Core Viewpoint - HCW Biologics Inc. has received a notice from Nasdaq regarding its failure to meet the market value listing requirements, which may lead to delisting unless the company successfully appeals [1][5]. Company Overview - HCW Biologics is a clinical-stage biopharmaceutical company focused on developing novel immunotherapies aimed at extending healthspan by addressing chronic inflammation linked to age-related diseases, including cancer, cardiovascular diseases, diabetes, neurodegenerative diseases, autoimmune diseases, and long-haul COVID-19 [6]. Compliance and Delisting Notice - On June 20, 2024, HCW Biologics was notified that its market value of listed securities fell below the $50 million threshold for 30 consecutive business days, leading to a compliance period of 180 days, which ended on December 16, 2024 [1]. - The company did not regain compliance by the deadline, resulting in a notice of potential delisting from Nasdaq unless a hearing is requested [1][5]. Appeal Process - HCW Biologics intends to request a hearing before the Nasdaq Hearing Panel, which will pause any delisting actions while the appeal is considered [5]. - The Panel can grant an extension of up to 180 days for the company to demonstrate compliance with the listing criteria [5].

HCW Biologics entered into License, Research and Co-Development Agreement with WY Biotech for one of its new proprietary preclinical molecules HCW Biologics to receive upfront payment of $7 million and is eligible to receive additional milestone payments and double-digit royalties on future product sales MIRAMAR, Fla., Nov. 18, 2024 (GLOBE NEWSWIRE) -- HCW Biologics Inc. (“HCWB” or “HCW Biologics”), (NASDAQ: HCWB), a U.S.-based clinical-stage biopharmaceutical company focused on discovering and developing n ...

Drug Development and Clinical Trials - HCW Biologics reported a focus on developing novel immunotherapies targeting age-related diseases linked to chronic inflammation, with a significant emphasis on the TOBI™ drug discovery platform[61]. - The company has manufactured quantities of four TOBI-based molecules in a cGMP manufacturing setting, indicating readiness for clinical applications[65]. - HCW9218 is a clinical-stage bifunctional molecule aimed at reducing senescent cells and their proinflammatory factors, with a Phase 2 study planned for ovarian cancer[66]. - The company has exclusive rights to develop HCW9218 for age-related diseases other than cancer, leveraging findings from Phase 1 studies completed in early 2024[67]. - HCW9302 is under FDA review for an IND application, targeting autoimmune indications, with plans to explore its utility in neurodegenerative diseases[71][72]. - The company has initiated IND-enabling activities for HCW9206, which is designed to stimulate T cell proliferation and enhance immune responses against tumors[73]. - HCW9201 is currently being evaluated in a Phase 1 clinical trial for Acute Myeloid Leukemia, with potential for further indications[74]. - A new drug discovery platform utilizing a novel protein scaffold has been developed, expanding treatment possibilities beyond the TOBI™ platform[75]. Financial Performance and Revenue - Revenues for the three months ended September 30, 2024, were $426,423, a decrease of 50% from $853,102 in the same period of 2023[101]. - Revenues for the nine months ended September 30, 2024, were $2,171,988, an increase from $1,517,792 for the same period in 2023[100]. - The principal source of revenue has been from the Wugen License and Master Services Agreement, which includes nonrefundable upfront payments and royalties[86]. - The company has not generated any revenue from commercial product sales of its internally-developed immunotherapeutic products as of September 30, 2024[133]. Expenses and Losses - Operating expenses are primarily composed of research and development expenses and general and administrative expenses[88]. - Research and development expenses are expected to increase substantially as the Company continues to develop its product candidates[90]. - General and administrative expenses increased by $129,216, or 9%, from $1,509,936 for the three months ended September 30, 2023, to $1,639,152 for the same period in 2024[109]. - Net loss for the three months ended September 30, 2024, was $3,902,288, compared to a net loss of $14,313,746 for the same period in 2023[100]. - Total operating expenses for the three months ended September 30, 2024, were $3,775,520, compared to $15,256,684 for the same period in 2023[100]. - Legal expenses increased from $4.6 million for the nine months ended September 30, 2023, to $15.8 million for the nine months ended September 30, 2024[129]. Funding and Financial Strategy - The company signed an out-license agreement with Wugen, Inc., receiving a 5.6% ownership interest, which supports its financing strategy for clinical development[78]. - The Company has launched a new financing plan, issuing $6.9 million in Secured Notes and is authorized to issue up to $10.0 million[81]. - The Company raised $9.4 million in financing in 2024, including a $2.5 million private placement of common stock and $6.5 million from the issuance of Secured Notes[134]. - Cash provided by financing activities for the nine months ended September 30, 2024, was $8.9 million, significantly higher than the previous year's $716[144]. - The Company continues to seek financing to complete the construction of its new headquarters, which is currently facing mechanics liens from subcontractors[134]. Operational Challenges - As of September 30, 2024, substantial doubt exists regarding the Company's ability to continue as a going concern for at least 12 months without additional funding[82]. - The Company is facing headwinds from inflation, rising interest rates, and supply chain disruptions impacting operations and costs[83]. - The Company anticipates further cost reductions or restructuring after reassessing its clinical development strategy[134]. - As of September 30, 2024, the company had $1.0 million in cash and cash equivalents, raising substantial doubt about its ability to operate for the next 12 months[133].

