Gameto Presents New Data on In Vitro Maturation Product Candidate Fertilo During Seven Presentations at the 2024 American Society for Reproductive Medicine (ASRM) Annual Meeting

NEW YORK, October 23rd, 2024 — Gameto, a biotechnology company dedicated to advancing treatment options in women’s health and reproductive longevity, today announced the presentation of seven studies at the American Society for Reproductive Medicine (ASRM) 2024 Annual Meeting, the largest reproductive medicine conference in the United States. Gameto’s presentations highlight progress across both safety and efficacy endpoints using its product candidate for in vitro maturation, Fertilo. These findings indicate Fertilo’s potential to improve patient outcomes and experiences whilst utilizing assisted reproductive technologies (ART). 

“We are very excited to have the opportunity to share our work with the scientific and medical community at ASRM this year,” said Dr. Dina Radenkovic, Co-founder and CEO at Gameto. “This recognition is especially important as we aspire to push forward our research and bring the first application of iPSCs to the fertility field.”

Key Data Presented

• Gameto reported first Fertilo pregnancies, and presented a case study of the most advanced pregnancy, currently in the third trimester, with ultrasound images – Luis Guzmán, PhD, who presented this case study at ASRM, is Gameto’s partner at Pranor Concebir, the second largest fertility clinic in Peru 
• In expanded animal reprotoxicology studies evaluating Fertilo, Gameto reported healthy animal live births as well as improved blastocyst quality in both animal and human models
• Gameto’s overall results have broad implications on the field of reproductive medicine, suggesting that Fertilo allows patients to benefit from a reduced hormonal stimulation protocol without compromising on quality or efficacy

Within the US, Gameto is now preparing to initiate a Phase 3 trial, pending final manufacturing and assay requirements. Although IVM was invented in 1991, upon initiation of the upcoming Phase 3 trial, this will be the first ever Phase 3 double-blind, randomized control IVM trial in the United States. Fertilo also marks the first usage of iPSCs in an infertility indication, and upon initiation of a Phase 3 trial will be the more advanced iPSC treatment across all indications. For more details regarding the new data presented at ASRM, please see the summaries below.

Oral Presentations

1. Ovarian Support Cell-Assisted In Vitro Maturation of Immature Oocytes from Truncated Hormonal Stimulation Used in Donor Egg Cycles
   Presenter: Christian Kramme, PhD
   1. This study is a case series from ongoing clinical use of the product candidate Fertilo for egg donation and fertility treatment. The case series discusses the first four cases of egg donation using Fertilo and demonstrates strong functional utility to obtain an average of nine retrieved oocytes after truncated stimulation and yield an average of six mature oocytes after Fertilo treatment for egg donation. 
   2. In the presentation, Gameto presented an expanded analysis of the first 21 patients treated for egg donation with Fertilo, showing an average of 14 oocytes retrieved and 8 mature oocytes yielded per cycle. Gameto further presented an additional analysis of 9 patients who underwent embryo formation with Fertilo egg donation, showing an average of 2 transferable vitrified blastocysts yielded per cycle. Findings showed no cases of ovarian hyperstimulation syndrome and an average total gonadotropin dosage used of 3 injections (450 IU).
2. Clinical Procedures for In Vitro Maturation (IVM) Treatment
   Presenter: Michel De Vos, MD, PhD
   1. This video presentation was made in collaboration with Brussels IVF, CCRM, UNSW, and Gameto Inc. and provides comprehensive recommendations and visual demonstrations of common IVM clinical practice procedures for physicians and embryologists. 
   2. The video was presented by leading global IVM physician Dr. Michel De Vos of Brussels IVF and featured an in-depth discussion of key techniques and recommendations for successful IVM practice. 
3. Ovarian Support Cell In Vitro Maturation Results in Healthy Murine Live Births with No Evidence of Reprotoxicology in a Multigenerational Study
   Presenter: Christian Kramme, PhD
   1. This study is a comprehensive multigenerational analysis of the reproductive toxicology profile of the product candidate Fertilo using a three generation mouse model in collaboration with Embryotools, Inc. The study uncovered no developmental, behavioral, or general health red flags in Fertilo treatment.
   2. Gameto additionally reported the findings of a multi-organ histopathology study, with no apparent additional prevalence of tissue or organ level abnormalities in Fertilo-derived offsprings compared to their traditional IVF and IVM siblings. 
4. Novel Cell-Based Strategy Utilizing Ovarian Support Cells for In Vitro Maturation: From Proof-of-Concept to Clinical Manufacturing
   Presenter: Christian Kramme, PhD
   1. This study details the manufacturing approach of the clinical grade Fertilo product candidate, including the key development work to align Fertilo to good manufacturing practice (GMP) standards. We demonstrate that the clinical grade product candidate displays similar ability to significantly improve human oocyte maturation as previous research-grade iterations. 
   2. In the presentation Gameto reported further outcomes showing that the clinical-grade Fertilo product candidate significantly improves blastocyst formation rates in a mouse model as well as bovine model. Further, Gameto reported outcomes of ongoing, multi-center, global clinical studies showing an improved vitrifiable blastocyst formation rate in humans compared to traditional IVM as well as a report of the first ongoing clinical pregnancy. 

