Evelo Biosciences, Inc. (Nasdaq: EVLO), a clinical stage
biotechnology company developing SINTAX™ medicines as a new
modality of orally delivered treatments for inflammatory disease,
today reported financial results and business highlights for the
fourth quarter and full year 2021.
“We heard from Dr. Bruce Strober and Dr. Daniel Roling at our
recent KOL event, that Evelo’s Phase 2 clinical data supports the
potential use of EDP1815 in almost all patients, including the mild
and moderate population which represents over 85% of the 55 million
patients with psoriasis worldwide. These patients are generally not
treated with biologics or oral small molecules. The primary unmet
need in psoriasis is for this segment of patients,” said Simba
Gill, Ph.D., Chief Executive Officer of Evelo. “In the last quarter
we have hit all three of our major clinical milestones with
positive results: 1) the maintenance and deepening of clinical
responses of psoriasis patients in the Part B follow-up of the
Phase 2 trial of EDP1815; 2) the reduction in inflammatory
cytokines produced by systemically circulating immune cells and
inflammatory cytokine production at the site of disease; and 3) the
faster release profile of EDP1815 capsules. The data from the Phase
2 trial have also been selected for a coveted late-breaking oral
presentation on Saturday, March 26th, at the 2022 meeting of the
American Association of Dermatology (AAD) - an important external
recognition of the potential of SINTAX medicines. We believe this
puts EDP1815 and SINTAX medicines in a strong position as we move
closer to realizing our vision to improve health for the hundreds
of millions of people living with inflammatory disease around the
globe.”
Highlights and Recent Progress
EDP1815 in Psoriasis Summary of Data
from Phase 2 Trial
- The Phase 2 trial evaluated EDP1815 versus placebo for the
treatment of mild and moderate psoriasis, and was comprised of a
Part A, where patients received either EDP1815 or placebo for 16
weeks, and a Part B, where patients were followed for up to 24
weeks after they had stopped receiving EDP1815 or placebo.
- During the 16-week dosing period, statistically significant
reductions in the Psoriasis Area and Severity Index (PASI) score
were observed in two of the three cohorts treated with EDP1815, as
measured by the proportion of patients achieving at least 50%
improvement in PASI (PASI-50) from baseline at week 16. An ad hoc
analysis comparing the combined EDP1815 group also showed a
statistically significant improvement over placebo in rates of
PASI-50 response.
- For patients who achieved a PASI-50 response or better,
consistent effects in secondary and exploratory endpoints were
observed, including improvements in patient reported outcomes such
as Dermatology Life Quality Index (DLQI) and Psoriasis Symptom
Inventory (PSI).
- Blood samples were taken from 96 patients at baseline and after
16 weeks of dosing with EDP1815 or placebo. Treatment with EDP1815
led to a statistically significant reduction in the release of
pro-inflammatory cytokines compared to placebo: interleukin 6
(IL-6) (p=0.0003), interleukin 8 (IL-8) (p=0.0007), and tumor
necrosis factor (TNF) (p=0.0037).
- During the post-treatment period, durable and deepening
clinical responses were observed, with no flare or rebound of
psoriasis. There were 83 patients who had received EDP1815 in Part
A who entered Part B. Thirty of these 83 patients achieved a
PASI-50 or greater reduction at the end of the 16-week dosing
period. Eighteen of the 30 patients remained at PASI-50 or greater
at the end of Part B. Ten of these 30 patients achieved a PASI-75
or greater at the end of Part A and 5 of them remained at PASI-75
or greater at the end of Part B.
- EDP1815 safety and tolerability data were comparable to placebo
in the trial.
Human Volunteer Scintigraphy Study
- In March 2022, results from an ongoing Phase 1 single center
clinical trial in healthy volunteers showed that a capsule with an
improved release profile was able to deliver EDP1815 higher up in
the small intestine. 88% (15 out of 17) of the human volunteers
studied showed EDP1815 released in the jejunum, the upper part of
the small intestine.
- Preclinical data have shown that the higher EDP1815 is released
in the small intestine, the greater the observed effect.
- Evelo plans to evaluate this faster release capsule in an
upcoming clinical trial.
Pediatric Investigation Plan (PIP)
- The European Medicines Agency (EMA) agreed to Evelo’s pediatric
investigation plan for EDP1815 in psoriasis, in accordance with
Regulation (EC) No 1901/2006 of the European Parliament and of the
Council.
- The PIP allows Evelo to:
- include patients 12–17 years old in Phase 3 trials,
- conduct a single clinical trial in patients 2–5 years old and
6-11 years old after the adult Marketing Authorization Application
has been submitted, and
- develop a pediatric formulation suitable for administration to
patients 2 -11 years old.
- The EMA also confirmed juvenile
toxicity studies are not required for EDP1815 and granted the
Company a waiver from studying EDP1815 in patients <2 years
old.
EDP1815 in Atopic Dermatitis
- Evelo announced dosing of the first patient in the Phase 2
trial of EDP1815 in atopic dermatitis in February 2022.
