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8-K
0001810182false00018101822022-11-082022-11-08

 

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): November 8, 2022

 

ALX ONCOLOGY HOLDINGS INC.

(Exact name of Registrant as Specified in Its Charter)

 

 

Delaware

001-39386

85-0642577

(State or Other Jurisdiction

of Incorporation)

(Commission File Number)

(IRS Employer

Identification No.)

 

 

 

323 Allerton Avenue,

South San Francisco, California

 

94080

(Address of Principal Executive Offices)

 

(Zip Code)

 

Registrant’s Telephone Number, Including Area Code: (650) 466-7125

N/A

(Former Name or Former Address, if Changed Since Last Report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

☐

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))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

 

Trading

Symbol(s)

 

Name of each exchange on which registered

Common Stock, par value $0.001 per share

 

ALXO

 

The Nasdaq Global Select Market

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

 

 

 

 

Item 2.02 Results of Operations and Financial Condition.

On November 8, 2022, ALX Oncology Holdings Inc. (the "Company"), issued a press release announcing its financial results for the third quarter ended September 30, 2022. A copy of this press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

The information contained in this Item 2.02 of this Current Report on Form 8-K, including Exhibit 99.1 hereto shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, except as shall be expressly stated by specific reference in such filing.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

 

Exhibit

Number

 

Description

 

 

 

99.1

 

Press Release dated November 8, 2022

 

 

 

104

 

Cover Page Interactive Data File (formatted as Inline XBRL)

 

1

 

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

 

 

ALX ONCOLOGY HOLDINGS INC.

 

 

 

 

Date: November 8, 2022

 

By:

/s/ Peter Garcia

 

 

 

Peter Garcia

 

 

 

Chief Financial Officer

 

2
EX-99.1

 

https://cdn.kscope.io/d4d739ce573c37da5874e2d11db5d87b-img62044099_0.jpg 

Exhibit 99.1

 

ALX Oncology Reports Third Quarter 2022 Financial Results and Provides Clinical Development and Operational Highlights

 

SOUTH SAN FRANCISCO, Calif., November 8, 2022 (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 third quarter ended September 30, 2022 and provided clinical development and operational highlights.

“We continued to expand the clinical development of our lead program, evorpacept, during the third quarter of 2022, with the announcement of a new investigational treatment arm in the I-SPY-P1 TRIAL for the treatment of patients with unresectable or metastatic HER2-positive and HER2-low breast cancer in partnership with Quantum Leap Healthcare Collaborative,” said Jaume Pons, Ph.D., Founder, President and Chief Executive Officer of ALX Oncology. “With our recently announced non-dilutive term loan facility expected to extend our cash runway to mid-2025, we are focused on the advancement of evorpacept through multiple clinical milestones over the next two years.”

Recent Clinical Developments for Evorpacept

•
Abstract Data for Phase 1 Dose Escalation Portion of ASPEN-05 Study in acute myeloid leukemia (“AML”) Released as Part of the 64th American Society of Hematology (“ASH”) Annual Meeting
o
In November 2022, ALX Oncology’s ASH abstract was released online with initial results of the Phase 1 dose escalation portion of ASPEN-05, a Phase 1/2 clinical trial of evorpacept in combination with venetoclax and azacitidine for the treatment of patients with AML. Session 616: Poster III; Publication Number: 4076.
o
The results presented were as of July 8, 2022. 14 subjects were treated at evorpacept doses of 20 mg/kg Q2W (N=4), 30 mg/kg Q2W (N=4), and 60 mg/kg Q4W (N=6). The addition of evorpacept to standard dose venetoclax and azacitidine for AML was well tolerated with no maximum tolerated dose reached. Preliminary dose-proportional pharmacokinetics was seen along with full CD47 target occupancy in both peripheral blood and bone marrow across all dose levels evaluated. Initial anti-leukemic activity was observed in subjects with both newly diagnosed and relapse refractory AML. These initial results support further evaluation of evorpacept in myeloid malignancies, including AML.
o
A poster presentation from the dose escalation portion of ASPEN-05 with updated results will be presented at the ASH Annual Meeting on Monday, December 12, 2022, 6:00pm to 8:00pm CT, at the Ernest N. Morial Convention Center, Hall D, New Orleans, LA.
•
Trials in Progress Abstracts Related to Data from ASPEN-03 and ASPEN-04 Clinical Trials Accepted for Poster Presentation at the Society for Immunotherapy of Cancer (“SITC”) 37th Annual Meeting
o
In October 2022, ALX Oncology announced the acceptance of two Trials in Progress abstracts related to ASPEN-03 and ASPEN-04, the Company’s Phase 2 head and neck squamous cell carcinoma (“HNSCC”) studies which will be presented at SITC in Boston, MA, from November 10–11, 2022 (abstracts 678 and 676).

