GMTX Gemini Therapeutics Inc.

4.77
+0.11  (+2%)
Previous Close 4.66
Open 4.66
52 Week Low 3.22
52 Week High 19.085
Market Cap $205,632,181
Shares 43,109,472
Float 22,146,324
Enterprise Value $41,302,139
Volume 793,095
Av. Daily Volume 290,622
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Upcoming Catalysts

Drug Stage Catalyst Date
GEM103
Wet Age-Related Macular Degeneration (AMD)
Phase 2a
Phase 2a
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Drug Pipeline

Drug Stage Notes
GEM103 (ReGAtta)
Dry Age-related Macular Degeneration / Geographic Atrophy
Phase 2a
Phase 2a
Phase 2a data released June 22, 2021. GA progression at three months and six months in the study eye compared to fellow eyes was statistically indistinguishable.

Latest News

  1. MENLO PARK, Calif. and BOSTON, Sept. 14, 2021 /PRNewswire/ -- Lightstone Ventures today announced the closing of Lightstone Ventures III with $375 million in capital commitments, to invest in early-stage companies developing high impact therapeutics and technologies that have the potential to change patients' lives. The new fund was oversubscribed, exceeding the firm's targeted raise, and included strong support from both new and existing limited partners. With the closing of Fund III, Lightstone Ventures also announced the appointments of Christina Isacson, Ph.D., as Partner and Young Kwon, Ph.D., as Operating Partner.

    "We are very excited for the future of Lightstone and the important work that this new fund will enable," said Mike Carusi

    MENLO PARK, Calif. and BOSTON, Sept. 14, 2021 /PRNewswire/ -- Lightstone Ventures today announced the closing of Lightstone Ventures III with $375 million in capital commitments, to invest in early-stage companies developing high impact therapeutics and technologies that have the potential to change patients' lives. The new fund was oversubscribed, exceeding the firm's targeted raise, and included strong support from both new and existing limited partners. With the closing of Fund III, Lightstone Ventures also announced the appointments of Christina Isacson, Ph.D., as Partner and Young Kwon, Ph.D., as Operating Partner.

    "We are very excited for the future of Lightstone and the important work that this new fund will enable," said Mike Carusi, General Partner at Lightstone. "Our investment philosophy is guided by a commitment not just to exciting ideas but to the people leading them forward. This is an important moment for the firm that builds upon the successes we have had with our previous two funds and the companies we have invested in that are already making an impact on patients. We look forward to continuing our partnership with driven entrepreneurs developing therapies and technologies that have the potential to be industry-leading products."

    Since its inception in 2012, Lightstone has invested in more than 30 companies, all of which share a commitment to translating scientific breakthroughs into clinically and commercially meaningful therapies and technologies. In addition to venture capital experience, Lightstone's senior investment team brings significant operational leadership experience, enabling the firm to collaborate with founders to establish strategies that transform their visions into commercially viable products. Lightstone has a global presence, with offices in Menlo Park, Calif., Boston, Mass., Singapore, and Dublin, Ireland. The team includes:

    • Mike Carusi, General Partner
    • Jean George, General Partner
    • Jason Lettmann, General Partner
    • Hanson S. Gifford, III, Partner
    • Christina Isacson, Ph.D., Partner
    • Caroline Gaynor, Principal
    • Hank Plain, Special Partner
    • Mark Deem, Operating Partner
    • Young Kwon, Ph.D., Operating Partner
    • Stacy Enxing Seng, Operating Partner
    • Kenneth D. Noonan, Ph.D., CEO, Lightstone Singapore PTE. LTD.
    • Travis Boettner, CFO & CCO

    The Lightstone team has raised over $850 million since inception and has invested in companies such as Alchemab Therapeutics, ALX Oncology (NASDAQ:ALXO), Catamaran Bio, Cyteir Therapeutics (NASDAQ:CYT), Claret Medical (Acquired by Boston Scientific), Disarm Therapeutics (Acquired by Eli Lilly and Co.), Gemini Therapeutics (NASDAQ:GMTX), LocanaBio, Nimbus, Ra Pharma (Acquired by UCB), Tizona (Acquired by Gilead Sciences), and Willow.  

    "With Lightstone Ventures III, we look forward to empowering visionary entrepreneurs who are changing medicine, providing the same high-touch collaboration that founders have come to expect from our team along with increased financial resources," said Jason Lettmann, General Partner at Lightstone Ventures. "In addition, we are delighted to welcome Christina and Young to the team. One of Lightstone's key differentiators is our ability to leverage our team's leadership experience to provide hands-on guidance to the founders and teams we support. Both Christina and Young have held multiple C-suite level leadership roles, and they bring significant operational experience that will prove incredibly valuable to our portfolio companies."

