Delaware

001-39386

85-0642577

(State or Other Jurisdiction

of Incorporation)

(Commission File Number)

(IRS Employer

Identification No.)

866 Malcolm Road, Suite 100

Burlingame, California

94010

(Address of Principal Executive Offices)

(Zip Code)

☐

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Title of each class

Trading

Symbol(s)

Name of each exchange on which registered

Common Stock, $0.001 par value per share

ALXO

The Nasdaq Global Select Market

Exhibit

Number

Description

99.1

Press Release dated March 18, 2021

ALX ONCOLOGY HOLDINGS INC.

Date: March 18, 2021

By:

/s/ Peter Garcia

Peter Garcia

Chief Financial Officer

Exhibit 99.1

•

Full results of a Phase 1b clinical trial with ALX148 in combination with Herceptin^® (trastuzumab), Cyramza^® (ramucirumab) and paclitaxel in patients with second line or greater (“≥2L”) G/GEJ cancer (ASPEN-01) is planned to be presented in mid-2021.  

•

Initiation of two randomized Phase 2 studies with ALX148 in combination with KEYTRUDA in patients with HNSCC are planned in the first half of 2021. The first study (ASPEN-03) will evaluate the efficacy of ALX148 in combination with KEYTRUDA for the first line (“1L”) treatment of patients with PD-L1 expressing metastatic or unresectable, recurrent HNSCC. The second study (ASPEN-04) will evaluate ALX148 in combination with KEYTRUDA and standard 5-fluorouracil and platinum chemotherapy for the 1L treatment of patients with metastatic or unresectable, recurrent HNSCC.

•

Initiation of a Phase 1b clinical trial with ALX148 in combination with Zymeworks’ zanidatamab in patients with advanced HER2-expressing breast cancer and other solid tumors in the first half of 2021.

•

Full results of a Phase 1b study of ALX148 in combination with Merck’s KEYTRUDA (pembrolizumab) and chemotherapy for the treatment of patients with HNSCC (ASPEN-01) is planned to be presented in the second half of 2021.

•

Initiation of a Phase 1 clinical trial evaluating ALX148 in combination with azacitidine and venetoclax in patients with acute myeloid leukemia (“AML”) (ASPEN-05) in the second half of 2021.

•

Initiation of a randomized Phase 2 trial of ALX148 in combination with Herceptin (trastuzumab), Cyramza (ramucirumab) and paclitaxel in second- or third-line (“2L or 3L”) treatment of patients with G/GEJ cancer (ASPEN-06) is expected in the second half of 2021.

•

Results of a Phase 1 clinical trial of ALX148 in combination with azacitidine in patients with MDS and the initiation of the Phase 2 clinical trial in MDS (ASPEN-02) are expected in the fourth quarter 2021.

•

Announced Collaboration with Tallac Therapeutics on Novel Class of Cancer Immunotherapeutics

o

In March 2021, ALX Oncology and Tallac Therapeutics (“Tallac”), a privately held biopharmaceutical company, announced a collaboration to jointly develop, manufacture, and commercialize a novel class of cancer immunotherapeutics. The collaboration builds on ALX Oncology’s expertise in developing therapies that block the CD47 checkpoint pathway and expands its immuno-oncology pipeline with Tallac’s pipeline of next generation immunotherapies derived from its novel Toll-like Receptor Agonist Antibody Conjugate (“TRAAC”) platform. ALX Oncology and Tallac expect to submit an Investigational New Drug application by the end of 2022.  

