YMTX Yumanity Therapeutics Inc.

4.22
-0.16  -4%
Previous Close 4.38
Open 4.26
52 Week Low 4.18
52 Week High 23.47
Market Cap $43,501,237
Shares 10,308,350
Float 7,154,604
Enterprise Value $28,860,573
Volume 266,570
Av. Daily Volume 236,976
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Drug Pipeline

Drug Stage Notes
YTX-7739
Parkinson’s Disease
Phase 1b
Phase 1b
Phase 1b trial met primary endpoints noted November 10, 2021. Full Phase 1b data set will be presented at an upcoming medical conference, noted November 15, 2021.. Phase 2 trial planned in 2022.
YTX-9184
Dementia with Lewy Bodies
Phase 1
Phase 1
Phase 1 trial to commence 2H 2021.
YTX-7739
Healthy volunteers
Phase 1
Phase 1
Phase 1 data released April 21, 2021 - generally well tolerated.

Latest News

  1. BOSTON, Nov. 16, 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 that Richard Peters, M.D., Ph.D., President and Chief Executive Officer, will be presenting at the following investor conferences in November. He will discuss the results of the recently completed Phase 1b study of YTX-7739 in patients with Parkinson's disease and the development strategy going forward.

    Event:Stifel Healthcare Conference 2021
    Presentation:Virtual live webcast
    Date:Wednesday, November 17
    Time:
    9:20 a.m. EST
    Webcast:Events section of the Yumanity website


    Event:Jefferies London Healthcare

    BOSTON, Nov. 16, 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 that Richard Peters, M.D., Ph.D., President and Chief Executive Officer, will be presenting at the following investor conferences in November. He will discuss the results of the recently completed Phase 1b study of YTX-7739 in patients with Parkinson's disease and the development strategy going forward.

    Event:Stifel Healthcare Conference 2021
    Presentation:Virtual live webcast
    Date:Wednesday, November 17
    Time:

    9:20 a.m. EST

    Webcast:Events section of the Yumanity website



    Event:Jefferies London Healthcare Conference
    Presentation:Virtual on-demand webcast
    Date:November 16 to 18
    Time:

    Thursday, November 18 at 3:00 a.m. EST

    Webcast:Events section of the Yumanity website



    Event:Piper Sandler Annual Healthcare Conference
    Presentation:Virtual on-demand webcast
    Date:November 30 to December 2
    Time:

    Monday, November 22 at 10:00 a.m. EST

    Webcast:Events section of the Yumanity website

    An audio webcast of each presentation can be accessed through the Events section of the Company's website at yumanity.com/investor-relations/events-presentations. An archived replay of each webcast will also be available on the Company's website.

    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 in 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.

    Investors:

    Burns McClellan, Inc.

    Lee Roth



    (212) 213-0006

    Media:

    Burns McClellan, Inc.

    Ryo Imai / Robert Flamm, Ph.D.

    /

    (212) 213-0006 



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  2. Announced Successful Phase 1b trial for YTX-7739 in Parkinson's disease patients; YTX-7739 was well tolerated and demonstrated target engagement and favorable PK/PD and safety profiles

    Company anticipates initiating Phase 2 clinical trial of YTX-7739 in patients with Parkinson's disease in 2022

    Appointed Michael D. Wyzga as SVP, Chief Financial Officer

    BOSTON, Nov. 15, 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 third quarter ended September 30, 2021 and provided an overview of the Company's recent corporate developments…

    Announced Successful Phase 1b trial for YTX-7739 in Parkinson's disease patients; YTX-7739 was well tolerated and demonstrated target engagement and favorable PK/PD and safety profiles

    Company anticipates initiating Phase 2 clinical trial of YTX-7739 in patients with Parkinson's disease in 2022

    Appointed Michael D. Wyzga as SVP, Chief Financial Officer

    BOSTON, Nov. 15, 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 third quarter ended September 30, 2021 and provided an overview of the Company's recent corporate developments and upcoming milestones.

