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Opus Genetics (IRD) pipeline and stated timing

Pipeline at a glance

ProgramEventStageStated timingFiling
OPGx-BEST1OtherStage not statedin 20268-K ·
OPGx-LCA5OtherPhase 3in the fourth quarter of 20268-K ·
OPGx-RDH12OtherStage not statedin the fourth quarter of 20268-K ·
OPGx-MERTKOtherStage not statedin the first quarter of 20278-K ·
OPGx-BEST1/data readoutStage not statedin Q2 20278-K ·
OPGx-BEST1Topline/data readoutStage not statedin Q2 20278-K ·
OPGx-BEST1OtherStage not statedin 20278-K ·
OPGx-RHOOtherStage not statedin the second half of 20278-K ·
OPGx-LCA5Topline/data readoutStage not statedby the end of 20278-K ·

Source: ORION, orionbiotechai.com/company/IRD, data as of Oct 16, 2026
https://www.orionbiotechai.com/company/IRD

Nearest upcoming stated timing: OPGx-BEST1 · Other · in Q4 2026

SEC sources last checked .

Programs and stated timing

○ Quote matched to filing (not yet reviewed by founder) · ✓ Checked by founder.

OPGx-BEST1

Matched

Otherin Q4 2026

Stage: Not stated

Public float: Unknown (no public float found in SEC filings).

Based on the safety profile and positive proof-of-concept findings from Cohort 1, the Company has advanced to the higher-dose Cohort 2, evaluating OPGx-BEST1 at 4.5 x 10⁹ vg/eye, with dosing expected to be completed in Q4 2026 and topline three-month data expected in Q2 2027.

8-K · Filed · Last checked

Source details

Accession 0001140361-26-035979

SEC accepted the filing

OPGx-LCA5

Matched

Otherin the fourth quarter of 2026

Stage: Phase 3SEC filing · “Phase 3”

Public float: Unknown (no public float found in SEC filings).

The Phase 3 clinical trial’s natural history and treatment cohorts are fully enrolled, with dosing initiation expected in the fourth quarter of 2026.

SEC timing context:

Based on the encouraging Phase 1/2 findings, Opus advanced OPGx-LCA5 into Phase 3 development using the low dose without requiring further dose escalation.

8-K · Filed · Last checked

Source details

Accession 0001140361-26-039781

SEC accepted the filing

OPGx-RDH12

Matched

Otherin the fourth quarter of 2026

Stage: Not stated

Public float: Unknown (no public float found in SEC filings).

The OPGx-RDH12 program is expected to enter the clinic in the fourth quarter of 2026 and is partially funded through a partnership with the RDH12 Alliance.

8-K · Filed · Last checked

Source details

Accession 0001628280-26-053824

SEC accepted the filing

OPGx-MERTK

Matched

Otherin the first quarter of 2027

Stage: Not stated

Public float: Unknown (no public float found in SEC filings).

The OPGx-MERTK program is expected to initiate clinical testing at the Cleveland Clinic Abu Dhabi in the first quarter of 2027.

8-K · Filed · Last checked

Source details

Accession 0001628280-26-053824

SEC accepted the filing

OPGx-BEST1

Matched

Topline/data readoutin Q2 2027

Stage: Not stated

Public float: Unknown (no public float found in SEC filings).

The Company expects to announce 6-month data for the three participants with BVMD in Q2 2027.

SEC timing context:

BIRD-1

8-K · Filed · Last checked

Source details

Accession 0001140361-26-035979

SEC accepted the filing

OPGx-BEST1

Matched

Topline/data readoutin Q2 2027

Stage: Not stated

Public float: Unknown (no public float found in SEC filings).

Based on the safety profile and positive proof-of-concept findings from Cohort 1, the Company has advanced to the higher-dose Cohort 2, evaluating OPGx-BEST1 at 4.5 x 10⁹ vg/eye, with dosing expected to be completed in Q4 2026 and topline three-month data expected in Q2 2027.

8-K · Filed · Last checked

Source details

Accession 0001140361-26-035979

SEC accepted the filing

OPGx-BEST1

Matched

Otherin 2027

Stage: Not stated

Public float: Unknown (no public float found in SEC filings).

The Company expects to begin planning for the Phase 3 trial immediately, with participant dosing expected to begin in 2027.

SEC timing context:

The Company also aligned with the FDA on Phase 3 and commercial manufacturing requirements, which it expects to complete in early 2027.

8-K · Filed · Last checked

Source details

Accession 0001140361-26-035979

SEC accepted the filing

OPGx-RHO

Matched

Otherin the second half of 2027

Stage: Not stated

Public float: Unknown (no public float found in SEC filings).

The OPGx-RHO program is expected to initiate clinical testing globally in the second half of 2027.