Business Highlights
- Evelo will have an oral presentation in the Late Breaking
Abstract session of the 2022 AAD Annual Meeting on Saturday, March
26th, at 10:10 a.m. ET. The title of the presentation is “A phase 2
study investigating the effect of EDP1815, an orally-delivered,
anti-inflammatory, gut-restricted commensal microbe in the
treatment of mild and moderate plaque psoriasis.”
- On March 8, 2022, the United States Patent and Trademark Office
granted U.S. Patent No. 11,266,700 to Evelo. The claims of the
patent relate to a method of treating psoriasis using a bacterial
composition that comprises a proprietary Lactococcus lactis
strain.
Upcoming Key MilestonesEDP1815 – Psoriasis
- Evelo intends to move towards registration trials in psoriasis
following the completion of meetings with health authorities this
year
EDP1815 – Atopic Dermatitis
- Topline data from 16-weeks of dosing in the Phase 2 trial
anticipated in 1H 2023; recruitment on-track
EDP1867 – Atopic Dermatitis
- Interim data from Phase 1b trial expected in early 2Q 2022
EDP2939 – Inflammation
- Initiation of clinical development of first extracellular
vesicle (EV) anticipated in 3Q 2022
- Phase 2 data from a cohort of patients with psoriasis expected
in 2H 2023
Fourth Quarter and Full Year 2021 Financial Results
(Unaudited)
- Cash Position: As of December 31, 2021, cash
and cash equivalents were $68.4 million, as compared to cash and
cash equivalents of $68.9 million as of December 31, 2020. The $0.5
million decrease was primarily due to $96.7 million of cash used in
operating activities, principally offset by $97.5 million of net
proceeds received from the issuance of common shares and an
additional draw down of funds under our debt facility.
- Research and Development Expenses: R&D
expenses were $18.9 million and $83.6 million for the three and
twelve-month periods ended December 31, 2021, compared to $22.1
million and $69.6 million for the three and twelve-month periods
ended December 31, 2020, respectively. The year-over-year increase
of $14.0 million was primarily driven by higher personnel costs
related to Evelo’s clinical development and technical operations
headcount supporting clinical programs, higher inflammation program
costs from the progression of clinical trials, and increased
spending toward platform investment, partially offset by lower
spending on oncology programs.
- General and Administrative Expenses: G&A
expenses were $8.7 million and $31.8 million for the three and
twelve-month periods ended December 31, 2021, compared to $6.1
million and $22.3 million for the three and twelve-month periods
ended December 31, 2020, respectively. The increase of $9.5 million
year-over-year was due to increases in our pre-commercial and other
general and administrative headcount, higher consulting and other
professional fees, and increased travel and other costs associated
with a return to the office.
- Net Loss: Net loss was $28.7 million and
$122.2 million for the three and twelve-month periods ended
December 31, 2021, compared to $29.1 million and $93.7 million for
the three and twelve-month periods ended December 31, 2020,
respectively. Earnings per basic and diluted shares were $(0.54)
and $(2.31) for the three and twelve-month periods ended December
31, 2021, compared to $(0.62) and $(2.37) for the three and
twelve-month periods ended December 31, 2020, respectively.
Conference CallEvelo will host a conference
call and webcast at 8:30 a.m. ET today to review fourth quarter and
full year 2021 highlights. To access the call, please dial (866)
795-3242 (domestic) or (409) 937-8909 (international) and refer to
conference ID 6076311. A live webcast of the event will also be
available under “News and Events” in the Investors section of
Evelo's website at http://ir.evelobio.com. The archived webcast
will be available on Evelo's website approximately two hours after
the completion of the event and will be available for 30 days
following the call.
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 the 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 inflammatory diseases.
Evelo currently has three product candidates in development:
EDP1815, EDP1867, 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, EDP1867, 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 Annual Report on Form 10-K for the fiscal
year ended December 31, 2021, 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.
