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RZLT

Rezolute, Inc.

Biopharma developer (SEC filing verified)·Phase 3·Redwood City, CA, United States·CEO: Mr. Nevan Charles Elam J.D.
OncologyOphthalmology

RZLT evidence brief

What we can confirm

BioSniper Score:
7.1 / 10
Market Cap:
$395.3M
Lead Asset:
ersodetug (Phase 3)

What it means

The company data is ready for cross-source review; unsupported conclusions remain unknown.

What to watch

Market Cap: $395.3M · Lead Asset: ersodetug (Phase 3)
BioSniper AIPage evidence connected

Prepared research question

What matters most for RZLT—catalysts, financial risk and supporting evidence?

Run cited research

Traceable citations · Unknowns marked

BioSniper AI · RZLT

Rezolute, Inc. is a late-stage rare disease company developing therapies for refractory hypoglycemia caused by hyperinsulinism, with lead programs in congenital and tumor hyperinsulinism.

Key risk: No revenue, heavy losses

7.1/10

BioSniper Score

Based on 3 of 6 signals

Limited data coverage

Market Cap

$395.3M

Cash Runway

—

Next Catalyst

—

Financial data as of Jun 30, 2026.

Tracking 1 pipeline candidate · 5 clinical trials for Rezolute, Inc..

AI OverviewAI overview is shown in English only.

Rezolute, Inc. is a late-stage rare disease company developing therapies for refractory hypoglycemia caused by hyperinsulinism, with lead programs in congenital and tumor hyperinsulinism.

  • Rezolute is a late-stage ultra-rare disease company focused on treating refractory hypoglycemia caused by any form of hyperinsulinism (HI) [news · 2026-09-24].
  • Cash and equivalents were $10.6M as of 2026-06-30, with total cash, cash equivalents, and marketable debt securities of $107.8M as of June 30, 2026 [sec_mda · as of 2026-09-24].
  • The company has not generated any meaningful revenue to date and reported cumulative net losses of $481.4 million since inception [sec_mda · as of 2026-09-24].
  • Phase 3 sunRIZE study of ersodetug in congenital HI reported topline results in December 2025 [news · 2026-02-12].
  • Phase 3 upLIFT study of ersodetug in tumor HI reported interim data in June 2026, with topline results expected before end of 2026 [news · 2026-06-02].

What works

  • Rezolute has advanced two Phase 3 programs (sunRIZE for congenital HI and upLIFT for tumor HI) demonstrating late-stage clinical execution [news · 2026-02-12][news · 2026-06-02].
  • Interim data from the upLIFT study showed 6 of 8 initial participants met the responder criterion for the primary endpoint, suggesting potential efficacy [news · 2026-06-02].
  • The company has a focused pipeline addressing ultra-rare forms of hyperinsulinism, a clear unmet medical need [news · 2026-09-24].

What to weigh

  • Rezolute has not generated any meaningful revenue to date and has accumulated net losses of $481.4 million since inception [sec_mda · as of 2026-09-24].
  • Cash and equivalents were only $10.6M as of 2026-06-30, with total liquidity of $107.8M, but the company has ongoing cash obligations including $0.8M in lease payments [sec_mda · as of 2026-09-24].
  • The company is entirely dependent on equity financings for liquidity, with no product revenue to sustain operations [sec_mda · as of 2026-09-24].

From the filings

Quoted directly from source documents.

  • Company focus on refractory hypoglycemia caused by hyperinsulinism

    “Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”), a late-stage ultra-rare rare disease company focused on treating refractory hypoglycemia caused by any form of hyperinsulinism (HI)”

    News · September 24, 2026

  • No meaningful revenue and cumulative net losses

    “net losses of $481.4 million since our inception and as a clinical stage company we have not generated any meaningful revenue to date.”

