UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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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:
Securities registered pursuant to Section 12(b) of the Act:
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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 11, 2023, HCW Biologics Inc. issued a press release announcing its financial results for the quarter ended June 30, 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. |
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Description |
99.1 |
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104 |
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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.
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HCW BIOLOGICS INC. |
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Date: |
August 11, 2023 |
By: |
/s/ Hing C. Wong |
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Hing C. Wong |
Exhibit 99.1
HCW Biologics Reports Second Quarter 2023 Financial Results
And Recent Business Highlights
Miramar, FL – August 11, 2023 – 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, 2023.
“During the period ended June 30, 2023, we have made significant progress in crystalizing our understanding of the anti-cancer mechanism of action of HCW9218, especially in relation to how it complements immune checkpoint inhibitors ("ICIs"). HCW9218 has a unique mechanism that we believe allows it to turn a ‘cold’ tumor into a ‘hot’ tumor, potentially opening up the possibility of improving the response rate for checkpoint inhibitors which has remained stubbornly low,” stated Dr. Hing C. Wong, Founder and CEO of HCW Biologics.
Dr. Wong continued, “Our excitement about the potential of HCW9218 as a combination therapy with checkpoint inhibitors is fueled by key discoveries made as a result of extensive animal testing in different cold tumor models. First, HCW9218 stimulates and expands progenitor exhausted stem-like T cells and transitory CD8+ effector T cells in the tumor draining lymph nodes followed by trafficking of these cells into the tumors. This opens a pathway for enhancing the anti-tumor activity of checkpoint inhibitors. Secondly, HCW9218 also substantially lowers the TGF-β activity in the tumor microenvironment to lessen immunosuppression. This further boosts the ICI response to block the PD1/PDL1 axis and enhances the anti-tumor activity of HCW9218-activated CD8+ effector T cells.”
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Business Highlights:
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Second Quarter 2023 Financial Results:
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Financial Guidance
As of June 30, 2023, the Company held $17.4 million in cash, cash equivalents and U.S. Treasury bills of short duration. In addition, there were prepaid expenses of $6.6 million, including the $5.3 million deposit for interest reserve. The Company funded $3.2 million toward the new lab and manufacturing facilities while awaiting permits to begin construction and activating access to project financing. Funds for this project will be provided from financing in the future. With the current cash, cash equivalents and U.S. Treasury bills on hand, the Company has adequate capital to fund operations and other commitments to Q4 2024.
On April 27, 2023, in connection with the Altor/NantCell matter, the U.S. District Court for the Southern District of Florida (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. 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. In the year ahead, the Company expects to continue to incur legal expenses on its own behalf in connection with the legal proceedings brought against it by Altor/NantCell. However, legal expenses incurred by Dr. Wong in connection with the arbitration against him that was initiated by Altor/NantCell, are covered through advancement of expenses from Altor/NantCell.
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 Masonic Cancer Center, University of Minnesota, has initiated 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 also enrolling patients in a Company-sponsored Phase 1b/2 clinical trial to evaluate HCW9218 in chemo-refractory/chemo-resistant advanced pancreatic cancer (Clinicaltrials.gov: NCT05304936). The Company’s lead molecule for its regulatory T cell expansion program, HCW9302, is currently undergoing IND-enabling studies for an autoimmune indication.
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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 completion of Phase 1/1b clinical studies in cancer; potential of HCW9218 to treat other aging-associated diseases beyond cancer; potential of HCW9218 as a combination therapy with checkpoint inhibitors and of HCW9218’s mechanism of action; timing of completion and expected data readout for trials; duration of the supply of the Company’s lead molecules; 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 March 28, 2023, the Form 10-Q filed with the SEC on August 11, 2023, 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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Condensed Statements of Operations
(Unaudited)
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Three Months Ended |
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Six Months Ended |
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2022 |
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2023 |
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2022 |
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2023 |
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Revenues: |
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Revenues |
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$ |
454,000 |
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$ |
622,807 |
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$ |
3,571,545 |
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$ |
664,690 |
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Cost of revenues |
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(287,200 |
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(502,402 |
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(1,615,276 |
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(531,752 |
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Net revenues |
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166,800 |
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120,405 |
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1,956,269 |
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132,938 |
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Operating expenses: |
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Research and development |
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1,969,882 |
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1,616,666 |
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3,759,558 |
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3,872,479 |
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General and administrative |
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1,707,995 |
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3,014,260 |
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3,588,597 |
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6,131,550 |
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Total operating expenses |
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3,677,877 |
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4,630,926 |
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7,348,155 |
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10,004,029 |
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Loss from operations |
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(3,511,077 |
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(4,510,521 |
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(5,391,886 |
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(9,871,091 |
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Interest expense |
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— |
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(95,514 |
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— |
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(188,951 |
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Other (expense) income, net |
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516 |
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301,615 |
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(175,882 |
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684,936 |
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Net loss |
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$ |
(3,510,561 |
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$ |
(4,304,420 |
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$ |
(5,567,768 |
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$ |
(9,375,106 |
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HCW Biologics Inc.
Condensed Balance Sheets
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December 31, |
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June 30, |
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2022 |
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2023 |
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Unaudited |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
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$ |
22,326,356 |
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$ |
7,449,010 |
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Short-term investments |
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9,735,930 |
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9,959,370 |
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Accounts receivable, net |
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417,695 |
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707,211 |
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Prepaid expenses |
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1,394,923 |
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1,356,520 |
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Other current assets |
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196,015 |
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327,055 |
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Total current assets |
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34,070,919 |
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19,799,166 |
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Investments |
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1,599,751 |
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1,599,751 |
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Property, plant and equipment, net |
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10,804,610 |
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12,623,308 |
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Deposit for interest reserve |
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— |
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5,250,000 |
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Other assets |
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333,875 |
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211,019 |
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Total assets |
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$ |
46,809,155 |
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$ |
39,483,244 |
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LIABILITIES AND STOCKHOLDERS’ EQUITY |
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Liabilities |
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Current liabilities: |
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Accounts payable |
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$ |
1,226,156 |
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$ |
2,116,216 |
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Accrued liabilities and other current liabilities |
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1,730,325 |
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2,421,682 |
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Total current liabilities |
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2,956,481 |
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4,537,898 |
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Debt, net |
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6,409,893 |
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6,359,704 |
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Other liabilities |
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14,275 |
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— |
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Total liabilities |
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9,380,649 |
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10,897,602 |
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Commitments and contingencies |
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Stockholders’ equity: |
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Common stock: |
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Common, $0.0001 par value; 250,000,000 shares authorized |
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3,588 |
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3,593 |
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Additional paid-in capital |
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82,962,964 |
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83,495,201 |
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Accumulated deficit |
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(45,538,046 |
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(54,913,152 |
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Total stockholders’ equity |
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37,428,506 |
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28,585,642 |
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Total liabilities and stockholders’ equity |
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$ |
46,809,155 |
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$ |
39,483,244 |
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7