Evelo Biosciences Announces First Quarter 2022 Financial Results and Business Highlights
May 12 2022 - 6:00AM
Evelo Biosciences, Inc. (Nasdaq: EVLO), a clinical stage
biotechnology company developing a new modality of orally delivered
medicines, today reported financial results and business highlights
for the first quarter 2022.
“This quarter we reported positive data for EDP1815 in psoriasis
in three key areas: effects on systemic inflammatory cytokine
markers; depth and duration of response at 6-month follow-up post
dosing; and increased target site engagement with a faster release
capsule. These data, together with our previously reported Phase 2
clinical efficacy data and preclinical data, demonstrate the
central role of the small intestinal axis, SINTAX™, and supports
the potential of EDP1815 as a new type of inflammation-resolving
medicine with broad applicability,” said Simba Gill, Ph.D., Chief
Executive Officer of Evelo. “We continue to advance EDP1815 towards
later-stage clinical trials in psoriasis. Additionally, we are
recruiting ahead of plan in our Phase 2 trial of EDP1815 in atopic
dermatitis, and now expect data from the first three cohorts in the
trial to be available in the first quarter of 2023, and data from a
potential fourth cohort to be available in 2Q 2023.”
First Quarter 2022 Highlights
EDP1815 in Psoriasis
- In March 2022, Evelo presented a late-breaking oral abstract on
data from its Phase 2 trial of EDP1815 in mild and moderate
psoriasis at the 2022 American Academy of Dermatology (AAD) Annual
Meeting. The Company previously released positive clinical data,
confirmatory cytokine biomarker data, and post-treatment follow-up
findings from this trial.
EDP1815 in Atopic Dermatitis
- Recruitment for the Phase 2 trial of EDP1815 in atopic
dermatitis is ahead of plan.
- Evelo intends to add a fourth cohort to the on-going Phase 2
trial. Patients in this cohort, if enrolled, would receive 1
capsule of EDP1815 with a faster release profile once daily.
Business Highlights
- In April 2022, Jose-Carlos Gutiérrez-Ramos, Ph.D. and Tonya
Williams, J.D. were appointed to Evelo’s Board of Directors, and
John Mangalore, Ph.D. and Tassos Gianakakos were appointed as
strategic advisors to the Company.
Upcoming Key Milestones
EDP1815 – Atopic Dermatitis
- Data from the first 3 cohorts of the Phase 2 atopic dermatitis
trial in mild, moderate, and severe atopic dermatitis is
anticipated in 1Q 2023; data from a potential additional fourth
cohort is anticipated in 2Q 2023.
EDP2939 – Inflammation
- Initiation of clinical development in 3Q 2022.
- Phase 2 data from a cohort of patients with psoriasis expected
2H 2023.
First Quarter 2022 Financial Results
(Unaudited)
- Cash Position: As of December 31, 2021, cash
and cash equivalents were $39.6 million, as compared to cash and
cash equivalents of $68.4 million as of March 31, 2021.
- Research and Development Expenses: R&D
expenses were $19.3 million for the three months ended March 31,
2022, compared to $21.5 million for the three months ended March
31, 2021, respectively.
- General and Administrative Expenses: G&A
expenses were $9.4 million for the three months ended March 31,
2022, compared to $6.0 million for the three months ended March 31,
2021.
- Net Loss: Net loss was $29.9 million for the
three months ended March 31, 2022, compared to $28.2 million for
the three months ended March 31, 2021. Earnings per basic and
diluted shares were $(0.56) for the three months ended March 31,
2022, compared to $(0.55) three months ended March 31, 2021.
About Evelo BiosciencesEvelo Biosciences is a
clinical stage biotechnology company developing orally delivered
product candidates that are designed to act on the small intestinal
axis, SINTAX™, with systemic therapeutic effects. SINTAX plays a
central role in governing the immune, metabolic, and neurological
systems. The Company’s first product candidates are pharmaceutical
preparations of single strains of microbes selected for their
potential to offer defined pharmacological properties. Evelo’s
therapies have the potential to be effective, safe, and affordable
medicines to improve the lives of people with a broad range of
inflammatory diseases.
