0,58 por acción), mejorando desde una pérdida de $51,0 millones en comparación con el año anterior. Los gastos de I+D disminuyeron a $26,5 millones desde $45,8 millones, mientras que los gastos generales y administrativos se redujeron a $6,1 millones desde $7,5 millones.

ALX Oncology (NASDAQ: ALXO)는 2024년 3분기 재무 결과 및 임상 진행 상황을 보고했습니다. 회사의 주요 후보인 evorpacept는 ASPEN-06 2상 시험에서 40.3%의 전체 반응률을 기록하여 HER2 양성 위암 치료를 위한 대조군의 26.6%와 비교하여 유망한 결과를 보였습니다.

재무 하이라이트에는 $162.6 백만의 현금 보유가 포함되어 있으며, 이는 2026년 1분기까지 충분합니다. 3분기 순 손실은 $30.7 백만 ($0.58 per share)으로, 지난해 $51.0 백만 손실에서 개선되었습니다. 연구 개발(R&D) 비용은 $45.8 백만에서 $26.5 백만으로 감소하였고, 관리 및 일반(G&A) 비용은 $7.5 백만에서 $6.1 백만으로 줄었습니다.

ALX Oncology (NASDAQ: ALXO) a rapporté les résultats financiers et les progrès cliniques du troisième trimestre 2024. Le principal candidat de l'entreprise, evorpacept, a montré des résultats prometteurs dans l'essai de phase 2 ASPEN-06, atteignant un taux de réponse global de 40,3 % contre 26,6 % dans le groupe de contrôle pour le traitement du cancer gastrique HER2-positif.

Les points forts financiers incluent une position de trésorerie de $162,6 millions, suffisante jusqu'au premier trimestre 2026. La perte nette du troisième trimestre s'élevait à $30,7 millions ($0,58 par action), améliorée par rapport à une perte de $51,0 millions l'année précédente. Les dépenses de R&D ont diminué à $26,5 millions contre $45,8 millions, tandis que les dépenses générales et administratives (G&A) ont été réduites à $6,1 millions contre $7,5 millions.

ALX Oncology (NASDAQ: ALXO) hat die finanziellen Ergebnisse und klinischen Fortschritte für das dritte Quartal 2024 veröffentlicht. Der Hauptkandidat des Unternehmens, evorpacept, zeigte vielversprechende Ergebnisse in der ASPEN-06-Phase-2-Studie und erreichte eine Gesamtansprechrate von 40,3 % im Vergleich zu 26,6 % in der Kontrollgruppe für die Behandlung von HER2-positivem Magenkrebs.

Die finanziellen Eckdaten umfassen eine Barreserven von $162,6 Millionen, die bis zum 1. Quartal 2026 ausreichen. Der Nettoverlust im 3. Quartal betrug $30,7 Millionen ($0,58 pro Aktie) und verbesserte sich im Vergleich zu einem Verlust von $51,0 Millionen im Vorjahr. Forschung und Entwicklung (F&E)-Ausgaben verringerten sich auf $26,5 Millionen von $45,8 Millionen, während die allgemeinen und administrativen (G&A) Ausgaben auf $6,1 Millionen von $7,5 Millionen zurückgingen.

Positive
  • Evorpacept showed superior efficacy with 40.3% ORR vs 26.6% in control arm
  • Cash position of $162.6M provides runway into Q1 2026
  • Net loss improved to $30.7M from $51.0M year-over-year
  • R&D expenses decreased by $19.3M compared to prior year
  • G&A expenses reduced by $1.4M year-over-year
Negative
  • Continuing operational losses of $30.7M in Q3 2024
  • Secondary endpoints of PFS and OS were immature at analysis time

Insights

The Q3 results reveal a significant financial position with $162.6 million in cash and investments, providing runway into Q1 2026. Notable cost management is evident with R&D expenses decreasing by $19.3 million to $26.5 million, primarily due to reduced clinical trial material manufacturing costs. The net loss improved to $30.7 million ($0.58 per share) from $51.0 million year-over-year, demonstrating better operational efficiency.

The ASPEN-06 Phase 2 trial results showing 40.3% ORR vs 26.6% control and extended duration of response (15.7 vs 7.6 months) position evorpacept as a potential breakthrough therapy. With multiple clinical milestones approaching in 2025, including Phase 3 initiation, the company's pipeline progress could drive significant value creation despite current market cap of only $79.3 million.