    Dr. Isacson has spent over 16 years in the biotechnology industry and brings experience creating, launching, building and operating public and private biotech companies. Prior to joining Lightstone, she was a member of the founding team and Chief Business Officer at Magenta Therapeutics, and a part of the founding team at Decibel Therapeutics. She also has extensive experience in venture capital, most recently with Third Rock Ventures. Dr. Isacson holds a Ph.D. in Neuroscience from Tufts University School of Medicine, Graduate School of Biomedical Sciences, as well as a B.Sc. in Biology from McGill University.

    Dr. Kwon is a proven executive with significant operating and venture capital experience, and specializes in deal sourcing, due diligence, and portfolio company management. He has held a variety of leadership roles with over ten years as a C-suite executive at Momenta Pharmaceuticals, a public biotech company, prior to its sale to Johnson & Johnson for $6.5 billion. He holds a Ph.D. in Biological Chemistry and Molecular Pharmacology from Harvard University, as well as a B.S. in Biology from the Massachusetts Institute of Technology.

    About Lightstone Ventures

    Lightstone Ventures is a global venture capital firm investing in biotech and medtech companies pioneering big ideas poised to transform patient outcomes. We were founded in 2012 to empower visionary entrepreneurs with the resources and operational guidance necessary to bring their innovative therapeutics and technologies to the patients who need them most. Our investment team has led deals resulting in 19 acquisitions and 20 initial public offerings over the last two decades. The firm has offices in Boston, Mass., Menlo Park, Calif., Dublin, Ireland and Singapore.

    For more information, please visit www.lightstonevc.com

    Cision View original content:https://www.prnewswire.com/news-releases/lightstone-ventures-raises-375-million-fund-301375755.html

    SOURCE Lightstone Ventures

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  2. - Studies show mechanism of action and biodistribution of GEM103 and support continued development as a potential treatment for AMD

    Gemini Therapeutics, Inc. (NASDAQ:GMTX), a clinical stage precision medicine company developing innovative treatments for genetically defined age-related macular degeneration (AMD), today announced one oral presentation and the presentation of three posters at the 13th International Conference on Complement Therapeutics held in Ioannina, Greece from September 8-13, 2021.

    "The results presented today underscore the potential of GEM103 as the next class of complement therapeutic for the treatment of AMD by regulating complement. These results to date add to our understanding of GEM103's mechanism of action, points…

    - Studies show mechanism of action and biodistribution of GEM103 and support continued development as a potential treatment for AMD

    Gemini Therapeutics, Inc. (NASDAQ:GMTX), a clinical stage precision medicine company developing innovative treatments for genetically defined age-related macular degeneration (AMD), today announced one oral presentation and the presentation of three posters at the 13th International Conference on Complement Therapeutics held in Ioannina, Greece from September 8-13, 2021.

    "The results presented today underscore the potential of GEM103 as the next class of complement therapeutic for the treatment of AMD by regulating complement. These results to date add to our understanding of GEM103's mechanism of action, points of intervention in the pathway, duration and the ability of complement factor H to restore regulation of complement activity in the eye," said Walter Strapps, Ph.D., Chief Scientific Officer of Gemini Therapeutics. "Additionally, these data contribute to the growing body of evidence that gives us confidence in this potential novel intravitreal treatment and the importance of the restoration of complement regulation, rather than indiscriminate inhibition, as a therapeutic approach."

    Gemini is currently conducting the ReGAtta study, an ongoing Phase 2a open-label, single-arm study of GEM103 in genetically-defined patients with geographic atrophy (GA) secondary to dry AMD. ReGAtta is designed to investigate the safety and tolerability, PK, and evidence of complement regulation through ocular biomarkers following repeat intravitreal administration of GEM103. Based on the previously announced initial results of the ReGAtta study, Gemini plans to advance GEM103 into late-stage studies that will be designed to assess efficacy and safety of GEM103 in the treatment of GA.

    The oral presentation was given by Dr. Robyn Biggs, Associate Director – Research on September 10, 2021 at 9:35 am (GMT+3) and was titled "Mechanism of Action of Complement Factor H as a Therapeutic in AMD". The presentation covered a study designed to understand the non-canonical complement pathway mechanisms of action (MOA) as it relates to the RPE cell health and homeostasis, and GEM103's demonstration of several advantages as a potential therapeutic for the treatment of AMD. Notably, the study results show that GEM103 localized to "self cell" surfaces, including the RPE, using endogenous mechanisms and remained bound on the cell surface for an extended duration. GEM103 also inhibited inappropriate complement activation selectively on host cells by inhibiting deposition of C3-convertase while leading to a reduction in inflammation markers C3a and Ba levels.

    Posters presented include the following:

    "Recombinant Complement Factor H (GEM103) Ocular Biodistribution and Activity Following Intravitreal Administration in Cynomolgus Monkeys"

    Prior to initiating its ongoing Phase 2a clinical program of GEM103, researchers studied the biodistribution and half-life of GEM103 in the ocular tissue of non-human primates following a single IVT dose. Results demonstrate that GEM103 rapidly biodistributed to key tissues of interest including the retina, choroid and retinal pigment epithelium (RPE), and was retained on the RPE cell surface for an extended duration and remains functionally active in the eye following IVT-administration. Additionally, the pharmacokinetic profile for GEM103 was consistent across retinal tissues, with 24-hour Cmax observed in the vitreous humor, retina, RPE, choroid and aqueous humor post IVT dose.

