“2022 was a productive year for us, with numerous clinical and corporate development accomplishments highlighted by the advancement of our lead program, evorpacept, for the treatment of multiple solid tumor indications and hematological malignancies. We also expanded evorpacept into new indications and combinations,” said Dr
Anticipated Key Milestones in 2023
- Presentation of data from a randomized Phase 2 trial of evorpacept in combination with trastuzumab, ramucirumab and paclitaxel for the treatment of patients with HER2-positive gastric/GEJ cancer (
ASPEN -06) in the second half of 2023. - Presentation of dose optimization results of a Phase 1b clinical trial of evorpacept in combination with azacitidine in patients with MDS (
ASPEN -02) in the second half of 2023. - Initiation of a Phase 1b dose optimization clinical trial of evorpacept in combination with azacitidine and venetoclax for the treatment of patients with relapsed or refractory (“r/r”) or newly diagnosed (“ND”) acute myeloid leukemia (“AML”) (
ASPEN -05) in the second half of 2023. - Filing an IND for ALTA-002, a SIRPα Toll-like receptor agonist antibody conjugate in collaboration with Tallac Therapeutics in the first half of 2023.
- Expansion of the antibody-drug conjugate (“ADC”) platform acquired from ScalmiBio to identify clinical development candidates by the second half of 2023.
Recent Clinical Developments for Evorpacept
- First patient dosed in
ASPEN -07 study evaluating evorpacept in combination with PADCEV® (enfortumab vedotin-ejfv), an ADC, in patients with UC.- In
February 2023 ,ALX Oncology announced the first patient was dosed in the Phase 1 ASPEN-07 study evaluating evorpacept in combination with 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 enfortumab vedotin-ejfv in subjects with unresectable locally advanced or metastatic UC.
- In
- Presented initial clinical data from the Phase 1a dose escalation portion of the
ASPEN -05 trial evaluating evorpacept in combination with azacitidine and venetoclax for the treatment of patients with r/r or ND AML atAmerican Society of Hematology (“ASH”).- In
December 2022 ,ALX Oncology presented a poster presentation at ASH showing that the combination of evorpacept with azacitidine and venetoclax is active and generally well tolerated. As ofOctober 3, 2022 , 14 patients with either r/r or ND AML have been treated with evorpacept in the Phase 1 dose escalation part of the study, administered at 20 mg/kg or 30 mg/kg once every 2 weeks or 60 mg/kg once every 4 weeks (“Q4W”) together with standard dosing of azacitidine and venetoclax. - Evorpacept in combination with azacitidine and venetoclax was generally well tolerated (N=14) with no maximum tolerated dose identified and a maximum administered dose of 60 mg/kg Q4W. In 10 relapsed or refractory AML response-evaluable patients, including 8 that had progressed after prior venetoclax treatment, all experienced a reduction in bone marrow blasts, and 4 achieved a response. In 3 newly diagnosed AML response-evaluable patients, all 3 achieved a response, including 1 complete response (“CR”), 1 CR with incomplete hematologic recovery, and 1 morphologic leukemia free state.
- In
- Presented data from
ASPEN -03 andASPEN -04, the Company’s Phase 2 head and neck squamous cell carcinoma (“HNSCC”) studies atSociety for Immunotherapy of Cancer (“SITC”).- In
November 2022 ,ALX Oncology presented two Trials in Progress abstracts at SITC related toASPEN -03 andASPEN -04.ALX Oncology continues to advanceASPEN -03 andASPEN -04, which are two distinct randomized Phase 2 studies for the treatment of patients with advanced HNSCC in combination with pembrolizumab with or without chemotherapy. Patient enrollment forASPEN -03 andASPEN -04 continues as planned.
- In
Recent Corporate Updates
- In
October 2022 ,ALX Oncology entered into a loan facility withOxford Finance LLC andSilicon Valley Bank for up to$100 million of non-dilutive financing. Under the terms of the loan agreement,ALX Oncology drew$10 million of an initial$50 million tranche at closing, with the remaining$40 million available at its discretion through the end of 2023.ALX Oncology also has access up to an additional$50 million with$12.5 million available in each of two tranches based upon the achievement of milestones related to the development of evorpacept and one pre-clinical product candidate, and$25 million available at the Lenders’ discretion. - In
November 2022 , strengthened board of directors by adding an additional independent board member with significant operational and commercial leadership experience in the biopharmaceutical industry:Scott Garland , currently strategic advisor and member of the board of directors at Pact Pharma and previously Chief Executive Officer of Portola Pharmaceuticals, has more than 30 years of biopharmaceutical industry knowledge and brings deep commercial and executive leadership experience.