    "With the recent announcement of our positive Phase 1b clinical trial of YTX-7739 in Parkinson's disease patients, we are now developing plans for the Phase 2 clinical program," said Richard Peters, M.D., Ph.D., President, Chief Executive Officer and Director of Yumanity. "The results of the Phase 1b study and our translational efforts to date have given us a good understanding of the pharmacokinetic and pharmacodynamic relationship of YTX-7739 for target engagement in patients. While we were not expecting to see meaningful changes in clinical status of the patients or exploratory biomarkers after 28 days of dosing, we are excited by the exploratory quantitative electroencephalogram (qEEG) assessments observed, which may suggest improved synaptic function in Parkinson's patients. We continue to believe in the disease-modifying potential of YTX-7739, which may represent a major advancement in the treatment paradigm for Parkinson's patients. These data position Yumanity to be one of a few select companies with an asset to be advanced into Phase 2 clinical development for this devastating disease. Finally, with the arrival of Michael D. Wyzga as Senior Vice President, Chief Financial Officer, we have continued to improve the strength and depth of the management team."

    Third Quarter and Recent Corporate Developments

    • Announced successful Phase 1b clinical trial results for YTX-7739 in patients with Parkinson's disease. YTX-7739 demonstrated target engagement in patients with mild-to-moderate disease, and was found to be generally well tolerated, demonstrating favorable pharmacokinetic/ pharmacodynamic (PK/PD) profiles and a safety profile with no serious adverse events. In a subset of patients studied, YTX-7739 demonstrated a statistically significant change compared to baseline in an exploratory measurement of quantitative electroencephalogram, suggestive of a potential improvement in synaptic function that may benefit Parkinson's patients.
    • Appointed Michael D. Wyzga as Chief Financial Officer.

    Upcoming Milestones

    • The Company expects to initiate a Phase 2 clinical trial of YTX-7739 in patients with Parkinson's disease in 2022.
    • The full data set from the Phase 1b trial will be presented at an upcoming medical conference.
    • Based on recent promising preclinical data and pending confirmatory further preclinical validation, the Company plans to initiate a window-of-opportunity clinical study of YTX-7739 in glioblastoma multiforme patients, with data from such study expected in the second half of 2022.
    • The Company intends to explore additional indications for YTX-7739 through preclinical studies in additional disease models where the drug candidate's target, stearoyl-CoA desaturase (SCD) has been implicated as a potential therapeutic opportunity, with multiple readouts expected in 2022.

    Third Quarter 2021 Financial Highlights:

    • Cash position: As of September 30, 2021, cash, cash equivalents and investments were $46.4 million, compared to $85.3 million as of December 31, 2020. The decrease was primarily due to spending on the clinical development of YTX-7739 and costs related to being a public company. The Company believes its cash, cash equivalents and marketable securities are sufficient to fund operations into the third quarter of 2022.



    • Research and development expense: Research and development expense was $6.6 million for the third quarter of 2021 compared to $5.5 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 expense were $4.5 million for the third quarter of 2021 compared to $3.7 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 $10.0 million, or $0.97 per basic and diluted share, for the third quarter of 2021 compared to a net loss of $6.4 million, or $2.96 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.





    YUMANITY THERAPEUTICS, INC.

    CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS (unaudited)

    (in thousands, except share/unit amounts)

      Three Months Ended Nine Months Ended
      September 30, September 30,
       2021   2020   2021   2020 
    Collaboration revenue$1,635  $3,308  $7,282  $3,308 
    Operating expenses:       
     Research and development 6,624   5,489   20,729   14,457 
     General and administrative 4,513   3,725   15,277   8,356 
     Total operating expenses 11,137   9,214   36,006   22,813 
    Loss from operations (9,502)  (5,906)  (28,724)  (19,505)
     Other income (expense), net (454)  (479)  (368)  (1,317)
    Net loss$(9,956) $(6,385) $(29,092) $(20,822)
    Gain on extinguishment of Class B preferred units          6,697 
    Net loss applicable to common shareholders$(9,956) $(6,385) $(29,092) $(14,125)
             
    Net loss per share/unit, basic and diluted$(0.97) $(2.96) $(2.84) $(6.55)
             
