Evelo Biosciences Announces Fourth Quarter and Full Year 2022 Financial Results and Business Highlights
March 16 2023 - 7:00AM
Evelo Biosciences, Inc. (Nasdaq: EVLO), (“Evelo” or the “Company”)
a clinical stage biotechnology company developing a novel platform
of orally delivered inflammation-resolving medicines acting on the
small intestinal axis, SINTAX, today reported financial results and
business highlights for the fourth quarter and full year 2022.
“We continued to progress on our SINTAX platform and our
clinical pipeline in 2022. We look forward to important clinical
milestones in 2023. On mechanism of action, we have shown that the
action of SINTAX medicines in the small intestine generates
systemically circulating regulatory T cells. These T cells have the
potential to induce durable resolution of inflammation throughout
the body, as observed in Part B of the EDP1815 Phase 2 study in
psoriasis announced in 2022,” said Simba Gill, Ph.D., Chief
Executive Officer. “We also developed a faster release capsule in
2022 which we expect to improve exposure of drug substance to the
target of the upper regions of the small intestine. Our first
clinical testing of the faster release capsule is in a placebo
controlled fourth cohort of our ongoing atopic dermatitis Phase 2
trial of EDP1815, for which we anticipate reporting results in the
second quarter of this year.”
Dr. Gill continued, “Additionally, we have progressed our first
oral extracellular vesicle (EV) clinical program. We announced in
February 2023 that our product candidate, EDP2939, also formulated
with the faster release capsule, is now in the clinic. Following a
Phase 1 safety review in the first cohort of our healthy human
volunteers, we have started dosing in a Phase 2 study in moderate
plaque psoriasis patients. The Phase 2 clinical readout is expected
in the second half of 2023.”
2022 Highlights
- In February 2022, the Company reported
data from Part B of EDP1815 Phase 2 trial in psoriasis,
demonstrating durable and deepening responses in the post-treatment
period.
- 18/30 patients maintained a PASI-50 or greater response
- 9/20 patients experienced a deepening of response from PASI-50
to at least PASI-75
- In May 2022, the Company raised $79.2 million through a
Registered Direct Offering of common stock, led by Flagship
Pioneering with participation from key existing and new
investors.
- In December 2022, Evelo refinanced its existing $45 million
debt by executing a loan and security agreement with Horizon
Technology Finance, which provides for three years of interest-only
payments, followed by a two-year amortization period.
- Evelo received feedback from the U.S. Food and Drug
Administration (“FDA”), European Medicines Agency (“EMA”) and
Medicines and Healthcare products Regulatory Agency (“MHRA")
regarding a proposed Phase 3 study of EDP1815 in psoriasis,
advancement into which is funding dependent, including the
following:
- Agreement on primary endpoint of PGA 0/1 with a 2-point
improvement
- No need for active comparator in Europe, with placebo control
acceptable in the mild-to-moderate population
- Alignment on Chemistry, Manufacturing and Controls plan for
release and stability testing panels
- Evelo published a peer-reviewed article in Frontiers in
Immunology explaining the scientific basis of the Small Intestinal
Axis (“SINTAX”).
Upcoming Milestones
EDP1815 – Atopic Dermatitis
- Data from a fourth patient cohort of the Phase 2 study in
atopic dermatitis evaluating the faster release capsule is
anticipated in 2Q 2023.
- Cohorts one, two and three did not meet the primary endpoint of
EASI-50 improvement as compared to placebo, due to an unusually
high placebo response. No conclusions regarding the cause of the
high placebo response have been identified.
EDP2939 – Psoriasis
- A safety and tolerability review was conducted in a first
cohort of healthy volunteers in the Phase 1 portion of the trial,
with no safety or tolerability concerns identified and resulting in
approval to start the Phase 2 part of the trial.
- In February 2023, Evelo began dosing psoriasis patients in the
Phase 2 portion of the trial, with data expected 2H 2023.
- Safety and tolerability assessment of multiple ascending dose
cohorts continues, as the Company anticipates conducting additional
dose-ranging studies following acceptable safety and tolerability
data.
Fourth Quarter and Full Year 2022 Financial Results
(Unaudited)
- Cash Position: As of
December 31, 2022, cash and cash equivalents were
$47.9 million, as compared to cash and cash equivalents of
$68.4 million as of December 31, 2021.