    "Complement Factor H (CFH) Potentiating Antibody (PoAb) Enhances Cell Surface FH Localization and Activity and Maintains Fluid-phase Regulation in vivo"

    In-vitro assays demonstrate the ability of a novel CFH PoAb to promote CFH localization to cell surfaces and thereby enhance CFH complement regulatory function at the activation site. Subsequent treatment of the PoAb in a preclinical renal disease model showed similar behavior in vivo leading to reduction in the pathologic C3 deposits on kidney while maintaining fluid phase regulation and endogenous complement driven encapsulated bacteria clearance mechanisms.

    "AMD Associated Variants in Complement Factor I (CFI) Hinder CFI Expression, Function or Both"

    In a preclinical study evaluating the AMD risk-associated CFI protein variants for their effect on CFI expression and function as compared to a non-risk form in a panel of in vitro assays, risk variants were observed to have insufficient functional activity, reduced expression level, or both. Overall, the level of CFI functional deficiency correlated with AMD disease risk for the variants studied.

    Information on Gemini Therapeutics, including GEM103 and initial ReGAtta data, and posters and presentations made by the company at the 13th International Conference on Complement Therapeutics are available on Gemini Therapeutics' website under the Investors & Media section: Events and Presentations.

    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 and not assess GA efficacy of GEM103. GEM103 is delivered monthly by an intravitreal injection and PK and biomarkers of complement regulation are determined from aqueous humor sampling. To date, the study has enrolled 62 patients with gene variants that have been linked to the progression of dry AMD from early to late-stage. The study's design allowed for imbalances in GA baseline characteristics and does not inform GA efficacy and does not allow comparisons with uncontrolled fellow eye with similar imbalances.

    About GEM103

    Gemini's lead program, GEM103, is a pioneering precision medicine approach, targeting trial enrichment with genetically defined patients. GEM103 targets a genetically defined subset of age-related macular degeneration (AMD) patients with complement dysregulation. Of the 15 million dry AMD patients in the United States, approximately 40% (or six million) have variants in the complement factor H (CFH) gene. Such loss of function variants are associated with increased dry AMD disease risk. GEM103 is believed to be the first ever recombinant complement regulator and is a full-length and human, recombinant complement factor H (rCFH) protein. When delivered by intravitreal injection, we believe GEM103 has the potential to address unmet medical need in genetically defined AMD patients by circumventing the complement dysfunction resulting from CFH loss of function variants and slowing the progression of their retina disease. The U.S. Food and Drug Administration (FDA) granted Fast Track Designation for GEM103 for the treatment of dry AMD in patients with CFH loss of function gene variants.

    About Dry Age-Related Macular Degeneration (AMD)

    Age-related macular degeneration (AMD) is a progressive retinal disease affecting millions of older adults, and the leading cause of irreversible blindness in the western world. Symptoms, which include blurry vision, loss of night vision and loss of central vision, make activities of daily living such as reading, driving and even recognizing faces progressively more difficult. Third-party reports indicate there are approximately 16 million patients with AMD in the United States alone. Dry AMD, which results from an interaction of environmental and genetic risk factors, represents about 90% of that population (or about 15 million) in the US compared to about 1.4 million with wet AMD. Genetic risk of developing dry AMD is significant, with approximately 70% attributable risk of advanced disease to heritability, while aging and smoking confer the strongest non-genetic risk. CFH risk variants occur in approximately 40% of patients with dry AMD and these patients have a significantly increased risk of developing the disease as well as progression from intermediate AMD to GA. The complement system, of which CFH is a regulator, is dysregulated in patients with these risk variants, and results in amplification of aberrant inflammatory responses in the eye. Over time, this dysregulation leads to damage to the macular region of the retina.

    About Gemini Therapeutics

    Gemini Therapeutics is a clinical stage precision medicine company developing novel therapeutic compounds to treat genetically defined age-related macular degeneration (AMD). Gemini's lead candidate, GEM103, is a recombinant form of human complement factor H protein (CFH) and is designed to address both complement hyperactivity and restore retinal health in patients with AMD. GEM103 is currently in a Phase 2a trial in dry AMD patients with a CFH risk variant and a Phase 1/2a study in patients with neovascular age-related macular degeneration with or at risk for macular atrophy. Gemini has generated a rich pipeline including recombinant proteins, gene therapies, and monoclonal antibodies and is advancing a potentiating antibody for CFH, GEM307, into clinical development for treatment of systemic diseases.

    For more information, visit www.geminitherapeutics.com.