1

 

o
ALX Oncology continues to advance ASPEN-03 and ASPEN-04, which are two distinct randomized Phase 2 studies for the treatment of patients with advanced HNSCC in combination with KEYTRUDA® (pembrolizumab) with or without chemotherapy. Patient enrollment for ASPEN-03 and ASPEN-04 continues as planned with results expected to be presented by the middle of 2024.
•
Clinical Trial Agreement in Combination with ENHERTU® (Fam-trastuzumab deruxtecan-nxki) Entered with Quantum Leap
o
In August 2022, ALX Oncology entered into a collaboration and supply agreement with Quantum Leap Healthcare Collaborative™ (“Quantum Leap”) to evaluate evorpacept for a new investigational treatment arm in the I-SPY-P1 TRIAL for the treatment of patients with unresectable or metastatic HER2-positive and HER2-low breast cancer.
o
Sponsored by Quantum Leap, this Phase 1 (open-label), multi-center study arm will investigate evorpacept in combination with ENHERTU (fam-trastuzumab deruxtecan-nxki), a HER2 directed antibody-drug conjugate, to determine the safety, tolerability and efficacy of this drug combination.
•
First Patient Dosed in Phase 2 Investigator-sponsored Trial of Evorpacept in Combination with ERBITUX® (Cetuximab) and KEYTRUDA (Pembrolizumab) in Patients with Advanced Colorectal Cancer
o
In August 2022, ALX Oncology announced the initiation of a Phase 2 investigator-sponsored study of evorpacept in combination with ERBITUX (cetuximab) and KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, in patients with refractory microsatellite stable metastatic colorectal cancer who have progressed on at least two lines of systemic therapy. This trial, managed by Criterium, Inc., is led by the Academic GI Cancer Consortium.
•
Additional Clinical Program Updates for Evorpacept
o
In June 2022, ALX Oncology announced the initiation of ASPEN-07, a Phase 1 trial of evorpacept for the treatment of patients with urothelial cancer (“UC”), with the first patient expected to be dosed in the fourth quarter of 2022. ASPEN-07 will investigate evorpacept in combination with an antibody drug conjugate, PADCEV® (enfortumab vedotin-ejfv), for the treatment of patients with UC.
o
ALX Oncology continues to advance ASPEN-06, a randomized Phase 2 (open-label) / Phase 3 (double-blind), international, multi-center study to evaluate the efficacy of evorpacept and ramucirumab added to trastuzumab and paclitaxel for the treatment of patients with HER-positive gastric cancer or gastroesophageal junction cancer whose tumors have progressed following treatment with HER2-targeted therapy and chemotherapy. ASPEN-06 is being conducted in collaboration with Eli Lilly and Company. Patient enrollment continues to progress and results from the Phase 2 portion of ASPEN-06 are expected to be presented in 2023.

Recent Corporate Updates

•
Loan Facility Agreement with Oxford Finance LLC and Silicon Valley Bank of up to $100 Million of Non-dilutive Financing
o
In October 2022, 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.

2

 

 

Third Quarter 2022 Financial Results:

•
Cash, Cash Equivalents and Investments: Cash, cash equivalents and investments were $293.1 million as of September 30, 2022. ALX Oncology believes its cash, cash equivalents, investments and the ability to draw down up to $50 million of its term loan are sufficient to fund planned operations through mid-2025.
•
Research and Development (“R&D”) Expenses: These expenses for the three months ended September 30, 2022 were $29.4 million, compared to $18.2 million for the prior-year period. Research and development expenses increased by $11.2 million during the three months ended September 30, 2022 compared to the three months ended September 30, 2021. The increase was primarily attributable to an increase of $6.0 million in clinical and development costs primarily due to 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 our lead product candidate, as well as expenses related to the Tallac Collaboration for costs related to the IND filing planned for 2023, an increase of $0.9 million in preclinical costs primarily related to development of new targets, an increase of $2.0 million in personnel and related costs primarily due to an increase driven by headcount growth and a portion of a retention bonus payable to ScalmiBio stockholders, an increase of $1.4 million in stock-based compensation expense due to additional awards granted since September 30, 2021 and an increase of $0.9 million in other research costs due primarily to an increase in facility costs related to the expansion of our new laboratory space.
•
General and Administrative (“G&A”) Expenses: These expenses for the three months ended September 30, 2022 were $7.3 million, compared to $6.4 million for the prior-year period. General and administrative expenses increased by $0.9 million during the three months ended September 30, 2022 compared to the three months ended September 30, 2021. The increase was primarily attributable to an increase of $0.6 million in stock-based compensation expense due to additional stock option awards granted since September 30, 2021 and an increase in facility and information technology costs.
•
Net loss: GAAP net loss was $35.3 million for the third quarter ended September 30, 2022, or $0.87 per basic and diluted share, as compared to a net loss of $24.6 million for the third quarter ended September 30, 2021, or $0.61 per basic and diluted share. Non-GAAP net loss was $29.1 million for the third quarter ended September 30, 2022, as compared to a net loss of $20.4 million for the third quarter ended September 30, 2021. A reconciliation of GAAP to non-GAAP financial results can be found at the end of this news release.