Evelo currently has two product candidates in development:
EDP1815 and EDP2939 for the treatment of inflammatory diseases.
Evelo is advancing additional product candidates in other disease
areas.
For more information, please visit www.evelobio.com and engage
with Evelo on LinkedIn.
Forward Looking StatementsThis press release
contains forward-looking statements including within the meaning of
the Private Securities Litigation Reform Act of 1995. All
statements contained in this press release that do not relate to
matters of historical fact should be considered forward-looking
statements, including statements concerning the development of
EDP1815 and EDP2939, the promise and potential impact of our
product candidates, the timing of and plans for clinical trials,
and the timing and results of clinical trial readouts.
These forward-looking statements are based on management's
current expectations. These statements are neither promises nor
guarantees, but involve known and unknown risks, uncertainties and
other important factors that may cause our actual results,
performance or achievements to be materially different from any
future results, performance or achievements expressed or implied by
the forward-looking statements, including, but not limited to, the
following: the impact of the COVID-19 pandemic on our operations,
including our preclinical studies and clinical trials, and the
continuity of our business; we have incurred significant losses,
are not currently profitable and may never become profitable; our
need for additional funding; our limited operating history; our
unproven approach to therapeutic intervention; the lengthy,
expensive, and uncertain process of clinical drug development,
including potential delays in regulatory approval; our reliance on
third parties and collaborators to expand our microbial library,
conduct our clinical trials, manufacture our product candidates,
and develop and commercialize our product candidates, if approved;
our lack of experience in manufacturing, selling, marketing, and
distributing our product candidates; failure to compete
successfully against other drug companies; protection of our
proprietary technology and the confidentiality of our trade
secrets; potential lawsuits for, or claims of, infringement of
third-party intellectual property or challenges to the ownership of
our intellectual property; our patents being found invalid or
unenforceable; risks associated with international operations; our
ability to retain key personnel and to manage our growth; the
potential volatility of our common stock; our management and
principal stockholders have the ability to control or significantly
influence our business; costs and resources of operating as a
public company; unfavorable or no analyst research or reports; and
securities class action litigation against us.
These and other important factors discussed under the caption
"Risk Factors" in our Quarterly Report on Form 10-Q for the
three-month period ended March 31, 2022, and our other reports
filed with the SEC, could cause actual results to differ materially
from those indicated by the forward-looking statements made in this
press release. Any such forward-looking statements represent
management's estimates as of the date of this press release. While
we may elect to update such forward-looking statements at some
point in the future, except as required by law, we disclaim any
obligation to do so, even if subsequent events cause our views to
change. These forward-looking statements should not be relied upon
as representing our views as of any date subsequent to the date of
this press release.