    Availability of Other Information About Gemini Therapeutics

    Investors and others should note that we communicate with our investors and the public using our website (www.geminitherapeutics.com), the investor relations website (https://investors.geminitherapeutics.com/), and on social media (Twitter and LinkedIn), including but not limited to investor presentations and investor fact sheets, U.S. Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that Gemini posts on these channels and websites could be deemed to be material information. As a result, Gemini encourages investors, the media, and others interested in Gemini to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on Gemini's investor relations website and may include additional social media channels. The contents of Gemini's website or these channels, or any other website that may be accessed from its website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended.

    Gemini's Forward-Looking Statements

    Certain statements in this press release and the information incorporated herein by reference may constitute "forward-looking statements" for purposes of the federal securities laws. Our forward-looking statements include, but are not limited to, statements regarding our or our management team's expectations, hopes, beliefs, intentions or strategies regarding the future, including those relating to the success, cost and timing of our product development activities and clinical trials, whether such data, when final, will be consistent with interim reported data, the timing to commence future clinical trials, the potential attributes and benefits of our product candidates, including GEM103, the reliability of the interim or final results of studies relating to safety and possible adverse effects resulting from the administration of our product candidates, our ability to obtain and maintain regulatory approval for our product candidates, our projected cash runway and our ability to obtain funding for our operations when needed. Forward-looking statements include statements relating to our management team's expectations, hopes, beliefs, intentions or strategies regarding the future. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words "anticipate," "believe," "contemplate," "continue," "could," "estimate," "expect," "intends," "may," "might," "plan," "possible," "potential," "predict," "project," "should," "will," "would" and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements are based on current expectations and beliefs concerning future developments and their potential effects. There can be no assurance that future developments affecting us will be those that we have anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond our control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, those factors described under the heading "Risk Factors" in Gemini's most recent Annual Report on Form 10-K filed with the SEC, as well as discussions of potential risks, uncertainties, and other important factors included in any of our future filings with the SEC. Should one or more of these risks or uncertainties materialize, or should any of our assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. Some of these risks and uncertainties may in the future be amplified by the ongoing COVID-19 pandemic and there may be additional risks that we consider immaterial, or which are unknown. It is not possible to predict or identify all such risks. Our forward-looking statements only speak as of the date they are made, and we do not undertake any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.

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  3. - Study shows well-tolerated safety profile with no increased risk of CNV, complement regulation, reduction in inflammatory state and supports bi-monthly dosing

    Gemini Therapeutics, Inc. (NASDAQ:GMTX), a clinical stage precision medicine company developing innovative treatments for genetically defined age-related macular degeneration (AMD), today announced that Raj Maturi, M.D., Adjunct Clinical Assistant Professor of Ophthalmology at Indiana University School of Medicine and an investigator in the ReGAtta study, presented Gemini's previously released initial results from its ongoing Phase 2a study at EURETINA 2021 Virtual held from September 9-12, 2021. The ReGAtta study is an open-label, single-arm dose escalation study of GEM103 in genetically-defined…

    - Study shows well-tolerated safety profile with no increased risk of CNV, complement regulation, reduction in inflammatory state and supports bi-monthly dosing

    Gemini Therapeutics, Inc. (NASDAQ:GMTX), a clinical stage precision medicine company developing innovative treatments for genetically defined age-related macular degeneration (AMD), today announced that Raj Maturi, M.D., Adjunct Clinical Assistant Professor of Ophthalmology at Indiana University School of Medicine and an investigator in the ReGAtta study, presented Gemini's previously released initial results from its ongoing Phase 2a study at EURETINA 2021 Virtual held from September 9-12, 2021. The ReGAtta study is an open-label, single-arm dose escalation study of GEM103 in genetically-defined patients with geographic atrophy (GA) secondary to dry AMD.

    "The initial results presented at EURETINA 2021 highlight the potential of GEM103 as a new treatment method for AMD and add to the understanding of its safety profile, mechanism of action, and duration, all of which will inform late-stage trial design," said Samuel Barone, M.D., Chief Medical Officer at Gemini. "Results thus far demonstrate that GEM103 continues to be well-tolerated. In addition, GEM103's ability to regulate complement is evidenced through a rapid and sustained reduction of biomarkers elevated in AMD and pharmacokinetics support bi-monthly intravitreal dosing."

    Summarized observations from the ongoing Phase 2a ReGAtta study, as of May 2021, presented at EURETINA 2021 include the following:

    • For the 62 patients with GA enrolled, no systemic serious adverse events related to GEM103 were observed as of the May 2021 snapshot. Ocular adverse events observed were related to the intravitreal procedure and are commonly associated with IVT procedure. Ocular inflammation was rare, mild and did not result in interruption of GEM103 administration. No choroidal neovascularization (CNV) was detected via retinal imaging.
    • Repeat dosing with GEM103 resulted in rapid and sustained increased levels of complement factor H (CFH) in aqueous humor and supports the evaluation of every other month dosing in late-stage development studies.
    • GEM103 demonstrated the ability to regulate complement in patients with GA, with treatment resulting in a reduction of elevated complement biomarkers and a dose dependent reduction in overall inflammatory state converging at 90 days. Timing of biomarker reductions was consistent with the accumulation of CHF with repeat dosing.