The ASPEN-06 trial results represent a significant breakthrough in CD47 blocking therapeutics for HER2-positive gastric cancer. The data is particularly compelling in patients with fresh HER2-positive biopsies, showing an impressive 54.8% ORR compared to 23.1% in the control arm. The durability of response at 15.7 months is notably strong for this indication.

The expansion into multiple myeloma through the Sanofi partnership and the diverse pipeline spanning breast, head and neck and urothelial cancers demonstrates evorpacept's potential broad applicability. The well-tolerated safety profile and ability to combine with various standard-of-care treatments position evorpacept as a potentially best-in-class CD47 blocker.

SOUTH SAN FRANCISCO, Calif., Nov. 07, 2024 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., (“ALX Oncology” or “the Company”) (Nasdaq: ALXO), a clinical-stage biotechnology company advancing therapies that boost the immune system to treat cancer in new ways and extend patients’ lives, today reported financial results for the third quarter ended September 30, 2024, and provided a corporate update.

“We made substantial clinical progress during the third quarter, most notably announcing topline data from our ASPEN-06 Phase 2 trial in which our lead candidate evorpacept became the first and only CD47-blocking agent to show a durable clinical benefit and a well-tolerated safety profile in a prospective randomized clinical trial,” said Jason Lettmann, Chief Executive Officer of ALX Oncology. “These results provided further validation for evorpacept’s novel mechanism of action and our robust evorpacept clinical program. We anticipate achieving several additional clinical milestones in the near-term that could advance evorpacept towards being a best-in-class, combinable therapeutic across a wide range of cancer types.”

Third Quarter 2024 Highlights and Recent Developments

  • Reported topline data results in July from the multi-center, international ASPEN-06 Phase 2 clinical trial (NCT05002127) evaluating evorpacept in combination with HERCEPTIN® (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.
    • 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.
    • Evo-TRP achieved a confirmed overall response rate (ORR) of 40.3% compared to 26.6% for the TRP control arm and demonstrated a median duration of response 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 of 30% 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 to 23.1% in the TRP control arm in a pre-specified population of patients with fresh HER2-positive biopsies (n=48).
  • In September, commenced patient dosing to investigate evorpacept plus SARCLISA® (isatuximab-irfc) and dexamethasone in patients with relapsed or refractory multiple myeloma (RRMM) in the Sanofi-partnered arm of the randomized UMBRELLA phase 1/2 clinical study.
    • Sanofi is conducting the two-part multicenter, randomized, open-label, controlled, parallel-group study (NCT04643002) to evaluate the safety, efficacy, pharmacokinetics and biomarker data of evorpacept in combination with SARCLISA and dexamethasone in patients with RRMM.
    • Part 1 is evaluating the dosing of evorpacept in combination with standard doses of SARCLISA and dexamethasone to identify a recommended evorpacept dose.
    • Part 2 is investigating the efficacy and safety of this three-drug combination in an expanded population of patients with RRMM.
  • In August, enhanced the leadership team by appointing Alan Sandler, M.D. to Board of Directors, a distinguished leader in oncology and drug development with over 30 years of experience across industry and academia.
    • Dr. Sandler’s industry background includes serving as Executive Vice President, Chief Medical Officer at Mirati Therapeutics, prior to its acquisition by Bristol Myers Squibb. Before joining Mirati, he served as President, Global Head of Development in Oncology at Zai Lab, and prior to that, he was the Senior Vice President and Global Head, Product Development of Oncology Solid Tumors at Genentech, a member of the Roche Group.
  • Presented at the 2024 Cantor Fitzgerald Global Healthcare Conference in New York City in September.
    • Participated in fireside chat with Analyst, Li Watsek and conducted investor meetings.

Upcoming Clinical Milestones for Evorpacept’s Development Pipeline

  • Breast Cancer – Results from a Phase 1b/2 combination trial evaluating evorpacept in combination with Jazz Pharmaceuticals’ zanidatamab in HER2-positive and HER2-low metastatic breast cancer will be presented at a poster spotlight presentation at the San Antonio Breast Cancer Symposium on December 12, 2024
  • Gastric/GEJ Cancer – Updated results of ASPEN-06 Phase 2 clinical trial (1H 2025)
  • Head and Neck Squamous Cell Carcinoma – Topline results from a Phase 2 randomized clinical trial of ASPEN-03 with KEYTRUDA® (pembrolizumab) (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)
  • Urothelial Cancer – Updated results from a Phase 1 clinical trial of ASPEN-07 in combination with PADCEV® (enfortumab vedotin) (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)