About ALX Oncology

ALX Oncology is a publicly traded, clinical-stage immuno-oncology company focused on helping patients fight cancer by developing therapies that block the CD47 checkpoint pathway and bridge the innate and adaptive immune system. ALX Oncology’s lead product candidate, evorpacept, is a next generation CD47 blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated, proprietary Fc domain. Evorpacept has demonstrated promising clinical responses across a range of hematologic and solid malignancies in combination with a number of leading anti-cancer agents. ALX Oncology intends to continue clinical development of evorpacept for the treatment of multiple solid tumor indications and hematologic malignancies.

3

 

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.

4

 

ALX ONCOLOGY HOLDINGS INC.

Condensed Consolidated Statements of Operations

(unaudited)

(in thousands, except share and per share amounts)

 

 

 

Three Months Ended

 

 

Nine Months Ended

 

 

 

September 30,

 

 

September 30,

 

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

$

29,382

 

 

$

18,214

 

 

$

73,203

 

 

$

39,276

 

General and administrative

 

 

7,299

 

 

 

6,362

 

 

 

22,014

 

 

 

15,807

 

Total operating expenses

 

 

36,681

 

 

 

24,576

 

 

 

95,217

 

 

 

55,083

 

Loss from operations

 

 

(36,681

)

 

 

(24,576

)

 

 

(95,217

)

 

 

(55,083

)

Interest income

 

 

1,370

 

 

 

22

 

 

 

2,471

 

 

 

70

 

Other expense, net

 

 

(9

)

 

 

(12

)

 

 

(27

)

 

 

(12

)

Net loss

 

$

(35,320

)

 

$

(24,566

)

 

$

(92,773

)

 

$

(55,025

)

Net loss per share, basic and diluted

 

$

(0.87

)

 

$

(0.61

)

 

$

(2.28

)

 

$

(1.37

)

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

 

 

40,747,026

 

 

 

40,396,188

 

 

 

40,684,172

 

 

 

40,234,159

 

 

Condensed Consolidated Balance Sheet Data

(unaudited)

(in thousands)

 

 

 

September 30,

 

 

December 31,

 

 

 

2022

 

 

2021

 

Cash, cash equivalents and investments

 

$

293,126

 

 

$

363,667

 

Total assets

 

$

317,689

 

 

$

380,183

 

Total liabilities

 

$

30,726

 

 

$

17,134

 

Accumulated deficit

 

$

(294,758

)

 

$

(201,985

)

Total stockholders’ equity

 

$

286,963

 

 

$

363,049

 

 

GAAP to Non-GAAP Reconciliation

(unaudited)

(in thousands)

 

 

 

Three Months Ended

 

 

Nine Months Ended

 

 

 

September 30,

 

 

September 30,

 

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

GAAP net loss, as reported

 

$

(35,320

)

 

$

(24,566

)

 

$

(92,773

)

 

$

(55,025

)

Adjustments:

 

 

 

 

 

 

 

 

 

 

 

 

Stock-based compensation expense

 

 

6,207

 

 

 

4,191

 

 

 

17,544

 

 

 

8,228

 

Non-GAAP net loss

 

$

(29,113

)

 

$

(20,375

)

 

$

(75,229

)

 

$

(46,797

)

 

5

 

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 attributable to common stockholders” 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 ALX Oncology may be calculated differently from, and therefore may not be comparable to, non-GAAP measures used by other companies.

Investor Contact:

Peter Garcia

Chief Financial Officer, ALX Oncology

(650) 466-7125 Ext. 113

peter@alxoncology.com

Argot Partners

(212) 600-1902

alxoncology@argotpartners.com

Media Contact:

Karen Sharma

MacDougall

(781) 235-3060

alx@macbiocom.com

6