Achilles Therapeutics Reports Third Quarter 2021 Financial Results and Recent Business Highlights
10 November 2021 - 12:00AM
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
third quarter ended September 30, 2021, and recent business
highlights.
“We have continued to make good progress during
the third quarter and will share an update from the first eight
patients across our CHIRON (non-small cell lung cancer, or NSCLC)
and THETIS (melanoma) studies at the upcoming SITC meeting. Our
unique ability to accurately quantify the tumor reactive component
of each product and to track clonal neoantigen reactive T cells
(cNeT) in the patients post-dosing is possible through the detailed
genomic analysis of the tumor and prospective clonal neoantigen
targeting afforded by our proprietary bioinformatics platform. We
believe this best-in-class analytical capability will be critical
for the successful development of TIL-based therapies,” said
Dr Iraj Ali, Chief Executive Officer of Achilles.
“At SITC, we will also share details of our VELOS™ Process 2
manufacturing, which is able to routinely generate significantly
higher doses of cNeT than our current Process 1. We will present
further GMP scale data from VELOS Process 2 at the upcoming ESMO
Immuno-Oncology Congress taking place December 8-11, 2021.”
Business Highlights
- Two abstracts for the SITC 36th
Annual Meeting were published today - Poster 543, underscoring the
ability to sensitively detect, quantify and track patient-specific
cNeT during manufacture and post dosing, and Poster 193,
highlighting our ability to generate increased doses of reactive
cNeT from VELOS Process 2
- Delivered an oral presentation at
the 2021 European Society for Gene and Cell Therapy (ESGCT)
Congress entitled, “Multicentre, prospective research protocol for
development of a clonal neoantigen-reactive T cell therapy pipeline
across multiple tumour types” highlighting the Company’s Material
Acquisition Platform (MAP) and supporting the potential use of
cNeT in a broad range of solid tumor indications
- Granted US patent US 11,098,121 and
European patent EP3347039B covering a method of identifying cancer
patients that are likely to respond to a checkpoint inhibitor (CPI)
by determining the total number of clonal neoantigens or the ratio
of clonal to sub-clonal neoantigens in patients’ cancer cells
- Enrolled the first patient in the
United States at the Moffitt Cancer Center in the Phase I/IIa
CHIRON clinical trial
- In-licensed from Secarna
Pharmaceuticals GmbH & Co antisense oligonucleotide technology
and intellectual property for the ex vivo manufacture of a T cell
pharmaceutical product
Financial Highlights
- Cash and cash
equivalents: Cash and cash equivalents were $281.9 million
as of September 30, 2021, as compared to $177.8 million as of
December 31, 2020. The Company anticipates that its cash and cash
equivalents 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
- Research and development
(R&D) expenses: R&D expenses were $10.7 million
for the third quarter ended September 30, 2021, an increase of $5.4
million compared to $5.3 million for the third quarter ended
September 30, 2020. R&D expenses were $30.4 million for the
nine months ended September 30, 2021, an increase of $16.7 million
compared to $13.7 million for the nine months ended September 30,
2020. 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 $5.0 million for
the third quarter ended September 30, 2021, an increase of $2.0
million compared to $3.0 million for the third quarter ended
September 30, 2020. G&A expenses were $15.3 million for the
nine months ended September 30, 2021, an increase of $8.2 million
compared to the $7.1 million for the nine months ended September
30, 2020. The increase was primarily driven by fees associated with
the Company’s public company obligations, and an increase in
headcount and related personnel costs
- Net loss: Net loss
for the third quarter ended September 30, 2021 was $12.9 million or
$0.34 per share compared to $8.2 million or $7.50 per share for the
third quarter ended September 30, 2020. Net loss for the nine
months ended September 30, 2021 was $42.9 million or $1.69 per
share compared to $20.3 million or $21.16 per share for the nine
months ended September 30, 2020. The decrease in loss per share is
due in part to the increased number of shares following the
conversion and issuance of shares from the IPO
Upcoming Events
Achilles will present at the following medical
and investor conferences in November and December 2021. Additional
details will be available in the Events & Presentations section
of the Company’s website:
- Society for Immunotherapy of Cancer (SITC) 36th Annual Meeting:
November 10 – 14, 2021
- Piper Sandler Annual Healthcare Conference: November 29 –
December 2, 2021
- ESMO Immuno-Oncology Congress 2021: December 8 – 11, 2021
In addition, the Company will host a live
webcast and conference call on Friday, November 12, 2021 at 8:30am
ET / 1:30pm UK to review the SITC presentations and provide a
corporate update. The live webcast can be accessed in the Events
& Presentations section of the Company’s website. The
conference call dial-in numbers for investors and analysts are
(833) 732-1204 (toll free within the USA), 0800 0288438 (toll free
within the United Kingdom) or (720) 405-2169 (outside the USA) with
the access code 4795875.
