April 23, 2025 4:49pm

New: On April 11, 2025, Marcum LLP (their accountants) informed Harvard Apparatus Regenerative Technology (OTCQB: HRGN) that Marcum resigned as the Registrant’s independent registered public accounting firm. Also on April 11, 2025, the Registrant, with the approval of the Audit Committee of the Registrant’s Board of Directors, engaged CBIZ CPAs P.C. as the Registrant’s independent registered public accounting firm.

  •  Marcum’s LLP had reported the addition of a paragraph expressing substantial doubt about the Company’s ability to continue as a going concern.

 

From the previous and continuation title, "The chokehold got tighter cutting-off any capacity to lift multiple going concern at-risk marker"

In FY24, OTCQB: HRGN net loss was -$7.73 M or -$0.52 per share with a cash position of $2.5 M with a runway until Q2/25.

Accumulated deficit of $99.7 M from 11/1/23, the spin-off from Harvard Bioscienes (HBIO)

Liabilities $1,220 M while (in addition) still owing accounts payable: Un. of Pittsburg -$130 K, Yale University -$61 K and former employees $133 k

Product Development: (from 10K, 3/31/25)

  • Our first esophageal product candidate, our esophageal implant was used in the first successful regeneration of the esophagus in a patient with esophageal cancer. This successful first-in-human experience, plus the research we have performed on over 50 pigs, led the FDA to approve our 10-patient phase 1 clinical trial. This combination trial will measure both safety and efficacy in the patient population.
  • “We have encountered delays in patient recruitment for our ongoing clinical trial, driven by several factors, including the existing comorbid conditions for clinical trial participants, the stringent eligibility criteria required by FDA for our studies, and logistical difficulties in enrolling participants across various sites.”
  • “Although we are actively implementing strategies to mitigate these challenges, such as increasing the number of trial sites and enhancing patient outreach efforts, there is a risk that these measures may not completely resolve the recruitment issues. Our product candidates are currently in development and have not yet received regulatory approval for sale anywhere in the world.”

I also noticed that OTCQB: HRGN initiated: Harvard Apparatus Regenerative Technology, Inc. and its subsidiaries are committed to complying with applicable securities regulations and maintaining the highest ethical standards.

  • “We prohibit the trading in Company securities while in possession of material non-public information about the Company by directors, employees, contractors, and part-time and temporary workers,
  • immediate family and those who share a household with someone otherwise subject to this Policy.
  • …  My question is does it apply to HRGN’s president Hong Yu Hong Yu, and also head of DST Capital … for his neighbor, Mrs. Mrs. bin Zhao of Weston, Mass.; the wife or former of Lui Dong Hai, chairman of Dixintong Technology Group (D. Phone, the largest smartphone retailer in China??

 

Also to compound ANY INVESTMENT, “In October 2018, the U.S. Department of Treasury announced a pilot program to implement part of the Foreign Investment Risk Review Modernization Act of 2018 (FIRRMA), effective November 10, 2018.

 

  • The pilot program expands the jurisdiction of CFIUS to include certain direct or indirect foreign investments in a defined category of U.S. companies, which may include companies such as Harvard Apparatus Regenerative Technology in the biotechnology industry.
  • Among other things, FIRRMA empowers CFIUS to require certain foreign investors to make mandatory filings and permits CFIUS to charge filing fees related to such filings. Such filings are subject to review by CFIUS.
  • Any such restrictions on the ability to purchase shares of our common stock may have the effect of delaying or deterring any particular investment and could also affect the price that some investors are willing to pay for our common stock.
  • In addition, such restrictions could also limit the opportunity for our stockholders to receive a premium for their shares of our common stock in relation to any potential change in control.

 

As I had written, 3/12/25 ... "Is it headed down the “Tube” as cash runs low and more questions arise on its viability with continuous “Going Concern” status for years?

Have investors close wallets with $98.3 M accumulated deficit and only 3.59 M <with -$1.471 in liabilities> as of 9/30/24 spending $2 - $2.9 M per Q with a “stated” runway until Q2/25?

After their “beg” for merger was rejected by another Chinese backed company?

Questions <1/6/25> from Division of Corporate Finance, SEC re Reporting Person – Regulation 13D-G arose regarding previous/current (?) Hong Kong investor (Mao Zhang) generating an SEC filing

Lest investors forget OTCQB: HRGN was the subject of a Netflix special, “Bad Surgeon: Love Under the Knife”

 

 

Question, did they forget to “award” “Secret Garden Share” to the CCP < public shares to the party? <The Chinese Communist Party (CCP), officially the Communist Party of China (CPC), is the founding and sole ruling party of the People's Republic of China>


Have investors noticed … how it barely trades unless volume is “pumped” – is it by DST Capital, run by the president of HRGN’s president Hong Yu and neighbor, Mrs. Mrs. bin Zhao of Weston, Mass.

