Acurx Pharmaceuticals (NASDAQ: ACXP) is a clinical-stage biopharmaceutical company developing a new class of antibiotics that could present the most meaningful changes to that sector in more than forty years. And while ACXP is lining up several potential near-term catalysts, its lead program utilizing ibezapolstat to target the debilitating C. difficile infection is getting the most attention. Deservedly so. But, keeping in mind that its other pipeline programs and drugs are expected to target and treat numerous other gram-positive infections, additional high-dollar drug market opportunities are also in play. Thus, ACXP is both in the right markets and timely.
It also puts Acurx Pharmaceuticals in an ideal spot to bring to market front-line treatments that target considerable opportunities. In fact, the potential from each drug can create enormous value in the coming quarters. CEO of Acurx Pharmaceuticals Mr. David Luci, provided his own insight into how the remainder of 2021 and 2022 can be a game-changing period of growth for his company. As transparent as ever, he laid out near-term expectations for Acurx and provided an informative overview of what investors can expect in the coming months.
HPM: Mr. David P. Luci, CEO of Acurx Pharmaceuticals, thanks for joining us. Let's jump right in.
Q: Dave, undoubtedly, 2021 has been an excellent year for Acurx Pharmaceuticals. Not only was your company welcomed to the NASDAQ markets with an oversubscribed IPO, but it was added to the Russell Microcap Index as well. Are you surprised by how quickly Acurx has gained traction?
DL: No, I'm not surprised. With no new antibiotics approved in over 30 years in the US, the story sells itself. We have two antibiotic candidates in a brand new class with proof on principal confirmed with efficacy, safety, and microbiome data in a small Phase 2a trial. The DNA Pol IIIC enzyme is a new therapeutic target attracting substantial attention, and we believe our position to advance this innovative treatment warrants the exposure we are getting.
Also, among antibiotics companies, there are those developing the same old classes of antibiotics or new courses of treatment that don't treat life-threatening infections. Those sponsors may be frustrated with investment and buy-out opportunities because their products may not qualify for QIDP or FDA Fast Track designation and may not have a long shelf life before resistance taking hold.
Acurx is outside that mold because we have a new class of antibiotics treating life-threatening infections with two in the class. Plus, we have FDA fast track and QIDP designations to go along with a 100% cure rate in the small Phase 2a clinical trial. Again, I think Acurx has earned the spotlight.
On a valuative basis, SMMT was about a $225 mm market cap company after reporting their Phase 2 data in C difficile infection. I believe our data, as limited as it is, has much higher cure rates and includes more cure microbiome restoration. So, after the Phase 2b data readout, while our market cap may not be the same as Summit – it may be more or less – we are confident the market cap would be significantly north of our current market cap of approximately $50 million.
Q: Speaking of traction, your ibezapolstat Phase2a topline results were incredible, reaching primary and secondary endpoints with 100% cure and sustained cure. Where do these results take you next?
DL: We move to Phase 2b enrollment in Q4 2021 and only need 64 patients to fully enroll. The 2b is designed as 32 patients on our drug, ibezapolstat, and 32 patients on vancomycin, the standard of care to treat C difficile infection.
The cure rates for ibezapolstat are underscored by the scientific facts, including getting over 100 X the concentration of ibezapolstat into the site of the infection (the colon) than is needed to cure the C diff infection based on MIC (Minimum Inhibitory Concentration) results.
We are also restoring the healthy microbiome in the process and recently filed for patent protection using ibezapolstat to restore the microbiome. Keep in mind, we have a dual impact drug targeted for front-line therapy because we have better cure rates, sustained cure rates, and distinct advantages restoring the healthy microbiome through antibiotic treatment, which we understand to be highly unusual for antibiotic therapy. Our scientific team has indicated publicly that these data portend future success in Phase 2a and Phase 3.
Q: The Phase 2b trial can be transformative to Acurx, especially if data proves superior to standard of care Vancomycin in the imminent head-to-head match-up. Expectations are that it will. What's contributing to the optimism?
DL: Several things. The most important consideration is that with 100x concentration getting to the site of the infection while restoring the microbiome through treatment and less than 10% absorption, we think few variables could go wrong in Phase 2b. Vancomycin has a 20-40% C difficile recurrence rate because it causes significant harm to the healthy microbiome. Of course, Acurx has to run the trial, and there are many variables at play in clinical trial work, but we like our prospects compared with other studies. Yes, the team, however, is optimistic about the outcomes.
Q: Videos on your website provide a compelling overview of ibezapolstat. What stands out the most in your opinion that could lead to ibezapolstat taking the front-line crown from Vancomycin?
DL: It's the restoration of the healthy microbiome and difference in recurrences that go together. It's a dual impact that is one-of-a-kind in antibiotic treatments for C difficile as we understand it. We know from the decades of vancomycin data that it has a 20-40% recurrence rate 30 days after the end of treatment, which we believe is based on the destruction of healthy bacteria in the gut microbiome. (Watch VIDEO)
If we have a minimal or even 10% recurrence rate in Ph2b and Ph3, that would constitute hundreds of millions of cost savings to the public health system in the US each year. For us, it would position our ibezapolstat as a front-line treatment because of the reduction of hospitalized C difficile patients with recurrent infection.