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)
|
|
September 30, |
|
|
December 31, |
|
|
|
2021 |
|
|
2020 |
|
ASSETS |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
281,875 |
|
|
$ |
177,849 |
|
Prepaid expenses and other
current assets |
|
|
16,401 |
|
|
|
9,948 |
|
Total current assets |
|
|
298,276 |
|
|
|
187,797 |
|
Non-current assets: |
|
|
|
|
|
|
|
|
Property and equipment, net |
|
|
16,378 |
|
|
|
13,369 |
|
Operating lease right of use
assets |
|
|
11,938 |
|
|
|
14,740 |
|
Deferred tax assets |
|
|
4 |
|
|
|
4 |
|
Restricted cash |
|
|
33 |
|
|
|
— |
|
Other assets |
|
|
3,370 |
|
|
|
3,008 |
|
Total non-current assets |
|
|
31,723 |
|
|
|
31,121 |
|
TOTAL ASSETS |
|
$ |
329,999 |
|
|
$ |
218,918 |
|
LIABILITIES AND
SHAREHOLDERS’ EQUITY |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
2,460 |
|
|
$ |
6,314 |
|
Income taxes payable |
|
|
36 |
|
|
|
7 |
|
Accrued expenses and other
liabilities |
|
|
8,472 |
|
|
|
6,590 |
|
Operating lease
liabilities-current |
|
|
4,398 |
|
|
|
3,712 |
|
Total current liabilities |
|
|
15,366 |
|
|
|
16,623 |
|
Non-current liabilities: |
|
|
|
|
|
|
|
|
Operating lease
liabilities-non-current |
|
|
8,881 |
|
|
|
12,271 |
|
Other long-term liability |
|
|
643 |
|
|
|
652 |
|
Total non-current
liabilities |
|
|
9,524 |
|
|
|
12,923 |
|
Total liabilities |
|
|
24,890 |
|
|
|
29,546 |
|
Commitments and contingencies
(Note 12) |
|
|
|
|
|
|
|
|
Shareholders’ equity: |
|
|
|
|
|
|
|
|
Ordinary shares, £0.001 par
value; 40,603,489 and 4,389,920 shares authorized, issued and
outstanding at September 30, 2021 and December 31, 2020,
respectively |
|
|
54 |
|
|
|
6 |
|
Deferred shares, £92,451.851
par value, one share authorized, issued and outstanding at
September 30, 2021; Deferred shares, £0.001 par value; 30,521
shares issued and outstanding December 31, 2020 |
|
|
128 |
|
|
|
— |
|
Convertible preferred shares,
£0.001 par value; no shares authorized, issued and outstanding as
of September 30, 2021;104,854,673 shares authorized, issued and
outstanding at December 31, 2020 |
|
|
— |
|
|
|
134 |
|
Additional paid in
capital |
|
|
400,058 |
|
|
|
234,922 |
|
Accumulated other
comprehensive income |
|
|
5,750 |
|
|
|
12,322 |
|
Accumulated deficit |
|
|
(100,881 |
) |
|
|
(58,012 |
) |
Total shareholders’
equity |
|
|
305,109 |
|
|
|
189,372 |
|
TOTAL LIABILITIES AND
SHAREHOLDERS’ EQUITY |
|
$ |
329,999 |
|
|
$ |
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 September 30, |
|
|
Nine Months Ended September 30, |
|
|
|
2021 |
|
|
2020 |
|
|
2021 |
|
|
2020 |
|
OPERATING EXPENSES: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
10,697 |
|
|
$ |
5,291 |
|
|
$ |
30,417 |
|
|
$ |
13,668 |
|
General and administrative |
|
|
5,041 |
|
|
|
3,009 |
|
|
|
15,318 |
|
|
|
7,140 |
|
Total operating expenses |
|
|
15,738 |
|
|
|
8,300 |
|
|
|
45,735 |
|
|
|
20,808 |
|
Loss from operations |
|
|
(15,738 |
) |
|
|
(8,300 |
) |
|
|
(45,735 |
) |
|
|
(20,808 |
) |
OTHER INCOME, NET: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income |
|
|
2,806 |
|
|
|
90 |
|
|
|
2,907 |
|
|
|
529 |
|
Total other income, net |
|
|
2,806 |
|
|
|
90 |
|
|
|
2,907 |
|
|
|
529 |
|
Loss before provision for income
taxes |
|
|
(12,932 |
) |
|
|
(8,210 |
) |
|
|
(42,828 |
) |
|
|
(20,279 |
) |
Provision for income taxes |
|
|
(16 |
) |
|
|
— |
|
|
|
(41 |
) |
|
|
— |
|
Net loss |
|
|
(12,948 |
) |
|
|
(8,210 |
) |
|
|
(42,869 |
) |
|
|
(20,279 |
) |
Other comprehensive income: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign exchange translation adjustment |
|
|
(7,710 |
) |
|
|
3,501 |
|
|
|
(6,572 |
) |
|
|
(3,088 |
) |
Comprehensive loss |
|
$ |
(20,658 |
) |
|
$ |
(4,709 |
) |
|
$ |
(49,441 |
) |
|
$ |
(23,367 |
) |
Net loss per share attributable
to ordinary shareholders—basic and diluted |
|
$ |
(0.34 |
) |
|
$ |
(7.50 |
) |
|
$ |
(1.69 |
) |
|
$ |
(21.16 |
) |
Weighted average ordinary shares
outstanding—basic and diluted |
|
|
38,261,480 |
|
|
|
1,094,543 |
|
|
|
25,329,672 |
|
|
|
958,373 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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