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Yumanity Therapeutics Reports Second Quarter 2021 Financial Results and Recent Corporate Developments

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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
lroth@burnsmc.com
(212) 213-0006 ext. 331

Media:
Burns McClellan, Inc.
Robert Flamm, Ph.D.
rflamm@burnsmc.com
(212) 213-0006 ext. 364

Source: Yumanity Therapeutics, Inc.