Novel Immunotherapeutics for Cancer and Other Age-Related Diseases MAXIM GROUP 2022 VIRTUAL GROWTH CONFERENCE MARCH 2022 1 Forward Looking Statements Certain information contained in this presentation and statements made orally during this presentation include forward-looking statements that involve substantial risks and uncertainties. All statements included in this presentation, other than statements of historical facts, are forward-looking statements. Forward-looking statements include, without limitatio ...

Product Development and Clinical Trials - The company has developed over 30 molecules using its TOBI™ platform, focusing on immunotherapeutic therapies administered by subcutaneous injection[17] - HCW9218 and HCW9302 are the lead product candidates, targeting age-related diseases and designed for subcutaneous administration[17] - The FDA has permitted two clinical trials for HCW9218, one for advanced pancreatic cancer and another for various solid tumors[25][27] - The company expects to initiate the Company-sponsored clinical trial in the first half of 2022, with a planned dose escalation study[26] - The Investigator-sponsored trial is designed as a "basket trial" and may include patients with breast, ovarian, prostate, and colorectal cancers[27] - The duration of both clinical trials is expected to be approximately 12 months once patient enrollment begins[28] - HCW9218 functions as both a senolytic and senomorphic immunotherapeutic, targeting senescent cells and their secreted factors[19] - HCW9302 is designed to activate regulatory T cells to suppress inflammatory responses, supporting its potential in treating autoimmune and age-related diseases[21] - The company plans to release additional cGMP material that meets FDA requirements by the end of 2022, with no anticipated delays in advancing clinical trials due to supply issues[29] - The company expects to submit an Investigational New Drug Application (IND) for HCW9302 by the end of 2022, targeting alopecia areata in a Phase 1b clinical trial[31] - HCW9218 has demonstrated robust anti-tumor activity in mouse models, reducing melanoma tumor growth following chemotherapy[46] - The company aims to develop transformative immunotherapies to address the link between cellular senescence, chronic inflammation, and age-related diseases[51] - HCW9302 has shown promise in reducing atherosclerosis plaques in animal models induced by a high-fat diet[50] - The company plans to expand clinical evaluation of HCW9218 to other age-related indications after establishing a safe treatment regimen in cancer patients[59] - IND-enabling activities for HCW9302 are expected to be completed in the second half of 2022, followed by an IND submission for evaluating HCW9302 in alopecia areata[66] - HCW9218 has demonstrated strong anti-tumor activity in preclinical studies, enhancing the efficacy of chemotherapy and reducing therapy-induced senescent cells and SASP factors[71] - The clinical development focus includes evaluating HCW9218 in fibrotic diseases, liver cancer, and Type 2 diabetes, while HCW9302 targets autoimmune and proinflammatory diseases[66] - HCW9218 shows potential as an effective immunotherapy for pancreatic cancer, which has a 10.8% five-year survival rate and is the 3rd leading cause of cancer-related deaths in the U.S.[82] - The company plans to submit an IND for a Phase 1b clinical trial for HCW9302 in an autoimmune indication in the first half of 2023, pending completion of nonclinical toxicology studies[82] Manufacturing and Supply Chain - The company entered into a manufacturing agreement with EirGenix, Inc. for the production of its internally-developed molecules, successfully launching cGMP production by the end of 2019[98] - The company currently relies on EirGenix and other third-party manufacturers for cGMP production of drug product candidates for clinical trials, with no long-term supply arrangements in place[99] - The company maintains an inventory of clinical material to mitigate risks associated with third-party manufacturing delays[99] - The company plans to use net proceeds from the IPO to establish its own manufacturing facilities in the US, leveraging its expertise in cGMP manufacturing for immunotherapeutics[100] Intellectual Property and Licensing - The company emphasizes the importance of strong intellectual property protection and well-tolerated safety profiles for its primary internally-developed molecules[53] - As of December 31, 2021, the company owns 61 pending patent applications worldwide, including 11 pending U.S. utility patent applications[104] - The earliest predicted expiration date for patents in the company's portfolio is 2039, with some extending to 2042[112] - The company has out-licensed limited rights for HCW9201 and HCW9206, with HCW9201 currently in Phase 2 trials for r/r AML[67] - The company intends to out-license certain rights for non-core assets while focusing on its lead product candidates[32] - The company has entered into an exclusive worldwide license agreement with Wugen, receiving shares equivalent to a 10% ownership interest valued at $1.6 million and agreeing to sell non-financial assets for $2.5 million[124] - The company may receive additional payments exceeding $200 million based on certain development milestones and will be eligible for royalties on commercial sales once product sales commence[124] Regulatory Environment - The FDA approval process for biologics involves extensive regulation and can take many years, requiring substantial financial resources[138] - The company must comply with Good Clinical Practice (GCP) and federal regulations during clinical trials, which are conducted in three phases to establish safety and efficacy[142][144] - A Biologics License Application (BLA) must be submitted to the FDA after clinical testing, with a review process that can take up to ten months for standard reviews and six months for priority reviews[147][149] - The FDA may require a risk evaluation and mitigation strategy (REMS) as a condition of BLA approval, which can impact market potential and profitability[149] - Product approvals can be withdrawn if regulatory compliance is not maintained, and changes to approved products require submission of a new BLA or supplement[150] - Fast track designation may be granted for products intended to treat serious conditions with no effective treatment, allowing for more frequent interactions with the FDA[152] - Breakthrough therapy designation requires preliminary clinical evidence indicating substantial improvement over existing therapies, with a determination made within 60 days of the request[155] - Accelerated approval can be granted based on surrogate endpoints that predict clinical benefit, particularly in long disease courses like cancer, contingent on post-approval confirmatory studies[157] - Regenerative Medicine Advanced Therapy (RMAT) designation allows for expedited development of regenerative medicine products, facilitating closer collaboration with the FDA[158] Market and Competitive Landscape - The biotechnology and pharmaceutical industries are characterized by intense competition, with the company facing potential competition from various sources including major pharmaceutical companies and academic institutions[127] - The company faces significant competition from larger pharmaceutical and biotechnology firms with greater financial resources and expertise in R&D, manufacturing, and regulatory approvals[128] - The company is expanding its focus to treat fibrotic diseases, particularly non-alcoholic fatty liver disease (NAFLD), for which there are currently no FDA-approved therapies[131] - The company is aware of several competitors developing IL-2 programs for Treg cell expansion, including Amgen, Roche, and Bristol Myers Squibb[134] Compliance and Legal Risks - The company is subject to various state and federal healthcare laws, which may involve substantial compliance costs and potential penalties for violations[176] - The company must navigate complex coverage and reimbursement processes for its pharmaceutical products, which can vary significantly by payor[182] - The Biden administration's healthcare reforms may lead to further reductions in coverage and reimbursement levels for pharmaceutical products, impacting pricing strategies[185] - Compliance with the GDPR may result in fines of up to €20 million or 4% of annual global revenues for noncompliance, increasing operational risks[181] - The company faces challenges in obtaining regulatory approvals for clinical trials in foreign countries, which can delay market entry[188] - The new EU Clinical Trials Regulation aims to streamline the approval process for clinical trials, potentially reducing time to market[192] - The company must comply with extensive pre- and post-market regulations for advanced therapy medicinal products (ATMPs) in the EU[196] - The company is required to report certain payments and transfers of value to healthcare practitioners, which may affect marketing strategies[174] - The company may incur significant legal expenses due to investigations related to compliance with healthcare laws, diverting management's focus from core operations[176] - The company must implement compliance programs to mitigate risks associated with healthcare regulations, which can be costly and complex[176] Pharmacovigilance and Market Authorization - The holder of a marketing authorization must comply with EU pharmacovigilance legislation, which includes ongoing assessments of risks and benefits of medicinal products[207] - The evaluation timeframe for a centralized marketing authorization application is 210 days, typically taking a year or more unless eligible for accelerated assessment[201] - Marketing authorizations have an initial duration of five years, which may be renewed for an unlimited period unless limited by the European Commission[200] - The company must maintain a traceability system for each product and its raw materials throughout the supply chain[199] - Regulatory authorities may impose specific obligations as a condition of the marketing authorization[198] - Non-compliance with EU laws may result in administrative, civil, or criminal penalties, including product withdrawals and recalls[206]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) HCW Biologics Inc. (Exact Name of Registrant as Specified in its Charter) | Delaware | 82-5024477 | | --- | --- | | ( State or other jurisdiction of | (I.R.S. Employer | | incorporation or organization) | 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 Securit ...

WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION For the transition period from to Commission File Number: 001-40591 HCW Biologics Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 82-5024477 ( State or ...