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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): April 01, 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. ☒

 

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Item 2.02 Results of Operations and Financial Condition.

On April 1, 2024, HCW Biologics Inc. issued a press release announcing its financial results for the fourth quarter and fiscal year ended December 31, 2023. 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 April 1, 2024.
104		Cover Page Interactive Data File (embedded within the Inline XBRL document).

 

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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:	April 1, 2024	By:	/s/ Hing C. Wong
			Hing C. Wong Founder and Chief Executive Officer

 

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Exhibit 99.1

 

 

 

HCW Biologics Reports Fourth Quarter 2023 and Fiscal Year End

Financial Results And Business Highlights

Miramar, FL – April 1, 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 fourth quarter and fiscal year ended December 31, 2023.

Dr. Hing C. Wong, Founder and CEO of HCW Biologics, stated, “These are exciting times at HCW Biologics. We achieved two major clinical milestones, with the completion of the Phase 1 clinical study to evaluate HCW9218 in solid tumors and the Phase 1b study to evaluate HCW9218 in pancreatic cancer. While it is still quite early in the clinical development process and we have only seen data when HCW9218 is administered as a monotherapy, we believe there are signs that HCW9218 provides clinical benefits to patients who have previously failed multiple lines of standard-of-care therapies. We believe that HCW9218 shows the potential to be a first in class immunotherapeutic cancer treatment.”

Dr. Wong continued, “Now we are on the verge of initiating multiple Phase 2 clinical studies, including randomized trials, to evaluate HCW9218 as a treatment in combination with standard-of-care therapy in patients with cancer. We intend to focus on ovarian and pancreatic cancer, and we hope to opportunistically join studies with investigators who want to add an arm to their study using HCW9218 in combination with their therapy. This approach could give us an opportunity to assess HCW9218 in more cancer indications that we believe will provide valuable data to inform us of the most appropriate indications and regimens for future registration trials.”

“Another piece of exciting news for 2024 is that we are planning on the initiation of investigative studies for age-related diseases using HCW9218. We are planning on using the Recommended Phase 2 Dose level of HCW9218 identified in our two now completed Phase 1/1b cancer trials. Dr. Wong added. “We believe age-associated dermatological conditions and diseases, such as senile lentigo and deep wrinkles, will be the first age-related indications we investigate beyond cancer.”

 

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Business Highlights

 

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Fourth Quarter 2023 and Year End Financial Results

 

Financial Guidance

 

As of December 31, 2023, there was substantial doubt about our ability to continue as a going concern. Since that time, we had successful financings of $12.5 million, for which we received funds or have a legally binding commitment to so as of March 31, 2024. And, we continue with other fundraising efforts that we are targeting to complete in the next three to six months. Under the guidance of Topic 205-40 for going concern assessment, we evaluated whether we mitigated the substantial doubt over our ability to remain a going concern for the next 12 months from the filing date. If no additional financings occur after the filing date, we believe the relevant conditions that brought about substantial doubt can be alleviated if we implement a plan that includes certain adjustments to our strategic and operating plans, such as cutting

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back on the number of investigative studies and Phase 2 clinical trials we initiate; reducing salaries and other spending, and limiting the amount of cash used to reduce accounts payable, as well as other adjustments to alleviate substantial doubt.

On December 23, 2022, Claimants Altor and NantCell (“Altor/NantCell”) filed a complaint against the Company in the U.S. District Court for the Southern District of Florida (the “Court”), alleging claims of misappropriation of trade secrets, tortious interference with contractual relations, inducement of breach of fiduciary duty, and specific performance/injunction for assignment of patents and patent applications, among other claims. That same day, Altor/NantCell also initiated an arbitration against the Company’s CEO and Founder, Dr. Wong, based on early identical allegations and alleging breach of contract, breach of fiduciary duty, and fraudulent concealment, among other claims. The Company moved to compel arbitration and the parties ultimately stipulated to the same. On April 27, 2023, in connection with the Altor/NantCell matter, the Court approved the parties’ stipulation and ordered the parties to arbitration. On May 1, 2023, Altor/NantCell filed a demand against the Company before JAMS. On May 3, 2023, Altor/NantCell dismissed the federal court action without prejudice and the Court ordered the case dismissed without prejudice and closed the case. Altor/NantCell’s proceeding against the Company is now proceeding in arbitration before JAMS, with an arbitration hearing scheduled for May 20, 2024. In addition, on March 26, 2024, Altor/NantCell gave notice that they are filing a complaint (the “Complaint”) against the Company in the Chancery Court of the State of Delaware for the contribution of legal fees and expenses advanced to Dr. Wong in connection with the arbitration discussed above. Prior to the filing of the Complaint, Altor/NantCell had previously sought advancement from the Company and the Company agreed to advance 50% of Dr. Wong’s legal fees going forward from December 2023. On January 8, 2024, Altor/NantCell reserved their right to pursue contribution against the Company for 50% of the amount Altor/NantCell sent for advancement of expenses for Dr. Wong. In the Complaint, Altor/NantCell seek 50% of the fees they have already advanced to Dr. Wong, a declaration that the Company has an obligation to contribute 50% of the advancement of Dr. Wong’s expenses including 50% of Dr. Wong’s expenses incurred in connection with the arbitration through final resolution of the matter, and costs and fees in bringing this action. Although adverse decisions (or settlements) may occur in arbitration, it is not possible to reasonably estimate the possible loss or range of loss, if any, associated therewith at this time. As such, no accrual for these matters has been recorded within the Company’s financial statements. The Company incurred significant legal expenses in connection with this matter in the period ended December 31, 2023, and expects to continue to incur material costs and expenses in the first half of 2024.