Contacts
Investors:Kendra Sweeney,
239-877-7474ksweeney@evelobio.com
Media:Jessica Cotrone,
978-760-5622jcotrone@evelobio.com
Evelo Biosciences,
Inc.Condensed Consolidated Statements of
Operations(In thousands, except share and per share
data)
(Unaudited) |
|
|
Three Months EndedMarch 31, |
|
|
|
2022 |
|
|
|
2021 |
|
Operating expenses: |
|
|
|
|
Research and development |
|
$ |
19,321 |
|
|
$ |
21,508 |
|
General and administrative |
|
|
9,417 |
|
|
|
5,963 |
|
Total operating expenses ¹ |
|
|
28,738 |
|
|
|
27,471 |
|
Loss from operations |
|
|
(28,738 |
) |
|
|
(27,471 |
) |
Other (expense) income: |
|
|
|
|
Interest expense, net |
|
|
(1,027 |
) |
|
|
(765 |
) |
Other miscellaneous income, net |
|
|
20 |
|
|
|
162 |
|
Total other expense, net |
|
|
(1,007 |
) |
|
|
(603 |
) |
Loss before income taxes |
|
|
(29,745 |
) |
|
|
(28,074 |
) |
Income tax expense |
|
|
(116 |
) |
|
|
(122 |
) |
Net loss |
|
$ |
(29,861 |
) |
|
$ |
(28,196 |
) |
|
|
|
|
|
Net loss per share
attributable to common stockholders, basic and diluted |
|
$ |
(0.56 |
) |
|
$ |
(0.55 |
) |
Weighted-average number of
common shares outstanding, basic and diluted |
|
|
53,619,635 |
|
|
|
51,343,923 |
|
|
|
|
|
|
|
|
|
|
|
¹ Expenses include
the following non-cash stock-based compensation expense. |
Research and development |
|
$ |
2,036 |
|
|
$ |
1,823 |
|
General and administrative |
|
|
2,239 |
|
|
|
1,441 |
|
Total stock-based compensation expense |
|
$ |
4,275 |
|
|
$ |
3,264 |
|
|
Evelo Biosciences,
Inc.Condensed Consolidated Balance
Sheets(In thousands, except per share and share)
(Unaudited) |
|
|
March 31, 2022 |
|
December 31, 2021 |
Assets |
|
|
|
|
Current assets: |
|
|
|
|
Cash and cash equivalents |
|
$ |
39,631 |
|
|
$ |
68,441 |
|
Prepaid expenses and other current assets |
|
|
3,494 |
|
|
|
2,585 |
|
Total current assets |
|
|
43,125 |
|
|
|
71,026 |
|
Property and equipment,
net |
|
|
6,126 |
|
|
|
6,622 |
|
Right of use asset - operating
lease |
|
|
8,419 |
|
|
|
8,910 |
|
Other assets |
|
|
1,155 |
|
|
|
1,313 |
|
Total assets |
|
$ |
58,825 |
|
|
$ |
87,871 |
|
Liabilities and
stockholders’ (deficit) equity |
|
|
|
|
Current liabilities: |
|
|
|
|
Debt, current portion |
|
$ |
1,844 |
|
|
$ |
— |
|
Accounts payable |
|
|
1,760 |
|
|
|
1,601 |
|
Accrued expenses |
|
|
9,876 |
|
|
|
13,068 |
|
Operating lease liability, current portion |
|
|
2,027 |
|
|
|
1,951 |
|
Other current liabilities |
|
|
665 |
|
|
|
742 |
|
Total current liabilities |
|
|
16,172 |
|
|
|
17,362 |
|
Noncurrent liabilities: |
|
|
|
|
Debt, net of current portion |
|
|
44,772 |
|
|
|
46,557 |
|
Operating lease liability, net of current portion |
|
|
7,183 |
|
|
|
7,785 |
|
Deferred revenue |
|
|
7,500 |
|
|
|
7,500 |
|
Total liabilities |
|
|
75,627 |
|
|
|
79,204 |
|
Commitments and contingencies
(Note 10) |
|
|
|
|
Stockholder’s (deficit)
equity: |
|
|
|
|
Preferred stock, $0.001 par value; 10,000,000 shares authorized; no
shares issued or outstanding as of March 31, 2022 and December 31,
2021, respectively |
|
|
— |
|
|
|
— |
|
Common stock, $0.001 par value; 200,000,000 shares authorized;
53,648,189 and 53,576,454 shares issued and outstanding as of March
31, 2022 and December 31, 2021, respectively |
|
|
54 |
|
|
|
54 |
|
Additional paid-in capital |
|
|
427,700 |
|
|
|
423,308 |
|
Accumulated deficit |
|
|
(444,556 |
) |
|
|
(414,695 |
) |
Total stockholders’ (deficit) equity |
|
|
(16,802 |
) |
|
|
8,667 |
|
Total liabilities and stockholders’ (deficit) equity |
|
$ |
58,825 |
|
|
$ |
87,871 |
|
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