“ALX Oncology achieved key milestones in 2021 to advance our lead program, evorpacept, a next-generation CD47 blocker, through multiple clinical trials,” said
Anticipated Key Clinical Milestones for 2022
- Initiation of a randomized Phase 2/3 clinical trial of evorpacept in combination with Herceptin® (trastuzumab), Cyramza® (ramucirumab) and paclitaxel in patients with 2nd line or greater gastric/GEJ cancer (
ASPEN -06). - Dose optimization readout of a Phase 1b clinical trial of evorpacept in combination with azacitidine in patients with MDS (
ASPEN -02). - Initiate and provide updates on investigator sponsored clinical trials with evorpacept.
- Provide updates on ongoing collaboration with Zymeworks in HER2-expressing breast cancer and other solid tumors.
- Select development candidate(s) from preclinical pipeline.
Recent Clinical Developments for Evorpacept (ALX148)
U.S. Food and Drug Administration (“FDA”) Granted Orphan Drug Designation (“ODD”) for Evorpacept for the Treatment of Patients with Gastric/GEJ Cancer- In
January 2022 , ALX announced that theU.S. FDA granted ODD to evorpacept, a next-generation CD47 blocker, for the treatment of patients with gastric/GEJ cancer.
- In
- Presented Initial Phase 1a Clinical Data in Combination with Azacitidine in Patients with MDS (
ASPEN -02) at ASH- In
December 2021 , the Company presented initial clinical data from its ongoing trial evaluating evorpacept in combination with azacitidine for the treatment of patients with previously untreated higher-risk or relapsed or refractory MDS. The new data, shared in a poster at the 63rdAmerican Society of Hematology (“ASH”) Annual Meeting [Abstract #2601], show that the combination of evorpacept and azacitidine is active and well-tolerated. Patient accrual is ongoing in the Phase 1b dose optimization part of the study.
- In
- Presented Updated Phase 1b Clinical Trial Data in Combination with Pembrolizumab with and without Chemotherapy in Patients with HNSCC and in Combination with Trastuzumab, Ramucirumab, and Paclitaxel in Patients with Gastric/GEJ Cancer (
ASPEN -01) at SITC- In
November 2021 , updated results from Phase 1b study (ASPEN -01) evaluating patients with solid tumor malignancies were presented at theSociety for Immunotherapy of Cancer’s 36th Anniversary Annual Meeting [Abstract #498].ALX Oncology reported updated results from the gastric/GEJ cancer patient cohort receiving evorpacept plus trastuzumab plus chemotherapy, and from the head and neck squamous cell carcinoma patient cohort receiving evorpacept plus pembrolizumab with and without chemotherapy. Data showed robust and durable responses with emerging signs of clinical benefit in survival-based endpoints in patients with advanced solid tumors. All data reflected response evaluable patients as ofSeptember 1, 2021 .
- In
- Initiation of a Phase 1a Clinical Trial in Combination with Venetoclax and Azacitidine in Acute Myeloid Leukemia (
ASPEN -05)- In
October 2021 , the first patient was dosed in the Phase 1/2ASPEN -05 study evaluating the combination of evorpacept with venetoclax and azacitidine for the treatment of patients with acute myeloid leukemia (“AML”). The Phase 1 portion will characterize the safety of evorpacept in combination with venetoclax and azacitidine for the treatment of patients with relapsed/refractory AML and previously untreated AML who are not candidates for intensive induction therapy.
- In
- Initiation of a Phase 1b/2 Clinical Trial in Combination with Zanidatamab in Patients with Advanced HER2-Expressing Breast Cancer and Other Solid Tumors
- In
October 2021 , Zymeworks andALX Oncology dosed the first patient in an open-label, multi-center Phase 1b/2 clinical trial to evaluate the safety and efficacy of zanidatamab, Zymeworks’ lead HER2-targeted bispecific antibody, in combination with evorpacept in patients with advanced HER2-positive breast cancer, HER2-low breast cancer and additional non-breast HER2-expressing solid tumors.
- In
Recent Corporate Updates
Acquired Privately Held ScalmiBio Inc. : InOctober 2021 ,ALX Oncology acquired ScalmiBio which further expanded its pipeline with plans to develop novel antibody-drug conjugates (“ADCs”) based on ScalmiBio’s SHIELD platform.
