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 full year ended
December 31, 2020 and provided an overview of the Company’s recent
corporate developments and upcoming milestones.
“Yumanity made important scientific and operational
progress throughout the course of the last year,” said Richard
Peters, M.D., Ph.D., President, Chief Executive Officer and
Director of Yumanity. “Following our transition to a
publicly-traded company in December, we achieved key clinical
milestones for our lead Parkinson’s disease program, YTX-7739,
including demonstrating safety, tolerability, and penetration in
the cerebrospinal fluid with a single ascending dose (SAD) study of
YTX-7739 in healthy volunteers, completing enrollment in the Phase
1a part of our multiple ascending dose (MAD) study in healthy
volunteers, and initiating dosing in the Phase 1b part in
Parkinson’s disease patients. Additionally, we strengthened our
balance sheet with the completion of the reverse merger and a $33.6
million PIPE, adding a total of $68.7 million to our balance sheet,
which will allow us to further accelerate growth towards our goal
of delivering disease-modifying drugs to patients suffering from
neurodegenerative diseases. We look forward to providing updates on
a number of key milestones throughout the year, including results
from the Phase 1a part of our MAD study of YTX-7739 in healthy
volunteers expected in the beginning of the second quarter of 2021,
preliminary results from the Phase 1b part of our MAD study of
YTX-7739 in patients with Parkinson’s disease expected in mid-2021,
and the start of a Phase 1 trial for our next program, YTX-9184,
for patients with dementia with Lewy Bodies anticipated in the
second half of 2021.”
Recent Corporate Developments
- Completed reverse merger with
Proteostasis Therapeutics, Inc. on December 22, 2020 and commenced
trading on the Nasdaq Capital Market on December 23, 2020, under
the ticker symbol “YMTX”.
- Closed $33.6 million common stock
private investment in public equity (“PIPE”) transaction
concurrently with the closing of the reverse merger.
- Announced the results from the Phase
1, single-ascending dose (SAD) study in healthy volunteers of
YTX-7739, a novel SCD inhibitor being developed for the treatment
of Parkinson’s disease. No safety concerns were identified and
YTX-7739 was found to be well tolerated with most adverse events
being mild or moderate in severity. Consistent with preclinical
data, YTX-7739 demonstrated clinically relevant drug concentrations
in the cerebral spinal fluid (CSF).
- Completed enrollment of the Phase 1a
part of our MAD study investigating the safety, tolerability, and
pharmacokinetics of once daily oral administration of 2 doses of
YTX-7739 in healthy volunteers.
- Initiated dosing of the Phase 1b
part of our MAD study of YTX-7739 in patients with Parkinson’s
disease. The Phase 1b part is expected to enroll 30 subjects and
will collect safety, tolerability, pharmacokinetic and
pharmacodynamic parameters including potential biomarkers of SCD
activity and target engagement in the CSF, plasma, and other fluids
or tissues.
- Presented results of a study of
YTX-7739 that demonstrate pharmacological, physiological and
behavioral pre-clinical proof of concept in a Parkinson’s disease
(PD) mouse model. This oral presentation and two posters were
presented at the 15th Annual International Conference on
Alzheimer’s and Parkinson’s Diseases (AD/PD™ 2021) Virtual
Conference, March 9 to 14, 2021.
Upcoming Milestones
- The Company expects to report the
results of the Phase 1a part of the MAD study of YTX-7739 in
healthy volunteers in the beginning of the second quarter of 2021.
Detailed clinical data from this Phase 1 study in healthy
volunteers with YTX-7739 will be presented at a future medical
conference.
- The Company remains on track to
announce preliminary results from the Phase 1b part of the MAD
study of YTX-7739 in patients with Parkinson’s disease by mid-year
2021.
- The Company anticipates initiating a
Phase 1 trial of YTX-9184, a novel SCD inhibitor being developed
for the treatment of dementia with Lewy Bodies, in the second half
of this 2021.
2020 Financial Highlights:
- Cash position: As of
December 31, 2020, cash, cash equivalents and investments were
$85.3 million, compared to $15.4 million as of December 31, 2019.
The increase in cash, cash equivalents and investments was
primarily due to the receipt of $35.1 million in cash, cash
equivalents, and investments from our merger with Proteostasis,
$33.6 million in gross proceeds from the sale of common stock in
our PIPE, $21.6 million in gross proceeds from the issuance of
Class C preferred units prior to the merger, and $15 million in
upfront payments received from Merck as part of the collaboration
agreement, offset by operating expenses incurred during the
year.