Full Year and Fourth Quarter 2022 Financial Results:
- Cash, Cash Equivalents and Investments: Cash, cash equivalents and investments as of
December 31, 2022 were$282.9 million .ALX Oncology believes its cash, cash equivalents, investments and the ability to draw down up to 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
December 31, 2022 were$25.2 million , compared to$20.9 million for the prior-year period. R&D expenses for the year endedDecember 31, 2022 were$98.4 million , compared to$60.2 million for the prior-year period. - 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
December 31, 2022 were$7.0 million , compared to$7.6 million for the prior-year period. G&A expenses for the year endedDecember 31, 2022 were$29.0 million , compared to$23.4 million for the prior-year period. - Net loss: GAAP net loss was
$30.7 million for the fourth quarter endedDecember 31, 2022 , or$0.75 per basic and diluted share, as compared to a net loss of$28.4 million for the fourth quarter endedDecember 31, 2021 , or$0.70 per basic and diluted share. GAAP net loss for the year endedDecember 31, 2022 was$123.5 million , or$3.03 per basic and diluted share, as compared to$83.5 million , or$2.07 per basic and diluted share, for the year endedDecember 31, 2021 . Non-GAAP net loss was$24.4 million for the fourth quarter endedDecember 31, 2022 , as compared to a net loss of$22.8 million for the fourth quarter endedDecember 31, 2021 . Non-GAAP net loss for the year endedDecember 31, 2022 was$99.6 million , as compared to$69.5 million for the year endedDecember 31, 2021 . A reconciliation of GAAP to non-GAAP financial results can be found at the end of this news release.
About
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
Consolidated Statements of Operations
(unaudited for the three months ended
(in thousands, except share and per share amounts)
Three Months Ended | Year Ended | |||||||||||||||
2022 | 2021 | 2022 | 2021 | |||||||||||||
Operating expenses: | ||||||||||||||||
Research and development | $ | 25,197 | $ | 20,894 | $ | 98,400 | $ | 60,170 | ||||||||
General and administrative | 7,022 | 7,578 | 29,036 | 23,385 | ||||||||||||
Total operating expenses | 32,219 | 28,472 | 127,436 | 83,555 | ||||||||||||
Loss from operations | (32,219 | ) | (28,472 | ) | (127,436 | ) | (83,555 | ) | ||||||||
Interest income | 1,807 | 21 | 4,278 | 91 | ||||||||||||
Other expense, net | (233 | ) | (8 | ) | (260 | ) | (20 | ) | ||||||||
Loss before income taxes | (30,645 | ) | (28,459 | ) | (123,418 | ) | (83,484 | ) | ||||||||
Income tax (provision) benefit | (64 | ) | 21 | (64 | ) | 21 | ||||||||||
Net loss | $ | (30,709 | ) | $ | (28,438 | ) | $ | (123,482 | ) | $ | (83,463 | ) | ||||
Net loss per share, basic and diluted | $ | (0.75 | ) | $ | (0.70 | ) | $ | (3.03 | ) | $ | (2.07 | ) | ||||
Weighted-average shares of common stock used to compute net loss per shares, basic and diluted | 40,755,520 | 40,527,314 | 40,699,612 | 40,308,050 |
Consolidated Balance Sheet Data
(in thousands)
2022 | 2021 | |||||||
Cash, cash equivalents and investments | $ | 282,906 | $ | 363,667 | ||||
Total assets | $ | 306,489 | $ | 380,183 | ||||
Total liabilities | $ | 43,025 | $ | 17,134 | ||||
Accumulated deficit | $ | (325,467 | ) | $ | (201,985 | ) | ||
Total stockholders’ equity | $ | 263,464 | $ | 363,049 |
GAAP to Non-GAAP Reconciliation
(unaudited)
(in thousands)
Three Months Ended | Year Ended | |||||||||||||||
2022 | 2021 | 2022 | 2021 | |||||||||||||
GAAP net loss, as reported | $ | (30,709 | ) | $ | (28,438 | ) | $ | (123,482 | ) | $ | (83,463 | ) | ||||
Adjustments: | ||||||||||||||||
Stock-based compensation expense | 6,295 | 5,686 | 23,839 | 13,914 | ||||||||||||
Accretion of term loan | 44 | — | 44 | — | ||||||||||||
Total adjustments | 6,339 | 5,686 | 23,883 | 13,914 | ||||||||||||
Non-GAAP net loss | $ | (24,370 | ) | $ | (22,752 | ) | $ | (99,599 | ) | $ | (69,549 | ) |
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. 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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