Harvard Apparatus Regenerative Technology Reports First Quarter 2024 Financial Results and Recent Business Highlights

  • Entered into securities purchase agreements with accredited investors for a $1.5 million private investment in public equity (PIPE) financing. The transaction closed on April 15, 2024.
  • Received $0.5 million in convertible debt from Company’s CEO in February 2024.

Holliston, MA, May 13, 2024 (GLOBE NEWSWIRE) -- Harvard Apparatus Regenerative Technology, Inc. (OTCQB: HRGN) (“Harvard Apparatus Regenerative Technology” or the “Company”), a clinical-stage biotechnology company developing the technology to regenerate organs inside the body to treat severe diseases, today reported first quarter 2024 financial results.

First Quarter 2024 Financial Results

For the three months ended March 31, 2024, the Company reported a net loss of $2.0 million, ($0.15) per share, compared to a net loss of $3.0 million, ($0.24) per share, for the three months ended March 31, 2023. The $1.0 million quarter-over-quarter net loss decrease was primarily due to one-time share-based compensation expense of $1.5 million from the vesting of performance-based awards in the first quarter of 2023 offset by the addition of preclinical trial activities to increase our product pipeline and increased clinical trial activities in Q1 2024.

Balance Sheet and Cash and Cash Equivalents

At March 31, 2024, the Company had operating cash on-hand as of $0.3 million. The Company received $0.5 million in debt financing from a related party in February 2024.

During the three months ended March 31, 2024, the Company used net cash in operations of $1.0 million and received $0.3 million from financing activities which consisted of advances received for a private placement transaction which closed in April 2024 for the issuance of common stock.

About Harvard Apparatus Regenerative Technology, Inc.

We are a clinical-stage biotechnology company developing regenerative-medicine treatments for disorders of the gastro-intestinal system and other organs resulting from cancer, trauma or birth defects. Our technology is based on our proprietary cell-therapy platform that uses a patient’s own stem cells to regenerate and restore function to damaged organs. We believe that our technology represents a next-generation solution for restoring organ function because it allows the patient to regenerate their own organ, thus eliminating the need for human donor or animal transplants, the sacrifice of another of the patient’s own organs or permanent artificial implants.

We conducted the world’s first successful regeneration of the esophagus in a patient with esophageal cancer in August 2017. This surgery was performed by Dr. Dennis Wigle, Chair of Thoracic Surgery at the Mayo Clinic. The results were published in the Journal of Thoracic Oncology Clinical and Research Reports in August 2021. The procedure demonstrated that our technology was able to successfully regenerate esophageal tissue, including the mucosal lining, to restore the integrity, continuity and functionality of the esophageal tube. 

HRGN has 13 issued U.S. patents, 2 issued in China, 1 issued in Japan, 2 issued in Europe and 2 orphan-drug designations which can provide seven years of market exclusivity once we won the market approval.

For more information, please visit www.hregen.com and connect with the Company on  LinkedIn.

Forward-Looking Statements

Some of the statements in this press release are “forward-looking” and are made pursuant to the safe harbor provision of the Private Securities Litigation Reform Act of 1995. These “forward-looking” statements in this press release include, but are not limited to, statements relating to the capabilities and performance of our products and product candidates; development expectations and regulatory approval of any of the Company’s products, by the U.S. Food and Drug Administration, the European Medicines Agency or otherwise, which expectations or approvals may not be achieved or obtained on a timely basis or at all; and success with respect to any collaborations, clinical trials and other development and commercialization efforts of the Company’s products, which such success may not be achieved or obtained on a timely basis or at all. These statements involve risks and uncertainties that may cause results to differ materially from the statements set forth in this press release, including, among other things, the Company’s inability to obtain needed funds in the immediate future; the Company's ability to obtain and maintain regulatory approval for its products; plus other factors described under the heading “Item 1A. Risk Factors” in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023 or described in the Company’s other public filings. The Company’s results may also be affected by factors of which the Company is not currently aware. The forward-looking statements in this press release speak only as of the date of this press release. The Company expressly disclaims any obligation or undertaking to release publicly any updates or revisions to such statements to reflect any change in its expectations with regard thereto or any changes in the events, conditions or circumstances on which any such statement is based.

Investor Relations Contacts

Joseph Damasio
Chief Financial Officer

(In thousands, except par value and share data)

  March 31,  December 31, 
  2024  2023 
Current assets:        
Cash and cash equivalents $272  $432 
Accounts receivable  7   4 
Inventory  44   50 
Prepaid research and development  159   210 
Prepaid expenses and other current assets  135   87 
Total current assets  617   783 
Property, plant and equipment, net  19   25 
Right-of-use assets, net  21   48 
Deferred financing costs  544   544 
Long-term prepaid contracts  1,214   1,214 
Total assets $2,415  $2,614 
Current liabilities:        
Accounts payable $890  $445 
Accrued and other current liabilities  528   475 
Advance from private placement  301    
Convertible debt – related party  500    
Operating lease liability  21   48 
Total current liabilities  2,240   968 
Commitments and contingencies        
Stockholders’ equity:        
Common stock, par value $0.01 per share, 60,000,000 shares authorized; 13,947,324 issued and outstanding at March 31, 2024 and December 31, 2023, respectively  139   139 
Additional paid-in capital  94,023   93,463 
Accumulated deficit  (93,986)  (91,956)
Accumulated other comprehensive loss  (1)   
Total stockholders’ equity  175   1,646 
Total liabilities and stockholders’ equity $2,415  $2,614 

(In thousands, except per share amounts)

  Three Months Ended 
  March 31, 
  2024  2023 
Product revenue $57  $ 
Operating expenses:        
Cost of sales  12    
Research and development  840   509 
Sales and marketing  115    
General and administrative  1,111   2,378 
Total operating expenses  2,078   2,887 
Operating loss  (2,021)  (2,887)
Other expense, net:        
Other expense, net  (9)  (3)
Net loss  (2,030)  (2,890)
Preferred stock dividends     (80)
Net loss attributable to common stockholders $(2,030) $(2,970)
Basic and diluted net loss per share attributable to common stockholders $(0.15) $(0.24)
Weighted average common shares outstanding, basic and diluted  13,947,324   12,206,036 
Comprehensive loss:        
Net loss $(2,030) $(2,890)
Foreign currency translation adjustments  (1)   
Comprehensive loss  (2,031)  (2,890)
Less: Preferred stock dividends     (80)
Comprehensive loss attributable to common stockholders $(2,031) $(2,970)