Full Year and Fourth Quarter 2021 Financial Results:
- Cash and Cash Equivalents: Cash and cash equivalents as of
December 31, 2021 were$363.7 million .ALX Oncology believes its cash and cash equivalents is sufficient to fund planned operations through mid-2024. - Related-party Revenue: There was no related-party revenue for the three months ended
December 31, 2021 and 2020. There was no related-party revenue for the year endedDecember 31, 2021 , compared to$1.2 million for the prior-year period. The decrease in related-party revenue relates to the termination of the research and development agreement withTallac Therapeutics, Inc. inJuly 2020 . - 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, 2021 , were$20.9 million , compared to$12.1 million for the prior-year period. Expenses for the three months endedDecember 31, 2021 included$4.7 million of acquired in-process research and development expenses related to the acquisition of ScalmiBio. R&D expenses for the year endedDecember 31, 2021 , were$60.2 million , compared to$29.0 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, 2021 , were$7.6 million , compared to$5.7 million for the prior-year period. G&A expenses for the year endedDecember 31, 2021 , were$23.4 million , compared to$14.8 million for the prior-year period. - Net loss: GAAP net loss attributable to common stockholders was
$28.4 million for the fourth quarter endedDecember 31, 2021 , or$0.70 per basic and diluted share, as compared to a net loss of$18.8 million for the fourth quarter endedDecember 31, 2020 , or$0.50 per basic and diluted share. GAAP net loss for the year endedDecember 31, 2021 was$83.5 million , or$2.07 per basic and diluted share, as compared to$50.9 million , or$2.76 per basic and diluted share, for the year endedDecember 31, 2020 . Non-GAAP net loss was$22.8 million for the fourth quarter endedDecember 31, 2021 , as compared to a net loss of$16.3 million for the fourth quarter endedDecember 31, 2020 . Non-GAAP net loss for the year endedDecember 31, 2021 was$69.5 million , as compared to$43.8 million for the year endedDecember 31, 2020 . 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
Condensed Consolidated Statements of Operations and Comprehensive Loss
(unaudited)
(in thousands, except share and per share amounts)
Three Months Ended | Year Ended | |||||||||||||||
2021 | 2020 | 2021 | 2020 | |||||||||||||
Related-party revenue | $ | — | $ | — | $ | — | $ | 1,182 | ||||||||
Operating expenses: | ||||||||||||||||
Research and development | 20,894 | 12,142 | 60,170 | 28,961 | ||||||||||||
General and administrative | 7,578 | 5,683 | 23,385 | 14,809 | ||||||||||||
Cost of services for related-party revenue | — | — | — | 1,075 | ||||||||||||
Total operating expenses | 28,472 | 17,825 | 83,555 | 44,845 | ||||||||||||
Loss from operations | (28,472 | ) | (17,825 | ) | (83,555 | ) | (43,663 | ) | ||||||||
Interest expense | (3 | ) | (151 | ) | (13 | ) | (811 | ) | ||||||||
Other income (expense), net | 16 | 5 | 84 | (404 | ) | |||||||||||
Loss on early debt extinguishment | — | (621 | ) | — | (621 | ) | ||||||||||
Loss before income taxes | (28,459 | ) | (18,592 | ) | (83,484 | ) | (45,499 | ) | ||||||||
Income tax benefit (provision) | 21 | (182 | ) | 21 | (241 | ) | ||||||||||
Net loss and comprehensive loss | (28,438 | ) | (18,774 | ) | (83,463 | ) | (45,740 | ) | ||||||||
Cumulative dividends allocated to preferred stockholders | — | — | — | (5,202 | ) | |||||||||||
Net loss attributable to common stockholders | $ | (28,438 | ) | $ | (18,774 | ) | $ | (83,463 | ) | $ | (50,942 | ) | ||||
Net loss per share attributable to common stockholders, basic and diluted | $ | (0.70 | ) | $ | (0.50 | ) | $ | (2.07 | ) | $ | (2.76 | ) | ||||
Weighted-average shares of common stock used to compute net loss per share attributable to common stockholders, basic and diluted | 40,527,314 | 37,642,897 | 40,308,050 | 18,485,343 |
Condensed Consolidated Balance Sheet Data
(unaudited)
(in thousands)
2021 | 2020 | |||||||
Cash and cash equivalents | $ | 363,667 | $ | 434,219 | ||||
Total assets | $ | 380,183 | $ | 436,054 | ||||
Total liabilities | $ | 17,134 | $ | 6,209 | ||||
Accumulated deficit | $ | (201,985 | ) | $ | (118,522 | ) | ||
Total stockholders’ equity | $ | 363,049 | $ | 429,845 |
GAAP to Non-GAAP Reconciliation
(unaudited)
(in thousands)
Three Months Ended | Year Ended | |||||||||||||||
2021 | 2020 | 2021 | 2020 | |||||||||||||
GAAP net loss attributable to common stockholders, as Reported | $ | (28,438 | ) | $ | (18,774 | ) | $ | (83,463 | ) | $ | (50,942 | ) | ||||
Adjustments: | ||||||||||||||||
Stock-based compensation expense | 5,686 | 1,743 | 13,914 | 5,436 | ||||||||||||
Accretion of term loan | — | 82 | — | 421 | ||||||||||||
Mark-to-market adjustment on financial instruments | — | — | — | 650 | ||||||||||||
Loss on early debt extinguishment | — | 621 | — | 621 | ||||||||||||
Total adjustments | 5,686 | 2,446 | 13,914 | 7,128 | ||||||||||||
Non-GAAP net loss attributable to common stockholders | $ | (22,752 | ) | $ | (16,328 | ) | $ | (69,549 | ) | $ | (43,814 | ) |
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 attributable to common stockholders” is not based on any standardized methodology prescribed by GAAP and represent GAAP net loss adjusted to exclude (1) stock-based compensation expense, (2) accretion of term loan (interest expense related to ALX Oncology’s amortization of debt discount), (3) mark-to-market adjustment on financial instruments (which include preferred stock warrants and derivatives) and (4) loss on early debt extinguishment. 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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