    Information on Gemini Therapeutics, including GEM103 and initial ReGAtta data, and presentations made at EURETINA 2021 Virtual are available on Gemini Therapeutics' website under the Investors & Media section: Events and Presentations.

    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 and not assess efficacy of GEM103 in GA. GEM103 is delivered monthly by an intravitreal injection and PK and biomarkers of complement regulation are determined from aqueous humor sampling. To date, the study has enrolled 62 patients with gene variants that have been linked to the progression of dry AMD from early to late-stage. The study's design allowed for imbalances in GA baseline characteristics and does not inform GA efficacy and does not allow comparisons with uncontrolled fellow eye with similar imbalances.

    About GEM103

    Gemini's lead program, GEM103, is a pioneering precision medicine approach, targeting trial enrichment with genetically defined patients. GEM103 targets a genetically defined subset of age-related macular degeneration (AMD) patients with complement dysregulation. Of the 15 million dry AMD patients in the United States, approximately 40% (or six million) have variants in the complement factor H (CFH) gene. Such loss of function variants are associated with increased dry AMD disease risk. GEM103 is believed to be the first ever recombinant complement regulator and is a full-length and human, recombinant complement factor H (rCFH) protein. When delivered by intravitreal injection, we believe GEM103 has the potential to address unmet medical need in genetically defined AMD patients by circumventing the complement dysfunction resulting from CFH loss of function variants and slowing the progression of their retina disease. The U.S. Food and Drug Administration (FDA) granted Fast Track Designation for GEM103 for the treatment of dry AMD in patients with CFH loss of function gene variants.

    About Dry Age-Related Macular Degeneration (AMD)

    Age-related macular degeneration (AMD) is a progressive retinal disease affecting millions of older adults, and the leading cause of irreversible blindness in the western world. Symptoms, which include blurry vision, loss of night vision and loss of central vision, make activities of daily living such as reading, driving and even recognizing faces progressively more difficult. Third-party reports indicate there are approximately 16 million patients with AMD in the United States alone. Dry AMD, which results from an interaction of environmental and genetic risk factors, represents about 90% of that population (or about 15 million) in the US compared to about 1.4 million with wet AMD. Genetic risk of developing dry AMD is significant, with approximately 70% attributable risk of advanced disease to heritability, while aging and smoking confer the strongest non-genetic risk. CFH risk variants occur in approximately 40% of patients with dry AMD and these patients have a significantly increased risk of developing the disease as well as progression from intermediate AMD to GA. The complement system, of which CFH is a regulator, is dysregulated in patients with these risk variants, and results in amplification of aberrant inflammatory responses in the eye. Over time, this dysregulation leads to damage to the macular region of the retina.

    About Gemini Therapeutics

    Gemini Therapeutics is a clinical stage precision medicine company developing novel therapeutic compounds to treat genetically defined age-related macular degeneration (AMD). Gemini's lead candidate, GEM103, is a recombinant form of human complement factor H protein (CFH) and is designed to address both complement hyperactivity and restore retinal health in patients with AMD. GEM103 is currently in a Phase 2a trial in dry AMD patients with a CFH risk variant and a Phase 1/2a study in patients with neovascular age-related macular degeneration with or at risk for macular atrophy. Gemini has generated a rich pipeline including recombinant proteins, gene therapies, and monoclonal antibodies and is advancing a potentiating antibody for CFH, GEM307, into clinical development for treatment of systemic diseases.

    For more information, visit www.geminitherapeutics.com.

    Availability of Other Information About Gemini Therapeutics

    Investors and others should note that we communicate with our investors and the public using our website (www.geminitherapeutics.com), the investor relations website (https://investors.geminitherapeutics.com/), and on social media (Twitter and LinkedIn), including but not limited to investor presentations and investor fact sheets, U.S. Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that Gemini posts on these channels and websites could be deemed to be material information. As a result, Gemini encourages investors, the media, and others interested in Gemini to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on Gemini's investor relations website and may include additional social media channels. The contents of Gemini's website or these channels, or any other website that may be accessed from its website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended.

