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 first quarter ended March 31, 2023, and highlighted
additional recent corporate achievements.
“The past several months have been transformative
for ACELYRIN. We continue to work toward our mission to develop
clinically meaningful, differentiated medicines by executing on
development plans to test our hypotheses and determine how our
assets might best address the significant unmet need that remains
for patients across a multitude of autoimmune and inflammatory
diseases,” said Shao-Lee Lin, MD, PhD, founder and CEO, ACELYRIN.
“I am particularly pleased for patients that in the past six months
we have been able to share izokibep data demonstrating resolution
of important manifestations of disease and significant evidence of
positive impact on quality of life. With the proceeds of our recent
initial public offering, we will continue to drive towards key
value-driving milestones to deliver efficiently on our development
plans. We are pleased today to be sharing the acceleration of
timing for top-line pivotal data for izokibep in Hidradenitis
Suppurativa (HS), now expected in the third quarter of 2023, and
that a second confirmatory Phase 3 trial in HS is now actively
enrolling.”
Recent Highlights and Upcoming Milestones
Initial Public OfferingOn May 9, 2023, we
closed our upsized initial public offering of 34,500,000 shares of
common stock, which included the full exercise of the underwriters’
option to purchase up to 4,500,000 additional shares, at a price to
the public of $18.00 per share. The aggregate gross proceeds to
ACELYRIN from the offering, before deducting underwriting discounts
and commissions and other offering expenses payable by ACELYRIN,
were $621 million.
IzokibepIn March, we shared as a late-breaking
presentation at the 2023 American Academy of Dermatology (AAD)
Annual Meeting data showing that treatment with izokibep led to
high orders of HiSCR response at 12 weeks in the open label Part A
of the Phase 2b/3 trial in HS. These responses included achieving
HiSCR100, defined as complete resolution of abscesses and nodules
with no new fistulae/draining tunnels, in moderate to severe
patients representing both Hurley Stage II and III.
Part B of the Phase 2b/3 trial completed enrollment early and
top-line results are now anticipated in Q3 2023. An independent
Data Monitoring Committee (DMC) conducted a planned interim
analysis, reported no safety concerns, and confirmed 160mg weekly
(QW) as the dose for the second Phase 3 trial in HS. This Phase 3
trial is now actively enrolling.
In April, we announced 46-week data from the Phase 2 trial of
izokibep in Psoriatic Arthritis (PsA) showing that continued
treatment of 80mg every two weeks (Q2W) led to further improvements
beyond 16 weeks in magnitude of response across key manifestations
of the disease including complete resolution of enthesitis in 89%
of participants, PASI100 responses in 71% of participants, ACR50
responses in 79% of participants, and ACR70 responses in 50% of
participants. A Phase 2b/3 trial in PsA is ongoing and includes
further dose ranging up to 160mg QW.
The totality of evidence across these two independent datasets
of HS and PsA continues to support the hypothesis that the high
potency and small molecular size of izokibep can lead to clinically
meaningful, differentiated benefits for patients, including
resolution of important manifestations of each disease associated
with residual pain and severity of disease.
LonigutamabAs announced in January, we added to
our portfolio lonigutamab, an anti-IGF-1R in development for
thyroid eye disease (TED), via our acquisition of ValenzaBio. In
March we presented at the North American Neuro-Ophthalmology
meeting and in May at the Asia-Pacific Orbital Disease and Thyroid
Eye Disease Meeting data from the Phase 1 single-ascending dose
study in healthy volunteers demonstrating that lonigutamab
administered subcutaneously achieved the drug concentration we
believe necessary for optimal therapeutic response in TED. A Phase
1/2 Proof-of-Concept (PoC) trial in TED patients is ongoing with
subcutaneous administration.
SLRN-517We also added to our portfolio
SLRN-517, a fully human monoclonal antibody targeting c-KIT, via
the acquisition of ValenzaBio. This program has now entered the
clinic, and a Phase 1/2 PoC trial in healthy volunteers as well as
chronic urticaria patients is actively enrolling.
First Quarter 2023 Financial Highlights
Cash Position: Cash and cash
equivalents totaled $289.2 million at March 31, 2023. The
subsequent IPO raised $573.7 million in net proceeds and the
Company expects the combined cash balance of $862.9 million as of
March 31, 2023 to fund operations through key value-driving
milestones across all three clinical programs and beyond.
