0000950170-24-097108.txt : 20240814 0000950170-24-097108.hdr.sgml : 20240814 20240814164008 ACCESSION NUMBER: 0000950170-24-097108 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 13 CONFORMED PERIOD OF REPORT: 20240814 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20240814 DATE AS OF CHANGE: 20240814 FILER: COMPANY DATA: COMPANY CONFORMED NAME: HCW Biologics Inc. CENTRAL INDEX KEY: 0001828673 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] ORGANIZATION NAME: 03 Life Sciences IRS NUMBER: 825024477 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-40591 FILM NUMBER: 241208890 BUSINESS ADDRESS: STREET 1: 2929 N COMMERCE PKWY CITY: MIRAMAR STATE: FL ZIP: 33025 BUSINESS PHONE: 954-842-2024 MAIL ADDRESS: STREET 1: 2929 N COMMERCE PKWY CITY: MIRAMAR STATE: FL ZIP: 33025 8-K 1 hcwb-20240814.htm 8-K 8-K
false000182867300018286732024-08-142024-08-14

 

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): August 14, 2024

 

 

HCW Biologics Inc.

(Exact name of Registrant as Specified in Its Charter)

 

 

Delaware

001-40591

82-5024477

(State or Other Jurisdiction
of Incorporation)

(Commission File Number)

(IRS Employer
Identification No.)

 

 

 

 

 

2929 N. Commerce Parkway

 

Miramar, Florida

 

33025

(Address of Principal Executive Offices)

 

(Zip Code)

 

Registrant’s Telephone Number, Including Area Code: 954 842-2024

 

Not Applicable

(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 $0.0001 per share

 

HCWB

 

The Nasdaq Stock Market LLC

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 August 14, 2024, HCW Biologics Inc. issued a press release announcing its financial results for the quarter ended June 30, 2024. The full text of the press release issued in connection with the announcement is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

The information set forth in this Item 2.02 (including Exhibit 99.1) is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), 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 Exchange Act, regardless of any general incorporation language in such filing, except as expressly set forth by specific reference in such a filing.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

 

Exhibit No.

Description

99.1

Press release dated August 14, 2024.

104

Cover Page Interactive Data File (embedded within the Inline XBRL document).

 

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.

 

 

 

HCW BIOLOGICS INC.

 

 

 

 

Date:

August 14, 2024

By:

/s/ Hing C. Wong

 

 

 

Hing C. Wong
Founder and Chief Executive Officer

 

 EX-99.1 2 hcwb-ex99_1.htm EX-99.1 EX-99.1

 

Exhibit 99.1

img90053791_0.jpg 

 

 

HCW Biologics Reports Second Quarter 2024

Financial Results and Business Highlights

Miramar, FL– August 14, 2024 – HCW Biologics Inc. (the “Company” or “HCW Biologics”) (NASDAQ: HCWB), a clinical-stage biopharmaceutical company focused on discovering and developing novel immunotherapies to lengthen healthspan by disrupting the link between inflammation and age-related diseases, today reported financial results and recent business highlights for its second quarter ended June 30, 2024.

Dr. Hing C. Wong, Founder and CEO of HCW Biologics, stated, “We reached a critical milestone recently that has profound implications for the future of our Company -- we successfully reached a settlement agreement for an arbitration that created an overhang that hampered our progress for nearly two years. We wasted no time in launching our multi-faceted financing plan, including a significant equity offering and a reinvigorated out-licensing program. We have a bright future ahead, as we have emerged with the TOBITM platform and a strong portfolio of TOBITM-based molecules, as well as several development-stage ideas that we consider “next generation” immunotherapeutics which leverage what we learned from the human data readouts from the initial phases of our clinical trials. We remain committed to developing immunotherapeutic drugs that target the reduction of senescent cells and the proinflammatory factors they secrete. Our focus continues to be on senescence-associated disorders, most typical in age-related diseases, including cancer. We are also excited to bring HCW9302 to the clinic in the very near future to evaluate this drug in the treatment of autoimmune diseases by expanding regulatory T cells.”

Business Highlights

•
On July 13, 2024, the Company entered into a confidential Settlement Agreement and Release (“Settlement Agreement”) to resolve arbitration brought against the Company and Dr. Hing C. Wong, the Company’s Founder and Chief Executive Officer. The Settlement Agreement includes mutual general releases by and among all the parties. There were no monetary payments or damages paid by any party under the Settlement Agreement. See “Financial Guidance.”
•
Going forward, the Company retains ownership and control of the TOBITM platform and TOBITM-based molecules, with no restrictions under the Settlement Agreement on its ability to use the TOBITM platform for protein-fusion molecules for non-oncology indications. The Company may pursue the clinical development of treatments for cancer indications based on HCW9302, HCW9206 and HCW9201. Further, HCW Biologics retains ownership of the Wugen license and shares of Wugen common stock transferred to the Company as the upfront licensing fee from Wugen for granting the Wugen license.
•
A new financing plan was launched including an equity offering, which the Company intends to close before the end of 2024. Financing plans also include out-licensing non-core assets, and there are several discussions underway with potential licensing partners.