    Weighted average common shares/units outstanding, basic and diluted 10,304,775   2,159,403   10,239,502   2,155,276 
      
      

    SELECTED CONSOLIDATED BALANCE SHEET DATA (unaudited)

    (in thousands)

     September 30, December 31,
     2021 2020
    Cash, cash equivalents and investments$46,431 $85,317
    Total current assets 48,156  87,581
    Working capital 30,293  56,717
    Total assets 69,821  114,835
    Total debt 14,420  16,128
    Total stockholders' equity 32,469  56,207

    About YTX-7739

    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.

    About SCD

    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.

    Investors:

    Burns McClellan, Inc.

    Lee Roth



    (212) 213-0006 ext. 331

    Media:

    Burns McClellan, Inc.

    Robert Flamm, Ph.D.



    (212) 213-0006 ext. 364

    Source: Yumanity Therapeutics, Inc.



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  3. YTX-7739 demonstrated target engagement in Phase 1b clinical trial in patients with mild-to-moderate Parkinson's disease

    YTX-7739 found to be generally well tolerated, demonstrating favorable pharmacokinetic/pharmacodynamic (PK/PD) profiles and a safety profile with no serious adverse events

    Conference call scheduled for 8:30 a.m. EST, Wednesday, November 10

    BOSTON, Nov. 10, 2021 (GLOBE NEWSWIRE) -- Yumanity Therapeutics (NASDAQ:YMTX) is a clinical-stage biopharmaceutical company focused on the discovery and development of innovative, disease-modifying therapies for neurodegenerative disease. The Company today reported that its lead product candidate, YTX-7739, in development for the treatment of Parkinson's disease, achieved its…

    YTX-7739 demonstrated target engagement in Phase 1b clinical trial in patients with mild-to-moderate Parkinson's disease

    YTX-7739 found to be generally well tolerated, demonstrating favorable pharmacokinetic/pharmacodynamic (PK/PD) profiles and a safety profile with no serious adverse events

    Conference call scheduled for 8:30 a.m. EST, Wednesday, November 10

    BOSTON, Nov. 10, 2021 (GLOBE NEWSWIRE) -- Yumanity Therapeutics (NASDAQ:YMTX) is a clinical-stage biopharmaceutical company focused on the discovery and development of innovative, disease-modifying therapies for neurodegenerative disease. The Company today reported that its lead product candidate, YTX-7739, in development for the treatment of Parkinson's disease, achieved its primary endpoints in a randomized, placebo-controlled Phase 1b clinical trial in patients with mild-to-moderate Parkinson's disease.

    YTX-7739 is an investigational drug with a potentially first-in-class disease-modifying mechanism of action. There are no currently available disease-modifying treatments for Parkinson's disease.

    YTX-7739 was generally well tolerated and demonstrated favorable pharmacokinetic/pharmacodynamic (PK/PD) profiles and a safety profile with no serious adverse events. YTX-7739 achieved the expected target engagement in the patients studied and results were consistent with earlier studies in healthy volunteers and preclinical models.

    Notably, YTX-7739 was shown to inhibit its primary target, stearoyl-CoA desaturase (SCD), an enzyme whose inhibition has been closely linked to neuronal survival and improved motor function in a Parkinson's disease model. After 28 days of treatment, the 20 mg dose given once-daily reduced the fatty acid desaturation index (FA-DI), a biomarker of SCD inhibition, by approximately 20%-40%, the range expected to be clinically relevant based on preclinical studies. Target engagement in the cerebrospinal fluid suggested that YTX-7739 effectively crossed the blood-brain barrier. Additionally, the PK/PD profile of YTX-7739 was consistent with previous studies and informs dose selection for future studies.

