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Pipeline (12 active programs)

Capital (as filed)

Cash

$88.8M cash and cash equivalents · Jun 30, 2026 (10-Q)

Operating cash flow

−$11.9M quarter Mar 31, 2026 → Jun 30, 2026, year-to-date difference (10-Q)

As stated in coverage

$88.8M cash, runway into 2029 per the update of Aug 6, 2026 — the company's own words as read there, not the filed figure

Offering documents (1)

• 2026-08-07 S-3 · Shelf registration up to $300M aggregate

Cash, investments and operating cash flow are the company's own XBRL facts as filed with the SEC, each shown with its period end and tag. As-stated figures come from the company's own words as read in Biotech Distilled coverage, dated, and routinely count securities and planned financing that a balance sheet does not. Offering rows are the SEC cover pages as filed. Not investment advice. Figures as of Nov 7, 2026.

Biotech Distilled coverage (8)

• 2026-10-30 UPDATE: Opus Genetics (IRD) - Half the Seat Is Filled 🔒 Paid
• 2026-10-22 UPDATE: Opus Genetics (IRD) - One Door Opens, Another Closes 🔒 Paid
• 2026-10-16 UPDATE: Opus Genetics (IRD) - The Fine Print Arrives 🔒 Paid
• 2026-09-09 UPDATE: Opus Genetics (IRD) - The Sentinel Was a Signal 🔒 Paid
• 2026-09-03 UPDATE: Opus Genetics (IRD) - Wednesday, 8:00 a.m. ET 🔒 Paid
• 2026-08-07 UPDATE: Opus Genetics (IRD) - The September Date Is Back On 🔒 Paid
• 2026-08-04 UPDATE: Opus Genetics (IRD) - The Registrational Trial Is Full 🔒 Paid
• 2026-06-17 Opus Genetics (IRD) — Scientific Deep Dive for OPGx-LCA5, OPGx-BEST1, and the IRD Gene Therapy Pipeline

Articles open on Substack. Some are subscriber-only; those marked ★ Distilled Pro are for Distilled Pro members.

Verdict history (8 calls)

Every verdict Biotech Distilled has published on Opus Genetics, oldest first — the full history, never a selection. How calls are scored: the track record.

1. 2026-06-17 Watch Opus Genetics (IRD) — Scientific Deep Dive for OPGx-LCA5, OPGx-BEST1, and the IRD Gene Therapy Pipeline Genuine clinical signal in two genes but ultra-orphan commercial math, N=6/N=1 datasets, pending COM patent, and warrant/debt-heavy balance sheet leave risk/reward balanced after a 7x run; wait for September BEST1 readout.
2. 2026-08-04 Speculative buy speculative UPDATE: Opus Genetics (IRD) - The Registrational Trial Is Full Enrollment completion in the LCA5 registrational Phase 3 de-risks the regulatory path, the RDEP framework produced an FDA-aligned design with BLA gated to six-month data, and at $3.64 the price is lower than the June watch-list level with BEST1 readout still ahead.
3. 2026-08-07 Speculative buy speculative UPDATE: Opus Genetics (IRD) - The September Date Is Back On September BEST1 date confirmed, LCA5 Phase 3 primary endpoint now public and pre-specified, Phase 3 supply from commercial process retiring CMC risk, and $88.8M cash covers both near-term catalysts without an equity raise.
4. 2026-09-03 Speculative buy speculative UPDATE: Opus Genetics (IRD) - Wednesday, 8:00 a.m. ET BEST1 readout date is now fixed for September 9 with a hard webcast time, but a 19.6% pre-catalyst run to $4.45 has narrowed the risk/reward; conviction maintained but initiating at current price is a materially worse trade than a month ago.
5. 2026-09-09 Hold UPDATE: Opus Genetics (IRD) - The Sentinel Was a Signal BEST1 Cohort 1 read clean on safety and showed structural/functional signal in 4-5 of 5 patients, but the stock surged 28.8% on the day and 54% in five weeks, making the entry unattractive; downgrade to HOLD with post-binary trimming discipline advised.
6. 2026-10-16 Hold UPDATE: Opus Genetics (IRD) - The Fine Print Arrives Granular Retina in Rio BEST1 data shows microperimetry responses clearing the 3 dB FDA bar but only narrowly, structure-function changes barely correlate over time, and the effect leans on one patient; LCA5 durability to 24 months in adults is a positive, keeping the hold intact.
7. 2026-10-22 Hold UPDATE: Opus Genetics (IRD) - One Door Opens, Another Closes RDH12 IND clearance arrived on schedule but is grant-funded optionality; the departure of the Chief Scientific and Development Officer weeks before LCA5 Phase 3 dosing adds execution risk without changing the core LCA5/PRV thesis.
8. 2026-10-30 Hold UPDATE: Opus Genetics (IRD) - Half the Seat Is Filled New CSO with AAV vector and potency-assay expertise fills the science half of the departed role within eight days, slightly reducing leadership risk, but the development half remains unfilled ahead of LCA5 Phase 3 dosing.

