ACELYRIN, INC. Reports Third Quarter 2024 Financial Results and Recent Highlights
13 Novembre 2024 - 10:00PM
ACELYRIN, INC. (Nasdaq: SLRN), a late-stage clinical biopharma
company focused on accelerating the development and delivery of
transformative medicines in immunology, today reported financial
results for the third quarter ended September 30, 2024 and
highlighted other corporate updates and milestones.
“We are executing on our refocused pipeline strategy and are
excited by the near-term catalysts ahead for ACELYRIN, particularly
as we advance subcutaneous lonigutamab into Phase 3 development as
the next generation IGF-1R inhibitor for thyroid eye disease. We
recently concluded a positive end of phase 2 interaction with the
FDA, established a world-class scientific and patient advisory
board, and remain on track to initiate our Phase 3 development
program in TED next quarter,” said Mina Kim, Chief Executive
Officer of ACELYRIN. “We are also looking forward to announcing
topline results from our Phase 2b/3 trial of izokibep in uveitis in
December 2024 and hosting a lonigutamab investor event in early
2025.”
Recent Pipeline Updates and Upcoming
Milestones
LonigutamabLonigutamab is a subcutaneously (SC)
delivered humanized IgG1 monoclonal antibody targeting the
insulin-like growth factor-1 receptor (IGF-1R), a validated
mechanism of action (MoA) for the treatment for thyroid eye disease
(TED).
- ACELYRIN recently completed a positive end of Phase 2 (EOP2)
interaction with the U.S. Food and Drug Administration (FDA),
achieving alignment on important elements of the Phase 3
registrational program design including size, primary and secondary
endpoints, and proposed dose selection. The Company will host a
webcast event in early 2025 to review the Phase 2 data, FDA
feedback and Phase 3 program design.
- Earlier this year, ACELYRIN reported the first positive proof
of concept data for an anti-IGF-1R in TED patients, which showed
that lonigutamab was well-tolerated and demonstrated rapid
improvements in proptosis and clinical activity score (CAS) –
within three weeks after the first dose. Additional data from the
ongoing Phase 2 trial has been recently presented by leading
clinicians at international medical congresses including those of
the American Society of Ophthalmic Plastic and Reconstructive
Surgery, the European Society of Ophthalmic Plastic and
Reconstructive Surgery, and the American Academy of Ophthalmology.
These presentations can be found on the “Presentations and
Publications” section of ACELYRIN’s website
at www.acelyrin.com.
- The Phase 2 dose exploration trial is continuing with
additional cohorts to establish both a minimum effective and optimal
dose level and dose regimen for the Phase 3 registrational program.
Cohort 3 testing 50mg of lonigutamab administered every four weeks
has been completed and Cohort 4 testing 70-100mg of lonigutamab
administered every four weeks is ongoing.
- Finally, ACELYRIN established a scientific and patient advisory
board convening world class clinicians and advocates to provide
important strategic input, clinical expertise and patient
perspectives as the Company prepares to advance lonigutamab into
Phase 3 clinical development for TED.
IzokibepIzokibep is a small protein therapeutic
designed to inhibit IL-17A with high potency and small molecular
size, approximately 1/10th the size of a monoclonal antibody.
ACELYRIN previously announced that enrollment in a Phase 2b/3
trial evaluating 160mg of izokibep administered weekly as a
treatment for non-infectious, non-interior uveitis had been
completed in May 2024 with 96 patients. The Company expects to
report topline data from the trial in December 2024.
Third Quarter 2024 Financial Highlights
Cash Position: Cash, cash equivalents and
short-term marketable securities totaled $562.4 million at
September 30, 2024. The Company expects these to fund
operations to mid-2027.
R&D Expenses: Research and development
expenses were $31.6 million for the third quarter ended September
30, 2024, as compared to $74.6 million for the same period in 2023.
The decreases were primarily a result of reduced clinical
development activity as the Phase 3 trials for izokibep move toward
completion.
G&A Expenses: For the third quarter
ended September 30, 2024, general and administrative expenses were
$12.3 million, compared to $19.9 million for the same period in
2023. The decreases were primarily a result of lower stock-based
compensation expenses.
Net Loss: Net loss for the third quarter
ended September 30, 2024 totaled $48.5 million, compared to $83.9
million for the same period in 2023. The net loss for the
third quarter ended September 30, 2024 includes non-recurring
restructuring expenses of $10.8 million related to the August 2024
announcement of a refocused pipeline strategy that prioritizes
development of lonigutamab in thyroid eye disease. These
restructuring expenses are net of a $35.7 million credit voucher
that can be used to offset cash obligations for manufacturing costs
including those for the lonigutamab program.
Webcast and Conference Call InformationACELYRIN
will host a conference call and webcast today, November 13, 2024,
at 4:30pm ET to discuss these recent corporate updates. A live
webcast of the conference call can be accessed in the “Events &
Presentations” section of ACELYRIN’s website
at www.acelyrin.com. A recording of the webcast will be
available and archived on the Company’s website for
approximately 30 days.
Upcoming Investor PresentationACELYRIN
management will attend the Jefferies London Healthcare Conference
2024 taking place from November 19-21, 2024, holding 1x1 meetings
and a webcasted fireside chat on November 20, 2024. An archive of
the webcast will be available in the “Events &
Presentations” section of ACELYRIN’s website
at www.acelyrin.com.