    SEC MD&A · September 24, 2026

  • Interim data from upLIFT study

    “6 of 8 participants have already met the responder criterion for the study’s primary endpoint”

    News · June 2, 2026

Catalyst timeline

  • 2024-01-11 · Phase 3 start for RZ358 in Congenital Hyperinsulinism — A Phase 3, randomized, double-blind, placebo-controlled study evaluating efficacy and safety of RZ358 in patients with congenital hyperinsulinism.
  • 2025-04-16 · Phase 3 start for Ersodetug in Tumor Hyperinsulinism — A Phase 3, single-arm, open-label, pivotal study evaluating efficacy and safety of Ersodetug in patients with inadequately controlled hypoglycemia due to tumor hyperinsulinism.
Risks & what to watch (4)›

Key risks

  • No revenue, heavy losses — No meaningful revenue to date; cumulative net losses of $481.4M [sec_mda · as of 2026-09-24].
  • Limited cash runway — Cash & equivalents only $10.6M as of 2026-06-30; total liquidity $107.8M but ongoing obligations [sec].
  • Dependence on equity financing — Primary liquidity source is equity financings; no product revenue [sec_mda · as of 2026-09-24].
  • Clinical trial risk — Phase 3 upLIFT study truncated to single-arm, open-label; results pending [sec_mda · as of 2026-09-24].

What to watch

  • Topline results from the Phase 3 upLIFT study of ersodetug in tumor HI, expected before end of 2026 [news · 2026-06-02].
  • Cash burn rate and any new equity financings or partnerships to extend runway [sec_mda · as of 2026-09-24].
  • Regulatory interactions or potential filing for ersodetug in congenital HI following sunRIZE results [news · 2026-02-12].

Sources: Catalysts · News · SEC MD&A · Generated October 12, 2026 · How we verify sources →

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Evidence & data

Score breakdownBased on 3 of 6 signals · derived from public data

Cash RunwayN/A

Cash runway data unavailable

Financial Health9.6

D/E 0.12

Pipeline Maturity8.5

Lead: Phase 3

Pipeline Breadth3.3

1 candidate

Catalyst MomentumN/A

No upcoming catalysts tracked

Insider SignalN/A

No insider transactions in the last 180 days

Pipeline

Regulatory

Financials

Institutional Holdings

Source: SEC Form 13F · as of Mar 2026

Institutional holders

125

Total value held

$261.7M

HolderSharesValue
federated hermes, inc.12,990,659$39.6M
ra capital management, l.p.9,180,000$28.0M
blackrock, inc.6,313,503$19.3M
opaleye management inc.6,300,000$19.2M
balyasny asset management l.p.5,048,421$15.4M
vanguard capital management llc3,522,080$10.7M
jennison associates llc3,438,881$10.5M
siren, l.l.c.3,328,287$10.2M
vanguard portfolio management llc2,981,765$9.1M
bank of america corp /de/2,970,549$9.1M

Showing top 10 of 125 institutional holders of Rezolute, Inc.. Open the full 13F history after sign-in.

Short Interest

as of May 22, 2026
% of float
21.7%
Days to cover
9.1
Shares short
13,725,344
Daily short volume
-

Short percent of float and days-to-cover reflect reported short positioning. Daily short volume is the exchange-reported short share of a single day's trading volume and is noisier. See the most-shorted biotech ranking →

RZLT short interest

Governance

Frequently asked questions

What is the AI investment thesis for Rezolute, Inc.?

Rezolute, Inc. is a late-stage rare disease company developing therapies for refractory hypoglycemia caused by hyperinsulinism, with lead programs in congenital and tumor hyperinsulinism.

What is Rezolute, Inc.'s lead drug candidate?

Rezolute, Inc.'s most advanced tracked candidate is ersodetug (Phase 3) for Tumor Hyperinsulinism (Tumor HI).

Who is the CEO of Rezolute, Inc.?

Mr. Nevan Charles Elam J.D. is the chief executive officer of Rezolute, Inc. (RZLT).

Where is Rezolute, Inc. headquartered?

Rezolute, Inc. (RZLT) is headquartered in Redwood City, CA, United States.

What therapeutic areas does Rezolute, Inc. focus on?

Rezolute, Inc. develops therapies across Oncology, Ophthalmology.

923 companies304,846 SEC filings22,682 clinical trials100% citation-verification pass rate (7d)How we verify →

The AI overview and BioSniper Score are neutral, data-derived signals built from public SEC filings, ClinicalTrials.gov and FDA records — not investment advice.