    YTX-7739 was generally well tolerated with all treatment emergent adverse events being mild to moderate in severity. There were no serious adverse events. Moderate adverse events (AEs) in the active treatment group consisted of 2 patients with increased Parkinson's symptoms, 2 patients with lower back pain, 1 patient with headache, 1 patient with myalgia, 1 patient with insomnia, 1 patient with ligament sprain, and 1 patient with vaccination complication. One patient on placebo had moderate worsening of tremors and Parkinsonism, which led to discontinuation. AEs occurring at a higher percentage in 2 or more patients administered YTX-7739 compared to placebo were procedural pain, myalgia, dry eye, hyperbilirubinemia, hypesthesia, lower back pain, and constipation. AEs occurring at a higher percentage with placebo included orthostatic hypotension, headache, tremor, fatigue and dizziness.

    As expected, after only 28 days of dosing, there were no statistically significant differences in clinical assessments (UPDRS III, MoCA) or most exploratory biomarkers. Quantitative electroencephalogram (qEEG) assessments of the effect of YTX-7739 on brain activity were completed in a subset of 8 patients and demonstrated a statistically significant change compared to baseline, suggestive of a potential improvement in synaptic function. The company expects to further validate the role of this diagnostic marker in future clinical studies.

    "Today's announcement provides yet another strong validation of our proprietary approach to the development of disease-modifying drugs for neurodegenerative diseases," said Richard Peters, M.D., Ph.D., President and CEO of Yumanity Therapeutics. "Together with our ongoing collaboration with Merck in amyotrophic lateral sclerosis and frontotemporal lobar dementia, which was announced last year, Yumanity has demonstrated that it continues to lead in identifying new targets and new drug candidates that have the potential for disease modification in these terrible diseases and remains one of the few select companies with an asset to be advanced into Phase 2 clinical development for the potential treatment of Parkinson's disease."

    "Parkinson's disease is a devastating neurodegenerative disease for which treatments address only temporarily symptoms without any impact on the inevitable disease progression," said Dr. Geert Jan Groeneveld, Chief Scientific and Medical Officer at the Center for Human Drug Research in Leiden and Professor of Clinical Neuropharmacology at the Leiden University Medical Center. "To truly alter the course of the disease, we need new insights into the underlying cellular pathology and novel treatments that interfere with those processes. Recent advances made on the role of lipids in the normal and pathological activity of alpha synuclein have provided a new therapeutic avenue to pursue in Parkinson's with SCD inhibition emerging as a rational approach. The results of this trial are a very encouraging outcome and position YTX-7739 as potentially the first therapeutic candidate to test the lipidopathy hypothesis of synuclein."

    The Phase 1b clinical trial was a randomized, placebo-controlled, double-blind multi dose study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of YTX-7739. Data were reported from 20 patients with mild-to-moderate Parkinson's disease. Patients received once-daily oral doses of YTX-7739 (20 mg or placebo) for 28 days. More information on the design of the trial can be found on the Netherlands Clinical trial Registry, Trial NL9172.

    "We are very encouraged by the results from this Phase 1b trial, which are consistent with the data from the Phase 1a portion of the trial in healthy volunteers," said Ajay Verma, M.D., Ph.D., Executive Vice President of Research and Development of Yumanity Therapeutics. "The favorable tolerability and PK/PD profiles, absence of serious adverse events and evidence of target engagement in patients support the continued development of YTX-7739 as a potential treatment for Parkinson's disease. In addition, the observed qEEG changes, even after only 28 days of treatment, increase our enthusiasm for the potential of YTX-7739. We believe we are well-positioned to test the SCD hypothesis in a Phase 2 randomized clinical trial in Parkinson's disease, which we expect to start in 2022. In the meantime, we anticipate presenting the full data set at an upcoming medical conference."

    Management will host a conference call to discuss the results of the Phase 1b clinical trial at 8:30 a.m. EST, Wednesday, November 10. To participate in the conference call, dial +1 (833) 562-0153 (U.S.) or +1 (661) 567-1235 (International), confirmation code 1261348 shortly before 8:30 a.m. EST. The webcast can be accessed at https://www.yumanity.com/investor-relations/events-presentations/ and will be archived for at least 30 days. A replay of the call will be available from 11:00 a.m. EST, November 10, 2021 to 7:30 p.m. ET, November 17, 2021. The replay number is +1 (855) 859-2056 (U.S.) or +1 (404) 537-3406 (International), confirmation code 1261348.