8-K · Filed · Last checked

Source details

Accession 0001628280-26-053824

SEC accepted the filing

OPGx-LCA5

Matched

Topline/data readoutby the end of 2027

Stage: Not stated

Public float: Unknown (no public float found in SEC filings).

Topline data from the study is expected by the end of 2027.

SEC timing context:

Enrollment in the trial was completed, with dosing of OPGx-LCA5 expected to begin in the fourth quarter of 2026 using clinical drug supply manufactured with the intended commercial processes.

8-K · Filed · Last checked

Source details

Accession 0001628280-26-053824

SEC accepted the filing

How this date was described over time

Company periods and sentences are quoted as written. A matching disclosure uses the SEC filing date for the same program and event type. As of .

Program / eventStated period and SEC wordingDisclosure in stated period
OPGx-LCA5Otherin the fourth quarter of 2026
“The Phase 3 clinical trial’s natural history and treatment cohorts are fully enrolled, with dosing initiation expected in the fourth quarter of 2026.”

Filed · EX-99.1

Still within period

As of Oct 19, 2026

OPGx-BEST1Clinical resultsin Q2 2027
“The Company expects to announce 6-month data for the three participants with BVMD in Q2 2027.”

Filed · EX-99.1

Period not started

The stated period has not started yet, so there is nothing to compare.

OPGx-BEST1Clinical resultsin Q2 2027
“Based on the safety profile and positive proof-of-concept findings from Cohort 1, the Company has advanced to the higher-dose Cohort 2, evaluating OPGx-BEST1 at 4.5 x 10⁹ vg/eye, with dosing expected to be completed in Q4 2026 and topline three-month data expected in Q2 2027.”

Filed · EX-99.1

Period not started

The stated period has not started yet, so there is nothing to compare.

OPGx-BEST1Otherin Q4 2026
“Based on the safety profile and positive proof-of-concept findings from Cohort 1, the Company has advanced to the higher-dose Cohort 2, evaluating OPGx-BEST1 at 4.5 x 10⁹ vg/eye, with dosing expected to be completed in Q4 2026 and topline three-month data expected in Q2 2027.”

Filed · EX-99.1

Still within period

As of Oct 19, 2026

OPGx-BEST1Otherin 2027
“The Company expects to begin planning for the Phase 3 trial immediately, with participant dosing expected to begin in 2027.”

Filed · EX-99.1

Period not started

The stated period has not started yet, so there is nothing to compare.

OPGx-LCA5Otherin the fourth quarter of 2026
“Enrollment in the trial was completed, with dosing of OPGx-LCA5 expected to begin in the fourth quarter of 2026 using clinical drug supply manufactured with the intended commercial processes.”

Filed · EX-99.1

Still within period

As of Oct 19, 2026

OPGx-LCA5Clinical resultsby the end of 2027
“Topline data from the study is expected by the end of 2027.”

Filed · EX-99.1

Not compared

ORION has no confirmed start and end dates for this wording, so it is not compared with filings.

OPGx-MERTKOtherin the first quarter of 2027
“The OPGx-MERTK program is expected to initiate clinical testing at the Cleveland Clinic Abu Dhabi in the first quarter of 2027.”

Filed · EX-99.1

Period not started

The stated period has not started yet, so there is nothing to compare.

OPGx-RDH12Otherin the fourth quarter of 2026
“The OPGx-RDH12 program is expected to enter the clinic in the fourth quarter of 2026 and is partially funded through a partnership with the RDH12 Alliance.”

Filed · EX-99.1

Still within period

As of Oct 19, 2026

OPGx-RHOOtherin the second half of 2027
“The OPGx-RHO program is expected to initiate clinical testing globally in the second half of 2027.”

Filed · EX-99.1

Period not started

The stated period has not started yet, so there is nothing to compare.

“Not compared” means ORION has not matched this wording against a complete set of SEC filings for its period. It says nothing either way about whether a matching filing exists. Wording without exact dates is not given calendar dates.

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Reading these records

First stated window
The timing wording in the earliest company statement located within the sources checked, quoted as written (for example “2H 2026”). An earlier statement may exist outside those sources.
Disclosure date
The date of the filing or company release that disclosed the readout. “None found” means no such disclosure was located in the sources checked. SEC filings were searched through the “SEC filings searched through” date shown.
1H, 2H, 1Q–4Q
First or second half, or first to fourth quarter, of the year named, as the company wrote it. Equivalent notations are compared together; the original wording stays visible.
SEC original
The filing as published on the SEC EDGAR system. “Company original” is the release on the company's own investor site.
Status
One of seven labels set by founder review of the original filings. Definitions: Methodology.

See IRD in the calendar · Review labels and methodology

Q1–Q4 (also written 1Q–4Q) are quarters of the year: Q1 is January–March, Q2 April–June, Q3 July–September and Q4 October–December, unless the company uses a different fiscal year.Topline results are the main summary results of a clinical trial, released before the full data.