Gemini Therapeutics Reports First Quarter 2021 Financial Results and Provides Business Update

Rhea-AI Summary

Gemini Therapeutics, Inc. (Nasdaq: GMTX) reported its Q1 2021 financial results and a business update. The company is advancing GEM103 in clinical trials for age-related macular degeneration (AMD) and recently completed enrollment in the Phase 2a trial of GEM103 for wet AMD. The FDA granted Fast Track Designation for GEM103 targeting dry AMD with genetic variants. Q1 expenses rose to $11.8 million in R&D and $4.7 million in G&A, leading to a net loss of $19.0 million. As of March 31, 2021, Gemini had $185.0 million in cash, positioning them well for future studies.

Positive

• Received Fast Track Designation from FDA for GEM103 targeting dry AMD.
• Completed enrollment in Phase 2a trial of GEM103 in wet AMD.
• Net proceeds of $195.9 million from business combination, providing funding into 2023.

Negative

• Net loss increased to $19.0 million in Q1 2021 from $9.7 million in Q1 2020.
• R&D expenses rose significantly, indicating higher operational costs.

Gemini Therapeutics, Inc. (Nasdaq: GMTX), a clinical stage precision medicine company developing innovative treatments for genetically-defined age-related macular degeneration (AMD), today reported its financial results for the first quarter ended March 31, 2021 and provided a business update.

“During the first quarter, we continued to make significant progress in the clinical development of GEM103 and look forward to releasing initial data from the ongoing Phase 2a ReGAtta study later this quarter,” said Jason Meyenburg, Chief Executive Officer of Gemini Therapeutics, Inc. “With Gemini’s transition to a public company complete, we have the financial resources and leadership team in place to rapidly advance GEM103 into its first pivotal trial and continuing to advance our pipeline. Today’s announcement that we completed enrollment in the Phase 2a study of GEM103 in wet AMD demonstrates our commitment to fully explore and harness the use of CFH’s role as primary endogenous complement regulator, which may represent a best-in-class approach in complement therapeutics.”

Recent Business and Clinical Highlights

• Received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for GEM103 for the treatment of dry AMD in patients with complement factor H (CFH) loss of function gene variants. In January 2021, the Company announced that GEM103 had been granted Fast Track Designation by the FDA, a designation intended to facilitate development and expedite review of investigational therapies to address unmet medical needs.
• Completed enrollment in Phase 2a trial of GEM103 in dry AMD in patients with high-risk genetic variants. In February 2021, the Company announced the completion of enrollment of approximately 60 patients in its Phase 2a “ReGAtta” study, a dose escalation trial of GEM103, a recombinant human CFH, in dry AMD patients with loss of function CFH variants. The Company expects to share initial data from the trial, designed to evaluate safety and tolerability, as well as measures of intraocular pharmacokinetics and exploratory, disease-relevant biomarkers, in the second quarter of 2021. The Company believes the learnings from the Phase 2a trial will inform the design of the Phase 2b/3 sham-controlled study which will be powered for efficacy.
• Commenced and completed enrollment of a Phase 2a study of GEM103 as a potential add-on to anti-vascular endothelial growth factor (anti-VEGF) therapy for patients suffering from wet AMD. In February 2021, The Company initiated a Phase 2a study investigating GEM103 as a potential add-on therapy for patients suffering from wet AMD who have, or may be at risk for, macular atrophy (MA) but require ongoing anti-VEGF treatment. Enrollment of this trial completed in May 2021 and the Company expects to release six-month dosing data related to safety, tolerability, effect on intraocular CFH levels and disease-related biomarkers in the fourth quarter of 2021.
• Presented preclinical data on GEM103 at the 2021 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting. In May 2021, the Company presented a poster at ARVO that demonstrated GEM103 does not pose an increased risk of choroidal neovascularization (CNV) following intravitreal administration in a laser induced mouse model of disease. In addition, GEM103 demonstrated an anti-angiogenic effect in this model.
• Closed business combination with FS Development Corp (FSDC) transitioning to a public company with funding into 2023. Business combination with FSDC, a special purpose acquisition company (SPAC) sponsored by Foresite Capital, and the PIPE financing closed in February 2021, resulting in net proceeds to Gemini of $195.9 million.
• Continued expansion of leadership team. In May 2021, Gemini appointed Samuel Barone, M.D., as Chief Medical Officer. Dr. Barone brings to Gemini extensive expertise as a board-certified ophthalmologist specializing in the treatment of retinal and macular diseases. Additionally, the Company appointed Georges Gemayel, Ph.D., as the Chair of the Company’s Board of Directors. Dr. Gemayel brings to Gemini 30 years of experience in the pharmaceutical industry developing and commercializing drugs.

