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Demonstrated lead program YMTX-7739 inhibits novel target in healthy volunteers at levels consistent with improved motor function in an animal model of Parkinson’s disease
Initiated dosing in Phase 1b portion of multi-dose trial of YMTX-7739 in patients with Parkinson’s disease; preliminary results expected in mid-2021
Appointed neuroscience drug development veteran, Ajay Verma, M.D., Ph.D., as EVP, Head of Research & Development
BOSTON, May 13, 2021 (GLOBE NEWSWIRE) -- Yumanity Therapeutics (NASDAQ: YMTX), a clinical-stage biopharmaceutical company focused on the discovery and development of innovative, disease-modifying therapies for neurodegenerative diseases, today announced financial results for the first quarter ended March 31, 2021, and provided an overview of the Company’s recent corporate developments and upcoming milestones.
“The first quarter of 2021 was Yumanity’s first as a public company and we made continued progress advancing our lead program, YTX-7739, in clinical development for Parkinson’s disease,” said Richard Peters, M.D., Ph.D., President, Chief Executive Officer and Director of Yumanity. “Notably, we recently reported topline results from our Phase 1a multiple-ascending dose (MAD) healthy volunteers study of YTX-7739, which demonstrated its ability to engage a novel biological target that, when engaged at similar levels in an animal model of Parkinson’s disease, improved motor function. We look forward to continued progress throughout the year, including reporting preliminary results from the Phase 1b portion of the MAD study in patients with Parkinson’s disease and introducing a second program into clinical development later this year. We will be hosting our first R&D Day on May 17, 2021 when we will further detail the results of our Phase 1 trial of YTX-7739 in healthy subjects.”
First Quarter and Recent Corporate Developments
YTX-7739, a novel inhibitor of stearoyl co-A desaturase (SCD) being developed for the treatment of Parkinson’s disease, achieved target engagement at doses that were generally well tolerated in a Phase 1a MAD clinical trial in healthy volunteers.
Announced the results from the Phase 1, single-ascending dose (SAD) study in healthy volunteers of YTX-7739.
Presented results of a study of YTX-7739 at the 15th Annual International Conference on Alzheimer’s and Parkinson’s Diseases (AD/PD™ 2021) Virtual Conference that demonstrated target engagement and motor activity improvement in a mouse model of Parkinson’s disease (PD).
Presented results of a study by researchers from the Massachusetts General Hospital demonstrating YTX-7739 in vivo efficacy in a glioblastoma multiforme (GBM) mouse model at the Society for NeuroOncology/National Cancer Institute (SNO/NCI) Joint Symposium: Targeting CNS Tumor Metabolism.
Appointed Ajay Verma, M.D., Ph.D., as Executive Vice President, Head of Research & Development.
The Company remains on track to announce preliminary results from the Phase 1b part of the MAD study of YTX-7739 in patients with Parkinson’s disease by mid-year 2021.
The Company anticipates initiating a Phase 1 trial of YTX-9184, a novel SCD inhibitor being developed for the treatment of dementia with Lewy Bodies, in the second half of 2021.
Yumanity is hosting a virtual R&D Day on May 17, 2021 at 12:00 p.m. EDT. The event is available via webcast at https://www.yumanity.com/investor-relations/events-presentations. Following the conclusion of the live event, a replay will be available for 60 days on the Events & Presentations page of the Yumanity website.
First Quarter 2021 Financial Highlights:
Cash position: As of March 31, 2021, cash, cash equivalents and investments was $62.9 million, compared to $85.3 million as of December 31, 2021. The decrease was primarily due to spending on the clinical development of YMTX-7739 and costs related to being a public company, as well as certain one-time costs related to the Company’s reverse merger with Proteostasis Therapeutics. The Company believes its cash, cash equivalents and marketable securities are sufficient to fund operations into the third quarter of 2022.
Research and development (R&D) expense: Research and development expenses were $6.8 million for the first quarter of 2021 compared to $5.0 million for the comparable period of the prior year. The increase in R&D expense was due to the costs associated with the YTX-7739 clinical program, the YTX-9184 preclinical program, and increased spending on early-stage discovery efforts.
General and administrative expense: General and administrative expenses were $6.1 million for the first quarter of 2021 compared to $2.0 million for the comparable period of the prior year. The increase was primarily attributable to increased professional services fees associated with operating as a public company.
Net loss: The company reported a net loss of $8.7 million, or $0.85 per basic and diluted share, for the first quarter of 2021 compared to a net loss of $7.5 million, or $3.47 per basic and diluted share, for the comparable period of the prior year. The increase was due to increased research and development expenses as well as increased general and administrative expenses.