• Long call · opened Aug 4, 2026 at $3.71 · +12.7% vs XBI +0.2% (Nov 6, 2026)

Every verdict Biotech Distilled has published on this company, in order, with the post it came from — the full history, never a selection. Position figures are the same ones shown on /track-record, computed by the same method. Editorial opinion, not investment advice.

Timing, in the company's words (7 quotes from 3 filings)

Sentences quoted verbatim from the company's SEC filings, newest filing first. Each sits under the filing it appeared in; the "matched to" tag names the calendar row it was read for.

• 2026-08-06 10-Q in filings ↓

  • “We expect to announce three-month topline data from Cohort 1 during the second week of September 2026, assuming all participants complete their assessments as scheduled.”

    matched to OPGx-BEST1 · topline data · read as September 2026

  • “In February 2026, the FDA accepted the sNDA and set a Prescription Drug User Fee Act (PDUFA) action date of October 17, 2026.”

    matched to OPGx-BEST1 (BIRD-1 Cohort 2, 4.5e9 vg/eye) · topline data · read as October 17, 2026
• 2026-08-06 8-K in filings ↓

  • “Enrollment was completed in Cohort 1 of the Phase 1/2 trial (BIRD-1), with 3-month topline data from Cohort 1 expected during the second week of September 2026, assuming all participants complete their assessments as scheduled.”

    matched to OPGx-BEST1 · topline data · read as September 2026
• 2026-08-06 10-Q in filings ↓

  • “We expect to announce three-month topline data from Cohort 1 during the second week of September 2026, assuming all participants complete their assessments as scheduled.”

    matched to OPGx-BEST1 · topline data · read as September 2026

  • “Enrollment was completed in Cohort 1 of the Phase 1/2 trial (BIRD-1), with 3-month topline data from Cohort 1 expected during the second week of September 2026, assuming all participants complete their assessments as scheduled.”

    matched to OPGx-BEST1 · topline data · read as September 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.”

    matched to OPGx-RDH12 · trial initiation · read as fourth quarter of 2026

  • “In February 2026, the FDA accepted the sNDA and set a Prescription Drug User Fee Act (PDUFA) action date of October 17, 2026.”

    matched to Phentolamine Ophthalmic Solution 0.75% (PS) · regulatory decision · read as October 17, 2026

Timing sentences quoted from the company's own SEC filings, each under the filing it appeared in. The 'matched to' tag is the calendar row the sentence was read for; the filing is the source. Not investment advice.

Filings & releases (34)

SEC filings from EDGAR and press releases captured from the company's investor-relations site, newest first. Releases captured from Aug 3, 2026; filings from March 2026. Summaries come from the BD update that read the document; "BD extracted" counts point at the pipeline table above. All companies →