    Gemini's Forward-Looking Statements

    Certain statements in this press release and the information incorporated herein by reference may constitute "forward-looking statements" for purposes of the federal securities laws. Our forward-looking statements include, but are not limited to, statements regarding our or our management team's expectations, hopes, beliefs, intentions or strategies regarding the future, including those relating to the success, cost and timing of our product development activities and clinical trials, whether such data, when final, will be consistent with interim reported data, the timing to commence future clinical trials, the potential attributes and benefits of our product candidates, including GEM103, the reliability of the interim or final results of studies relating to safety and possible adverse effects resulting from the administration of our product candidates, our ability to obtain and maintain regulatory approval for our product candidates, our projected cash runway and our ability to obtain funding for our operations when needed. Forward-looking statements include statements relating to our management team's expectations, hopes, beliefs, intentions or strategies regarding the future. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words "anticipate," "believe," "contemplate," "continue," "could," "estimate," "expect," "intends," "may," "might," "plan," "possible," "potential," "predict," "project," "should," "will," "would" and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements are based on current expectations and beliefs concerning future developments and their potential effects. There can be no assurance that future developments affecting us will be those that we have anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond our control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, those factors described under the heading "Risk Factors" in Gemini's most recent Annual Report on Form 10-K filed with the SEC, as well as discussions of potential risks, uncertainties, and other important factors included in any of our future filings with the SEC. Should one or more of these risks or uncertainties materialize, or should any of our assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. Some of these risks and uncertainties may in the future be amplified by the ongoing COVID-19 pandemic and there may be additional risks that we consider immaterial, or which are unknown. It is not possible to predict or identify all such risks. Our forward-looking statements only speak as of the date they are made, and we do not undertake any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.

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  4. Gemini Therapeutics, Inc. (NASDAQ:GMTX), a clinical stage precision medicine company developing innovative treatments for genetically defined age-related macular degeneration (AMD), today announced that Jason Meyeburg, Chief Executive Officer of Gemini Therapeutics, is scheduled to participate virtually in the H.C. Wainwright 23rd Annual Global Investment Conference. The presentation will be available on-demand starting at 7 AM ET on Monday, September 13, 2021.

    A webcast of the event will be available on the "Events & Presentations" page on the Company's website. A replay of the webcast will be archived on the Company's website for 30 days following the presentation.

    About Gemini Therapeutics

    Gemini Therapeutics is a clinical stage precision…

    Gemini Therapeutics, Inc. (NASDAQ:GMTX), a clinical stage precision medicine company developing innovative treatments for genetically defined age-related macular degeneration (AMD), today announced that Jason Meyeburg, Chief Executive Officer of Gemini Therapeutics, is scheduled to participate virtually in the H.C. Wainwright 23rd Annual Global Investment Conference. The presentation will be available on-demand starting at 7 AM ET on Monday, September 13, 2021.

    A webcast of the event will be available on the "Events & Presentations" page on the Company's website. A replay of the webcast will be archived on the Company's website for 30 days following the presentation.

    About Gemini Therapeutics

    Gemini Therapeutics is a clinical stage precision medicine company developing novel therapeutic compounds to treat genetically defined age-related macular degeneration (AMD). Gemini's lead candidate, GEM103, is a recombinant form of human complement factor H protein (CFH) and is designed to address both complement hyperactivity and restore retinal health in patients with AMD. GEM103 is currently in a Phase 2a trial in dry AMD patients with a CFH risk variant and a Phase 1/2a study in patients with neovascular age-related macular degeneration with or at risk for macular atrophy. Gemini has generated a rich pipeline including recombinant proteins, gene therapies, and monoclonal antibodies and is advancing a potentiating antibody for CFH, GEM307, into clinical development for treatment of systemic diseases.

    For more information, visit www.geminitherapeutics.com.

    Availability of Other Information About Gemini Therapeutics

    Investors and others should note that we communicate with our investors and the public using our website (www.geminitherapeutics.com), the investor relations website (https://investors.geminitherapeutics.com/), and on social media (Twitter and LinkedIn), including but not limited to investor presentations and investor fact sheets, U.S. Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that Gemini posts on these channels and websites could be deemed to be material information. As a result, Gemini encourages investors, the media, and others interested in Gemini to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on Gemini's investor relations website and may include additional social media channels. The contents of Gemini's website or these channels, or any other website that may be accessed from its website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended.

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  5. - GEM103 biological activity in intraocular compartment showed ability of potential first in class complement regulator to inhibit C3 activation and amplification

    - GEM103 continues to be well tolerated and intraocular pharmacokinetics support advancing program to late-stage, adequately sized and controlled study to evaluate efficacy in geographic atrophy

    - Analyses presented show imbalances in GA baseline characteristics in study eye and fellow eye that prevent efficacy assessment in uncontrolled open-label study

    Gemini Therapeutics, Inc. (NASDAQ:GMTX), a clinical stage precision medicine company developing innovative treatments for genetically defined age-related macular degeneration (AMD), today announced that Chief Executive Officer…

    - GEM103 biological activity in intraocular compartment showed ability of potential first in class complement regulator to inhibit C3 activation and amplification

    - GEM103 continues to be well tolerated and intraocular pharmacokinetics support advancing program to late-stage, adequately sized and controlled study to evaluate efficacy in geographic atrophy

    - Analyses presented show imbalances in GA baseline characteristics in study eye and fellow eye that prevent efficacy assessment in uncontrolled open-label study

    Gemini Therapeutics, Inc. (NASDAQ:GMTX), a clinical stage precision medicine company developing innovative treatments for genetically defined age-related macular degeneration (AMD), today announced that Chief Executive Officer, Jason Meyenburg, and Chief Medical Officer, Samuel Barone, M.D., presented in panel discussions at the Clinical Trials at the Summit on August 28, 2021. As part of the panel discussions, which included: Concept to Concrete: Turning Ideas into Action and Clinical Trials Addressing Dry AMD, management discussed some of the previously released initial data from its ongoing Phase 2a ReGAtta study of GEM103 in patients with geographic atrophy (GA) secondary to dry AMD as of May 2021.