MIRAMAR, Fla., Nov. 14, 2024 (GLOBE NEWSWIRE) -- 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 third quarter ended September 30, 2024.  Dr. Hing C. Wong, Founder and CEO of HCW Biologics, stated, “In the third quarter 20 ...

This release has made a correction to a release issued under the same headline on August 14, 2024, by HCW Biologics, Inc. (NASDAQ: HCWB), to show the amount included in the condensed interim balance sheet for Cash and cash equivalents as of December 31, 2023 as $3,595,101, not $95,101 as previously stated. The full text of the corrected release is as follows: MIRAMAR, Fla., Aug. 23, 2024 (GLOBE NEWSWIRE) -- HCW Biologics Inc. (the "Company" or "HCW Biologics") (NASDAQ: HCWB), a clinical-stage biopharmaceuti ...

Exhibit 99.1 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 ...

MIRAMAR, Fla., Aug. 14, 2024 (GLOBE NEWSWIRE) -- 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 milest ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) (Exact Name of Registrant as Specified in its Charter) Delaware 82-5024477 (State or other jurisdiction of incorporation or organization) (I.R.S. 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 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCH ...

[HCW Biologics First Quarter 2024 Report](index=1&type=section&id=HCW%20Biologics%20First%20Quarter%202024%20Report) [Overview and Business Highlights](index=1&type=section&id=Business%20Highlights) HCW Biologics completed HCW9218 Phase 1/1b enrollment, advancing to Phase 2 for ovarian cancer, expanding into age-related skin diseases, while preparing an HCW9302 IND and securing financing - Enrollment completed for two HCW9218 clinical trials in solid tumors and pancreatic cancer, establishing the **recommended Phase 2 dose (RP2D)**[3](index=3&type=chunk)[5](index=5&type=chunk) - HCW9218 is planned to advance into a sponsored **Phase 2 trial for advanced ovarian cancer** with UPMC, with enrollment anticipated in H2 2024[5](index=5&type=chunk) - The company plans to expand its clinical focus to **age-related indications**, including skin diseases, for potentially faster data readouts[3](index=3&type=chunk) - An **Investigational New Drug (IND) application for HCW9302** in an autoimmune disease is being prepared, with submission planned for Q3 2024[5](index=5&type=chunk) - **$6.1 million** raised in 2024 through private placements and senior secured notes, with management planning a **bridge financing of up to $10.0 million** via Secured Notes[5](index=5&type=chunk) [First Quarter 2024 Financial Results](index=3&type=section&id=First%20Quarter%202024%20Financial%20Results) Q1 2024 revenues significantly increased, R&D expenses decreased, while G&A expenses surged due to legal costs, resulting in a higher net loss Q1 2024 vs. Q1 2023 Financial Performance | Financial Metric | Q1 2024 | Q1 2023 | Change | | :--- | :--- | :--- | :--- | | Revenues | $1.1 million | $41,883 | +2550% | | R&D Expenses | $2.1 million | $2.3 million | -6% | | G&A Expenses | $6.0 million | $3.1 million | +94% | | Net Loss | ($7.5 million) | ($5.1 million) | +47% | - Revenues were exclusively from **licensed molecule sales to Wugen**, reflecting recovery from prior program changes and manufacturing delays[7](index=7&type=chunk) - The **94% increase in G&A expenses** was primarily due to higher legal costs from the ongoing Altor/NantCell arbitration[7](index=7&type=chunk) - **R&D expenses decreased by 6%** due to a shift in preclinical activities, with lower IND-enabling study costs for HCW9302 partially offset by increased HCW9101 manufacturing costs[7](index=7&type=chunk) [Financial Guidance and Contingencies](index=4&type=section&id=Financial%20Guidance) The company faces going concern doubts without additional funding, plans bridge financing, and manages significant legal expenses from ongoing arbitration - Substantial doubt exists regarding the company's ability to continue as a **going concern** for at least 12 months without additional funding[8](index=8&type=chunk) - Management is pursuing a **bridge financing of up to $10.0 million** in Secured Notes, with **$3.6 million** already issued in 2024, to fund clinical development[9](index=9&type=chunk) - The company is involved in a consolidated arbitration with Altor/NantCell concerning **trade secret misappropriation**, incurring significant and material legal expenses expected through Q3 2024[10](index=10&type=chunk)[12](index=12&type=chunk) - A reasonable estimate of possible loss from the **Altor/NantCell arbitration** cannot be made, thus no accrual has been recorded[10](index=10&type=chunk) [Financial Statements](index=7&type=section&id=Financial%20Statements) [Unaudited Statements of Operations](index=7&type=section&id=Unaudited%20Statements%20of%20Operations) Q1 2024 operations resulted in a **$7.5 million** net loss, or **($0.20) per share**, driven by **$614,747** net revenues and **$8.1 million** in operating expenses, an increase from the prior year Q1 2024 Statement of Operations Summary | Line Item | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :--- | :--- | :--- | | Net Revenues | $614,747 | $12,533 | | Total Operating Expenses | $8,108,410 | $5,373,103 | | Loss from Operations | ($7,493,663) | ($5,360,570) | | Net Loss | ($7,468,061) | ($5,070,686) | | Net Loss Per Share | ($0.20) | ($0.14) | [Condensed Balance Sheets](index=8&type=section&id=Condensed%20Balance%20Sheets) As of March 31, 2024, total assets were **$30.4 million** including **$4.1 million** cash, total liabilities increased to **$21.7 million**, and total stockholders' equity decreased to **$8.7 million** Balance Sheet Summary | Account | March 31, 2024 (Unaudited) | December 31, 2023 | | :--- | :--- | :--- | | Cash and cash equivalents | $4,084,076 | $3,595,101 | | Total Current Assets | $6,208,650 | $6,404,187 | | Total Assets | $30,427,656 | $28,513,660 | | Total Current Liabilities | $13,412,606 | $8,747,625 | | Total Liabilities | $21,687,055 | $15,051,943 | | Total Stockholders' Equity | $8,740,601 | $13,461,717 |

He added, "With the recommended Phase 2 dose established in our early studies, we plan to expand into age- related indications in skin diseases and conditions associated with senescence. These studies will be designed as investigative studies, and we anticipate that it will be quicker to see human data read outs from this type of indication than would be possible in a cancer study. We are interested to see the aesthetic effects with the deep wrinkles and senile lentigo, perhaps as secondary endpoints." MIRA ...