Welcome to the HCW Biologics, Inc. 2026 annual stockholder meeting.
Good morning. I would like to note that during Dr. Wong's opening remarks, we may make forward-looking statements regarding future events which involve certain risks and uncertainties. Such statements are only predictions, and actual events or results could differ materially from those predictions due to a number of risks and uncertainties. I refer you to the documents the company files from time to time with the SEC, specifically the company's most recently filed annual report on Form 10-K, which was filed on March 31st, 2026, and its most recently filed quarterly report on Form 10-Q, which was filed on May 14th, 2026. These documents contain and identify important factors that could cause actual results to differ materially from those contained in our projections or forward-looking statements. Dr. Wong, our Founder and Chief Executive Officer, will be making opening remarks. Dr. Wong?
Thank you, Nicole. Good morning. This is Hing C. Wong, Founder and CEO of HCW Biologics, Inc. I also have the privilege of serving our stockholders as a member of HCW Biologics Board of Directors. Thank you to our stockholders for your continued support. I want to share an update that I hope conveys to you that we have earned it. In the last year, we have achieved many milestones. We have raised $17.5 million in equity, which we have used this fund to open, initiate, and progress the HCW9302 phase I clinical trial to complete the assessment of the 50 molecule we create with our proprietary platform technology, TRBC, and to restructure, settle, and repay $18 million of troubled debt. On November 17, 2025, we initiate dose-escalating phase I clinical trial to evaluate HCW9302 in alopecia areata.
This is a skin autoimmune disease. Two dose cohort have completed, and the first cohort enrollment is continuing. We analyzed the finding. We are on track to provide a preliminary human data read-out from this trial in the first half of 2026. We have seen patient enrollment continue on pace to complete this study by the end of this year and to identify the recommend phase II dose for our planned phase II trials early next year. A full phase I read-out in Q4 2026 is expected. The TRBC molecules we select for clinical trials including T-cell engager, and we call it the Big BiTE. The reason we call it the Big BiTE, because the traditional BiTE have a lot of deficiency. We actually use our technology to create, to enhance the efficacy of components to equip them to against solid tumor.
The best-in-class T-cell engager we select for clinical development is HCW11-018b. It is actually a tetravalent with four binding domain. In preclinical trial, they have been shown to diffuse into the tumor and actually able to really activate and the T-cell to be antigen-specific against pancreatic cancer. HCW's 18b utilize a so-called a cis-binding mechanism and able the molecules to be more effective and also have a much better safety profile. We expect the IND will be filed in the first half of 2027 to seek authorization for clinical development in patient with solid tumor. We particularly interest in focusing on pancreatic, ovarian, cervical, and mesothelioma as well as glioblastoma. This molecule and the entire TRBC Platform is already attract the attention of a very large pharmaceutical companies. They are interested in our technology.
We are excited for the potential of this molecule and the entire TRBC Platform technology. The other best in class we select for clinical development is HCW11-040. We continue to believe this molecule could be a franchise-building molecule that could be the breakout window our portfolio of over 50 different molecules. HCW11-040 is made with the genetic form of KEYTRUDA, and in animal trial and in the lab, this molecule is outperforming KEYTRUDA. It expands and activate the memory T-cell much better than KEYTRUDA monotherapy. This also expand a group of cell called progenitor exhausted T cell, we call it the TPEX. This type of cell is the reason our patient respond to a checkpoint inhibitor just like KEYTRUDA. Our mouse analog is very interesting.
It actually can prevent a senescence-associated dysplasia we call bronchopulmonary dysplasia, in short is BPD, in a very stringent mouse model. IND enabling study are underway for HCW11-040. We expect to complete in the second half of 2027, then we would immediately file an IND application to evaluate HCW11-040 in BPD. We chose this orphan indication, BPD, because it is a serious unmet medical need for neonatal infants. Because our medical technology advanced, today, a lot of the infant can survive even though it's just a 25-week gestation. Unfortunately, to really keep them and to survive, we had to use high oxygen chamber, and the high oxygen chamber caused this disease and BPD. As I mentioned before, we have seen our mouse analog homolog is very effective to prevent BPD. Now this BPD, if it's untreated, of course, today have no effective medication for this disease.