    "We were pleased to have the opportunity to present at the Clinical Trials at the Summit to further discuss our initial data released from our Phase 2a ReGAtta study of GEM103 in patients with GA secondary to dry AMD," said Dr. Barone. "Results thus far showed that GEM103 continues to be safe and well-tolerated with no serious adverse events related to study drug and no serious ocular adverse events observed. Additionally, GEM103 also demonstrated biological activity that supports the ability of complement factor H (CFH) to regulate complement activity in patients with dry AMD and stop C3 activation and amplification in the alternative pathway. These encouraging results allow us to meet with regulators and move forward with our development plan and finalize the design of the next studies that will be powered to assess efficacy of GEM103 in the treatment of GA."

    The current ongoing Phase 2a study is open-label, uncontrolled, and was not designed to detect statistically significant treatment effect. The study design is enriched for patients with Factor H loss of function variants and permitted investigators to enroll patients with varying GA baseline characteristics. The baseline imbalances in GA characteristics in the study eye and the fellow eye do not support a reliable assessment of GA efficacy of treatment with GEM103.

    Summarized observations to date regarding the previously released initial data of the ongoing Phase 2a ReGAtta study include the following:

    ReGAtta study design and imbalances in GA baseline characteristics

    Sixty-two patients with GA were enrolled in an open-label, single arm, uncontrolled study with 76% of patients with a CFH risk variant who received repeat doses of GEM103. The first 36 patients were enrolled in a cohort and received monthly 250μg intravitreal injections of GEM103 in a designated study eye for three months. As a result of no observed dose limiting toxicities, dosing was then increased to 500μg IVT monthly for additional three months. Additional 26 patients were enrolled in a second cohort and received three monthly doses of 500μg of GEM103 intravitreally. Total drug exposure was 28 patient years in data recently presented. This study design resulted in:

    • Investigators enrolled patients with more progressed GA in the study eye in the first "250mg Cohort" and less progressed GA in the study eye in the second "500mg Cohort." These imbalances are seen in lesion size and morphology at baseline.
    • Patients in the first "250mg Cohort" were on study longer, average 6.7 months compared to 3.7 months in the second "500mg Cohort."
    • Among the 62 patients enrolled, only 45 patients (73%) had baseline GA in the fellow eye. This was not a requirement for enrollment. This, along with study eye baseline GA heterogeneity and imbalances in baseline GA size, focality and foveal involvement between study and fellow eyes do not allow the use of the fellow eye as a comparator group to assess GA efficacy.

    Demonstration of biological activity, complement regulation and support for extended dosing frequency

    • Both 250mg and 500mg repeat dosing resulted in immediate, durable and dose proportional reductions of intraocular complement biomarkers of C3 activation and alternative pathway amplification indicating regulation.
    • Complement intraocular biomarkers continued to decrease durably with repeat dosing and will be followed as patients continue in study.
    • CFH levels accumulated with GEM103 repeat intravitreal administration of 250mg and 500mg, supporting evaluation of every other month dosing in late-stage development studies.

    GEM103 continued to be well-tolerated with a differentiated safety profile

    • GEM103 was well-tolerated with no serious adverse events related to study drug and no serious ocular adverse events as of the recent data cut-off. There were no early discontinuations due to the study drug.
    • No cases of CNV in the study eyes have been confirmed by the independent reading center's retinal imaging analyses based on the initial data. Macular hemorrhage, suspected of neovascular AMD, was observed in the study eye of one patient at month 1 in the 500µg cohort and was determined by the investigator to be unrelated to GEM103 or the intravitreal administration procedure.
    • Visual acuity remained stable (±5 EDTRS letters) throughout the study.

    Information on Gemini Therapeutics, including GEM103 and initial ReGAtta data, and presentations made by the company at CTS are included in its corporate presentation which is available on Gemini Therapeutics' website under the Investors & Media section: Events and Presentations.

    Presentations of further analyses will be presented at upcoming medical conferences.

    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 and not assess efficacy of GEM103 in GA. GEM103 is delivered monthly by an intravitreal injection and PK and biomarkers of complement regulation are determined from aqueous humor sampling. To date, the study has enrolled 62 patients with gene variants that have been linked to the progression of dry AMD from early to late-stage. The study's design allowed for imbalances in GA baseline characteristics and does not inform GA efficacy and do not allow comparisons with uncontrolled fellow eye with similar imbalances.