In our scientists' view, the recurrence rate for C difficile infection is driven by the disruption of the microbiome. Our trials show vancomycin uses a 2 to 3 log reduction in healthy bacteria in the gut, a limiting factor of that drug we believe ibezapolstat will overcome.
Q: Assuming the Phase 2b trial turns in the results expected, massive funding opportunities could come into play, correct? Can you discuss what Acurx could be positioned to get in regards to non-dilutive funding?
DL: If the Pasteur Act is passed by congress (currently in congress and we believe should enjoy bipartisan support), it alone could pay for Phase 3 and pay upwards of $750 million to $3 billion to Acurx to stockpile the drug at public hospitals in the US. Other financing sources are available, like the Novo Repair Impact Fund and AMR Action Fund, but these are dilutive.
Q: While funding is always a welcome addition to the biotech world, Acurx appears well-positioned to fund itself. Last quarter, you reported having more than $16 million in cash. How far does that get you without outside contributions?
DL: We believe the cash on hand will comfortably get us through the Phase 2b value inflection point. We have initiatives ongoing that would expand that cash balance but absent a "good deal," we will be fine financially into 2023.
Q: Also attractive is that your company only has about 10.3 million shares outstanding. While investors don't like non-accretive dilution, your company is well-positioned at today's prices to raise substantial capital and still remain well below the O/S counts of your peers. Would you raise money pro-actively if markets and prices warranted?
DL: We maintain a flexible and proactive approach to capital raising. Although we don't need money for at least two years, if it presented itself non-dilutively or in an attractive format, we would always
consider the opportunity and even look for these types of options along the way. This includes territorial rights in places like Japan and other locations where we hope to out-license our programs to raise non-dilutive capital.
Q: We discussed ibezapolstat. However, a second program, ACX-375, can also be a considerable value driver. It, too, targets unmet medical needs in the gram-positive infection space and could contribute substantially to Acrux's long-term value proposition. Why should investors be excited about that program despite it being a bit further down the production line?
DL: ACX-375 is in pre-clinical right now and therefore too early to be totally excited about in the near term. However, ACX-375 is at "lead optimization" in pre-clinical development, and the Novo Repair
funding, if approved, would elevate the program significantly. That said, ACX-375 has the same MIC kill profile (Minimum Inhibitory Concentration) as daptomycin, more or less, which achieved blockbuster status as a $1 billion per year revenue maker as an intravenous (IV) only drug.
Further, ACX-375 is IV and oral (expected) and addresses the same infections as daptomycin, which should be off-patent by the time ACX-375 is approved. From that point, ACX-375 has patents expiring in December 2039, and we anticipate it will be FDA QIDP and Fast Track designated. Thus, while the program is developing, it represents an exciting opportunity for Acurx.
Q: From an investor's perspective, Acurx offers compelling clinical assets, is well-funded, targets multiple unmet medical needs, and is staring down at least one potential near-term catalyst by Q2 of 2022. Am I leaving anything out that investors need to know?
DL: Here's something. We believe the public and private sectors are moving toward addressing the problem of antimicrobial resistance and combining to pull the antibiotics sector back to profitability, at least for new classes of antibiotics that treat life-threatening infections. We see this playing out with private sector investments, acquisitions, and sector legislation to ensure antibiotics for life-threatening infections are manufactured and available in the US and Europe.
Q: Finally, if you were in a perfect world of biotech, can you lay out how the next six months would play out for Acurx Pharmaceuticals?
DL: In a perfect world in the next six months, we would be nearly complete with Phase 2b treating patients with C difficile infection, and we would have at least one of our grants or partnering
opportunities closed to demonstrate the validity of our programs to our investors.
Many thanks, and, as always, a pleasure to speak with you. Best of luck in your upcoming Phase 2b trial.
End interview
Trading at roughly $5.30 per share and a market cap of about $54 million, Acurx Pharmaceuticals is attracting the attention of investors. The better news is that they may soon, if they haven't already, get the attention of Big Pharma wanting to renew its presence in the antibiotics space. Thus, a compelling value-based investment opportunity could be in play. Moreover, at current levels, the share price may be ignoring a large part of its already valuable intrinsic assets. Its near-term Phase 2b trial alone presents considerable upside, especially in comparison to Summit. (*share price as of 11:49am est, 9/13/21)
Further, with a healthy balance sheet, which Mr. Luci says can extend into the end of 2023, the near-term fear of dilution is mitigated before and after that trial, adding to the value proposition. And by combining the sum of its parts, Acurx Pharmaceuticals is well-positioned to show that being new to the public markets isn't a distraction from getting best-in-class drugs to market. In fact, it can help expedite the opportunities.
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