They will go on and they survive, and they will develop a long-term respiratory problem, including asthma and also cardiovascular problem. By working on treatment for this indication, we may be able to take advantage of the voucher program offered by the U.S. FDA. If we are success in obtaining a voucher, we will be entitled to expedite review of a future, potentially more profitable drug, significantly reduce the standard reviews time. We always consider licensing and other business development deals as one of the pillar of our financing and clinical development strategy. As of March 2026, HCW11-006 was licensed to Trimmune for in vivo use. Under the Trimmune's license, we have an option to reclaim rights for the U.S. markets after their completion of phase I study in China. The option required no payment to exercise and is royalty-free.
We also have exercised our option to regain the in vitro right of HCW9206 and 9201 from Wugen by terminating the Wugen license. These molecules are commercial-ready reagent. We are in discussion with potential corporate partners. We expect to close a reagent license deal with a biomanufacturing company for commercialization of this molecule as reagent used to support a more effective and lower-cost manufacturing process for CAR T and the other cell-based therapy before the end of this year. We head into the next year with the possibility of multiple active phase I and phase II clinical trial to be underway in 2027. We will be able to do this with a much lighter burden from debt on our balance sheet. We look forward to a very bright future and hope you will stay with us on this journey.
I would like to turn the meeting over to our Chairman, Scott Garrett.
Thank you, Hing. Welcome to the 2026 annual meeting of shareholders, which I will now call to order. Before proceeding further, let me introduce the non-employee directors, who in addition to myself, are with us today, being Lisa Giles and Rick Greene. Also in attendance today from HCW Biologics executive staff are Hing Wong, CEO and Director, Rebecca Byam, Chief Financial Officer, Peter Rhode, Chief Scientific Officer and Vice President of Clinical Operations, Lee Flowers, Senior Vice President, Business Development, Jack Egan, Vice President, Manufacturing and Quality Control, and Nicole Valdivieso, Vice President, Legal Affairs. Also present are representatives from our outside corporate counsel, Clark Hill, and from Crowe LLP, our independent public accounting firm. Rebecca Byam is acting as Inspector of Election for this meeting and has executed an Oath of the Inspector of Election. The rules of procedure are posted on the virtual annual meeting website.
Please review them. In order to conduct an orderly meeting and give all eligible stockholders and proxy holders an opportunity to participate, we ask that you adhere to these rules at all times. An opportunity will be provided to present questions during the question and answer session of the annual meeting. However, please note that you may submit questions at any time during this virtual annual meeting in the space provided on the virtual annual meeting screen. Please follow the instructions provided on the virtual annual meeting screen to submit questions. We intend to make every effort to answer all the questions. However, if multiple questions are submitted on the same topic, we will summarize and respond collectively. I will now turn the meeting over to Nicole Valdivieso, our Vice President, Legal Affairs, who is acting as Secretary of the meeting.
Thank you, Scott. The board fixed April 22nd, 2026, as the record date for determining stockholders entitled to notice of and to vote at this meeting. An affidavit has been given to the Inspector of Elections attesting to the fact that the notice of meeting, the proxy statement, and the company's 2026 annual report to stockholders were mailed to all stockholders of record beginning April 30th, 2026. As of the close of business on April 22nd, 2026, HCW Biologics had outstanding and entitled to vote 6,734,104 shares of common stock, each of which is entitled to one vote. Based on the tabulation of proxies already received from stockholders and to the best of our knowledge, there are present at this meeting a quorum for the transaction of business.
