Harvard Apprats Reg Tch

Q2 2023 Earnings Conference Call

8/14/2023

spk01: Greetings. Welcome to Harvard Apparatus' Regenerative Technologies' second quarter 2023 conference call. At this time, all participants are in listen-only mode. A question and answer session will follow the formal presentation. If anyone this morning should require operator assistance during the conference, please press star zero from your telephone keypad. As a reminder, this conference is being recorded. At this time, I'll hand the conference over to Joe Damasio. Joe, you may now begin.
spk02: Thank you, Rob. Good morning, this is Joe DiMaggio, Chief Financial Officer. On the call with me today is Jerry He, our Chairman and Chief Executive Officer. Before I turn it over to Jerry, let me review the company's forward-looking statements. In our discussion today, we will make statements that constitute forward-looking statements. Our actual results and performance may differ materially from what we have previously projected due to risks and uncertainties. including those detailed in our annual report on Form 10-K for the year ended December 31, 2022, and our other public filings. Any forward-looking statements, including those related to our future results and activities, represent our estimates as of today and should not be relied upon as representing our estimates at any subsequent day. Additionally, any material, financial, or statistical information presented in the call which is not included in our press release will be archived and available in the investor section of our website under events and presentation. Now I will turn it over to Jerry.
spk00: Thank you, Joe. Welcome everyone to this quarterly conference call for Regen to discuss earnings and the related matters. Ex-Regen has had a number of developments in the first half of 2023. We changed our corporate name back to Harvard Apparatus Regenerative Technology, Inc., and have been trading under the ticker HRGN since July 20, 2023. Concurrently, the company launched a new website, www.hrgen.com, to provide greater clarity and visibility for its regenerative technology and expanding strategies on regeneration or anti-aging. The company intends to use the Harvard Apparatus regenerative technology name on its new anti-aging business, which launched in China. We expect this business to do cash flow positives in the current fiscal year of 2023. This positive cash flow will help to fund our clinical trials in the US while gaining understanding the China market for its regenerative technology. We officially activated the first clinical trial site with Mayo Clinic and are currently screening patients in the third quarter of 2023. The initiation of our first clinical study for self-blend esophageal implant, or CEI for short, marked an important milestone for each region. Our numerous preclinical studies have demonstrated our technology as an effective platform for tubular organ regeneration. We look forward to testing CEI in the clinics as we further our understanding of its potential benefits for patients and bringing the treatment to patients as soon as possible. In the second quarter of 2023, the company subsidiaries in Hong Kong, Harvard Apparatus Regenerative Technology Limited, or HRGN Limited, started a consumer health business. The consumer health business will include a broad range of products focused on anti-aging dietary supplements. The company plans to start selling anti-aging supplements through the Hong Kong subsidiary in the third quarter of 2023. These products are marketed to the general public and initially targeted at consumers in the Great China region through e-commerce online sales. We also closed private placement of shares in the company for approximate proceeds of $6 million. in March, we laid out the groundwork for us to be able to raise additional capital and to apply to relist our NASDAQ. I think it's worth recapping some of the additional milestone achievements that got us here. First, we performed the first ever regeneration of esophagus in a human cancer treatment patient. This was performed by Dr. Dennis Wiggle, the chair of Thoracic Surgery at Mayo Clinic, one of the world's most respected hospitals. The paper concluded that H. regens esophageal implant would have a considerable clinical use. Other surgeons have described our products as revolutionary and a breakthrough. Second, This perfect human experience is backed up by the research of the esophageal implant in 45 pigs, some of which went on for almost two years. And third, one of these implants was not in the esophagus, but in the bronchus. This pig showed regeneration of a functional bronchus. The patent was issued in Q1 protects this application in the bronchus. The fourth, the FDA approved our clinical trial for a maximum of 10 patients in up to five hospitals in the US. This trial mirrors both the safety and efficacy in the actual patient population. Hence, it is more like a miniature phase three child than a physical phase one safety study of our pharmaceuticals in health adult volunteers. The fifth, X region has raised over $11 million in the last two years, mostly from private individuals who have gotten known X region is a hedge fund. Number six, we have 13 issued U.S. patents and two issued in China. These cover the bioreactor, scaffold, and the retrievable nature of the scaffold, which leaves no permanent implant in the body. We also have two often brought designations which can provide seven years' exclusivity in addition to the patents in the U.S. from the date of approval of the product. So, Atterergen has accomplished a lot in the last three years, and its current short-term goals are to make progress on clinical trials and pipeline, generate cash flow from consumer health business, and raise additional capital released on NASDAQs. I will now turn this call over to Joe to review the financials for Q2. Joe, please.
spk02: I want to briefly cover the highlights of our second quarter financial results. For the three months ended June 30, 2023, the company reported a net loss of $2.6 million, 19 cents per share, compared to a net loss of 1.4 million, or 12 cents, loss per share for the three months ended June 30, 2022. The $1.2 million year-over-year net loss increase was due primarily to the clinical trial activities resulting in our first site activation. At June 30, 2023, we had cash, cash equivalents, and short-term investments on hand of approximately $4.7 million, and we have no debt. We used $2.6 million in cash for operations, during the six months ended June 30, 2023. As of June 30, 2023, we have received the aggregate proceeds of approximately $6 million from a private placement, which closed on April 12, 2023 of this year. Based on our current operating plan and given consideration to this cash infusion, we expect that our current cash will be sufficient to fund our normal operating expenses and capital expenditure requirements through the first quarter of 2024. And with that, we'll open the- Thank you, Joe. Sure, Jerry.
spk00: Thank you, Joe. We will now open the call for questions.
spk01: Thank you. We'll now be conducting a question and answer session. If you'd like to ask a question, please press star one from your telephone keypad and the confirmation tone will indicate your line is in the question queue. You may press star two if you'd like to move your question from the queue. For participants who are using speaker equipment, It may be necessary to pick up your handset before pressing the star keys. One moment, please, while we poll for questions. Thank you. Once again, if you'd like to ask a question, star 1 from your telephone keypad. Thank you. Thank you. At this time, we have no questions on the phone. And let's turn it back to Jerry for any further remarks.
spk00: Thank you very much for joining us call today. We look forward to making HRGEN a success for both the patient and the shareholders. We look forward to see you again next time. Thank you.
spk01: Thank you. This will conclude today's conference. We disconnect your lines at this time. We thank you for your participation. Have a wonderful day.
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