Achilles Therapeutics Reports First Quarter 2021 Financial Results and Recent Business Highlights
May 11 2021 - 7:00AM
Achilles Therapeutics plc (NASDAQ: ACHL), a clinical-stage
biopharmaceutical company developing precision T cell therapies to
treat solid tumors, today announced its financial results for the
first quarter ended March 31, 2021 and recent business highlights.
“Achilles made significant progress in the first quarter of
2021. We reported the first clinical data from our ongoing CHIRON
and THETIS trials evaluating our precision TIL cNeT therapy in
patients with non-small cell lung cancer and melanoma,
respectively, and priced our successful US initial public offering
on Nasdaq, which closed just after quarter-end,” said Dr
Iraj Ali, Chief Executive Officer of Achilles. “We
continue to enroll and dose patients and have opened our first
clinical sites in the US and EU. This year, we expect to report
interim data from a total of ten patients that have received cNeT
monotherapy across the CHIRON and THETIS trials and will also begin
enrolling patients to receive higher dose cNeT. In addition, we
will open Cohort B in the THETIS study to evaluate the addition of
a PD-1 inhibitor to our cNeT therapy.”
Business Highlights
- Received a recommendation from the Independent Data Safety
Monitoring Committee to continue the ongoing Phase I/IIa CHIRON and
THETIS trials as planned
- Announced initial clinical data from the first six patients
dosed with the Company’s cNeT therapy showing encouraging evidence
of cNeT engraftment, an overall tolerability profile similar to
that of standard TIL products, stable disease in four out of the
six patients, and one patient with tumor lesion reduction
- Presented data at the American Association of Cancer Research
(AACR) annual meeting detailing the Company’s comprehensive
translational research program and insights into the in
vivo dynamics of cNeT post-dosing, and the potential to
develop a potency-based release assay
- Strengthened the Board of Directors and Scientific Advisory
Board with the additions of Julie O’Neill and Markwin Velders,
Ph.D., respectively, and continued to build the team in the UK
& US, including key appointments across manufacturing, supply
chain and clinical operations, bio-processing and intellectual
property
- Received a Horizon 2020 grant as part of the Neoantigen
Consortium, with the aim of developing a tool to predict neoantigen
immunogenicity.
Financial Highlights
- IPO: Priced an initial public offering of
9,750,000 ADRs at a public offering price of $18.00 per share for
gross proceeds of $175.5 million. The IPO closed on April 6, 2021,
after the quarter end.
- Cash and cash equivalents: Cash and cash
equivalents were $159.3 million as of March 31, 2021 as compared to
$177.8 million as of December 31, 2020, not including $160.6
million in net proceeds from the IPO which closed on April 6, 2021.
The Company anticipates that its existing cash and cash equivalents
plus the IPO proceeds are sufficient to fund its planned operations
into the second half of 2023, including full funding of the ongoing
Phase I/IIa CHIRON and THETIS clinical trials.
- Operating Expenses: Operating Expenses were
$13.7 million for the quarter ended March 31, 2021, which included
$8.9 million in Research & Development, and General and
Administrative expenses of $4.8 million.
- Net loss: Net loss attributable to ordinary
shareholders was $13.8 million for the quarter ended March 31, 2021
and the basic and diluted net loss per ordinary share was $8.38 for
the quarter ended March 31, 2021.
Upcoming Events
- Iraj Ali, Chief Executive Officer, will participate in a
fireside chat at the BofA Securities 2021 Virtual Healthcare
Conference at on Thursday, May 13, 2021, at 9:30 a.m. ET / 2:30
p.m. BST.
- A poster detailing abstract TPS9138 entitled, An Open-Label,
Multi-Centre Phase I/IIa Study Evaluating the Safety and
Clinical Activity of Clonal Neoantigen Reactive T cells
in Patients with Advanced Non-Small Cell Lung Cancer (CHIRON), will
be presented at the 2021 ASCO Annual Meeting taking place virtually
from June 4-9, 2021. Full abstracts will be released on May 19,
2021 at ASCO.org.
About Achilles Therapeutics
Achilles is a clinical-stage biopharmaceutical
company developing precision T cell therapies targeting clonal
neoantigens: protein markers unique to the individual that are
expressed on the surface of every cancer cell. The Company has two
ongoing Phase I/IIa trials, the CHIRON trial in patients with
advanced non-small cell lung cancer (NSCLC) and the THETIS trial in
patients with recurrent or metastatic melanoma. Achilles uses DNA
sequencing data from each patient, together with its proprietary
PELEUS™ bioinformatics platform, to identify clonal neoantigens
specific to that patient, and then develop precision T cell-based
product candidates specifically targeting those clonal
neoantigens.
Forward-Looking Statements
This press release contains express or implied
forward-looking statements that are based on our management's
belief and assumptions and on information currently available to
our management. Although we believe that the expectations reflected
in these forward-looking statements are reasonable, these
statements relate to future events or our future operational or
financial performance, and involve known and unknown risks,
uncertainties and other 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
these forward-looking statements. The forward-looking statements in
this press release represent our views as of the date of this press
release. We anticipate that subsequent events and developments will
cause our views to change. However, while we may elect to update
these forward-looking statements at some point in the future, we
have no current intention of doing so except to the extent required
by applicable law. You should therefore not rely on these
forward-looking statements as representing our views as of any date
subsequent to the date of this press release.