About ACELYRINACELYRIN, INC. (Nasdaq: SLRN) is
focused on providing patients life-changing new treatment options
by identifying, acquiring, and accelerating the development and
commercialization of transformative medicines. ACELYRIN’s lead
program, lonigutamab, is a subcutaneously delivered monoclonal
antibody targeting IGF-1R being investigated for the treatment of
thyroid eye disease.
For more information about ACELYRIN, visit us at
www.acelyrin.com or follow us on LinkedIn and X.
Forward Looking StatementsThis press release
contains forward-looking statements including, but not limited to,
statements related to ACELYRIN’s expectations regarding its cash
runway and ability to fund several key milestones; the advancement
of ACELYRIN’s programs and ability to accelerate the development
and delivery of transformative medicines; anticipated development
activities including the planned initiation of Phase 3 clinical
trial of lonigutamab, establishment of proof of concept and/or the
availability of clinical data; the therapeutic potential of
ACELYRIN’s product candidates; the potential commercial launch of
ACELYRIN’s product candidates; and other statements that are not
historical fact. These forward-looking statements are based on
ACELYRIN’s current plans, objectives and projections, and are
inherently subject to risks and uncertainties that may cause
ACELYRIN’s actual results to materially differ from those
anticipated in such forward-looking statements. Such risks and
uncertainties include, without limitation, those associated with
the successful completion of development and regulatory activities
with respect to ACELYRIN’s product candidates; maintaining and
defending intellectual property protection; delays or failures to
secure adequate supply of its product candidates; ACELYRIN’s
failure to realize the expected benefits of its acquisition of
additional programs; legal proceedings, government investigations
or other actions; macroeconomic conditions; market volatility; and
other risks and uncertainties affecting ACELYRIN including those
described from time to time under the caption “Risk Factors” and
elsewhere in ACELYRIN’s current and future reports filed with the
Securities and Exchange Commission, including its Quarterly Report
on Form 10-Q for the quarter ended September 30, 2024.
Forward-looking statements contained in this press release are made
as of this date, and ACELYRIN undertakes no duty to update such
information except as required under applicable law.
ACELYRIN, INC. |
Condensed Consolidated Statements of Operations and
Comprehensive Loss |
(in thousands, except share and per share
data) |
(unaudited) |
|
|
|
|
|
Three Months EndedSeptember 30, |
|
Nine Months EndedSeptember 30, |
|
|
|
|
|
2024 |
|
|
|
2023 |
|
|
|
2024 |
|
|
|
2023 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development |
$ |
31,612 |
|
|
$ |
74,562 |
|
|
$ |
166,026 |
|
|
$ |
272,512 |
|
|
General and
administrative |
|
12,326 |
|
|
|
19,861 |
|
|
|
53,711 |
|
|
|
44,440 |
|
|
Restructuring |
|
|
10,809 |
|
|
|
- |
|
|
|
10,809 |
|
|
|
- |
|
|
|
Total operating
expenses |
|
54,747 |
|
|
|
94,423 |
|
|
|
230,546 |
|
|
|
316,952 |
|
Loss from
operations |
|
(54,747 |
) |
|
|
(94,423 |
) |
|
|
(230,546 |
) |
|
|
(316,952 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Change in fair
value of derivative tranche liability |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
10,291 |
|
|
Interest
income |
|
|
7,535 |
|
|
|
10,502 |
|
|
|
25,132 |
|
|
|
20,486 |
|
|
Other income
(expense), net |
|
(1,336 |
) |
|
|
(19 |
) |
|
|
36,221 |
|
|
|
(254 |
) |
Net loss |
|
$ |
(48,548 |
) |
|
$ |
(83,940 |
) |
|
$ |
(169,193 |
) |
|
$ |
(286,429 |
) |
Other
comprehensive gain (loss) |
|
|
|
|
|
|
|
|
Unrealized gain
(loss) on short-term marketable securities, net |
|
551 |
|
|
|
(94 |
) |
|
|
222 |
|
|
|
36 |
|
|
|
Total other
comprehensive gain (loss) |
$ |
551 |
|
|
$ |
(94 |
) |
|
$ |
222 |
|
|
$ |
36 |
|
Net loss and other
comprehensive loss |
$ |
(47,997 |
) |
|
$ |
(84,034 |
) |
|
$ |
(168,971 |
) |
|
$ |
(286,393 |
) |
Net loss per share
attributable to common stockholders, basic and diluted |
$ |
(0.49 |
) |
|
$ |
(0.87 |
) |
|
$ |
(1.71 |
) |
|
$ |
(4.68 |
) |
Weighted-average
common shares outstanding, basic and diluted |
|
99,835,707 |
|
|
|
96,872,747 |
|
|
|
98,973,518 |
|
|
|
61,138,105 |
|
ACELYRIN, INC. |
Selected Consolidated Balance Sheet Data |
(unaudited) |
(in thousands) |
|
|
|
|
September 30, |
|
December 31, |
|
|
|
|
2024 |
|
|
|
2023 |
|
|
Cash and cash
equivalents |
$ |
216,326 |
|
|
$ |
218,097 |
|
|
Short-term
marketable securities |
|
346,047 |
|
|
|
503,229 |
|
|
Total assets |
|
618,310 |
|
|
|
742,690 |
|
|
Total
liabilities |
|
90,029 |
|
|
|
86,353 |
|
|
Accumulated
deficit |
|
(657,912 |
) |
|
|
(488,719 |
) |
ACELYRIN Contacts:Tyler
MarciniakVice President of Investor Relations and Corporate
Affairsinvestors@acelyrin.commedia@acelyrin.com
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