1

 

 



 

Second Quarter 2024 Financial Results

•
Revenues: Revenues for the quarter ended June 30, 2023 and 2024 were $622,807 and $618,854, respectively. Revenues for the six months ended June 30, 2023 and 2024 were $664,690 and $1.7 million, respectively. Revenues in both periods were derived exclusively from the sale of licensed molecules to the Company’s licensee, Wugen. The licensed molecules are one of the inputs for manufacturing Wugen’s products.
•
Research and development (R&D) expenses: R&D expenses for the quarter ended June 30, 2023 and 2024 were $1.6 million and $2.0 million, respectively, an increase of $412,520, or 26%. R&D expenses for the six months ended June 30, 2023 and 2024 were $3.9 million and $4.2 million, respectively, an increase of $279,991, or 7%. Manufacturing costs increased in three- and six-month periods ended June 30, 2024 because the Company was replenishing its supply of a high-expressing cell line of HCW9101. Preclinical expenses declined in the three- and six-month periods ended June 30, 2024 due to a change in the types of activities being performed in connection with IND-enabling activities to prepare an IND application to obtain permission from the FDA to evaluate HCW9302 in an autoimmune indication. In the three- and six-month periods ended June 30, 2023, preclinical costs were incurred for setup costs for toxicology studies and other IND-enabling studies. In the three- and six-month periods ended June 30, 2024, costs were incurred for supplemental research studies. Clinical trial expenses were incurred in the three- and six-month period ended June 30, 2023 related to two clinical studies to evaluate HCW9218 in chemo-refractory / chemo-resistant solid tumors. Clinical trial expenses declined in the three- and six-month periods ended June 30, 2024 because these trials were fully enrolled in the first quarter of 2024.
•
General and administrative (G&A) expenses: G&A expenses for the quarter ended June 30, 2023 and 2024 were $1.6 million and $1.6 million, respectively, an increase of $6,332, or 0%. The increase was primarily attributable to an increase in fees for auditing and tax advisory services, offset by a reduction in salaries and benefits arising from the Company’s cost-cutting measures. G&A expenses for the six months ended June 30, 2023 and 2024 were $3.6 million and $3.2 million, a decrease of $436,454, or 12%. The decrease was a result of cost-cutting measures and a decrease in legal fees incurred in procuring patents and insurance-related costs, partially offset by an increase in financing costs.
•
Legal Expenses: Legal expenses for the quarter ended June 30, 2023 and 2024 were $1.4 million and $10.4 million, respectively, an increase of $9.0 million, or 629%. Legal expenses for the six months ended June 30, 2023 and 2024 were $2.5 million and $14.8 million, an increase of $12.3 million, or 484%. The increase in legal expenses is related to the Altor/NantCell matter. See further discussion of the Altor/NantCell arbitration in “Financial Guidance.”
•
Net loss: Net loss for the quarter ended June 30, 2023 and 2024 was $4.3 million and $15.3 million, respectively, an increase of $11.0 million, or 255%. Net loss for the six months ended June 30, 2023 and 2024 was $9.4 million and $22.7 million, respectively, an increase of $13.4 million, or 143%.

2

 

 

Financial Guidance

The Company has raised $8.0 million to date in 2024, through a $2.5 million private placement of common stock to officers and directors and $5.5 million issuance of Secured Notes secured by the Company’s Wugen shares. The Company is authorized to raise up to $10.0 million in Secured Notes and intends to have the Secured Notes offering fully subscribed.

As of June 30, 2024, the Company believes that substantial doubt exists regarding its ability to continue as a going concern for at least 12 months from the issuance date of the condensed interim financial statements, without additional funding or financial support. After considering the elements of the Company’s financing plan that were probable to occur within a year of the date of issuance, the Company concluded that substantial doubt was not alleviated in its going concern analysis.