    About YTX-7739

    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.

    About SCD

    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 laboratories 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 in 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 initiatives focused on multi-system atrophy, Lewy body dementia, amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease), frontotemporal lobar dementia, 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 YTX-7739 and the design, commencement, enrollment, and timing of 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 and 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 the Company's current expectations, estimates and projections about its 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 the Company is unable to execute on its business strategy; the risk that YTX-7739 will not have the safety or efficacy profile that the Company anticipates; the risk that prior results, such as signals of safety, activity or durability of effect, observed from preclinical studies and clinical trials of YTX-7739 will not be replicated or will not continue in ongoing or future studies or trials; and the risk that the Company will be unable to obtain and maintain regulatory approval for its product candidates. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause the Company's actual results to differ materially and adversely from those contained in the forward-looking statements, see the section entitled "Risk Factors" in the Company's most recent Annual or Quarterly Report, as well as discussions of potential risks, uncertainties, and other important factors in the Company's subsequent filings with the Securities and Exchange Commission. The Company explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.

    Investors:

    Burns McClellan, Inc.

    Lee Roth

    .com

    (212) 213-0006

    Media:

    Burns McClellan, Inc.

    Robert Flamm, Ph.D. / Harrison Wong

    /

    (212) 213-0006 ext. 364 / 316



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  4. BOSTON, Sept. 09, 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 that Richard Peters, M.D., Ph.D., President and Chief Executive Officer, will present at the H.C. Wainwright 23rd Global Investment Conference.

    The presentation will be available on-demand via the conference portal and through the Company's website at www.yumanity.com/events beginning at 7 a.m. EDT, September 13.

    About Yumanity Therapeutics
    Yumanity Therapeutics is a clinical-stage biopharmaceutical company dedicated to accelerating the revolution in the treatment of neurodegenerative diseases…

    BOSTON, Sept. 09, 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 that Richard Peters, M.D., Ph.D., President and Chief Executive Officer, will present at the H.C. Wainwright 23rd Global Investment Conference.

    The presentation will be available on-demand via the conference portal and through the Company's website at www.yumanity.com/events beginning at 7 a.m. EDT, September 13.

    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.

    Investors:

    Burns McClellan, Inc.

    Lee Roth



    (212) 213-0006

    Media:

    Burns McClellan, Inc.

    Robert Flamm, Ph.D. / Harrison Wong

    /

    (212) 213-0006 ext. 364 / 316



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  5. YTX-7739 shown to inhibit its novel target in healthy volunteers at levels consistent with improved motor function in an animal model of Parkinson's disease

    Topline results for the YTX-7739 Phase 1b trial in Parkinson's disease patients expected Fall of 2021

    Appointed neuroscience drug development veteran, Ajay Verma, M.D., Ph.D., as EVP, Head of Research & Development

    Appointed Devin W. Smith, J.D., as SVP, General Counsel

    BOSTON, Aug. 12, 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 second quarter ended June 30, 2021, and…

    YTX-7739 shown to inhibit its novel target in healthy volunteers at levels consistent with improved motor function in an animal model of Parkinson's disease

    Topline results for the YTX-7739 Phase 1b trial in Parkinson's disease patients expected Fall of 2021

    Appointed neuroscience drug development veteran, Ajay Verma, M.D., Ph.D., as EVP, Head of Research & Development

    Appointed Devin W. Smith, J.D., as SVP, General Counsel

    BOSTON, Aug. 12, 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 second quarter ended June 30, 2021, and provided an overview of the Company's recent corporate developments and upcoming milestones.