Poster Presentations

1. Donor Side Effects Experienced Under Minimal Controlled Ovarian Stimulation (COS) with In Vitro Maturation (IVM) versus Conventional COS for In Vitro Fertilization (IVF) Treatment
   Presenter: Sabrina Piechota
   1. This study analyzes the side effects patients experience in minimal stimulation with IVM treatment versus conventional stimulation with IVF treatment in 123 patients in 3 centers. The study shows that on average patients who underwent minimal stimulation with IVM experience significantly less pain after stimulation and retrieval as well as less prevalence of common side effects such as nausea, bloating, and bleeding compared to conventional IVF patients.  
   2. In this presentation, Gameto discussed findings from both United States and European centers showing multiple approaches to minimal stimulation that all resulted in a more patient friendly, shorter cycle for fertility treatment. 
2. First Case of Reported Positive Pregnancy from Novel Ovarian Support Cell-Assisted In Vitro Maturation of Immature Oocytes Derived from Truncated Hormonal Stimulation
   Presenter: Luis Guzmán, PhD
   1. This report is a case study of the first patient from ongoing clinical studies of the Fertilo product candidate to obtain a transfer resulting in pregnancy of an embryo from a Fertilo IVM treatment cycle. The report details the stimulation and embryological outcomes as well as outcomes up to  the biochemical pregnancy. 
   2. In the presentation, additional in vivo outcomes were presented including measurement of clinical pregnancy, ongoing clinical pregnancy with fetal heartbeat, and week 21 comprehensive fetal health screening demonstrating healthy, normal fetal development. The patient has now entered her third trimester and will be followed through to live birth. 
3. Ovarian Support Cells Enhance Oocyte Maturation and Developmental Competence by Recreating a Complex Follicle-Like Environment In Vitro
   Presenter: Christian Kramme, PhD
   1. This study discusses key findings of the mechanism of action of the product candidate Fertilo, which is investigated through gene expression and protein secretion analysis. This is the first report of a study into the specific molecular mechanisms that underlie Fertilo’s functionality. 
   2. Gameto presented an additional analysis of Fertilo’s ovarian support cells, demonstrating their high degree of molecular similarity to the key cell type of the ovarian follicle, in vivo antral and preovulatory granulosa cells, using the human cell atlas.

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About Gameto

Gameto is a biotechnology company developing novel treatment solutions for women's health. Gameto brings together an experienced scientific management team with the vision and passion to develop a product suite to support women throughout their reproductive journeys. The company’s lead program, Fertilo, aims to make IVF and egg freezing shorter, safer, and more accessible through reduced hormonal injections by maturing eggs outside of the body. Beyond turning IVF into something everyone can do, Gameto has a cell engineering platform that was developed in collaboration with Professor George Church’s lab at Harvard Medical School. The platform yields a pipeline of products in women’s and reproductive health, including a menopause program that is currently undergoing animal testing in order to begin first-in-human trials. Gameto is led by physician-turned-entrepreneur Dina Radenkovic as CEO and serial entrepreneur and founder of North America's largest fertility network Prelude Fertility, Martin Varsavsky, as Chairman. For more information, go to gametogen.com or follow us on Twitter and Instagram @gametogen and on LinkedIn.

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Investor and Press Contact

Kylie Jordan

kylie@gametogen.com

These statements are based on current plans, estimates, targets and projections, and are subject to inherent risks, uncertainties and other factors which could cause actual results to differ materially from the future results expressed or implied by such forward-looking statements.

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