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Interim Results Put Biopharma with Tenbagger Potential 'Back on the Map'
Research Report

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A key upcoming catalyst and the impact of recent positive trial results are addressed in a ROTH Capital Partners report.

In a June 5 research note, ROTH Capital Partners analyst Yasmeen Rahimi explained how recent results from Allena Pharmaceuticals Inc. (ALNA:NASDAQ) "took pressure off the stock, thus setting the stage for a run-up to URIROX-1 data in H2/19." ROTH's $61 per share price target on the company reflects more than a potential tenbagger return as Allena is currently trading at around $4.60 per share.

Previously, Allena reported data from 206, its 12-week, open-label, single-arm study designed to test 7,500 units of reloxaliase in 15–20 patients with enteric or primary hyperoxaluria and advanced chronic kidney disease, either on dialysis or with a transplant.

The new results from four study patients with enteric hyperoxaluria showed a 29–42% drop in urine oxalate and a 16–49% reduction in plasma oxalate. Of three other study patients with primary hyperoxaluria and renal function, one demonstrated a lowering of urine oxalate.

On those data, Allena's stock rose about 25%. "This news came from left field, as the Street did not expect much from this small study given the heterogeneous patient population," Rahimi commented. "Investors are flocking back to Allena as we are getting closer, month by month, to a key binary event."

The urine oxalate results are "impressive," Rahimi noted, and bode well for the future. Specifically, "if reloxaliase hits 30%-plus drops in urine oxalate in two severely renal impaired enteric hyperoxaluria patients, we foresee a significant readthrough into Allena's URIROX-1 Phase 3 trial in 124 patients," she highlighted. Topline results from that study are estimated to be released about three months after enrollment is finished.

Rahimi pointed out, too, that whereas the urine oxalate results are important because they are the primary endpoint in upcoming Phase 3 trials, the plasma oxalate findings have value, too, because they validate reloxaliase's mechanism of action. They matter, she added, because "by reducing plasma oxalate levels, reloxaliase delays the need for dialysis, reduces the frequency of dialysis regimens and allows for getting selected for a kidney transplant, opening the door to a high unmet need niche market opportunity."

ROTH will hold a related call at noon ET on June 12, 2019, a replay of which will not be made available. The call will feature Dr. Sushrut Waikar, an expert on enteric hyperoxaluria and the relationship between urine oxalate and progressive kidney disease, and include a discussion of Allena's 206 results and expectations for its URIROX-1.

ROTH has a Buy rating on Allena Pharmaceuticals.


1) Doresa Banning compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. She or members of her household own securities of the following companies mentioned in the article: None. She or members of her household are paid by the following companies mentioned in this article: None.
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Disclosures from ROTH Capital Partners, Allena Pharmaceuticals Inc., Company Note, June 5, 2019

Regulation Analyst Certification ("Reg AC"): The research analyst primarily responsible for the content of this report certifies the following under Reg AC: I hereby certify that all views expressed in this report accurately reflect my personal views about the subject company or companies and its or their securities. I also certify that no part of my compensation was, is or will be, directly or indirectly, related to the specific recommendations or views expressed in this report.

ROTH makes a market in shares of Allena Pharmaceuticals, Inc. and as such, buys and sells from customers on a principal basis

ROTH Capital Partners, LLC expects to receive or intends to seek compensation for investment banking or other business relationships with the covered companies mentioned in this report in the next three months.

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