1. Investment Snapshot
2. Thesis
3. Valuation & Price Target
4. Business & Product Moat
5. People & Governance
6. Market & Macro
7. Financial Quality
8. Risk Register
9. Prediction Market
10. 𝕏 Posts
Discussion
1. Investment Snapshot
2. Thesis
3. Valuation & Price Target
4. Business & Product Moat
5. People & Governance
6. Market & Macro
7. Financial Quality
8. Risk Register
9. Prediction Market
10. 𝕏 Posts
Discussion
1. Investment Snapshot
2. Metrics vs Peers
3. Price Chart
4. Valuation
5. Offer Terms
6. Financial Statements
Discussion
Research report, target price, DCF and forensic scores are for subscribers. View plans
Symbol
HCWB
Listed on
2021-07-20
Sector
Health Care
Subsector
Pharmaceuticals
Offer Price
$8.00
first filed $8.00–$10.00Shares Offered
7M
35.65M
$285.2M
19.6%
Implied Upside vs Midpoint
Description
We are an innovative preclinical stage biopharmaceutical company focused on discovering and developing novel immunotherapies to lengthen health span by disrupting the link between chronic, low-grade inflammation and age-related diseases. We believe age-related low-grade chronic inflammation, or “inflammaging,” is a significant contributing factor to several chronic diseases and conditions, such as cancer, cardiovascular disease, diabetes, neurodegenerative disease, and autoimmune disease. We believe our approach has the potential to provide an innovative treatment of these age-related diseases. --- Our gateway indication is oncology. Advances in immuno-stimulatory and anti-immunosuppressive therapeutics have revolutionized cancer treatment. Our lead molecule, HCW9218, is designed with both of these functionalities – it rejuvenates the immune system to reduce senescence, and it captures transforming growth factor-ß (“TGF-ß”) to neutralize its immunosuppressive activity. We are preparing to submit an investigational new drug application (“IND”) for a Phase 1b/2 clinical trial in pancreatic cancer to evaluate HCW9218, which includes completing drug product testing and nonclinical animal toxicity/pharmacokinetic studies, as well as finalizing clinical protocol. Pending submission and the U.S. Food and Drug Administration’s (“FDA”) acceptance of the IND to proceed, we expect to initiate this clinical trial by the end of 2021 after obtaining Institutional Review Board (“IRB”) approval of our clinical research, completing clinical site initiation, and finalizing clinical trial agreements. However, we have not submitted the IND for the planned trial, and we cannot provide any assurance that the FDA will authorize us to initiate our planned clinical trials on a timely basis, or at all. In the event that the FDA does not accept our IND, we may also be required to seek feedback, and the feedback may be unfavorable. In the event we do not receive feedback on a timely basis, or we are required to change the design of our clinical protocol or address other feedback, clinical development of our products would be delayed and our costs may increase. Moreover, if the FDA does not accept the IND we file, we may be required to conduct additional preclinical testing or other IND-enabling activities, which would result in further delay and additional costs. We are initially developing HCW9218 as an injectable immunotherapeutic for patients with solid tumors. Our initial goal is to evaluate HCW9218 in patients with cancer as we attempt to minimize the side effects of chemotherapy through stimulating anti-tumor effector immune cell responses, blocking TGF-ß immunosuppressive activity, eliminating chemotherapy-induced senescent cells in tumors and normal tissues (i.e., senolytic effect), and reducing senescence-associated secretory phenotype (“SASP”) factor activity (i.e., senomorphic effect). We are leveraging extensive clinical expertise to structure clinical trials with clear, objective, and measurable endpoints. We expect to manage our clinical trials internally, relying on our in-house expertise in managing clinical trials conducted in collaboration with National Cancer Institute (NCI)-Designated Comprehensive Cancer Centers. Currently, we are engaged in preliminary discussions with seven leading institutions who have shown interest in participating in our clinical trials as clinical sites. We are presently working with the identified Principal Investigators from these institutions to establish clinical development strategies for our product candidates and to refine study protocols for pancreatic, ovarian, breast, prostate, and colorectal cancer trials. Because the discussions with these clinical sites and Principal Investigators are considered preliminary, we are not certain we will be successful in reaching an agreement with any or all of these institutions. The course of these discussions and whether we might need to identify alternative clinical sites could impact the start date for our clinical trials. Any delays in our clinical trials could increase our costs and slow down the development and approval process, which could harm our commercial prospects. The aim of the Phase 1b/2 clinical trial