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.

Allena Pharma (ALNA)

FN Rating

NR
0/10

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!

Experienced Management

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)

X

Next Catalyst

Interium Analysis of 2nd Phase 3 ~ 1st Q 2022
Countdown Timer 👇
days until Jan 1
P3 interim readout any day!

Interactive Chart

Catalyst-Chart Overlay

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

$$$$

40M

4M

Notes

nice cushion...

just an estimate

Est Cash End of Dec 2021

28M

Enough cash until (expected)1Q 2022 interim readout, but not enough until final P3 readout in Q3 2022.

Pipeline

Products & Sales Potential

Indication

Enteric Hyperoxaluria
Hyperuricemia and Gout with Chronic Kidney Disease

US Market

.

$1B

ROW Market

.

$1B

For Context: Allena Pharma Market Cap ~ $39M as of Jan 14, 2022

Management

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.

Company PDFs

Read all of this 👇

Corp Presentation - Nov 2021

KOL to Review Topline results of ALLN-346 Phase 2a data

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.

Ownership

Insider Ownership % (not precise)

Insider Transactions

Unfortunately, there have been no insider buys recently. Considering the SP is near a 1 year low, it would be nice to see.

Institutional Holdings

Notable Institutional Holdings (as of 9/30/21)

Short Interest

Daily Short Volume Chart

Shares Available to Short

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Best ALNA Seeking Alpha Article

Yes, we read them all and this is the best one if you are short on time. But serious FN investors read all of them.  🙂

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.

 

ALNA Videos

We don't include TA videos - sorry, not sorry

Risks

Phase 3 was slowed as hospitals focused exclusively on Covid patients. It is possible that a data variation was created which will adversely affect the results.

Phase 3 pulls in a slighter larger group of patients than Phase 2. Anytime this occurs, new variables can be introduced that Phase 2 did not uncover. These variables can cause adverse results resulting in the company not hitting their endpoints.

Competition

Competition is ramping up. More info coming soon...

Email us at info@frugalnorwegian.com if you have more.  We want to list all risk factors for the drug & trial.

Have questions about this info? Did we miss a fact? We want to hear from you.

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