- Research and Development
Expenses: R&D expenses were $16.1 million and
$78.6 million for the three and twelve-month periods ended
December 31, 2022, compared to $18.9 million and
$83.6 million for the three and twelve-month periods ended
December 31, 2021, respectively.
- General and Administrative
Expenses: G&A expenses were $5.0 million and
$29.9 million for the three and twelve-month periods ended
December 31, 2022, compared to $8.7 million and
$31.8 million for the three and twelve-month periods ended
December 31, 2021, respectively.
- Net Loss: Net loss was
$23.5 million and $114.5 million for the three and
twelve-month periods ended December 31, 2022, compared to
$28.7 million and $122.2 million for the three and
twelve-month periods ended December 31, 2021,
respectively.
Conference CallEvelo will host a conference
call and webcast at 8:30 a.m. ET today to review fourth quarter and
full year 2022 highlights. To listen to the conference call by
phone, participants must pre-register here. A live webcast can be
accessed under "News & Events" in the investors section of
Evelo’s website, https://ir.evelobio.com/news-events. The archived
webcast will be available on Evelo’s website for approximately 30
days following the event.
About Evelo BiosciencesEvelo Biosciences is a
clinical stage biotechnology company developing a novel platform of
orally delivered anti-inflammatory medicines acting on the small
intestinal axis, SINTAX, with systemic therapeutic effects. The
small intestine plays a central role in governing inflammation
throughout the body. The Company’s product candidates are
pharmaceutical preparations of single strains of microbes or their
extracellular vesicles (EVs). Evelo initially is developing EDP1815
in psoriasis and atopic dermatitis and EDP2939 in psoriasis.
Evelo’s vision is to create therapies that are effective, safe,
well-tolerated, and affordable to improve the lives of the billions
of people living with inflammatory diseases. If shown to be
effective in inflammatory disease mediated by the Th1, Th2 or Th17
inflammatory pathways, these same investigational medicines could
be effective in additional inflammatory diseases, such as psoriatic
and other forms of arthritis, asthma, allergy, and inflammatory
bowel disease.
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 expected timing and
advancement of, and data results from, trials and clinical studies
involving our product candidates.
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: we have incurred significant losses, are not currently
profitable and may never become profitable; our projected cash
runway; our need for additional funding; our ability to meet our
debt obligations (including restrictive and operational covenants
and terms of refinanced debt); our ability to cure or
satisfactorily resolve any default arising from our debt
agreements; our limited operating history; our unproven approach to
therapeutic intervention; our ability to address regulatory
questions and the likelihood of regulatory filings and approvals;
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 operate with a reduced workforce, to manage potential
growth and to retain key personnel, particularly following a
significant downsizing; 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; the impact of the COVID-19 pandemic on
our operations, including our preclinical studies and clinical
trials, and the continuity of our business; and securities class
action litigation against us.
These and other important factors discussed under the caption
"Risk Factors" in our Annual Report on Form 10-K for the fiscal
year ended December 31, 2022, and our other reports filed with the
United States Securities and Exchange Commission, 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.