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YTX-7739 is Yumanity Therapeutics’ proprietary lead small molecule investigational therapy designed to penetrate the blood-brain barrier and inhibit the activity of a novel target, stearoyl-CoA desaturase (SCD). SCD appears to play an important and previously unrecognized role in mitigating neurotoxicity arising from the effects of pathogenic alpha-synuclein protein aggregation and accumulation, which ultimately results in the death of neurons and the subsequent dysregulation of movement and cognition that afflicts patients living with these diseases. Through inhibition of SCD, YTX-7739 modulates an upstream process in the alpha-synuclein pathological cascade and has been shown to rescue or prevent toxicity in preclinical cellular and animal models. The company is assessing the potential utility of YTX-7739 as a disease modifying therapy for Parkinson’s disease.
SCD is an enzyme that catalyzes fatty acid desaturation, the products of which are incorporated into phospholipids, triglycerides, or cholesterol esters. These classes of lipid molecules regulate multiple diverse cellular properties and processes, including membrane structure and function, vesicle and organelle trafficking, intracellular signaling and inflammation. SCD expression is regulated by a transcription factor known as SREBF1, which has been identified in human genome-wide association studies as a risk factor for Parkinson’s disease. In preclinical models, SCD inhibition appears to normalize the dynamic interaction of pathological alpha-synuclein with membranes, which improves neuronal function and reduces toxicity, leading to enhanced neuronal survival. Following the initial discovery of SCD’s role in synucleinopathy by Yumanity’s unbiased discovery engine, several prominent academic labs have independently focused on SCD as a promising upstream target for mitigating alpha-synuclein mediated neurodegeneration. Alpha-synuclein-dependent disruption of membrane-related biological pathways, such as vesicle trafficking, is closely linked to the formation of Lewy body protein/membrane aggregations a hallmark pathological feature of Parkinson’s disease, Lewy body dementia and other neurodegenerative diseases.
About Yumanity Therapeutics
Yumanity Therapeutics is a clinical-stage biopharmaceutical company dedicated to accelerating the revolution in the treatment of neurodegenerative diseases through its scientific foundation and drug discovery platform. The Company’s most advanced product candidate, YTX-7739, is currently in Phase 1 clinical development for Parkinson’s disease. Yumanity’s drug discovery platform enables the Company to rapidly screen for potential disease-modifying therapies by overcoming the toxicity of misfolded proteins associated with neurogenerative diseases. Yumanity’s pipeline consists of additional programs focused on Lewy body dementia, multi-system atrophy, amyotrophic lateral sclerosis (ALS or Lou Gehrig’s disease), frontotemporal lobar dementia (FTLD), and Alzheimer’s disease. For more information, please visit www.yumanity.com.
Forward Looking Statements
This press release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words and phrases such as “aims,” “anticipates,” “believes,” “could,” “designed to,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will,” and variations of these words and phrases or similar expressions that are intended to identify forward-looking statements. These forward-looking statements include, without limitation, statements regarding our business strategy for and the potential therapeutic benefits of our current and prospective product candidates and results of preclinical studies, and the design, commencement, enrollment, and timing of ongoing or planned clinical trials, clinical trial results, product approvals and regulatory pathways, the anticipated benefits of our drug discovery platform, and statements regarding our financial and cash position and expected cash runway. Any such statements in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Results in preclinical or early-stage clinical trials may not be indicative of results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements, or the scientific data presented.
Any forward-looking statements in this press release are based on Yumanity’s current expectations, estimates and projections about our industry as well as management’s current beliefs and expectations of future events only as of today and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk that any one or more of Yumanity’s product candidates will not be successfully developed or commercialized, the risk of cessation or delay of any ongoing or planned clinical trials of Yumanity’s or our collaborators, the risk that Yumanity may not successfully recruit or enroll a sufficient number of patients for our clinical trials, the risk that Yumanity may not realize the intended benefits of our drug discovery platform, the risk that our product candidates will not have the safety or efficacy profile that we anticipate, the risk that prior results, such as signals of safety, activity or durability of effect, observed from preclinical or clinical trials, will not be replicated or will not continue in ongoing or future studies or trials involving Yumanity’s product candidates, the risk that we will be unable to obtain and maintain regulatory approval for our product candidates, the risk that the size and growth potential of the market for our product candidates will not materialize as expected, risks associated with our dependence on third-party suppliers and manufacturers, risks regarding the accuracy of our estimates of expenses and future revenue, risks relating to our capital requirements and needs for additional financing, risks relating to clinical trial and business interruptions resulting from the COVID-19 outbreak or similar public health crises, including that such interruptions may materially delay our enrollment and development timelines and/or increase our development costs or that data collection efforts may be impaired or otherwise impacted by such crises, and risks relating to our ability to obtain and maintain intellectual property protection for our product candidates. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause Yumanity’s actual results to differ materially and adversely from those contained in the forward-looking statements, see the section entitled “Risk Factors” in Yumanity’s most recent Annual or Quarterly Report, as well as discussions of potential risks, uncertainties and other important factors in Yumanity’s subsequent filings with the Securities and Exchange Commission. Yumanity explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.
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Source: Yumanity Therapeutics, Inc.