“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.
Recent Clinical Developments for Evorpacept
- First patient dosed in Phase 2 investigator-sponsored trial of evorpacept in combination with KEYTRUDA in patients with ovarian cancer.
- In
May 2023 , we announced the initiation of a Phase 2 investigator-sponsored trial of evorpacept in combination with liposomal doxorubicin and KEYTRUDA (pembrolizumab) in patients with recurrent platinum-resistant ovarian cancer at theUPMC Hillman Cancer Center . This is an open-label, single-arm Phase 2 clinical trial. The study is being led byHaider Mahdi , M.D., M.P.H., Assistant Professor,Department of Obstetrics, Gynecology and Reproductive Sciences , TheUniversity of Pittsburgh andUPMC Magee-Womens Research Institute .
- In
- Announced clinical trial collaboration with Sanofi to evaluate evorpacept in combination with SARCLISA in patients with multiple myeloma.
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April 2023 , we entered into a clinical trial collaboration and supply agreement with Sanofi to evaluate evorpacept and SARCLISA (isatuximab-irfc), Sanofi’s monoclonal antibody that targets a specific epitope on the CD38 receptor on multiple myeloma cells, for the treatment of patients with relapsed or refractory multiple myeloma (“RRMM”). Under the terms of the agreement, Sanofi will conduct a Phase 1/2 study to evaluate the safety, efficacy, pharmacokinetics and biomarker data of evorpacept in combination with SARCLISA and dexamethasone in patients with RRMM.
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- First patient dosed in I-SPY-PI TRIAL evaluating evorpacept in combination with ENHERTU, a HER2 directed antibody-drug conjugate (“ADC”), in breast cancer.
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March 2023 , we announced the dosing of the first patient in the I-SPY-PI TRIAL for the treatment of patients with breast cancer. Sponsored by Quantum Leap, this Phase 1 (open label), multi-center study arm is investigating evorpacept in combination with ENHERTU (fam-trastuzumab deruxtecan-nxki) to determine the safety, tolerability and efficacy of this drug combination in patients with unresectable or metastatic HER2-positive and HER2-low breast cancer.
- In
- First patient dosed in
ASPEN -07 study evaluating evorpacept in combination with PADCEV, an ADC, in patients with urothelial cancer (“UC”).- 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.
- In
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 sinceMarch 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 endedMarch 31, 2023 , or$0.74 per basic and diluted share, as compared to GAAP net loss of$24.5 million for the first quarter endedMarch 31, 2022 , or$0.60 per basic and diluted share. Non-GAAP net loss was$23.8 million for the first quarter endedMarch 31, 2023 , as compared to a non-GAAP net loss of$19.0 million for the first quarter endedMarch 31, 2022 . A reconciliation of GAAP to non-GAAP financial results can be found at the end of this press release.
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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
Condensed Consolidated Statements of Operations | ||||||||
(unaudited) | ||||||||
(in thousands, except share and per share amounts) | ||||||||
Three Months Ended | ||||||||
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) | ||||||||
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 | ||||||||
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
“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
Investor Contact:Peter Garcia Chief Financial Officer,ALX Oncology (650) 466-7125 Ext. 113 peter@alxoncology.comArgot Partners (212) 600-1902 alxoncology@argotpartners.com Media Contact:Karen Sharma MacDougall (781) 235-3060 alx@macbiocom.com
Source:
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