in pancreatic cancer is to evaluate HCW9218 as an adjunct therapy to chemotherapy. The Phase 1b portion will be a dose escalation study of HCW9218 as monotherapy in refractory patients with advanced pancreatic cancer. The Phase 2 portion of this clinical trial will include a cohort of patients receiving HCW9218 as monotherapy and a cohort of patients receiving HCW9218 as an adjunct to chemotherapy. Pending submission and FDA acceptance of the IND to proceed with a company-sponsored Phase 1b/2 clinical trial to evaluate HCW9218 in patients with pancreatic cancer, we plan to have an additional clinical trial to evaluate HCW9218 in solid tumors with an investigator-sponsored IND. Our ability to proceed with this trial depends on the submission and acceptance of both INDs for our company-sponsored pancreatic cancer clinical trial and the investigator-initiated solid tumor clinical trial as well as finalizing our agreement with the sponsor. We are currently engaged in preliminary discussions with an institution that has expressed interest to be a sponsor for an IND using HCW9218 as an adjunct to chemotherapy in patients with solid tumors (breast, ovarian, prostate, and colorectal cancers). However, these discussions are preliminary, and we may not succeed in reaching an agreement with this institution. Depending on the course of these discussions and whether we need to seek an alternative sponsor for an IND, there could be a delay in initiating a Phase 1b/2 clinical trial to evaluate HCW9218 in patients with solid tumors. Any delays in our clinical trials could increase our costs and slow down the development and approval process, which could harm our commercial prospects. We have internally-developed over 30 molecules using our TOBI (Tissue factOr-Based fusIon) platform. Our core focus will be development of our lead product candidates, HCW9218 and HCW9302, as transformative immunotherapeutics, administered subcutaneously. We are actively seeking to out-license certain rights for molecules with great potential but outside of our focus area. We signed our first out-license agreement at the end of 2020 when we entered into an exclusive worldwide license with Wugen, Inc. (“Wugen”), a company that specializes in cell-based therapies for cancer. Wugen licensed limited rights to develop cell therapy treatments for cancer based on two of our internally-developed multi-cytokine fusion protein molecules, one of which is our clinical-stage molecule, HCW9201. This molecule is currently being evaluated for generation of memory-like NK (“ML-NK”) cell products in two Phase 2 studies in patients with relapse/refractory acute myeloid leukemia (“r/r AML”) in trials that are initiated by Washington University and supported by Wugen. Patient enrollment and treatment have commenced, and preliminary data from these clinical trials are expected to begin to become available in the second half of 2021. --- We were incorporated in Delaware on April 2, 2018. Our principal executive offices are located at 2929 N Commerce Parkway, Miramar, FL 33025. Our telephone number at that location is (954) 842-2024. Our corporate website address is www.hcwbiologics.com.
| Metric | Value | Peer median | Among peers | |
|---|---|---|---|---|
EV / revenue | 67.5x | — | — | |
Operating margin | -142% | — | — | |
Net margin | -142% | — | — | |
Free cash flow margin | -259% | — | — | |
Net cash / market cap | 3.0% | 4.9% | ||
Debt / equity | 0.00 | 0.00 | ||
Current ratio | 12.14 | 7.18 | ||
Stock comp / revenue | 0.5% | — | — | |
9 premium metrics: DCF value / price, Growth the price needs: how common, Last 12 months vs full year and 6 more Unlock | ||||
▼ Priced at $8.00, 11% below the midpoint of the first filed range ($8.00–$10.00, 2021-07-07).
Each filing is plotted ahead of the first trading day on the price chart.
| Filed | Form | Price range | Price | Shares offered | Deal size |
|---|---|---|---|---|---|
| 2021-07-07 | S-1/A | $8.00–$10.00 | — | 5,600,000 | $50.4M |
| 2021-07-09 | S-1/A | $8.00–$10.00 | — | 5,600,000 | $50.4M |
| 2021-07-21 | 424B4 | — | $8.00 | 7,000,000 | $56.0M |
HCW Biologics Inc. income statement and balance sheet, FY Dec 2022 to FY Dec 2025, as reported in SEC filings.
| Metric | FY Dec 2022after listing | FY Dec 2023after listing | FY Dec 2024after listing | FY Dec 2025after listing |
|---|---|---|---|---|
| Revenue | $6.7M | — | $2.6M | $54.2K |
| Gross profit | $2.6M | — | $959K | $10.8K |
| Operating income | ($15.1M) | — | ($29.5M) | ($13.2M) |
| Net income | ($14.9M) | — | ($30.0M) | ($8.0M) |
| Revenue growth | — | — | — | −97.9% |
| Gross margin | 38.5% | — | 37.4% | 20.0% |
| Operating margin | −224% | — | −1148% | −24271% |
| Net margin | −222% | — | −1170% | −14677% |
| Metric | FY Dec 2022after listing | FY Dec 2023after listing | FY Dec 2024after listing | FY Dec 2025after listing |
|---|---|---|---|---|
| Total assets | $46.8M | — | $30.2M | — |
| Total liabilities | $9.4M | — | $37.0M | — |
| Total equity | $37.4M | $13.5M | ($6.8M) | — |
| Cash & equivalents | $22.3M | $3.6M | $4.7M | — |