1Q26 Reports: OLC's June 29th PDUFA On-Track & NYC Mgmt Meetings May 18th

研报英文原文证据摘录

1Q26 Reports: OLC's June 29th PDUFA On-Track & NYC Mgmt Meetings May 18th

ions (note here). Furthermore, it is important to understand that the top prescribers tend

to be geographically concentrated where the top three states for hyperphosphatemia patients

are Texas, Florida, and California. Thus, this allows sales reps to cover large territories despite

the small team size. Upon launch in ~3Q26, UNCY plans to initially target the ~2,100 prescribers

before TDAPA kicks in, and later capture a broader market (note here). Beyond this, UNCY

highlighted that they have been active in attending relevant medical conferences in order to

continue to engage with the community and boost awareness of OLC ahead of its PDUFA.

Hence, UNCY is confident that a small sales team of ~30 would be effective at reaching a large

proportion of OLC's target market while simultaneously being capital efficient.

There are multiple key inflection points to pay attention over the next ~8 months. Finally,

it is important to recognize that there are several key inflection points upcoming over the next ~8

months. Accordingly, mgmt highlighted that investors can look forward to the June 29th PDUFA,

disclosures regarding OLC pricing (to come within a few weeks after PDUFA), partnerships with

dialysis centers (potentially by end of the year), and a TDAPA designation decision (by ~January

2027).

Catalysts

• OLC PDUFA date set for June 29th, 2026

• UNI-494 (selective ATP-sensitive mitochondrial potassium channel activator) ready for Ph2

PoC study in AKI with preparation ongoing

Cash. As of May 11, 2026, UNCY had $57.1M in cash, cash equivalents, and marketable

securities (unaudited). Accordingly, mgmt anticipates this will support the company's planned

operations into 2027.

Unicycive Therapeutics, Inc.