·         Previously funded by Lui Dong Hai, chairman of Dixintong Technology Group (D. Phone, the largest smartphone retailer in China) the husband of Mrs. bin Zhao??

 

Also, on 10/31/24, OTCQB: HRGN entered into an exclusive distribution agreement (the with Health Regen, Inc. pursuant to purchase and sell consumer health and dietary supplement products. Many Chinese “hands’ know to sell medical products into China, they must SELL into the People's Liberation Army (PLA) < The PLA is not a traditional nation-state military; it is a part, and the armed wing, of the CCP and controlled by the party, not by the state>. Question to be asked and answered - isn’t this TREASON, without US DOD approval – run by ShunFu Hu, Ph.D. Corporate Secretary of OTCQB: HRGN?

 

OTCQB: HRGN currently has a co-development initiative with Yale University and the McGowan Institute for Regenerative Medicine at the University of Pittsburgh. “We’ owe advance payments of approximately $100,000 and $61,000, respectively at September 30, 2024, with the $100,000 advance payment paid to Yale University in October 2024.” <10-Q, 11/24>

 

Appendix: some back-up reading …

RegMed Investors (RMi) Research Note: Harvard Apparatus Regenerative Medicine (OTCQB: HRGN) shares wrongful death lawsuit settlement with back story on Netflix … https://www.regmedinvestors.com/articles/13228

RegMed Investors (RMi) Research Note: Harvard Apparatus RT (OTCQB: HRGN) raises $5 M without name identification … https://www.regmedinvestors.com/articles/13590

RegMed Investors (RMI) Research Note: Harvard Apparatus RT (OTCQB: HRGN) Chronicles: Reports Q2/24 results … https://www.regmedinvestors.com/articles/13580

The Biostage (BSTG) Chronicles: Who is or what is behind the purchases and pump/promote of BSTG’s volume and share pricing? … https://www.regmedinvestors.com/articles/12588

 

Appendix 2:

From the title, a history of BAD decisions and a Netflix special, “Bad Surgeon: Love Under the Knife”

·         Dr. Paolo Macchiarini is world famous for his revolutionary stem cell-infused windpipe transplants. There's just one problem: His patients keep dying.

 

On April 27, 2022, OTCQB: HRGN and Harvard Bioscience (HBIO) executed a settlement, relating to an ongoing wrongful death lawsuit, which resolved all claims relating to the litigation. The settlement resulted in the dismissal with prejudice of the wrongful death claim, and neither we nor Harvard Bioscience admitted any fault or liability in connection with the claim.

The WHY of lawsuit and pay-off:

On April 14, 2017, representatives for the estate of an individual plaintiff filed a wrongful death complaint with the Suffolk Superior Court, in the County of Suffolk, Massachusetts, against the Company and other defendants, including Harvard Bioscience, Inc., or HBIO, the former parent of the Company that spun off the Company in 2013, as well as another third party.

·         The complaint sought payment for an unspecified number/amount of damages and alleged that the plaintiff sustained terminal injuries allegedly caused by products provided by certain of the named defendants and utilized in connection with surgeries performed by third parties in Europe in 2012 and 2013.

In relation to the litigation, OTCQB: HRGN paid approximately $5.9 million of aggregate costs related to the lawsuit. As of December 31, 2022, all such lawsuit related costs had been paid or otherwise satisfied …

·         And if the facts overwhelmed OTCQB: HRGN only received a cash payment of approximately $100 K from Medmarc, the Company’s insurance carrier.

·         With respect to such $5.9 million of costs described above, OTCQB: HRGN was required to either pay such costs directly and indemnify Havard Bioscience (HBIO) as to such amounts it incurs.

·         On June 10, 2022, following the execution of a subscription agreement and HBIO providing evidence of payment of the requisite $4 M amount, OTCQB: HRGN issued HBIO 4,000 shares of Series E 8% Convertible Preferred Stock at a price of $1,000 per share to satisfy the Company’s related indemnification obligations aggregating $4 M, which included the accrual for contingency of $3.3 M and approximately $800 K of legal and related costs paid on behalf of OTCQB: HRGN by HBIO previously included in accrued expenses.
 

There is more but, isn’t this enough to TOTALLY question the VIABILITARY of Harvard Apparatus GT (OTCQB: HRGN) going forward?

 

This treatise reminds me of Casey Stengel’s exasperated question about the hapless 1962 Mets: “Can’t anybody here play this game?”

 

How much lipstick is a lot on this pig; the facts outweigh their future and circumstance to raise capital, they have burned too many bridges!

I keep asking the same question, Is it a Ponzi Scheme?

Net Loss ’24 = 6/388 M

Net loss ’23 = 7.119 M

Shares Outstanding: 15,918,979 shares <11/4/24>

 

BEWARE… How MANY TIMES AM I RIGHT …