> ## Content Index > Fetch the complete content index at: https://www.bullished.co/llms.txt > Use this file to discover other available public pages before exploring further. # Ocugen Says September Stargardt Panel Review Was No Efficacy Test, And Baselines Will Balance By Month 12 - URL: https://www.bullished.co/ocugen-says-september-stargardt-panel-review-was-no-efficacy-test-and-baselines-will-809d158a/ - Published: 2026-11-04T14:31:41.000Z - Updated: 2026-11-04T14:31:41.000Z - Description: The chief medical officer says the 63-patient trial is powered at close to 90%, with topline data due in the second quarter of 2027. - Author: Matteo Parrino - Tags: Earnings, OCGN, Industry: Healthcare [Ocugen](https://www.bullished.co/tag/ocgn/)'s chief medical officer, Dr. Mohamed Genead, told analysts on the company's third-quarter earnings call Wednesday that a September look at its Stargardt disease trial was "not an efficacy analysis," and that uneven patient baselines in a small early group should level out once all patients reach month 12\. Ocugen, a biotechnology company developing gene therapies for blinding eye diseases, reported $84.6 million in cash and short-term investments at September 30. ## Pressing on the Stargardt baselines Analysts spent much of the call on the interim review of the Stargardt trial of OCU410ST. Genead said the independent data monitoring committee, which sees unblinded data, was part of the trial's adaptive design and recommended continuing "without modification." He said the company and its trial team remain blinded. Asked by an analyst from Maxim Group what lay behind the issues in that review, Genead said "it's all of the above." He cited an early month-8 time point in a slowly progressing disease, a look at fewer than half the enrolled patients, and baseline traits that were "quite variable from small to large." "We cannot claim anything," he said. Another analyst asked whether the committee modeled evening out the baselines. Genead said the committee had full access to the efficacy and functional data, and continued the study because it believes the heterogeneity will normalize with the full set of patients at month 12\. There will be no second committee analysis at month 8; the company will see the full data at month 12. ## Powered for 25%, benchmarked at 54% Asked by an analyst from Maxim Group whether 63 patients is enough, Genead pointed to Phase 1-2 results in nine patients, where treated eyes showed 54% slower lesion growth than untreated eyes. The study is powered at close to 90% to detect a difference of about 25% in lesion growth, which he called a more conservative bar than that early result. CEO Dr. Shankar Musunuri said topline Stargardt data are expected in the second quarter of 2027\. Following the data, he said, the company would discuss them with the FDA, hold a pre-BLA meeting and then file its BLA, the FDA approval application. ## Cash, costs and the next readout Chief Financial Officer Rita Johnson-Greene said the cash balance supports operations into 2028, funding two of the three late-stage programs through their expected BLA filings. Operating expenses were $19.7 million in the third quarter, versus $19.4 million a year earlier, and the net loss was [one cent a share](https://finance.yahoo.com/healthcare/articles/ocugen-q3-earnings-snapshot-121438756.html?ref=bullished.co) against seven cents. The company had 339.3 million shares outstanding. The other two programs target retinitis pigmentosa and geographic atrophy. Topline data from the Phase 3 trial of the retinitis pigmentosa candidate OCU400, which enrolled 140 patients, are expected in the first quarter of 2027, ahead of the Stargardt readout. In October Ocugen completed a Middle East and North Africa license for OCU400 worth up to $4 million in upfront and initial milestone payments, up to $255 million in sales milestones and a 22% royalty. The retinitis pigmentosa readout in the first quarter of 2027 comes first; the Stargardt data follow in the second quarter. Learn - [How To Read An Earnings Call Transcript: Start With Guidance, Then Find What's Missing →](https://www.bullished.co/learn/how-to-read-an-earnings-call/) How to read an earnings call transcript: check guidance first, look for dropped metrics, compare growth with last quarter, and watch hedged wording. ### Sources - [Ocugen: Q3 Earnings Snapshot](https://finance.yahoo.com/healthcare/articles/ocugen-q3-earnings-snapshot-121438756.html?ref=bullished.co) — Associated Press - [Ocugen (OCGN) Reports Q3 Loss, Tops Revenue Estimates](https://finance.yahoo.com/healthcare/articles/ocugen-ocgn-reports-q3-loss-125505091.html?.tsrc=rss&ref=bullished.co) — Yahoo Finance - [Ocugen: Q3 Earnings Snapshot – WTOP News](https://wtop.com/national/2026/11/ocugen-q3-earnings-snapshot/?ref=bullished.co) — wtop.com - [Ocugen: Q3 Earnings Snapshot | wusa9.com](https://www.wusa9.com/article/syndication/associatedpress/ocugen-q3-earnings-snapshot/616-8f70e036-46a0-4457-a783-1eabcbd8ec90?ref=bullished.co) — Associated Press - [Ocugen: Q3 Earnings Snapshot | wfaa.com](https://www.wfaa.com/article/syndication/associatedpress/ocugen-q3-earnings-snapshot/616-8f70e036-46a0-4457-a783-1eabcbd8ec90?ref=bullished.co) — Associated Press ### More on Ocugen - [Ocugen's Quarterly Loss Shrinks To $3.6 Million On A Derivative Gain, Not Core Results](https://www.bullished.co/ocugens-quarterly-loss-shrinks-to-3-6-million-on-a-derivative-gain-not-core-results-5f65e76a/) - [Ocugen Says Bahamas Regulator Gave Provisional Approval To OCU400 Early Access Program](https://www.bullished.co/ocugen-says-bahamas-regulator-gave-provisional-approval-to-ocu400-early-access-program-60af3195/) - [Ocugen Gives Roots Pharmaceutical Middle East Rights To OCU400 For Up To $255 Million In Sales Milestones](https://www.bullished.co/ocugen-gives-roots-pharmaceutical-middle-east-rights-to-ocu400-for-up-to-255-million-in-7cc2909e/) [All Ocugen (OCGN) coverage →](https://www.bullished.co/tag/ocgn/)