•

Presented Updated Data at the 62^nd American Society of Hematology Annual Meeting from the ASPEN-01 Phase 1b Study of ALX148 in Combination with Rituximab in Patients with Advanced Relapsed/Refractory (“r/r”) non-Hodgkin lymphoma (“NHL”)

o

In December 2020, ALX Oncology reported updated clinical data from its ongoing trial evaluating ALX148 in combination with rituximab for the treatment of advanced r/r NHL. ALX148 in combination with rituximab was well tolerated with no dose limiting toxicities observed.

o

As of the data cutoff of October 1, 2020, 33 subjects had been treated with ALX148 administered at 10 or 15 mg/kg once weekly (“QW”) with standard regimens of rituximab. In response-evaluable subjects (n=10) who received ALX148 at 15 mg/kg QW, the objective response rate (“ORR”) was 70.0%. In response-evaluable subjects (n=22) who received ALX148 at 10 mg/kg QW, the ORR was 40.9%. A statistically significant improvement in clinical response was demonstrated with increased ALX148 exposure across the doses evaluated (p=0.023)

•

Announced Collaboration with Zymeworks Inc. to Conduct Phase 1b Study to Evaluate Zanidatamab with ALX148 in Patients with HER2 Expressing Breast Cancer

o

In November 2020, ALX Oncology announced a collaboration with Zymeworks to jointly run a clinical trial to evaluate the combination of Zymeworks’ zanidatamab, a HER2-targeted bispecific antibody, and ALX148, a next-generation CD47 blocker, for the treatment of patients with advanced HER2-expressing breast cancer and other solid tumors. Under the collaboration, Zymeworks will conduct an open label, multi-center Phase 1b study to assess the safety and efficacy of the combination of zanidatamab and ALX148 in subjects with HER2-positive breast cancer, HER2-low breast cancer, and non-breast HER2-expressing solid tumors.  

•

Presented New Data at the SITC 35th Anniversary Annual Meeting from ASPEN-01 Phase 1b Study of ALX148 in Combination with Standard Chemotherapy and Antibody Regimens in Patients with G/GEJ Cancer and HNSCC.  

o

In November 2020, ALX Oncology reported preliminary data from the G/GEJ cancer patient cohort receiving ALX148 plus trastuzumab plus chemotherapy. In patients with ≥2L HER2 positive G/GEJ cancer (n=14), whose tumors have progressed upon prior trastuzumab therapy, ALX148 in combination with trastuzumab plus ramucirumab and paclitaxel demonstrated an initial ORR of 64.3% that compares favorably with historical data.  In addition, updated data

from patients with ≥2L HER2 positive G/GEJ cancer receiving ALX148 plus trastuzumab suggested promising clinical activity after their tumors have progressed upon prior trastuzumab therapy.

o

ALX Oncology also reported preliminary data from a HNSCC patient cohort receiving ALX148 plus pembrolizumab plus chemotherapy. In patients with first line HNSCC who have not received prior treatment for advanced disease (n=4), ALX148 demonstrated an initial ORR of 75.0%, including a complete response, in combination with pembrolizumab plus 5-fluorouracil and platinum. In addition, updated data from subjects who were treatment naïve to a PD-1/PD-L1 inhibitor for their ≥2L HNSCC and who received ALX148 plus pembrolizumab suggested greater clinical activity than with pembrolizumab as a monotherapy.

•

Appointed New Member to the Board of Directors. In March 2021, ALX Oncology appointed Sophia Randolph, M.D., Ph.D. to its Board of Directors. Dr. Randolph has served as Chief Medical Officer of ALX Oncology since June 2016 and will continue in this role.

•

Added to the NASDAQ Biotechnology Index^®. In December 2020, ALX Oncology was added to the NASDAQ Biotechnology Index^® (NASDAQ: NBI) effective Monday, December 21, 2020.                          

•

Raised Gross Proceeds of $208 Million in Oversubscribed Follow-on Public Offering. In December 2020, ALX Oncology announced the closing of an oversubscribed underwritten follow-on public offering yielding aggregate gross proceeds of approximately $208.0 million. All of the shares in the offering were offered by ALX Oncology.

•

Cash and Cash Equivalents: Cash and cash equivalents as of December 31, 2020 were $434.2 million. ALX Oncology believes its current cash and cash equivalents are sufficient to fund planned operations through 2024.

•

Related-party Revenue: There was no related-party revenue for the three months ended December 31, 2020, compared to $1.2 million for the prior-year period. There was $1.2 million related-party revenue for the year ended December 31, 2020, compared to $4.8 million for the prior-year period. The decrease in related-party revenue relates to the termination of the research and development agreement with Tallac in July 2020.

