- Established a Analysis Collaboration with the McGowan Institute for Regenerative Medication on the College of Pittsburgh to Examine the Restore and Regeneration of the Colon following Colectomy
- Established a Collaboration with Hugh Taylor, MD, chair of Obstetrics, Gynecology & Reproductive Sciences at Yale College of Medication to Restore and Regenerate the Uterus
- Activated the second scientific trial web site with the College of Michigan in August 2023 to increase the screening of sufferers.
- Obtained approval of an Orphan Illness Utility for our lead product, the Cellspan Esophageal Implant by the European Medicines Company (EMA for Esophageal Atresia). The EMA is the centralized regulatory company for the evaluate and approval of latest medicines within the European Union.
- Activated Mayo Clinic as The First Web site for Scientific Trial in Extreme Esophageal Illness
- Firm’s subsidiary in Hong Kong launched its longevity product enterprise in Asia, producing greater than $100,000 in 2023 gross sales.
- Entered into securities buy agreements with accredited buyers for a $6 million non-public funding in public fairness (PIPE) financing. The transaction closed on April 6, 2023.
Holliston, MA, April 02, 2024 (GLOBE NEWSWIRE) — Harvard Apparatus Regenerative Technology, Inc. (OTCQB: HRGN) (“Harvard Equipment Regenerative Know-how” or the “Firm”), a clinical-stage biotechnology firm creating the expertise to regenerate organs contained in the physique to deal with extreme ailments, as we speak reported fourth quarter and full 12 months 2023 monetary outcomes.
Fourth Quarter 2023 Monetary Outcomes
For the three months ended December 31, 2023, the Firm reported a internet lack of $1.8 million, ($0.13) per share, in comparison with a internet lack of $1.6 million, ($0.14) per share, for the three months ended December 31, 2022. The $0.2 million year-over-year internet loss improve was due primarily to share-based compensation expense of $0.3 million from the vesting of time-based awards within the fourth quarter of 2023 and elevated headcount associated prices of roughly $0.1 million offset by decreased pre-clinical actions.
Full Yr 2023 Monetary Outcomes
For the 12 months ended December 31, 2023, the Firm reported a internet lack of $9.0 million, ($0.67) per share, in comparison with a internet lack of $6.3 million, ($0.55) per share, for the 12 months ended December 31, 2022. The $2.8 million year-over-year internet loss improve was because of scientific trial actions leading to our activation of two websites, elevated headcount prices and a rise in share-based compensation expense from the vesting of performance-based awards in 2023.
Steadiness Sheet and Money and Money Equivalents
At December 31, 2023, the Firm had working money on-hand as of $0.4 million. The Firm acquired $0.5 million in debt financing from a associated social gathering in February 2024.
Through the 12 months ended December 31, 2023, the Firm used internet money in operations of $6.9 million and acquired $6.1 million from financing actions and consisted of internet proceeds acquired from a non-public placement transaction for the issuance of widespread inventory and inventory possibility workouts.
About Harvard Equipment Regenerative Know-how, Inc.
We’re a clinical-stage biotechnology firm creating regenerative-medicine therapies for issues of the gastro-intestinal system and different organs ensuing from most cancers, trauma or beginning defects. Our expertise is predicated on our proprietary cell-therapy platform that makes use of a affected person’s personal stem cells to regenerate and restore operate to broken organs. We imagine that our expertise represents a next-generation answer for restoring organ operate as a result of it permits the affected person to regenerate their very own organ, thus eliminating the necessity for human donor or animal transplants, the sacrifice of one other of the affected person’s personal organs or everlasting synthetic implants.
We performed the world’s first profitable regeneration of the esophagus in a affected person with esophageal most cancers in August 2017. This surgical procedure was carried out by Dr. Dennis Wigle, Chair of Thoracic Surgical procedure on the Mayo Clinic. The outcomes had been printed within the Journal of Thoracic Oncology Scientific and Analysis Studies in August 2021. The process demonstrated that our expertise was capable of efficiently regenerate esophageal tissue, together with the mucosal lining, to revive the integrity, continuity and performance of the esophageal tube.
HRGN has 13 issued U.S. patents, 2 issued in China, 1 issued in Japan, 2 issued in Europe and a pair of orphan-drug designations which might present seven years of market exclusivity as soon as we gained the market approval.
For extra data, please go to www.hregen.com and join with the Firm on LinkedIn.