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’ two lead molecules, HCW9218 and HCW9302, was made via the TOBI™ discovery platform. The Company completed the initial stages of two clinical trials to evaluate HCW9218 in cancer indications. The Masonic Cancer Center, University of Minnesota, was the sponsor of a Phase 1 clinical trial to evaluate HCW9218 in chemo-refractory/chemo-resistant solid tumors that have progressed after prior chemotherapies (Clinicaltrials.gov: NCT05322408). The Company is the sponsor of a Phase 1b/2 clinical trial to evaluate HCW9218 in chemo-refractory/chemo-resistant advanced pancreatic cancer (Clinicaltrials.gov: NCT05304936). The Company is preparing an IND application for its lead molecule for its regulatory T cell expansion program, HCW9302, expected to be submitted in the first half of 2024.

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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, without limitation, statements regarding potential of HCW9218 to be a first in class immunotherapeutic cancer treatment. initiation of Phase 2 clinical studies in cancer indications; potential to join other studies so HCW9218 can be assessed in more cancer indications; timing of initiation of studies for age-related diseases; the Company’s cash runway; the Company’s expectations regarding future purchases by Wugen; and timing and outcome of the Altor/NantCell arbitration and the Company’s liability related thereto. 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 filed with the United States Securities and Exchange Commission (the “SEC”) on April 1, 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
 

 

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HCW Biologics Inc.

Statements of Operations

 

 

		For the Three Months Ended December 31,				Years Ended December 31,
		2022		2023		2022		2023
Revenues:		Unaudited				Audited
Revenues		$ 1,341,520		$ 1,324,003		$ 6,722,090		$ 2,841,794
Cost of revenues		(1,073,216)		(1,071,357)		(4,135,712)		(2,281,434)
Total revenues		268,304		252,646		2,586,378		560,360
Operating expenses:
Research and development		2,930,013		2,136,397		9,338,366		7,676,316
General and administrative		3,005,529		3,634,439		8,326,790		13,351,204
Reserve for credit losses		—		5,250,000		—		5,250,000
Total operating expenses		5,935,542		11,020,836		17,665,156		26,277,520
Loss from operations		(5,667,238)		(10,768,190)		(15,078,778)		(25,717,160)
Interest expense		(94,476)		—		(126,660)		(283,042)
Other (expense) income, net		342,973		87,660		304,735		1,005,925
Net loss		$ (5,418,741)		$ (10,680,530)		$ (14,900,703)		$ (24,994,277)
Net loss per share, basic and diluted		$ (0.15)		$ (0.30)		$ (0.42)		$ (0.70)
Weighted average shares outstanding, basic and diluted		35,861,348		35,996,415		35,822,249		35,929,446

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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HCW Biologics Inc.

Audited Balance Sheets

 

		December 31,		December 31,
		2022		2023
ASSETS
Current assets:
Cash and cash equivalents		$ 22,326,356		$ 3,595,101
Short-term investments		9,735,930		—
Accounts receivable, net		417,695		1,535,757
Prepaid expenses		1,394,923		1,042,413
Other current assets		196,015		230,916
Total current assets		34,070,919		6,404,187
Investments		1,599,751		1,599,751
Property, plant and equipment, net		10,804,610		20,453,184
Other assets		333,875		56,538
Total assets		$ 46,809,155		$ 28,513,660
LIABILITIES AND STOCKHOLDERS’ EQUITY
Liabilities
Current liabilities:
Accounts payable		$ 1,226,156		$ 6,167,223
Accrued liabilities and other current liabilities		1,730,325		2,580,402
Total current liabilities		2,956,481		8,747,625
Debt, net		6,409,893		6,304,318
Other liabilities		14,275		—
Total liabilities		9,380,649		15,051,943
Commitments and contingencies (Note 15)
Stockholders’ equity:
Common stock:
Common, $0.0001 par value; 250,000,000 shares authorized    and 35,876,440 shares issued at December 31, 2022; 250,000,000 shares    authorized and 36,025,104 shares issued at December 31, 2023		3,588		3,603
Additional paid-in capital		82,962,964		83,990,437
Accumulated deficit		(45,538,046)		(70,532,323)
Total stockholders’ equity		37,428,506		13,461,717
Total liabilities and stockholders’ equity		$ 46,809,155		$ 28,513,660

 

 

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