    About GEM103

    Gemini's lead program, GEM103, is a pioneering precision medicine approach, targeting trial enrichment with genetically defined patients. GEM103 targets a genetically defined subset of age-related macular degeneration (AMD) patients with complement dysregulation. Of the 15 million dry AMD patients in the United States, approximately 40% (or six million) have variants in the complement factor H (CFH) gene. Such loss of function variants are associated with increased dry AMD disease risk. GEM103 is believed to be the first ever recombinant complement regulator and is a full-length and human, recombinant complement factor H (rCFH) protein. When delivered by intravitreal injection, we believe GEM103 has the potential to address unmet medical need in genetically defined AMD patients by circumventing the complement dysfunction resulting from CFH loss of function variants and slowing the progression of their retina disease. The U.S. Food and Drug Administration (FDA) granted Fast Track Designation for GEM103 for the treatment of dry AMD in patients with CFH loss of function gene variants.

    About Dry Age-Related Macular Degeneration (AMD)

    Age-related macular degeneration (AMD) is a progressive retinal disease affecting millions of older adults, and the leading cause of irreversible blindness in the western world. Symptoms, which include blurry vision, loss of night vision and loss of central vision, make activities of daily living such as reading, driving and even recognizing faces progressively more difficult. Third-party reports indicate there are approximately 16 million patients with AMD in the United States alone. Dry AMD, which results from an interaction of environmental and genetic risk factors, represents about 90% of that population (or about 15 million) in the US compared to about 1.4 million with wet AMD. Genetic risk of developing dry AMD is significant, with approximately 70% attributable risk of advanced disease to heritability, while aging and smoking confer the strongest non-genetic risk. CFH risk variants occur in approximately 40% of patients with dry AMD and these patients have a significantly increased risk of developing the disease as well as progression from intermediate AMD to GA. The complement system, of which CFH is a regulator, is dysregulated in patients with these risk variants, and results in amplification of aberrant inflammatory responses in the eye. Over time, this dysregulation leads to damage to the macular region of the retina.

    About Gemini Therapeutics

    Gemini Therapeutics is a clinical stage precision medicine company developing novel therapeutic compounds to treat genetically defined age-related macular degeneration (AMD). Gemini's lead candidate, GEM103, is a recombinant form of human complement factor H protein (CFH) and is designed to address both complement hyperactivity and restore retinal health in patients with AMD. GEM103 is currently in a Phase 2a trial in dry AMD patients with a CFH risk variant and a Phase 1/2a study in patients with neovascular age-related macular degeneration with or at risk for macular atrophy. Gemini has generated a rich pipeline including recombinant proteins, gene therapies, and monoclonal antibodies and is advancing a potentiating antibody for CFH, GEM307, into clinical development for treatment of systemic diseases.

    For more information, visit www.geminitherapeutics.com.

    Availability of Other Information About Gemini Therapeutics

    Investors and others should note that we communicate with our investors and the public using our website (www.geminitherapeutics.com), the investor relations website (https://investors.geminitherapeutics.com/), and on social media (Twitter and LinkedIn), including but not limited to investor presentations and investor fact sheets, U.S. Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that Gemini posts on these channels and websites could be deemed to be material information. As a result, Gemini encourages investors, the media, and others interested in Gemini to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on Gemini's investor relations website and may include additional social media channels. The contents of Gemini's website or these channels, or any other website that may be accessed from its website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended.

    Gemini's Forward-Looking Statements

    Certain statements in this press release and the information incorporated herein by reference may constitute "forward-looking statements" for purposes of the federal securities laws. Our forward-looking statements include, but are not limited to, statements regarding our or our management team's expectations, hopes, beliefs, intentions or strategies regarding the future, including those relating to the success, cost and timing of our product development activities and clinical trials, whether such data, when final, will be consistent with interim reported data, the timing to commence future clinical trials, the potential attributes and benefits of our product candidates, including GEM103, the reliability of the interim or final results of studies relating to safety and possible adverse effects resulting from the administration of our product candidates, our ability to obtain and maintain regulatory approval for our product candidates, our projected cash runway and our ability to obtain funding for our operations when needed. Forward-looking statements include statements relating to our management team's expectations, hopes, beliefs, intentions or strategies regarding the future. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words "anticipate," "believe," "contemplate," "continue," "could," "estimate," "expect," "intends," "may," "might," "plan," "possible," "potential," "predict," "project," "should," "will," "would" and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements are based on current expectations and beliefs concerning future developments and their potential effects. There can be no assurance that future developments affecting us will be those that we have anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond our control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, those factors described under the heading "Risk Factors" in Gemini's most recent Annual Report on Form 10-K filed with the SEC, as well as discussions of potential risks, uncertainties, and other important factors included in any of our future filings with the SEC. Should one or more of these risks or uncertainties materialize, or should any of our assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. Some of these risks and uncertainties may in the future be amplified by the ongoing COVID-19 pandemic and there may be additional risks that we consider immaterial, or which are unknown. It is not possible to predict or identify all such risks. Our forward-looking statements only speak as of the date they are made, and we do not undertake any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.

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