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-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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