As reported in the Company’s Form 8-K filed on July 18, 2024, as of July 13, 2024, the Company and Dr. Hing C. Wong, the Company’s Founder and Chief Executive Officer, entered into the Settlement Agreement, with Altor BioScience, LLC (“Altor”), NantCell, Inc. (“NantCell”), and ImmunityBio, Inc. (the parent of Altor and NantCell, together with Altor and NantCell, “ImmunityBio”), to resolve the previously disclosed arbitration before JAMS brought by Altor and NantCell (the “Arbitration”) as well as a complaint Altor filed against the Company in the Chancery Court of the State of Delaware for the contribution of legal fees and expenses advanced to Dr. Wong (“Complaint”). The parties entered into the Settlement Agreement to avoid the costs, disruption and distraction of further litigation. Under the terms of the Settlement Agreement, no party will make monetary payments to any other party or person and each party will bear its own expenses. The Company is completing procedures required to be in compliance with the terms of the Settlement Agreement. The Settlement Agreement provides that, upon completion of these procedures, the parties will stipulate that the Arbitration and Complaint should be dismissed. The Company retains rights to develop immunotherapeutic treatments based on TOBITM-based molecules as well as the TOBITM platform, in addition to the Wugen license and Wugen equity interest. The Company reported a balance of $10.0 million for legal fees incurred but not yet paid that were included within Accounts payable and an accrual of $4.8 million for accrued legal fees within Accrued liabilities and other current liabilities in the accompany condensed balance sheet as of June 30, 2024. In order not to overwhelm the Company’s resources, a reasonable payment plan will be required. The Company is engaged in discussions with the law firms involved with this matter.

As reported on the Company’s Form 8-K filed on August 12, 2024, the Company received written notices from the Listing Qualifications Staff (“Staff”) of the Nasdaq Stock Market LLC (“Nasdaq”) notifying the Company that it is not in compliance with Nasdaq Listing Rules. The notifications from Nasdaq do not impact the listing of the Company’s common stock at this time. The Company received a notice that it was not in compliance with Nasdaq Listing Rules for the $50.0 million market value listed securities requirement as of June 17, 2024; the minimum bid price as of August 6, 2024; and the $15.0 million market value of publicly held shares requirement as of August 8, 2024. The Company has 180 days from the respective date of notice to address each deficiency. While the Company is exercising diligent efforts to maintain the listing of its common stock on Nasdaq, there can be no assurance that the Company will be able to regain or maintain compliance with the applicable continued listing standards set forth in the Nasdaq Listing Rules.

3

 

 

About HCW Biologics:

HCW Biologics is a clinical-stage biopharmaceutical company focused on discovering and developing novel immunotherapies to lengthen healthspan by disrupting the link between chronic, low-grade inflammation, and age-related diseases, such as cancer, cardiovascular diseases, diabetes, neurodegenerative diseases, autoimmune diseases, as well as other conditions such as long-haul COVID-19. The Company has combined a deep understanding of disease-related immunology with its expertise in advanced protein engineering to develop the TOBI™ (Tissue factOr-Based fusIon) discovery platform. The Company uses its TOBITM discovery platform to generate designer, novel multi-functional fusion molecules with immunotherapeutic properties. The invention of HCW Biologics’ lead molecules, HCW9218, HCW9302, HCW9206 and HCW9201, was made via the proprietary TOBI™ discovery platform. The University of Pittsburgh Medical Center has agreed to include HCW9218 in an Investigator-sponsored Phase 2 clinical trial to evaluate HCW9218 in patients with metastatic, advanced stage ovarian cancer in combination with neoadjuvant chemotherapy (NCT05145569).

Forward Looking Statements:

Statements in this press release contain “forward-looking statements” that are subject to substantial risks and uncertainties. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “expect,” “believe,” “will,” “may,” “should,” “estimate,” “project,” “outlook,” “forecast” or other similar words and include, the Company’s ability to develop new immunotherapeutic treatments for non-oncology or oncology indications; timing of initiation of studies for age-related diseases; the Company’s ability to continue as a going concern; the Company’s cash runway; the Company’s expectations regarding future purchases of licensed molecules by Wugen; the Company’s future capital-raising plans and ability to continue with clinical development efforts until they are achieved, if at all; and Company’s ability to pay legal fees incurred in connection with the Altor/NantCell arbitration. Forward-looking statements are based on the Company’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Factors that could cause actual results to differ include, but are not limited to, the risks and uncertainties that are described in the section titled “Risk Factors” in the annual report on Form 10-K/A filed with the United States Securities and Exchange Commission (the “SEC”) on May 15, 2024, and in other filings filed from time to time with the SEC. Forward-looking statements contained in this press release are made as of this date, and the Company undertakes no duty to update such information except as required under applicable law.

 

Company Contact:

Rebecca Byam

CFO

HCW Biologics Inc.

rebeccabyam@hcwbiologics.com

 

 

4

 

 

HCW Biologics Inc.