Further information:
Lee M. Stern – VP, IR & External
Communications+1 (332) 373-2634l.stern@achillestx.com
Consilium Strategic CommunicationsMary-Jane
Elliott, Sukaina Virji, Melissa Gardiner+44 (0) 203 709
5000achillestx@consilium-comms.com
ACHILLES THERAPEUTICS PLC
Condensed Consolidated Balance
Sheets (Unaudited)
(in thousands, except share and per share
amounts)
(expressed in U.S. Dollars, unless otherwise
stated)
|
|
March 31, |
|
|
December 31, |
|
|
|
2021 |
|
|
2020 |
|
ASSETS |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
159,262 |
|
|
$ |
177,849 |
|
Prepaid expenses and other
current assets |
|
|
14,058 |
|
|
|
9,948 |
|
Total current assets |
|
|
173,320 |
|
|
|
187,797 |
|
Non-current assets: |
|
|
|
|
|
|
|
|
Property and equipment, net |
|
|
15,479 |
|
|
|
13,369 |
|
Operating lease right of use
assets |
|
|
14,155 |
|
|
|
14,740 |
|
Deferred tax assets |
|
|
4 |
|
|
|
4 |
|
Other assets |
|
|
3,145 |
|
|
|
3,008 |
|
Total non-current assets |
|
|
32,783 |
|
|
|
31,121 |
|
TOTAL ASSETS |
|
$ |
206,103 |
|
|
$ |
218,918 |
|
LIABILITIES AND
SHAREHOLDERS’ EQUITY |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
1,787 |
|
|
$ |
6,314 |
|
Income taxes payable |
|
|
19 |
|
|
|
7 |
|
Accrued expenses and other
liabilities |
|
|
8,646 |
|
|
|
6,590 |
|
Operating lease
liabilities-current |
|
|
4,610 |
|
|
|
3,712 |
|
Total current liabilities |
|
|
15,062 |
|
|
|
16,623 |
|
Non-current liabilities: |
|
|
|
|
|
|
|
|
Operating lease
liabilities-non-current |
|
|
11,329 |
|
|
|
12,271 |
|
Other long-term liability |
|
|
659 |
|
|
|
652 |
|
Total non-current liabilities |
|
|
11,988 |
|
|
|
12,923 |
|
Total liabilities |
|
|
27,050 |
|
|
|
29,546 |
|
Commitments and contingencies
(Note 11) |
|
|
|
|
|
|
|
|
Shareholders’ equity: |
|
|
|
|
|
|
|
|
Ordinary shares, £0.001 par value; 30,853,489 and 4,389,920 shares
authorized, issued and outstanding at March 31, 2021 and December
31, 2020, respectively |
|
|
6 |
|
|
|
6 |
|
Deferred shares, £0.001 par value; 109,058 and 30,521 shares issued
and outstanding as of March 31, 2021 and December 31, 2020,
respectively |
|
|
— |
|
|
|
— |
|
Convertible preferred shares, £0.001 par value; no shares
authorized, issued and outstanding as of March 31, 2021;104,854,673
shares authorized, issued and outstanding at December 31, 2020 |
|
|
134 |
|
|
|
134 |
|
Additional paid in
capital |
|
|
236,305 |
|
|
|
234,922 |
|
Accumulated other
comprehensive income |
|
|
14,385 |
|
|
|
12,322 |
|
Accumulated deficit |
|
|
(71,777 |
) |
|
|
(58,012 |
) |
Total shareholders’ equity |
|
|
179,053 |
|
|
|
189,372 |
|
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY |
|
$ |
206,103 |
|
|
$ |
218,918 |
|
|
|
|
|
|
|
|
|
|
ACHILLES THERAPEUTICS PLC
Condensed Consolidated
Statements of Operations
and Comprehensive
Loss (Unaudited)
(in thousands, except share and per share
amounts)
|
|
Three Months Ended March 31, |
|
|
|
2021 |
|
|
2020 |
|
OPERATING EXPENSES: |
|
|
|
|
|
|
|
|
Research and development |
|
$ |
8,876 |
|
|
$ |
3,830 |
|
General and administrative |
|
|
4,832 |
|
|
|
1,736 |
|
Total operating expenses |
|
|
13,708 |
|
|
|
5,566 |
|
Loss from operations |
|
|
(13,708 |
) |
|
|
(5,566 |
) |
OTHER INCOME (EXPENSE),
NET: |
|
|
|
|
|
|
|
|
Other income (expense) |
|
|
(45 |
) |
|
|
352 |
|
Total other income (expense), net |
|
|
(45 |
) |
|
|
352 |
|
Loss before provision for income
taxes |
|
|
(13,753 |
) |
|
|
(5,214 |
) |
Provision for income taxes |
|
|
(12 |
) |
|
|
— |
|
Net loss |
|
|
(13,765 |
) |
|
|
(5,214 |
) |
Other comprehensive income: |
|
|
|
|
|
|
|
|
Foreign exchange translation adjustment |
|
|
2,063 |
|
|
|
(6,510 |
) |
Comprehensive loss |
|
$ |
(11,702 |
) |
|
$ |
(11,724 |
) |
Net loss per share attributable
to ordinary shareholders—basic and diluted |
|
$ |
(8.38 |
) |
|
$ |
(6.13 |
) |
Weighted average ordinary shares
outstanding—basic and diluted |
|
|
1,641,938 |
|
|
|
850,377 |
|
|
|
|
|
|
|
|
|
|
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