ALX Oncology Reports First Quarter 2023 Financial Results and Provides Clinical Development and Operational Highlights SOUTH SAN FRANCISCO, Calif., May 11, 2023 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., (“ALX Oncology”) (Nasdaq: ALXO), a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, today reported financial results for the first quarter ended March 31, 2023 and provided clinical development and operational highlights. “In the first quarter of 2023, we continued to make significant progress in advancing our lead program, evorpacept, through new collaborations and clinical trial starts,” said Dr. Jaume Pons, Founder, President and Chief Executive Officer of ALX Oncology. “This included our recently announced clinical trial collaboration with Sanofi to evaluate evorpacept in combination with SARCLISA® in patients with multiple myeloma, and the initiation of three new clinical studies. These studies encompass our initiation of a Phase 1 trial in urothelial cancer in combination with PADCEV®, the initiation of a Phase 1 I-SPY-PI TRIAL for the treatment of patients with unresectable or metastatic HER-positive and HER2-low breast cancerHER2-low breast cancer in combination with ENHERTU® in partnership with Quantum Leap Healthcare Collaborative (“Quantum Leap”), and the recently announced initiation of a Phase 2 investigator-sponsored trial of evorpacept, in combination with liposomal doxorubicin and KEYTRUDA® in patients with recurrent platinum-resistant ovarian cancer.” In February 2023, we announced the first patient was dosed in the Phase 1 ASPEN-07 study evaluating evorpacept in combination with PADCEV (enfortumab vedotin-ejfv), an ADC, in patients with UC. ASPEN-07 is a Phase 1, open-label, multi-center study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of evorpacept in combination with PADCEV in subjects with unresectable locally advanced or metastatic UC. First Quarter 2023 Financial Results:
Cash, Cash Equivalents and Investments: Cash, cash equivalents and investments as of March 31, 2023 were $256.2 million. ALX Oncology believes its cash, cash equivalents, investments along with the ability to draw down an additional $40 million of its term loan are sufficient to fund planned operations through mid-2025. 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 March 31, 2023 were $24.8 million, compared to $17.1 million for the prior-year period. The increase was primarily due to an increase of $5.3 million in clinical costs from an increase in the number of active trials and patient enrollment as well as manufacturing of clinical trial materials to support a higher number of active clinical trials and future expected patient enrollment related to the advancement of evorpacept, an increase of $1.5 million in personnel and related costs primarily driven by headcount growth, and an increase of $1.1 million in stock-based compensation expense due to additional awards granted since March 31, 2022 offset by a decrease of $0.6 million related to the Tallac Collaboration for costs related to the IND filing planned for 2023 in which the primary work was completed in 2022. 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 March 31, 2023 were $7.4 million, compared to $7.7 million for the prior-year period. The small decrease year over year was primarily attributable to reduced stock-based compensation expense primarily due to forfeited stock options during the quarter and a decrease in other general and administrative costs due primarily to corporate legal and patent costs.
Net loss: GAAP net loss was $30.2 million for the first quarter ended March 31, 2023, or $0.74 per basic and diluted share, as compared to GAAP net loss of $24.5 million for the first quarter ended March 31, 2022, or $0.60 per basic and diluted share. Non-GAAP net loss was $23.8 million for the first quarter ended March 31, 2023, as compared to a non-GAAP net loss of $19.0 million for the first quarter ended March 31, 2022. A reconciliation of GAAP to non-GAAP financial results can be found at the end of this press release.
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 March 31, 2023 2022 Operating expenses: Research and development $24,763 $17,073 General and administrative 7,440 7,674 Total operating expenses 32,203 24,747 Loss from operations (32,203) (24,747)Interest income 2,311 225 Interest expense (387) (3)Other income (expense), net 95 (8)Net loss $(30,184) $(24,533)Net loss per share, basic and diluted $(0.74) $(0.60)Weighted-average shares of common stock used to
compute net loss per shares, basic and diluted 40,862,513 40,616,302
Condensed Consolidated Balance Sheet Data
(unaudited)(in thousands) March 31, December 31, 2023 2022 Cash, cash equivalents and investments $256,164 $282,906 Total assets $278,138 $306,489 Total liabilities $37,750 $43,025 Accumulated deficit $(355,651) $(325,467)Total stockholders’ equity $240,388 $263,464
GAAP to Non-GAAP Reconciliation
(unaudited)(in thousands) Three Months Ended March 31, 2023 2022 GAAP net loss, as reported $(30,184) $(24,533)Adjustments: Stock-based compensation expense 6,351 5,501 Accretion of term loan discount and issuance costs 61 — Total adjustments 6,412 5,501 Non-GAAP net loss $(23,772) $(19,032)
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 represent 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.