Third Quarter 2024 Financial Results:

  • Cash, Cash Equivalents and Investments: Cash, cash equivalents and investments as of September 30, 2024, were $162.6 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 September 30, 2024, were $26.5 million, compared to $45.8 million for the prior-year period. R&D expenses decreased by $19.3 million during the three months ended September 30, 2024, compared to the three months ended September 30, 2023. Lower expense was primarily attributable to a decrease of $22.2 million in clinical and development costs primarily due to manufacturing of clinical trial materials to support active clinical trials for our lead product candidate, evorpacept, slightly offset by increased preclinical costs for development of new targets, an increase in personnel and related costs, and an increase in stock-based compensation expense.
  • 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 September 30, 2024, were $6.1 million, compared to $7.5 million for the prior year period. G&A expenses decreased by $1.4 million during the three months ended September 30, 2024, compared to the three months ended September 30, 2023. The decrease was primarily attributable to lower stock-based compensation expense and lower accounting consulting costs.
  • Net loss: GAAP net loss was $30.7 million for the three months ended September 30, 2024, or ($0.58) per basic and diluted share, as compared to a GAAP net loss of $51.0 million for the three months ended September 30, 2023, or ($1.24) per basic and diluted share. Non-GAAP net loss was $23.7 million for the three months ended September 30, 2024, as compared to a non-GAAP net loss of $44.0 million for the three months ended September 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 (Nasdaq: ALXO) is a clinical-stage biotechnology company advancing therapies that boost the immune system to treat cancer in new ways and extend patients’ lives. ALX Oncology’s lead therapeutic candidate, evorpacept, has demonstrated potential to serve as a cornerstone therapy upon which the future of immuno-oncology can be built. Evorpacept is currently being evaluated across multiple ongoing clinical trials in a wide range of cancer indications. More information is available at www.alxoncology.com and on LinkedIn @ALX Oncology.

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  Nine Months Ended 
 September 30,  September 30, 
 2024  2023  2024  2023 
Operating expenses:           
Research and development$26,471  $45,766  $92,841  $100,011 
General and administrative 6,096   7,509   19,013   22,244 
Total operating expenses 32,567   53,275   111,854   122,255 
Loss from operations (32,567)  (53,275)  (111,854)  (122,255)
Interest income 2,303   2,677   7,488   7,654 
Interest expense (446)  (391)  (1,302)  (1,150)
Other (expense) income, net 3   (1)  (19)  418 
Net loss$(30,707) $(50,990) $(105,687) $(115,333)
Net loss per share, basic and diluted$(0.58) $(1.24) $(2.05) $(2.82)
Weighted-average shares of common stock used to compute net loss per shares, basic and diluted 52,693,878   41,147,938   51,544,501   40,963,015 



Condensed Consolidated Balance Sheet Data
(in thousands)
 
 September 30,  December 31, 
 2024  2023 
Cash, cash equivalents and investments$162,610  $218,147 
Total assets$185,715  $242,553 
Total liabilities$48,908  $52,841 
Accumulated deficit$(591,959) $(486,272)
Total stockholders’ equity$136,807  $189,712 



GAAP to Non-GAAP Reconciliation
(unaudited)
(in thousands)
 
 Three Months Ended  Nine Months Ended 
 September 30,  September 30, 
 2024  2023  2024  2023 
GAAP net loss, as reported$(30,707) $(50,990) $(105,687) $(115,333)
Adjustments:           
Stock-based compensation expense 6,952   6,964   21,235   19,552 
Accretion of term loan discount and issuance costs 66   63   196   186 
Total adjustments 7,018   7,027   21,431   19,738 
Non-GAAP net loss$(23,689) $(43,963) $(84,256) $(95,595)

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) Q3 2024 financial results?

ALX Oncology reported a net loss of $30.7 million ($0.58 per share), with R&D expenses of $26.5 million and G&A expenses of $6.1 million. The company had $162.6 million in cash and investments as of September 30, 2024.

What were the key results from ALXO's ASPEN-06 Phase 2 trial?

The ASPEN-06 trial showed evorpacept achieved a 40.3% overall response rate compared to 26.6% for the control arm, with a median duration of response of 15.7 months versus 7.6 months in HER2-positive gastric cancer patients.

How long will ALXO's current cash position last?

ALX Oncology's cash position of $162.6 million is expected to fund planned operations well into Q1 2026.

ALX Oncology Holdings Inc.

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