Unaudited Statements of Operations

(Unaudited)

 

 

 

 

Three Months Ended
June 30,

 

Six Months Ended
June 30,

 

 

2023

 

2024

 

2023

 

2024

Revenues:

 

 

 

 

Revenues

 

$ 622,807

 

$ 618,854

 

$ 664,690

 

$ 1,745,566

Cost of revenues

 

  (502,402)

 

  (438,443)

 

  (531,752)

 

  (950,408)

Total revenues

 

  120,405

 

  180,411

 

  132,938

 

  795,158

Operating expenses:

 

 

 

 

 

 

 

 

Research and development

 

  1,616,666

 

  2,029,186

 

  3,872,479

 

  4,152,470

General and administrative

 

  1,587,861

 

  1,594,193

 

  3,596,739

 

  3,160,285

Legal expenses

 

  1,426,399

 

  10,393,042

 

  2,534,811

 

  14,812,076

Nonoperating loss

 

  —

 

  1,300,000

 

  —

 

  1,300,000

Total operating expenses

 

  4,630,926

 

  15,316,421

 

  10,004,029

 

  23,424,831

Loss from operations

 

  (4,510,521)

 

  (15,136,010)

 

  (9,871,091)

 

  (22,629,673)

Interest expense

 

  (95,514)

 

  (159,666)

 

  (188,951)

 

  (159,666)

Other (expense) income, net

 

  301,615

 

  15,485

 

  684,936

 

  41,086

Net loss

 

$ (4,304,420)

 

$(15,280,191)

 

$ (9,375,106)

 

$(22,748,253)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

5

 

 

 

HCW Biologics Inc.

Condensed Balance Sheets


 

 

 

December 31,

 

June 30,

 

 

2023

 

2024

 

 

 

 

Unaudited

ASSETS

 

 

 

 

Current assets:

 

 

 

 

Cash and cash equivalents

 

$ 95,101

 

$ 1,161,314

Accounts receivable, net

 

  1,535,757

 

  654,973

Prepaid expenses

 

  1,042,413

 

  404,918

Other current assets

 

  230,916

 

  164,607

Total current assets

 

  6,404,187

 

  2,385,812

Investments

 

  1,599,751

 

  1,599,751

Property, plant and equipment, net

 

  20,453,184

 

  22,806,052

Other assets

 

  56,538

 

  28,476

Total assets

 

 $ 28,513,660

 

$ 26,820,091

LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT)
   

 

 

 

 

Liabilities

 

 

 

 

Current liabilities:

 

 

 

 

Accounts payable

 

$ 6,167,223

 

$ 16,877,463

Accrued liabilities and other current liabilities

 

  2,580,402

 

  6,341,676

Total current liabilities

 

  8,747,625

 

  23,219,139

Debt, net

 

  6,304,318

 

  9,900,721

Total liabilities

 

  15,051,943

 

  33,119,860

Commitments and contingencies (Note 8)

 

 

 

 

Stockholders’ equity (deficit):

 

 

 

 

Common stock:

 

 

 

 

Common, $0.0001 par value; 250,000,000 shares authorized
   and 36,025,104 shares issued at December 31, 2023; 250,000,000 shares
   authorized and 37,823,394 shares issued at June 30, 2024

 

  3,603

 

  3,782

Additional paid-in capital

 

         83,990,437

 

            86,977,024

Accumulated deficit

 

  (70,532,323)

 

  (93,280,575)

Total stockholders’ equity (deficit)

 

  13,461,717

 

  (6,299,769)

Total liabilities and stockholders’ equity (deficit)

 

$ 28,513,660

 

$ 26,820,091

 

6

 

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Document And Entity Information
Aug. 14, 2024
Cover [Abstract]  
Document Type 8-K
Amendment Flag false
Document Period End Date Aug. 14, 2024
Entity Registrant Name HCW Biologics Inc.
Entity Central Index Key 0001828673
Entity Emerging Growth Company true
Entity File Number 001-40591
Entity Incorporation, State or Country Code DE
Entity Tax Identification Number 82-5024477
Entity Address, Address Line One 2929 N. Commerce Parkway
Entity Address, City or Town Miramar
Entity Address, State or Province FL
Entity Address, Postal Zip Code 33025
City Area Code 954
Local Phone Number 842-2024
Entity Information, Former Legal or Registered Name Not Applicable
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Entity Ex Transition Period true
Title of 12(b) Security Common Stock, par value $0.0001 per share
Trading Symbol HCWB
Security Exchange Name NASDAQ

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