Achilles Therapeutics Reports Third Quarter 2023 Financial Results and Recent Highlights
November 13 2023 - 4:30PM
Achilles Therapeutics plc (NASDAQ: ACHL), a clinical-stage
biopharmaceutical company developing AI-powered precision T cell
therapies targeting clonal neoantigens to treat solid tumors, today
announced its financial results for the quarter ended September 30,
2023, and recent business highlights.
“We are pleased with progress across the
scientific field that continues to demonstrate the importance of
neoantigens as the most attractive targets in solid-tumor oncology.
We believe that our proprietary capability to identify the most
immunogenic clonal neoantigens, recently shared at ESGCT and SITC,
puts us in a strong position with our clonal neoantigen-reactive T
cell (cNeT) therapy and potentially other neoantigen targeting
approaches,” said Dr Iraj Ali, Chief Executive Officer of
Achilles Therapeutics. “Our Phase I/IIa clinical trials
evaluating cNeT therapy for the treatment of advanced NSCLC
(CHIRON) and metastatic malignant melanoma (THETIS) continue to
progress and we are on track to dose patients in line with our
previous guidance. We look forward to sharing our next clinical and
translational data update in Q1 2024.”
Recent Highlights
- Presented posters (Abstract 437, Abstract 1312) at the Society
for Immunotherapy of Cancer (SITC) 38th Annual Meeting highlighting
a significant dose boost of reactive CD8 and CD4 cNeT from the
optimized VELOSTM manufacturing platform and the use of the PELEUS™
AI-powered bioinformatics platform for the identification and
validation of immunogenic clonal tumor neoantigens.
- Presented posters (P459, P485, P507) at the European Society of
Gene & Cell Therapy (ESGCT) 30th Annual Congress highlighting
the favorable cNeT phenotypic properties and polyfunctionality
critical for precision adoptive cell therapies and the expansion of
cNeT from the blood of patients with cancer.
- Delivered an oral presentation at the mRNA Cancer Vaccines
Summit highlighting neoRanker™, a new AI-based tool for the
selection of immunogenic clonal tumor neoantigens for personalized
therapies.
- Delivered oral presentations at the 5th Annual TIL Therapies
Summit highlighting optimized manufacturing of AI-powered precision
TIL therapies for solid cancer, and the potency and fitness of
cNeT.
- Presented posters (P319, P407, P518) at the Seventh
International Cancer Immunotherapy Conference (CICON23)
highlighting a precision adoptive cell therapy process based on
expansion of cNeT from blood of cancer patients.
Financial Highlights
- Cash and cash
equivalents: Cash and cash equivalents were $140.1 million
as of September 30, 2023, as compared to $173.3 million as of
December 31, 2022. The Company anticipates that its cash and cash
equivalents are sufficient to fund its planned operations through
2025.
- Research and development
(R&D) expenses: R&D expenses were $14.7 million
for the third quarter ended September 30, 2023, an increase of $4.1
million compared to $10.6 million for the third quarter ended
September 30, 2022. The increase was primarily driven by increased
activity related to our ongoing clinical trials and overall
R&D.
- General and administrative
(G&A) expenses: G&A expenses were $4.4 million for
the third quarter ended September 30, 2023, a decrease of $1.0
million compared to $5.4 million for the third quarter ended
September 30, 2022. This decrease was primarily driven by lower
professional fees, personnel costs and facilities
spend.
- Net loss: Net loss
for the third quarter ended September 30, 2023, was $16.7 million
or $0.42 per share compared to $12.5 million or $0.32 per share for
the third quarter ended September 30, 2022.
About Achilles Therapeutics
Achilles is a clinical-stage biopharmaceutical
company developing AI-powered 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. Forward-looking statements in this press release
include, but are not limited to, statements regarding the timing of
the Company’s clinical and translational data updates and the
Company’s beliefs about recent data updates, and expectations
related to the Company’s operating expenses and capital expense
requirements. 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.
For further information, please contact:
Investors:Meru AdvisorsLee M.
