On March 18, 2022 the company announced it did not achieve significance on the URIROX P3 trial interim analysis and will be discontinuing the trial. This company will no longer b e covered by FN.
This company is on our watch list because there is no insider buying on the open market despite SP being an all time low. Insider buying is important because it shows shareholders that management is willing to buy at the same levels. After all, if management isn't buying the opportunity, why should shareholders? If we see management buying in big (>$100K), we will immediately invest in this company and give it our rating.
FN Summary: Lead asset (Reloxaliase for Enteric Hyperoxaluria) is in P3 trial with interim results due 1Q 22. Final results should be in Q3 22. Indication has no approved therapies. 2nd drug (ALLN-346) received Fast Track Designation. Company has plenty of cash until interim readout, but not enough to finish P3. Appears to be competition brewing in the Hyperoxaluria space. Insiders have not purchased recently despite SP being at all time low.
Table of Contents
This company hits most the right spots!
Decent Institutional Ownership
Good 1st Phase 3 Trial
Recent Insider Buying
Decent Cash (as of Sept 2021)
SP at all time low (as of Jan 2022)
Interium Analysis of 2nd Phase 3 ~ 1st Q 2022
Countdown Timer 👇
Caveat! Stock movement can be very finicky and, at times, seemingly random. This is FN's best explanation of the price movement.
Cash on Hand
Est Monthly Cash Burn
just an estimate
Est Cash End of Dec 2021
Enough cash until (expected)1Q 2022 interim readout, but not enough until final P3 readout in Q3 2022.
Products & Sales Potential
For Context: Allena Pharma Market Cap ~ $39M as of Jan 14, 2022
Yes, we know. This is the boring part of the page. But, it is also the most important. Read this: Importance of Management
- Lou Brenner, MD, has served as chief executive officer of Allena since February 2019 and as president since February 2017. He previously served as chief operating officer from April 2015 to January 2019.
- Lou has more than a decade of industry leadership experience, including pharmaceutical development strategy, regulatory affairs, business development, and commercialization. Prior to joining Allena, Lou served as chief medical officer at Idera Pharmaceuticals, chief medical officer at Radius Health, and senior vice president at AMAG Pharmaceuticals. He began his industry career at Genzyme Corporation, where he led successful product development programs for medicines that are currently marketed in the renal and metabolic areas.
David J. Clark, M.D. has served as Chief Medical Officer since November 2020. He has over 20 years of global industry experience in biopharmaceutical companies based in the United States and Europe.
Before joining Allena, David served as the Chief Medical Officer of Aldeyra Therapeutics, a publicly-traded biotechnology company developing medicines for immune-mediated ocular and systemic diseases.
He also served as Chief Medical Officer of Wilson Therapeutics, a privately-held biotechnology company developing novel pharmaceuticals to treat Wilson Disease, a rare autosomal recessive disorder of copper metabolism. David further served as Chief Medical Officer at NormOxys Inc. and TransTech Pharma, LLC. He has held leadership positions at a range of pharmaceutical companies including Pfizer, GlaxoSmithKline, and SmithKline Beecham.
- Alexey Margolin, PhD, is Allena’s co-founder and has served as a director since September 2011. He previously served as chief executive officer president from September 2011 to January 2019, and as president from September 2011 to February 2017.
- Alexey also served as chief executive officer of Alcresta Therapeutics, Inc., or Alcresta, which he also co-founded and where he currently serves on the board of directors. Prior to Alcresta, Alexey co-founded Alnara Pharmaceuticals, Inc, in 2008, where he was president and chief executive officer and oversaw their acquisition by Eli Lilly.
- Previously, Alexey served as chief scientific officer of Altus, where he initiated and led several therapeutics programs based on protein crystallization technology. Alexey was elected fellow of the American Institute of Medicine and Biological Engineering.
- Alexey is the author of more than 60 publications and is an inventor on several patents. He holds both an MS in chemistry and a PhD in bio-organic chemistry from Moscow University.
Phase 3 Clinical Trial
The FDA required Reloxaliase to undergo two Phase 3 trials. The first Phase 3 trial (URIROX-1) was completed in 2019. The 2nd Phase 3 trial (URIROX-2) is underway.
Understanding URIROX-1 results is crucial to anticipate the success of the current URIROX-2 trial. In summary, the URIROX-1 trial was a success, but warrants some discussion.
URIROX-1 did meet its primary endpoint, and had a very good p-value of 0.004. (0.05 is the threshold for significance)
However, a secondary endpoint in the URIROX-1 trial, the proportion of patients in the treatment arm who achieved >=20% reduction from baseline in 24-H urine oxalate excretion did not meet statistical significance (48% vs. 31.6%, p=0.06). However, management asserts 1) that 20% or more reduction in 24-H urine oxalate reduction from the baseline is enough to result in a 25-50% reduction in the incidence of kidney stones recurrence as well as slow the progression of chronic kidney disease based on the medical literature, and 2) that the mean reduction in urine oxalate from the baseline is a more important efficacy measure than the responder analysis (proportion of patients achieving 20% or more reduction in urine oxalate from the baseline) not only from a clinical benefit but also a regulatory point of view.
Another potential issue with the URIROX-1 trial was a higher than expected placebo response. Management stated that higher placebo response in the responder analysis (that missed the significance in URIROX-1) could be resolved with a longer duration of treatment, e.g. at week 16.
It should be noted that patient compliance with the treatment was as high as 97%. This is very good as it indicates the majority of the population did not have serious adverse events.
With these impressive results, the company worked with the FDA to design URIROX-2. Here is a summary of the Targeted Differences the trial trial hopes to reach.
This is exactly what we like to see in a final Phase 3 trial - a design almost* identical to their 1st Phase 3 trial. This reduces the chance of unknown variables entering the trial (although it is still possible).
* URIROX-2 will enroll a more severe patient population than URIROX-1 (history of kidney stones is one of the inclusion criteria). This raises the bar for hitting the endpoint, but also increases the size of the addressable market.
Analyst Price Targets
Analyst Price Target History
One year ago 3 analysts had a Buy rating with an $11 price target. Now the company is closer than ever to finishing their P3 trial and the SP has dropped significantly, yet only 1 analyst still covers this stock. One would think analysts would jump at the opportunity to recommend this stock. Go figure.
ALNA Discussion Forums (listed in order of best DD potential)
Q. What is the anticipated cost for Reloxaliase?
A. We don’t know and are looking for this info.
Q. Are there any FDA granted protections on reloxaliase?
A. Yes – The FDA has granted separate orphan drug designations to reloxaliase for the treatment of primary hyperoxaluria (a form of the disease that results from a rare genetic disorder) and for the treatment of pediatric hyperoxaluria.