• Nov 5, 2026ReleaseOpus Genetics Completes Dosing in Cohort 2 of Phase 1/2 Clinical Trial of OPGx-BEST1 Gene Therapy for Inherited Retinal DiseasesOpus dosed all 11 Cohort 2 participants at the 3x higher BEST1 dose, putting topline data in Q1 2027 and a potential pivotal Phase 3 start in H2 2027 — the "other open question" from September is now closed on the input side.
• Nov 3, 2026ReleaseOpus Genetics to Present at the Guggenheim Annual Healthcare Innovation Conference
• Oct 29, 2026ReleaseOpus Genetics Appoints Dr. Andrew Murphy as Chief Scientific Officer and Jamie Lynne Hart as Executive Director, Executive Operations→ BD update
• Oct 21, 2026ReleaseOpus Genetics Announces FDA Clearance of IND Application for OPGx-RDH12 Gene Therapy for Inherited Childhood Blindness→ BD updateSummary on the 8-K
• Oct 21, 20268-KCurrent report: officer / director change→ BD updateOpus's third gene therapy just cleared the FDA's IND hurdle and will dose its first patient this quarter — but the same day, the Chief Scientific and Development Officer quietly walked out the door.
• Oct 16, 2026ReleaseOpus Genetics Announces FDA Approval of Phentolamine Ophthalmic Solution 0.75% for the Treatment of PresbyopiaThe FDA approved phentolamine 0.75% for presbyopia on its expected PDUFA date — the thesis called it "a royalty event, not an equity re-rating," and the market agreed, with IRD down 5.2% on the day. The milestone payment is real but the gene-therapy bull case is unchanged.BD extracted 1 program update from this document → IRD pipeline
• Oct 15, 2026ReleaseOpus Genetics Presents Positive Clinical Data from OPGx-BEST1 and OPGx-LCA5 Gene Therapy Programs at Retina in Rio 2026→ BD updateSummary on the 8-K
• Oct 15, 20268-KCurrent report: Reg FD disclosure · EX-99.1 EXHIBIT 99.1→ BD updateThe Retina in Rio presentations delivered the granular structure-function data I told readers to watch for after September 9 — EZ-to-RPE thickness moved in all three evaluable BEST1 participants, pediatric LCA5 patients showed cone sensitivity reaching normal ranges, and Cohort 2 now has 11 participants. Meanwhile the stock has drifted -29% from the post-readout high to $4.05, creating a fresh entry question.BD extracted 2 program updates from this document → IRD pipeline
• Oct 13, 2026ReleaseOpus Genetics to Present at the Chardan Annual Healthcare Conference
• Sep 11, 20268-KCurrent report: Reg FD disclosure · EX-99.1 EXHIBIT 99.1BD extracted 1 program update from this document → IRD pipeline
• Sep 9, 2026ReleaseOpus Genetics Announces Positive Low Dose Cohort 1 Data from Phase 1/2 Clinical Trial of OPGx-BEST1 and Successful FDA Type C Meeting with Potential Phase 3 Dosing in 2027→ BD update
• Sep 9, 20268-KCurrent report: Reg FD disclosure, other events · EX-99.1 EXHIBIT 99.1→ BD updateBD extracted 1 program update from this document → IRD pipeline
• Sep 2, 2026ReleaseOpus Genetics to Present OPGx-BEST1 Cohort 1 Clinical Data in Investor Webcast and at Upcoming Leading Ophthalmology Conferences→ BD updateThe BEST1 Cohort 1 topline data — the binary I've been flagging since the original deep dive — drops September 9 at 8 a.m. ET. Here's what to watch for and how to read the print when it lands.BD extracted 1 program update from this document → IRD pipeline
• Aug 7, 2026S-3Shelf registration
• Aug 6, 2026ReleaseOpus Genetics Announces Financial Results for Second Quarter 2026 and Provides Corporate UpdateBD extracted 3 program updates from this document → IRD pipeline
• Aug 6, 20268-KCurrent report: results of operations · EX-99.1
• Aug 6, 202610-QQuarterly report
• Aug 3, 2026ReleaseOpus Genetics Completes Patient Enrollment in Registrational Phase 3 Trial of OPGx-LCA5 for LCA5-Associated Inherited Retinal DiseaseBD extracted 1 program update from this document → IRD pipeline
• Jun 17, 2026424B2Prospectus supplement
• Jun 16, 20268-KCurrent report: Reg FD disclosure · EX-99.1 EXHIBIT 99.1
• Jun 16, 20268-KCurrent report: Reg FD disclosure · EX-99.1 EXHIBIT 99.1
• Jun 5, 2026S-3Shelf registration
• May 20, 2026SCHEDULE 13D/A13D amendment
• May 12, 20268-KCurrent report: results of operations · EX-99.1
• May 12, 202610-QQuarterly report
• Apr 24, 20268-KCurrent report: debt / obligation
• Apr 22, 20268-KCurrent report: shareholder vote
• Apr 21, 2026S-3/AShelf registration (amended)
• Apr 7, 20268-KCurrent report: officer / director change
• Apr 7, 20268-KCurrent report: material agreement, unregistered sale of equity, Reg FD disclosure · EX-99.1 EXHIBIT 99.1
• Mar 23, 2026DEF 14AProxy statement
• Mar 13, 2026S-3Shelf registration
• Mar 12, 202610-KAnnual report
• Mar 10, 20268-KCurrent report: results of operations · EX-99.1 EXHIBIT 99.1