Sternlstern@meruadvisors.com
Media:ICR ConsiliumSukaina Virji, Tracy Cheung,
Emmalee Hoppe+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) |
|
|
|
September 30, |
|
|
December 31, |
|
|
|
2023 |
|
|
2022 |
|
ASSETS |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
140,138 |
|
|
$ |
173,338 |
|
Prepaid expenses and other
current assets |
|
|
15,354 |
|
|
|
23,242 |
|
Total current assets |
|
|
155,492 |
|
|
|
196,580 |
|
Non-current assets: |
|
|
|
|
|
|
Property and equipment,
net |
|
|
9,648 |
|
|
|
12,399 |
|
Operating lease right of use
assets |
|
|
7,013 |
|
|
|
8,081 |
|
Deferred tax assets |
|
|
185 |
|
|
|
251 |
|
Restricted cash |
|
|
33 |
|
|
|
33 |
|
Other assets |
|
|
2,967 |
|
|
|
3,014 |
|
Total non-current assets |
|
|
19,846 |
|
|
|
23,778 |
|
TOTAL ASSETS |
|
$ |
175,338 |
|
|
$ |
220,358 |
|
LIABILITIES AND
SHAREHOLDERS’ EQUITY |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
5,352 |
|
|
$ |
5,187 |
|
Income taxes payable |
|
|
- |
|
|
|
326 |
|
Accrued expenses and other
liabilities |
|
|
8,209 |
|
|
|
8,292 |
|
Operating lease
liabilities-current |
|
|
4,620 |
|
|
|
4,188 |
|
Total current liabilities |
|
|
18,181 |
|
|
|
17,993 |
|
Non-current liabilities: |
|
|
|
|
|
|
Operating lease
liabilities-non-current |
|
|
2,731 |
|
|
|
4,388 |
|
Other long-term liability |
|
|
941 |
|
|
|
933 |
|
Total non-current liabilities |
|
|
3,672 |
|
|
|
5,321 |
|
Total liabilities |
|
|
21,853 |
|
|
|
23,314 |
|
Commitments and contingencies
(Note 12) |
|
|
|
|
|
|
Shareholders’ equity: |
|
|
|
|
|
|
Ordinary shares, £0.001 par value; 40,782,948 and 40,932,727 shares
authorized, issued and outstanding at September 30, 2023 and
December 31, 2022, respectively |
|
|
54 |
|
|
|
54 |
|
Deferred shares, £92,451.851 par value, one share authorized,
issued and outstanding at September 30, 2023 and December 31,
2022 |
|
|
128 |
|
|
|
128 |
|
Additional paid in
capital |
|
|
413,815 |
|
|
|
408,844 |
|
Accumulated other
comprehensive loss |
|
|
(19,190 |
) |
|
|
(21,695 |
) |
Accumulated deficit |
|
|
(241,322 |
) |
|
|
(190,287 |
) |
Total shareholders’ equity |
|
|
153,485 |
|
|
|
197,044 |
|
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY |
|
$ |
175,338 |
|
|
$ |
220,358 |
|
ACHILLES THERAPEUTICS PLC |
|
Condensed Consolidated Statements
of Operations
and Comprehensive Loss
(Unaudited) |
(in thousands, except share and per share amounts) |
(expressed in U.S. Dollars, unless otherwise stated) |
|
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
OPERATING EXPENSES: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
14,712 |
|
|
$ |
10,597 |
|
|
$ |
42,354 |
|
|
$ |
38,387 |
|
General and administrative |
|
|
4,384 |
|
|
|
5,437 |
|
|
|
13,387 |
|
|
|
17,162 |
|
Total operating expenses |
|
|
19,096 |
|
|
|
16,034 |
|
|
|
55,741 |
|
|
|
55,549 |
|
Loss from operations |
|
|
(19,096 |
) |
|
|
(16,034 |
) |
|
|
(55,741 |
) |
|
|
(55,549 |
) |
OTHER INCOME, NET: |
|
|
|
|
|
|
|
|
|
|
|
|
Other income |
|
|
2,389 |
|
|
|
3,599 |
|
|
|
4,692 |
|
|
|
8,499 |
|
Total other income, net |
|
|
2,389 |
|
|
|
3,599 |
|
|
|
4,692 |
|
|
|
8,499 |
|
Loss before provision for
income taxes |
|
|
(16,707 |
) |
|
|
(12,435 |
) |
|
|
(51,049 |
) |
|
|
(47,050 |
) |
Benefit (Provision) for income taxes |
|
|
24 |
|
|
|
(41 |
) |
|
|
14 |
|
|
|
(70 |
) |
Net loss |
|
|
(16,683 |
) |
|
|
(12,476 |
) |
|
|
(51,035 |
) |
|
|
(47,120 |
) |
Other comprehensive
income: |
|
|
|
|
|
|
|
|
|
|
|
|
Foreign exchange translation adjustment |
|
|
(5,289 |
) |
|
|
(18,147 |
) |
|
|
2,505 |
|
|
|
(45,126 |
) |
Comprehensive loss |
|
$ |
(21,972 |
) |
|
$ |
(30,623 |
) |
|
$ |
(48,530 |
) |
|
$ |
(92,246 |
) |
Net loss per share
attributable to ordinary shareholders—basic and diluted |
|
$ |
(0.42 |
) |
|
$ |
(0.32 |
) |
|
$ |
(1.28 |
) |
|
$ |
(1.20 |
) |
Weighted average ordinary shares
outstanding—basic and diluted |
|
|
40,066,922 |
|
|
|
39,313,764 |
|
|
|
39,900,910 |
|
|
|
39,104,866 |
|
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