Financial Results

Research and development expenses totaled $11.8 million for the three months ended March 31, 2021, compared to $8.2 million for the same period in 2020. The increase was primarily due to increased expenses related to clinical studies, salaries and benefits and stock-based compensation.

General and administrative expenses were $4.7 million for the three months ended March 31, 2021, compared to $1.4 million for the same period in 2020. The increase was primarily due to increased expenses related to professional fees related to being a public company, salaries and benefits and stock-based compensation.

For the three months ended March 31, 2021, Gemini reported a net loss of $19.0 million, or $0.59 per share, compared to a net loss of $9.7 million, or $0.67 per share, in the corresponding period in 2020. The increase in net loss and net loss per share for the three months ended March 31, 2021 was primarily due to an increase in operating expenses and interest expense related to the beneficial conversion feature of the convertible notes extinguished during the business combination.

At March 31, 2021, Gemini held $185.0 million in cash, $9.2 million of principal outstanding debt and 43.0 million shares outstanding.

About the Phase 2a ReGAtta Study

The ongoing Phase 2a, multi-center, open-label, multiple ascending dose study of GEM103 in genetically defined patients with GA secondary to dry AMD is designed to investigate safety and tolerability, PK, exploratory ocular biomarkers, and measures of retinal anatomy and function. In the study, GEM103 is delivered monthly by an intravitreal injection and PK and biomarkers of complement regulation are determined from aqueous humor sampling. The study was designed to enroll approximately 60 patients. The study population was enriched for patients with genetic variants in CFH that have been linked to the progression of dry AMD from early to late-stage.

About the Phase 2a Study of Repeat Intravitreal Injections of GEM103 in Neovascular Age-related Macular Degeneration

The ongoing Phase 2a, multicenter, multiple-dose study in subjects with Neovascular Age-related Macular Degeneration (nAMD) with or at risk for macular atrophy, is designed to investigate the safety and tolerability of GEM103 as an adjunct to standard of care aflibercept therapy. The study is designed to enroll approximately 45 patients randomized 2:1 between GEM103 plus aflibercept and sham plus aflibercept arms, with treatment administered via intravitreal injection every other month for twelve months. CFH levels and disease relevant biomarkers of complement regulation are determined from aqueous humor sampling throughout the study with visual acuity and macular atrophy size measured at defined dosing dates.

About GEM103

Gemini’s lead program, GEM103, a full-length recombinant complement factor H (rCFH) protein, is believed to be the first ever recombinant native complement regulator. GEM103 delivered by intravitreal injection is designed to address both complement hyperactivity and restore retinal health in patients with AMD. In a genetically-defined subset of AMD patients GEM103 may circumvent dysfunctional CFH loss-of-function variants and slow the progression of their retinal disease. In patients undergoing anti-VEGF treatment GEM103 may help regulate the hyperactive amplification of the alternative pathway believed to lead to cell loss and macular atrophy. The U.S. Food and Dr

FAQ

What are the latest financial results for Gemini Therapeutics (GMTX) for Q1 2021?

Gemini Therapeutics reported a net loss of $19.0 million, or $0.59 per share, for Q1 2021.

What progress has Gemini Therapeutics made in clinical trials for GEM103?

Gemini completed enrollment in the Phase 2a trial of GEM103 for wet AMD and expects data release in Q2 2021.

What significant designations has GEM103 received from the FDA?

GEM103 received Fast Track Designation from the FDA for treating dry AMD with specific genetic variants.

What is Gemini Therapeutics' cash position as of March 31, 2021?

As of March 31, 2021, Gemini held $185.0 million in cash.