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-7739YTX-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 SCDSCD 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 TherapeuticsYumanity
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
Rothlroth@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.
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