Ahead-Trying Statements
A number of the statements on this press launch are “forward-looking” and are made pursuant to the protected harbor provision of the Personal Securities Litigation Reform Act of 1995. These “forward-looking” statements on this press launch embody, however should not restricted to, statements referring to the capabilities and efficiency of our merchandise and product candidates; growth expectations and regulatory approval of any of the Firm’s merchandise, by the U.S. Meals and Drug Administration, the European Medicines Company or in any other case, which expectations or approvals might not be achieved or obtained on a well timed foundation or in any respect; and success with respect to any collaborations, scientific trials and different growth and commercialization efforts of the Firm’s merchandise, which such success might not be achieved or obtained on a well timed foundation or in any respect. These statements contain dangers and uncertainties that will trigger outcomes to vary materially from the statements set forth on this press launch, together with, amongst different issues, the Firm’s incapacity to acquire wanted funds within the speedy future; the Firm’s means to acquire and keep regulatory approval for its merchandise; plus different components described underneath the heading “Merchandise 1A. Threat Components” within the Firm’s Annual Report on Kind 10-Ok for the fiscal 12 months ended December 31, 2023 or described within the Firm’s different public filings. The Firm’s outcomes may additionally be affected by components of which the Firm shouldn’t be presently conscious. The forward-looking statements on this press launch converse solely as of the date of this press launch. The Firm expressly disclaims any obligation or enterprise to launch publicly any updates or revisions to such statements to mirror any change in its expectations with regard thereto or any modifications within the occasions, situations or circumstances on which any such assertion is predicated.
Investor Relations Contacts
Joseph Damasio
Chief Monetary Officer
774-233-7330
[email protected]
HARVARD APPARATUS REGENERATIVE TECHNOLOGY, INC.
CONSOLIDATED BALANCE SHEETS
(In 1000’s, besides par worth and share information)
| December 31, | December 31, | |||||||
| 2023 | 2022 | |||||||
| ASSETS | ||||||||
| Present belongings: | ||||||||
| Money and money equivalents | $ | 432 | $ | 1,241 | ||||
| Accounts receivable | 4 | — | ||||||
| Stock | 50 | — | ||||||
| Pay as you go analysis and growth | 210 | 274 | ||||||
| Pay as you go bills and different present belongings | 87 | 79 | ||||||
| Whole present belongings | 783 | 1,594 | ||||||
| Property, plant and gear, internet | 25 | 49 | ||||||
| Proper-of-use belongings, internet | 48 | 147 | ||||||
| Deferred financing prices | 544 | 610 | ||||||
| Lengthy-term pay as you go contracts | 1,214 | — | ||||||
| Whole belongings | $ | 2,614 | $ | 2,400 | ||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT) | ||||||||
| Present liabilities: | ||||||||
| Accounts payable | $ | 445 | $ | 682 | ||||
| Accrued and different present liabilities | 475 | 582 | ||||||
| Working lease legal responsibility, present | 48 | 99 | ||||||
| Whole present liabilities | 968 | 1,363 | ||||||
| Working lease legal responsibility, internet of present portion | — | 48 | ||||||
| Whole liabilities | 968 | 1,411 | ||||||
| Commitments and contingencies | ||||||||
| Sequence E convertible most popular inventory, par worth $0.01 per share, 5,000 shares licensed; 0 and 4,180 shares issued and excellent at December 31, 2023 and 2022, respectively | — | 4,180 | ||||||
| Stockholders’ fairness (deficit): | ||||||||
| Frequent inventory, par worth $0.01 per share, 60,000,000 shares licensed; 13,947,324 and 12,174,467 issued and excellent at December 31, 2023 and 2022, respectively | 139 | 122 | ||||||
| Extra paid-in capital | 93,463 | 79,698 | ||||||
| Collected deficit | (91,956 | ) | (83,011 | ) | ||||
| Whole stockholders’ fairness (deficit) | 1,646 | (3,191 | ) | |||||
| Whole liabilities and stockholders’ fairness (deficit) | $ | 2,614 | $ | 2,400 | ||||
HARVARD APPARATUS REGENERATIVE TECHNOLOGY, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(In 1000’s, besides per share quantities)