    "The second quarter of 2021 was significant for continued progress with our lead program, YTX-7739, which is in development to treat Parkinson's disease," said Richard Peters, M.D., Ph.D., President, Chief Executive Officer and Director of Yumanity. "We reported that YTX-7739 was generally well-tolerated in healthy subjects and achieved desired drug exposure and target engagement. This paves the way for the next series of clinical results in patients with Parkinson's disease this Fall. Additionally, preclinical results presented by researchers from the Massachusetts General Hospital open the possibility to explore another indication for our SCD inhibitors in the treatment of glioblastoma multiforme. On the financial side, we have continued to target investment in our programs and our people to ensure a cash runway late into the third quarter of 2022. Finally, we strengthened our leadership team with the addition of two seasoned industry veterans, Dr. Ajay Verma and Devin Smith, as Head of R&D and General Counsel, respectively."

    Second Quarter and Recent Corporate Developments

    • YTX-7739 achieved target engagement at doses that were generally well tolerated in a Phase 1a multiple ascending doses (MAD) clinical trial in healthy volunteers.
    • Presented results of a study by researchers from the Massachusetts General Hospital (MGH) demonstrating in vivo efficacy of stearoyl-CoA desaturase (SCD) inhibitors 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.
    • Appointed Devin W. Smith as Senior Vice President, General Counsel.

    Upcoming Milestones

    • The Company expects to announce topline results from the Phase 1b part of the MAD study of YTX-7739 in patients with Parkinson's disease in the fall of 2021.
    • The Company anticipates initiating a Phase 1 trial of an SCD inhibitor for the treatment of dementia with Lewy Bodies later this year.
    • The Company expects to initiate a window-of-opportunity clinical study of an SCD inhibitor in GBM patients next year pending validation of the MGH preclinical results in a second animal model.
    • The Company expects to initiate a Phase 2 trial of YTX-7739 in patients with Parkinson's disease next year.

    Second Quarter 2021 Financial Highlights:

    • Cash position: As of June 30, 2021, cash, cash equivalents and investments was $55.6 million, compared to $85.3 million as of December 31, 2021. The decrease was primarily due to spending on the clinical development of YTX-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 late into the third quarter of 2022.
    • Research and development (R&D) expense: Research and development expenses were $7.3 million for the second quarter of 2021 compared to $3.9 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 $4.7 million for the second quarter of 2021 compared to $2.6 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 $10.5 million, or $1.03 per basic and diluted share, for the second quarter of 2021 compared to a net loss of $7.0 million, which excludes the gain on extinguishment of Class B preferred units, or $0.13 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.

    YUMANITY THERAPEUTICS, INC.

    CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS (unaudited)

    (in thousands, except share/unit amounts)

     Three Months Ended Six Months Ended
     June 30, June 30,
      2021   2020   2021   2020 
    Collaboration revenue$2,114     $5,646    
    Operating expenses:       
    Research and development 7,327   3,939   14,106   8,968 
    General and administrative 4,712   2,599   10,764   4,631 
    Total operating expenses 12,039   6,538   24,870   13,599 
    Loss from operations (9,925)  (6,538)  (19,224)  (13,599)
    Other income (expense), net (529)  (434)  88   (838)
    Net loss$(10,454) $(6,972) $(19,136) $(14,437)
    Gain on extinguishment of Class B preferred units    6,697      6,697 
    Net loss applicable to common shareholders$(10,454)  (275)  (19,136)  (7,740)
            
    Net loss per share/unit, basic and diluted$(1.03) $(0.13) $(1.88) $(3.59)
            
    Weighted average common shares/units outstanding, basic and diluted 10,195,608   2,156,363   10,194,474   2,153,190 
                    

    SELECTED CONSOLIDATED BALANCE SHEET DATA (unaudited)

    (in thousands)

     June 30,

     December 31,
     2021

     2020
    Cash, cash equivalents and investments$55,628  $85,317 
    Total current assets 58,185   87,581 
    Working capital 40,336   56,717 
    Total assets 81,251   114,835 
    Total debt 15,186   16,128 
    Total stockholders' equity 41,107   56,207 
            

    About YTX-7739

    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.

    About SCD

    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.

    Investors:

    Burns McClellan, Inc.

    Lee Roth



    (212) 213-0006 ext. 331

    Media:

    Burns McClellan, Inc.

    Robert Flamm, Ph.D.



    (212) 213-0006 ext. 364

    Source: Yumanity Therapeutics, Inc.



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