•

Research and Development (“R&D”) Expenses: R&D expenses consist primarily of pre-clinical, clinical and manufacturing expenses related to the development of ALX148.  These expenses for the three months ended December 31, 2020, were $12.1 million, compared to $6.7 million for the prior-year period. These expenses for the year ended December 31, 2020, were $29.0 million, compared to $16.3 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, 2020, were $5.7 million, compared to $1.1 million for the prior-year period. These expenses for the year ended December 31, 2020, were $14.8 million, compared to $3.3 million for the prior-year period.

•

Net Loss: GAAP net loss attributable to common stockholders was $18.8 million for the fourth quarter ended December 31, 2020, or $0.50 per basic and diluted share, as compared to a net loss of $8.8 million for the fourth quarter ended December 31, 2019, or $2.83 per basic and diluted share. GAAP net loss for the year ended December 31, 2020 was $50.9 million, or $2.76 per basic and diluted share, as compared to $23.3 million, or $7.56 per basic and diluted share, for the year ended December 31, 2019.  Non-GAAP net loss was $16.3 million for the fourth quarter ended December 31, 2020, as

compared to a net loss of $8.7 million for the fourth quarter ended December 31, 2019. Non-GAAP net loss for the year ended December 31, 2020 was $43.8 million, as compared to $23.0 million for the year ended December 31, 2019.  A reconciliation of GAAP to non-GAAP financial results can be found at the end of this news release.

Three Months Ended

Year Ended

December 31,

December 31,

2020

2019

2020

2019

Related-party revenue

$

—

$

1,213

$

1,182

$

4,796

Operating expenses:

Research and development

12,142

6,735

28,961

16,306

General and administrative

5,683

1,108

14,809

3,313

Cost of services for related-party revenue

—

1,103

1,075

4,360

Total operating expenses

17,825

8,946

44,845

23,979

Loss from operations

(17,825

)

(7,733

)

(43,663

)

(19,183

)

Interest expense

(151

)

(21

)

(811

)

(21

)

Other expense, net

5

(1

)

(404

)

(5

)

Loss on early debt extinguishment

(621

)

—

(621

)

—

Loss before income taxes

(18,592

)

(7,755

)

(45,499

)

(19,209

)

Income tax provision

(182

)

(9

)

(241

)

(34

)

Net loss and comprehensive loss

(18,774

)

(7,764

)

(45,740

)

(19,243

)

Cumulative dividends allocated to preferred stockholders

—

(1,071

)

(5,202

)

(4,028

)

Net loss attributable to common stockholders

$

(18,774

)

$

(8,835

)

$

(50,942

)

$

(23,271

)

Net loss per share attributable to common stockholders, basic and diluted

$

(0.50

)

$

(2.83

)

$

(2.76

)

$

(7.56

)

Weighted-average shares of common stock used to compute net loss per share attributable to common stockholders, basic and diluted

37,642,897

3,122,204

18,485,343

3,076,461

December 31,

2020

December 31,

2019

Cash and cash equivalents

$

434,219

$

9,017

Total assets

$

436,054

$

10,676

Total liabilities

$

6,209

$

10,952

Convertible preferred stock

$

—

$

70,363

Total stockholders’ equity (deficit)

$

429,845

$

(70,639

)

Three Months Ended

Year Ended

December 31,

December 31,

2020

2019

2020

2019

GAAP net loss attributable to common stockholders, as reported

$

(18,774

)

$

(8,835

)

$

(50,942

)

$

(23,271

)

Adjustments:

Stock-based compensation expense

1,743

75

5,436

297

Accretion of term loan

82

11

421

11

Mark-to-market adjustment on financial instruments

—

—

650

—

Loss on early debt extinguishment

621

—

621

—

Total adjustments

2,446

86

7,128

308

Non-GAAP net loss attributable to common stockholders

$

(16,328

)

$

(8,749

)

$

(43,814

)

$

(22,963

)