The final report of the Inspector of Elections will include the votes, if any, of stockholders present and voting at this meeting. It is now 10:14 A.M. The polls are now open for voting. Any stockholders desiring to vote should do so at this time through the Internet using the virtual annual meeting website. If you have not yet voted, or if you have previously voted and you now wish to revoke your proxy and change your vote, you may do so by clicking on the Vote Here button on the right-hand side of the screen. Any proxy may be revoked at any time before the polling is closed by the electronic submission of a later dated vote at the meeting, as I just described. We have five proposals from the company that stockholders are being asked to approve.
The first item of business is to elect the Class II Directors of HCW Biologics, Lisa M. Giles and Rick S. Greene. The second item of business is to ratify the appointment of Crowe LLP as our independent registered public accounting firm for the year ending December 31st, 2026. The third item of business is to approve an amendment to the company's certificate of incorporation on or before the one-year anniversary of this annual meeting to implement one or more reverse stock splits of the outstanding shares of the company's common stock as necessary to maintain a listing of our common stock on the Nasdaq stock market in an aggregate range from one for five up - one for 20.
The fourth item of business is to approve, for purposes of complying with Nasdaq Listing Rule 5635(d), the issuance of shares of our common stock upon exercise of up to 2,477,292 common stock purchase warrants issued pursuant to a securities purchase agreement dated February 17th, 2026, entered into in connection with the company's follow-on public offering of units, consisting of one share of common stock purchased for $0.6055 and one common warrant, which may be exercised to purchase one share of common stock for $0.6055.
The fifth item of business is to approve, for purposes of complying with the Nasdaq Listing Rule 5635(d), the repricing of certain warrants issued on November 20, 2025, to purchase up to 3,020,410 shares of our common stock pursuant to an existing warrants amendment agreement dated February 17, 2026, to reduce the exercise price of the existing warrants to $0.6055 per share and to approve the issuance of shares of common stock upon the exercise of existing warrants as amended. Detailed information concerning these proposals is in the proxy statement sent or made available to HCW Biologics stockholders. We will now have a brief question and answer period on these proposals. If you have a question, please submit your question in the space provided on the virtual meeting screen and follow the instructions provided on the virtual meeting screen.
The time allotted for question and answers has expired. Is there anyone else who wishes to vote at the virtual meeting and who has not yet submitted their vote? All votes should be submitted through the Internet using the virtual meeting website at this time because votes cannot be accepted after the polls are closed, which will happen momentarily. All votes being submitted. It is now 10:18 A.M. and the polls are now closed. Based on the information we have received from our Inspector of Elections, I will now announce the preliminary voting results from the meeting, which remains subject to the Inspector of Elections' final report. The nominees, Lisa M. Giles and Rick S. Greene, have been elected. Crowe LLP has been ratified as HCW Biologics' independent registered public accounting firm for the year ending December 31, 2026. The reverse stock split has been approved.
The issuance of shares upon exercise of common warrants has been approved. The warrant repricing has been approved. Final results of the vote will be recorded as stated in the minutes of this meeting and also filed with the Securities and Exchange Commission on a Form 8-K within four business days. I'll now turn it over to Mr. Garrett.
This concludes the formal business of the meeting. The 2026 annual meeting is now adjourned. I would like to thank you for attending today's virtual meeting.
We will now entertain questions concerning matters that any of the stockholders of record may have. We will take stockholder questions that are being entered now on the web portal. Please note, we will attempt to answer as many questions as time allows, but only questions that are germane to the meeting will be addressed. I will pause to see if there's any questions coming in. I see no further questions, so I'll turn it over to Mr. Garrett to close the meeting.
Thank you, Nicole. I want to thank all of you for attending today's meeting and for the interest you've shown in the affairs of our company. As you could tell from Dr. Wong's comments, the company has made great progress over the course of the last 12 months. We very much appreciate your attendance, and as always, thank you for your support.
This concludes today's meeting. Thank you for attending. You may now disconnect and have a wonderful rest of your day.