- Collaboration revenue:
Revenue recognized in 2020 was GAAP revenue earned related to the
upfront fee of $15.0 million for the Company’s collaboration
agreement with Merck. Collaboration revenue was $6.9 million for
the year ended December 31, 2020. Yumanity did not recognize
collaboration revenue in 2019.
- Research and development
expenses: Research and development expenses were $22.3 and
$23.0 million for the years ended December 31, 2020 and 2019,
respectively. The decrease in research and development expenses was
primarily due to a $2.4 million decrease in platform and early
stages research external costs, partially offset by a $1.3 million
increase in manufacturing costs and GLP toxicology studies for
YTX-9184 and $0.9 million in clinical and consulting costs for
YTX-7739.
- General and administrative
expenses: General and administrative expenses were $11.9
million and $7.1 million for the years ended December 31, 2020 and
2019. The increase was primarily attributable to an increase in
professional services fees associated with the transactions listed
above.
- Net loss: The company
reported a net loss of $57.5 million and $31.2 million for the
years ended December 31, 2020 and 2019, respectively, which is an
increase of $26.3 million, resulting primarily from a $28.3 million
charge for in-process research and development expenses in
connection with our reverse merger with Proteostasis in December
2020.
YUMANITY THERAPEUTICS,
INC.CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS
(unaudited)(in thousands, except share/unit
amounts)
|
Year Ended December 31, |
|
2020 |
|
|
2019 |
|
Collaboration revenue |
$ |
6,896 |
|
|
— |
|
Operating expenses: |
|
|
|
|
|
Research and development |
22,310 |
|
|
22,969 |
|
General and administrative |
11,881 |
|
|
7,062 |
|
In-process research and development assets acquired |
28,336 |
|
|
— |
|
Total operating expenses |
62,527 |
|
|
30,031 |
|
Loss from operations |
(55,631 |
) |
|
(30,031 |
) |
Other income (expense), net |
(1,856 |
) |
|
(1,178 |
) |
Net loss |
$ |
(57,487 |
) |
|
$ |
(31,209 |
) |
Gain on extinguishment of
Class B preferrered units |
6,697 |
|
|
— |
|
Net loss applicable to common
shareholders |
$ |
(50,790 |
) |
|
$ |
(31,209 |
) |
Net loss per share/unit, basic
and diluted |
$ |
(21.57 |
) |
|
$ |
(14.71 |
) |
Weighted average common
shares/units outstanding, |
|
|
|
|
|
basic and diluted |
2,354,143 |
|
|
2,121,843 |
|
SELECTED CONSOLIDATED BALANCE SHEET DATA
(unaudited)(in thousands)
|
Year Ended December 31, |
|
2020 |
|
|
2019 |
|
Cash, cash equivalents and investments |
$ |
85,317 |
|
|
$ |
15,368 |
|
Total current assets |
87,581 |
|
|
16,174 |
|
Working capital |
56,717 |
|
|
11,214 |
|
Total assets |
114,835 |
|
|
17,606 |
|
Total debt |
16,128 |
|
|
14,470 |
|
Total stockholders'
equity/members' deficit |
56,207 |
|
|
(91,900 |
) |
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), that plays an important and
previously unrecognized role in modulating neurotoxicity arising
from the alpha-synuclein protein, a major driver of Parkinson’s
disease and related neurodegenerative disorders. Misfolding and
aggregation of alpha-synuclein triggers a cascade of events,
ultimately resulting in neurotoxicity and the subsequent impairment
of movement and cognition that afflicts patients living with this
disease. 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 models. The
company is assessing the potential utility of YTX-7739 in
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
lipid-related molecules regulate multiple diverse cellular
properties and processes, including membrane structure and
function, vesicle 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. 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.
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 is
designed to enable the Company to rapidly screen for potential
disease-modifying therapies by overcoming toxicity of misfolded
proteins in 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.John
Grimaldijgrimaldi@burnsmc.com (212) 213-0006
Media:Burns McClellan, Inc.Ryo Imai / Robert
Flamm, Ph.D.rimai@burnsmc.com / rflamm@burnsmc.com (212)
213-0006
Source: Yumanity Therapeutics, Inc.
Yumanity Therapeutics (NASDAQ:YMTX)
Historical Stock Chart
From Jun 2024 to Jul 2024
Yumanity Therapeutics (NASDAQ:YMTX)
Historical Stock Chart
From Jul 2023 to Jul 2024