| Three Months Ended | Yr Ended | |||||||||||||||
| December 31, | December 31, | |||||||||||||||
| 2023 | 2022 | 2023 | 2022 | |||||||||||||
| Product income | $ | 63 | $ | — | $ | 103 | $ | — | ||||||||
| Working bills: | ||||||||||||||||
| Price of gross sales | 11 | — | 24 | — | ||||||||||||
| Analysis and growth | 648 | 744 | 3,062 | 1,742 | ||||||||||||
| Gross sales and advertising and marketing | 96 | — | 294 | — | ||||||||||||
| Basic and administrative | 1,136 | 749 | 5,713 | 4,411 | ||||||||||||
| Whole working bills | 1,891 | 1,493 | 9,093 | 6,153 | ||||||||||||
| Working loss | (1,828 | ) | (1,493 | ) | (8,990 | ) | (6,153 | ) | ||||||||
| Different revenue (expense), internet: | ||||||||||||||||
| Sublease revenue | — | — | — | 87 | ||||||||||||
| Change in honest worth of warrant legal responsibility | — | 2 | — | 2 | ||||||||||||
| Curiosity revenue | 5 | — | 64 | — | ||||||||||||
| Curiosity expense | (3 | ) | (9 | ) | (14 | ) | (9 | ) | ||||||||
| Different expense | — | 5 | (5 | ) | — | |||||||||||
| Whole different revenue, internet | 2 | (2 | ) | 45 | 80 | |||||||||||
| Internet loss | (1,826 | ) | (1,495 | ) | (8,945 | ) | (6,073 | ) | ||||||||
| Most popular inventory dividends | — | (85 | ) | (77 | ) | (180 | ) | |||||||||
| Internet loss attributable to widespread stockholders | $ | (1,826 | ) | $ | (1,580 | ) | $ | (9,022 | ) | $ | (6,253 | ) | ||||
| Primary and diluted internet loss per share | $ | (0.13 | ) | $ | (0.14 | ) | $ | (0.67 | ) | $ | (0.55 | ) | ||||
| Weighted common widespread shares, primary and diluted | 13,925,333 | 11,615,642 | 13,455,666 | 11,349,610 | ||||||||||||
HARVARD APPARATUS REGENERATIVE TECHNOLOGY, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(In 1000’s)
| Yr ended December 31, | ||||||||
| 2023 | 2022 | |||||||
| OPERATING ACTIVITIES | ||||||||
| Internet loss | $ | (8,945 | ) | $ | (6,073 | ) | ||
| Changes to reconcile internet loss to internet money and money equivalents utilized in working actions: | ||||||||
| Share-based compensation expense | 3,461 | 1,031 | ||||||
| Depreciation | 35 | 52 | ||||||
| Amortization of working right-of-use belongings | 99 | 22 | ||||||
| Change in honest worth of warrant legal responsibility | — | (2 | ) | |||||
| Adjustments in working belongings and liabilities: | ||||||||
| Accounts receivable | (4 | ) | — | |||||
| Stock | (50 | ) | — | |||||
| Pay as you go analysis and growth | 64 | (274 | ) | |||||
| Pay as you go bills and different present belongings | (8 | ) | 216 | |||||
| Deferred financing prices | 66 | (610 | ) | |||||
| Lengthy-term pay as you go contracts | (1,214 | ) | — | |||||
| Accounts payable | (237 | ) | 6 | |||||
| Working lease legal responsibility | (99 | ) | (22 | ) | ||||
| Accrued and different present liabilities | (107 | ) | 548 | |||||
| Internet money utilized in working actions | (6,939 | ) | (5,106 | ) | ||||
| INVESTING ACTIVITIES | ||||||||
| Purchases of short-term investments | (2,523 | ) | — | |||||
| Redemption of short-term investments | 2,523 | — | ||||||
| Purchases of property, plant and gear | (11 | ) | (5 | ) | ||||
| Internet money utilized in investing actions | (11 | ) | (5 | ) | ||||
| FINANCING ACTIVITIES | ||||||||
| Proceeds from issuance of widespread inventory | 5,992 | 5,060 | ||||||
| Proceeds from train of inventory choices | 149 | — | ||||||
| Internet money supplied by financing actions | 6,141 | 5,060 | ||||||
| Internet lower in money and money equivalents | (809 | ) | (51 | ) | ||||
| Money and money equivalents firstly of the 12 months | 1,241 | 1,292 | ||||||
| Money and money equivalents on the finish of the 12 months | $ | 432 | $ | 1,241 | ||||
| SUPPLEMENTAL INFORMATION | ||||||||
| Curiosity paid in money | $ | 14 | $ | 9 | ||||
| Supplemental disclosure of non-cash actions: | ||||||||
| Settlement of contingency matter | $ | — | $ | (3,250 | ) | |||
| Settlement of because of Harvard Bioscience included in accrued and different present liabilities | $ | — | $ | (750 | ) | |||
| Issuance of Sequence E convertible most popular inventory | $ | — | $ | 4,000 | ||||
| Most popular inventory dividends | $ | 77 | $ | 180 | ||||
| Enhance of right-of-use asset and legal responsibility because of lease extension | $ | — | $ | 63 | ||||