ContactsInvestors:ir@evelobio.com
Media:media@evelobio.com
Evelo Biosciences,
Inc.Consolidated Statements of Operations
(Unaudited)(In thousands, except per share and share
amounts)
|
Three Months Ended December 31, |
|
Year Ended December 31, |
|
|
2022 |
|
|
|
2021 |
|
|
|
2022 |
|
|
|
2021 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
$ |
16,084 |
|
|
$ |
18,881 |
|
|
$ |
78,554 |
|
|
$ |
83,643 |
|
General and administrative |
|
5,003 |
|
|
|
8,678 |
|
|
|
29,912 |
|
|
|
31,753 |
|
Total operating expenses(1) |
|
21,087 |
|
|
|
27,559 |
|
|
|
108,466 |
|
|
|
115,396 |
|
Loss from operations |
|
(21,087 |
) |
|
|
(27,559 |
) |
|
|
(108,466 |
) |
|
|
(115,396 |
) |
Other
income (expense): |
|
|
|
|
|
|
|
Interest expense, net |
|
(1,837 |
) |
|
|
(1,010 |
) |
|
|
(4,672 |
) |
|
|
(3,612 |
) |
Loss on extinguishment of debt |
|
(520 |
) |
|
|
— |
|
|
|
(520 |
) |
|
|
(3,226 |
) |
Other miscellaneous income, net |
|
447 |
|
|
|
14 |
|
|
|
61 |
|
|
|
486 |
|
Total other expenses, net |
|
(1,910 |
) |
|
|
(996 |
) |
|
|
(5,131 |
) |
|
|
(6,352 |
) |
Loss before income taxes |
|
(22,997 |
) |
|
|
(28,555 |
) |
|
|
(113,597 |
) |
|
|
(121,748 |
) |
Income tax expense |
|
(544 |
) |
|
|
(97 |
) |
|
|
(930 |
) |
|
|
(428 |
) |
Net loss |
$ |
(23,541 |
) |
|
$ |
(28,652 |
) |
|
$ |
(114,527 |
) |
|
$ |
(122,176 |
) |
|
|
|
|
|
|
|
|
Net loss per share
attributable to common stockholders, basic and diluted |
$ |
(0.21 |
) |
|
$ |
(0.54 |
) |
|
$ |
(1.31 |
) |
|
$ |
(2.31 |
) |
Weighted average number of
common shares outstanding, basic and diluted |
|
109,839,320 |
|
|
|
53,515,636 |
|
|
|
87,168,683 |
|
|
|
52,910,982 |
|
(1) Expenses include the following amount of
non-cash stock-based compensation expense.
|
Three Months Ended December 31, |
|
Year Ended December 31, |
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
General and
administrative |
$ |
1,712 |
|
$ |
2,290 |
|
$ |
8,018 |
|
$ |
7,842 |
Research and development |
|
1,709 |
|
|
2,079 |
|
|
7,140 |
|
|
8,004 |
Total stock-based compensation
expense |
$ |
3,421 |
|
$ |
4,369 |
|
$ |
15,158 |
|
$ |
15,846 |
Evelo Biosciences,
Inc.Consolidated Balance Sheets
(Unaudited)(In thousands, except share amounts)
|
December 31, |
|
|
2022 |
|
|
|
2021 |
|
Assets |
|
|
|
Current
assets: |
|
|
|
Cash and cash equivalents |
$ |
47,940 |
|
|
$ |
68,441 |
|
Prepaid expenses and other current assets |
|
3,633 |
|
|
|
2,585 |
|
Total current assets |
|
51,573 |
|
|
|
71,026 |
|
Property and equipment,
net |
|
4,842 |
|
|
|
6,622 |
|
Right of use asset - operating
lease |
|
6,868 |
|
|
|
8,910 |
|
Other assets |
|
1,158 |
|
|
|
1,313 |
|
Total assets |
$ |
64,441 |
|
|
$ |
87,871 |
|
Liabilities and stockholders’ (deficit) equity |
|
|
|
Current
liabilities: |
|
|
|
Accounts payable |
$ |
1,764 |
|
|
$ |
1,601 |
|
Accrued expenses |
|
7,945 |
|
|
|
13,068 |
|
Operating lease liability, current portion |
|
2,259 |
|
|
|
1,951 |
|
Other current liabilities |
|
427 |
|
|
|
742 |
|
Total current liabilities |
|
12,395 |
|
|
|
17,362 |
|
Noncurrent liabilities: |
|
|
|
Debt, net of current
portion |
|
43,614 |
|
|
|
46,557 |
|
Operating lease liability, net
of current portion |
|
5,265 |
|
|
|
7,785 |
|
Deferred revenue |
|
7,500 |
|
|
|
7,500 |
|
Other noncurrent
liabilities |
|
659 |
|
|
|
— |
|
Total liabilities |
|
69,433 |
|
|
|
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 and outstanding as of December 31, 2022 and
2021, respectively |
|
— |
|
|
|
— |
|
Common stock, $0.001 par value; 200,000,000 shares
authorized; 110,852,741 and 53,576,454 shares issued
and outstanding as of December 31, 2022 and 2021,
respectively |
|
111 |
|
|
|
54 |
|
Additional paid-in
capital |
|
524,119 |
|
|
|
423,308 |
|
Accumulated deficit |
|
(529,222 |
) |
|
|
(414,695 |
) |
Total stockholders’ (deficit)
equity |
|
(4,992 |
) |
|
|
8,667 |
|
Total liabilities and
stockholders’ (deficit) equity |
$ |
64,441 |
|
|
$ |
87,871 |
|
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