ContactsInvestors:Kendra Sweeney,
239-877-7474ksweeney@evelobio.com
Media:Jessica Cotrone,
978-760-5622jcotrone@evelobio.com
Evelo Biosciences,
Inc.Consolidated Statements of Operations
(Unaudited)(In thousands, except share and per share
data)
|
|
Three Months
Ended December 31, |
|
Year Ended December 31, |
|
|
|
2021 |
|
|
|
2020 |
|
|
|
2021 |
|
|
|
2020 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
$ |
18,881 |
|
|
$ |
22,113 |
|
|
$ |
83,643 |
|
|
$ |
69,616 |
|
General and administrative |
|
|
8,678 |
|
|
|
6,085 |
|
|
|
31,753 |
|
|
|
22,270 |
|
Total operating expenses (1) |
|
|
27,559 |
|
|
|
28,198 |
|
|
|
115,396 |
|
|
|
91,886 |
|
Loss from operations |
|
|
(27,559 |
) |
|
|
(28,198 |
) |
|
|
(115,396 |
) |
|
|
(91,886 |
) |
Other (expense) income: |
|
|
|
|
|
|
|
|
Interest expense, net |
|
|
(1,010 |
) |
|
|
(756 |
) |
|
|
(3,612 |
) |
|
|
(2,109 |
) |
Loss on extinguishment of debt |
|
|
— |
|
|
|
— |
|
|
|
(3,226 |
) |
|
|
— |
|
Other income, net |
|
|
14 |
|
|
|
92 |
|
|
|
486 |
|
|
|
738 |
|
Other expense, net |
|
|
(996 |
) |
|
|
(664 |
) |
|
|
(6,352 |
) |
|
|
(1,371 |
) |
Net loss before income taxes |
|
|
(28,555 |
) |
|
|
(28,862 |
) |
|
|
(121,748 |
) |
|
|
(93,257 |
) |
Income tax expense |
|
|
(97 |
) |
|
|
(188 |
) |
|
|
(428 |
) |
|
|
(409 |
) |
Net loss |
|
$ |
(28,652 |
) |
|
$ |
(29,050 |
) |
|
$ |
(122,176 |
) |
|
$ |
(93,666 |
) |
|
|
|
|
|
|
|
|
|
Net loss per share attributable to common stockholders, basic
and diluted |
|
$ |
(0.54 |
) |
|
$ |
(0.62 |
) |
|
$ |
(2.31 |
) |
|
$ |
(2.37 |
) |
Weighted-average number of
common shares outstanding, basic and diluted |
|
|
53,515,636 |
|
|
|
46,711,281 |
|
|
|
52,910,982 |
|
|
|
39,479,197 |
|
|
|
|
|
|
|
|
|
|
(1) Expenses include the
following amount of non-cash stock-based compensation expense.
|
|
|
|
|
(Unaudited) |
|
Three Months Ended December 31, |
|
Year Ended December 31, |
|
|
|
2021 |
|
|
2020 |
|
|
2021 |
|
|
2020 |
|
Research and development |
|
$ |
2,079 |
|
$ |
1,262 |
|
$ |
8,004 |
|
$ |
4,487 |
|
General and
administrative |
|
|
2,290 |
|
|
1,113 |
|
|
7,842 |
|
|
3,981 |
|
Total stock-based compensation
expense |
|
$ |
4,369 |
|
$ |
2,375 |
|
$ |
15,846 |
|
$ |
8,468 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Evelo Biosciences,
Inc.Consolidated Balance Sheets
(Unaudited)(In thousands, except per share and share
amounts)
|
|
|
December 31, |
|
|
2021 |
|
|
|
2020 |
|
Assets |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
68,441 |
|
|
$ |
68,857 |
|
Prepaid expenses and other current assets |
|
2,585 |
|
|
|
2,123 |
|
Total current assets |
|
71,026 |
|
|
|
70,980 |
|
Property and equipment,
net |
|
6,622 |
|
|
|
7,478 |
|
Right of use asset - operating
lease |
|
8,910 |
|
|
|
10,757 |
|
Other assets |
|
1,313 |
|
|
|
1,424 |
|
Total assets |
$ |
87,871 |
|
|
$ |
90,639 |
|
Liabilities and stockholders’
equity |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
$ |
1,601 |
|
|
$ |
1,442 |
|
Accrued expenses |
|
13,068 |
|
|
|
16,254 |
|
Operating lease liability, current portion |
|
1,951 |
|
|
|
1,674 |
|
Other current liabilities |
|
742 |
|
|
|
463 |
|
Total current liabilities |
|
17,362 |
|
|
|
19,833 |
|
Noncurrent liabilities: |
|
|
|
Long-term debt |
|
46,557 |
|
|
|
30,048 |
|
Operating lease liability, net
of current portion |
|
7,785 |
|
|
|
9,989 |
|
Deferred revenue |
|
7,500 |
|
|
|
— |
|
Other noncurrent
liabilities |
|
— |
|
|
|
284 |
|
Total liabilities |
|
79,204 |
|
|
|
60,154 |
|
Commitments and contingencies
(Note 10) |
|
|
|
Stockholder’s equity: |
|
|
|
Preferred stock, $0.001 par
value; 10,000,000 shares authorized; no shares issued and
outstanding at December 31, 2021 and 2020, respectively |
|
— |
|
|
|
— |
|
Common stock, $0.001 par
value; 200,000,000 shares authorized; 53,576,454
and 47,488,505 shares issued
and 53,576,454 and 47,470,119 shares
outstanding at December 31, 2021 and 2020, respectively |
|
54 |
|
|
|
47 |
|
Additional paid-in
capital |
|
423,308 |
|
|
|
322,957 |
|
Accumulated deficit |
|
(414,695 |
) |
|
|
(292,519 |
) |
Total stockholders’
equity |
|
8,667 |
|
|
|
30,485 |
|
Total liabilities and
stockholders’ equity |
$ |
87,871 |
|
|
$ |
90,639 |
|
|
|
|
|
|
|
|
|
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