R&D Expenses: Research and development
expenses were $167.9 million for the first quarter ended March 31,
2023, as compared to $13.0 million for the same period in 2022. The
increase during the quarter was primarily due to a one-time $123.1
million in-process research and development (IPR&D) expense,
plus an additional $10.0 million license payment, both related to
the acquisition of ValenzaBio, which included lonigutamab and
SLRN-517.
G&A Expenses: General and
administrative expenses were $11.9 million for the first quarter
ended March 31, 2023, as compared to $3.1 million for the same
period in 2022. The increase during the quarter was primarily due
to increases in head count, consulting, legal, recruiting, audit
and accounting services to support our Company’s growth and
business development.
Net Loss: Net loss totaled $176.5 million
for the first quarter of 2023, compared to $16.1 million for the
first quarter of 2022. This includes the one-time $123.1 million
IPR&D charge and $10.0 million license payment, both related to
the acquisition of ValenzaBio.
About ACELYRINACELYRIN, INC. (Nasdaq: SLRN) is
a Los Angeles area-based late-stage clinical biopharma company –
with additional operations in the San Francisco Bay area – focused
on providing patients life-changing new treatment options by
identifying, acquiring, and accelerating the development and
commercialization of promising product candidates.
About IzokibepIzokibep is a small protein
therapeutic designed to inhibit IL-17A with high potency through
tight binding affinity, the potential for robust tissue penetration
due to its small molecular size, about one-tenth the size of a
monoclonal antibody, and an albumin binding domain that results in
improved pharmacokinetic (PK) properties. Clinical trial data
supports the hypothesis that these unique characteristics of
izokibep may provide clinically meaningful and differentiated
benefits for patients, including resolution of key manifestations
of disease. Izokibep is being evaluated in multiple late-stage
trials in moderate-to-severe hidradenitis suppurativa (HS),
psoriatic arthritis (PsA), and uveitis, with plans to initiate an
additional Phase 3 program in axial spondyloarthritis (AxSpA).
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 anticipated key milestones; the
advancement of ACELYRIN’s programs and ability to efficiently
deliver on its development plans; the expected timing of
development activities including establishment of proof of concept
and/or the announcement of clinical data; the therapeutic potential
of ACELYRIN’s product candidates including its ability to offer
clinically meaningful, differentiated benefits for patients that
may include resolution of key manifestations of disease; 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 ValenzaBio; 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 March 31, 2023.
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. |
Consolidated Statements of Operations and Comprehensive
Loss |
(in thousands, except share and per share
data) |
(unaudited) |
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
|
2023 |
|
|
|
2022 |
|
|
|
|
|
|
|
Operating
expenses |
|
|
|
|
Research and
development |
$ |
167,920 |
|
|
$ |
13,003 |
|
|
General and
administrative |
|
11,913 |
|
|
|
3,082 |
|
|
|
Total operating expenses |
|
179,833 |
|
|
|
16,085 |
|
Loss from
operations |
|
(179,833 |
) |
|
|
(16,085 |
) |
|
Change in fair
value of derivative liability |
|
147 |
|
|
|
- |
|
|
Interest
income |
|
3,299 |
|
|
|
- |
|
|
Other income
(expense), net |
|
(63 |
) |
|
|
- |
|
Net loss |
|
(176,450 |
) |
|
|
(16,085 |
) |
Other
comprehensive gain (loss) |
|
|
|
Unrealized gain on
marketable securities, net |
|
86 |
|
|
|
- |
|
Total other
comprehensive gain |
$ |
86 |
|
|
$ |
- |
|
Net loss and other
comprehensive loss |
$ |
(176,364 |
) |
|
$ |
(16,085 |
) |
Net loss per share
attributable to common stockholders, basic and diluted |
$ |
(8.61 |
) |
|
$ |
(17.89 |
) |
Weighted-average
common shares outstanding, basic and diluted |
|
20,492,101 |
|
|
|
899,319 |
|
ACELYRIN, INC. |
Selected Consolidated Balance Sheet Data |
(in thousands) |
(unaudited) |
|
March 31, |
|
December 31, |
|
|
2023 |
|
|
|
2022 |
|
Cash and cash equivalents |
$ |
289,194 |
|
|
$ |
267,110 |
|
Total assets |
|
298,519 |
|
|
|
319,923 |
|
Total liabilities |
|
45,278 |
|
|
|
26,192 |
|
Accumulated deficit |
|
(283,528 |
) |
|
|
(107,078 |
) |
Contacts:
Tyler Marciniak,
Vice President of Investor Relations,
Communications and Corporate Operations
investors@acelyrin.com
media@acelyrin.com
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