A Novel, First-in-Class Blood Clotting Agent Takes Shape as a Bloody Compelling Investment

January 12, 2021

Source: Dr. KSS, MD, PhD, for Streetwise Reports   01/11/2021

Private start-up RxMP’s safe way to stop bleeding inexpensively is already the envy of bigger players, states Dr. KSS, MD, PhD, editor-in-chief of PubBio.co. Can it go the distance through proof of concept?

Blood

It’s a mind game doctors in training play with one another: if you had to have a serious coagulation disorder, would you rather be someone who clots inexplicably or someone who bleeds spontaneously? Over the course of inpatient residency training, a doctor will see plenty of both….and the truth is that superficially more mischief seems to come from unwanted clotting (leading to more vigilance against it) than from bleeding. Young doctors imagine clots to spread quickly and are sure every DVT is moments away from becoming a flung pulmonary embolism and making death an acute, very real possibility.

Despite the morbid one-liner (“Well, ALL bleeding stops EVENTUALLY”) most are amazingly cavalier about bleeding….”you just chase it….no big deal.”


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But bleeding is a very big deal indeed, and the genuinely horrifying cases of exsanguination in hospital (yes, it’s happened to my patients) have a way of holding back and stalking you later in your career. Ruptured aortic aneurysms where patients bleed to death into their abdomens, turn white and go silent; bleeding aorto-enteric fistulas, where patients are likely to die even if operated on in time. Most strokes are caused by clotting but ones of genuine horror owe to intracranial bleeding, including dreaded subarachnoid hemorrhages. Among the most horrible things I’ve witnessed include a man with a large undiagnosed cerebral aneurysm that exploded, causing him to sit bolt upright in bed, clutch at one side of his head, scream, and then lapse into torpor and die as his brain was forced through the foramen magnum and down into his spinal column. In the distortion of recall it seems that all took about 30 seconds, while in real time perhaps five minutes elapsed.

The problem with sustained bleeding, such as during a problematic vaginal childbirth, is that beyond chasing blood loss and beyond attempts at mechanical control, medicine even with modern sophistication has had pitifully little to offer such patients. Simply juicing the clotting system with extra plasma or platelets, in the absence of a specific deficiency, does no good, wastes blood products, and generally will fetch you the scorn of your peers in quality assurance review. Novo Nordisk’s recombinant factor VIIa was supposed to be the vaunted ichor that would make stubborn bleeding a thing of the past by ramrodding the coagulation cascades….but even off patent that agent is $10,000 per mg and one dose is many mg. DVT and pulmonary embolism are remarkably common in the wake of recombinant factor VIIa therapy.

RxMP Therapeutics Inc. is ready to move its lead agent through proof of concept using intracranial hemorrhage, from either hemorrhagic stroke or subarachnoid hemorrhage, two conditions crying out for a definitive therapy, as unmet-medical-need conditions. The tiny firm is 75% owned by the Wallace Coulter Foundation, whose goal is seeing the company reach public markets. And while the company plans to pursue grants to help complete IND-enabling studies, getting human clinical trials underway will require the firm to raise capital. BioPub is working with San Diego Torrey Hills Capital in a business development relationship with RxMP, which prepared an extensive PPM in the fall and began quietly pitching itself to prospective investors. Now January 2021 is here and it’s time to begin the capital raise in earnest.

How does the new RxMP drug work? The science has nuance, and some might even call it abstruse. It’s based on an observation about 15 years old that bolstering the available supply of the right kind of phospholipid membrane can dial up coagulability. RxMP makes its product from expired red cells that had been procured as donations for patient treatment, and manipulates those in a proprietary way. The membrane is necessary to support the assembly architecture of coagulation complexes….but is not sufficient to initiate thrombosis acting on its own because the agent lacks tissue factor, a “root cause” cell surface-expressed protein that acts as a kind of final “go-code” for inciting a clot.

RxMP’s pre-money valuation is estimated at under $20 million, but careful analysis suggests that what’s at inception here could lead to a broadly applicable and highly appealing procoagulant agent for widespread use requiring no specialized monitoring, and at affordable costs. A company that takes on a valuation in the single digit billions in under five years is plausible by the company’s models, for which we vouch based on our own independent review. Via confidentiality arrangement I have reviewed the company’s online data vault pertaining to its work, and it’s of superior, exacting quality, among the most enviable coagulation science with clinical applicability I’ve ever seen. Still, the company is early stage, has certain contentions that need to be verified, and so early formulations and sentiments should be viewed with a “safe harbor” mentality, including that events could transpire that change views. That’s realism; meanwhile, our confidence and enthusiasm that this is an exceptional early stage pre-market investing opportunity are high.

Readers can see Pamukcu kick off BioPub’s 2021 webcast season here. He and colleague and RxMP Chief Scientific Officer WenChe Jy, PhD, an alumnus of both National Taiwan University and Taiwan Medical University, both in Taipei, introduce readers to mechanism of action of the lead agent and why clotting experts view it as particularly auspicious. The company has no meaningful competition, no one developing a similar agent, and good IP protections. Meanwhile, while all things remain early stage at least 10 established companies in this space are aware of RxMP’s work and have expressed in it more than mere passing interest. What remains is for the company first to complete a successful phase 2 study in human intracranial hemorrhage.

Pamukcu, who is American-born, is the son of immigrant Turkish physicians, and completed medical school at the University of Wisconsin. He founded his first biotech company, later sold to OSI Pharmaceuticals, when he was a gastroenterology fellow, that is, still in training. Since then he’s remained in angel investor and serial entrepreneur mode, advising other firms and serving as CEO of Midway Pharmaceuticals. He is a fellow of the American Institute for Medical and Biological Engineering.

Dr. KSS is the founder and editor-in-chief of BioPub.co. He is an MD with an additional PhD in biochemistry, and for the past 20 years, in addition to practicing, being a researcher, and conducting clinical trials, he has been investing in biotech companies with great success. Dr. KSS earned his degrees at a top 10 U.S. institution, where he was an NIH scholar and graduated with top honors. He has extensive post-doctoral research experience and am board certified in internal medicine and also gastroenterology. His goal is to discuss companies and use discussions of their technology, their drugs or planned drugs, as ways of teaching about physiology and disease states, along with their issues and opportunities.

 

Disclosure: The author is founder and editor-in-chief of BioPub which, allied with San Diego Torrey Hills Capital, has a business development contract with RxMP to introduce RxMP to prospective investors and work with the company to bring it public. Capital raising has not officially begun yet, and therefore the author has no equity in RxMP. He intends to invest in RxMP when the formal raising for the firm commences in about one week. Interested investors may contact BioPub about participation by writing [email protected]. The private placement memorandum may be requested via BioPub.

 

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