Apogee Therapeutics Highlights Pipeline Progress and Reports First Quarter 2024 Financial Results
May 13 2024 - 7:00AM
Apogee Therapeutics, Inc. (Nasdaq: APGE), a clinical-stage
biotechnology company advancing differentiated biologics for the
treatment of atopic dermatitis (AD), chronic obstructive pulmonary
disease (COPD), asthma and other inflammatory and immunology
(I&I) indications, today reported pipeline highlights and first
quarter financial results.
“I am proud of the continued momentum our team has achieved this
quarter, executing against our goals and successfully bringing our
programs forward ahead of schedule,” said Michael Henderson, MD,
Chief Executive Officer of Apogee. “We continue to maintain that
pace of progress with the selection of our development candidate
for APG990 and now plan to initiate a Phase 1 trial in healthy
volunteers by the end of the year. We commenced dosing of the first
healthy participants in our second clinical program, APG808, and
expect an interim readout in the second half of this year.
Following that readout, we're planning a Phase 1b readout for
APG808 in asthma to follow in the first half of 2025 that is
designed to determine the doses to then take into a Phase 2 trial
in COPD in the same year. We are on track to dose the first patient
in the APG777 Phase 2 trial in patients with moderate-to-severe AD
in the first half of this year. Additionally, on the heels of our
successful interim Phase 1 APG777 data readout, we raised $483
million in an upsized public offering providing capital into
2028.”
Pipeline and Corporate Highlights and Upcoming Milestones
- Initiated Phase 2 APG777 clinical trial:
APG777 is a novel, subcutaneous (SQ) half-life extended monoclonal
antibody (mAb) targeting IL-13 – a critical cytokine in
inflammation and a primary driver of AD.
- The company has commenced enrollment of patients for the Phase
2 clinical trial of APG777 in patients with moderate-to-severe AD
in the first half of 2024, with 16-week proof-of-concept data from
Part A of the trial expected in 2H 2025.
- The trial is designed to combine the typical Phase 2a and 2b
portions of a clinical trial into a single protocol. The primary
endpoint of each part of the study is mean percentage changes in
EASI score from baseline to Week 16.
- Initiation of a Phase 2 APG777 trial in asthma is expected to
commence in 2025.
- First participant dosed in APG808 Phase 1
trial: Apogee’s second program, APG808, is a novel, SQ
half-life extended mAb targeting IL-4Rα, a target with clinical
validation across eight Type 2 allergic diseases. APG808 has
similar binding and femtomolar affinity for IL-4Rα compared to
picomolar affinity in the first generation mAb, DUPIXENT, and has
demonstrated similar inhibition to DUPIXENT across three in vitro
assays that measure downstream functional inhibition of the
IL-13/IL-4 pathway (pSTAT6 induction, inhibition of TF-1
proliferation, and inhibition of TARC secretion).
- In March 2024, Apogee initiated dosing of healthy volunteers in
its Phase 1 clinical trial. The company expects to share initial
data in the second half of 2024 followed by a Phase 1b clinical
trial in asthma with data expected in the first half of 2025 and
initiation of a COPD trial in the same year.
- APG990 development candidate selected: Apogee
has selected a development candidate for its APG990 program, a
novel, SQ half-life extended mAb targeting OX40L, initially being
developed for AD. OX40L is located further upstream in the
inflammatory pathway than IL-13 or IL-4Rα and targeting it could
potentially have broader impact on the inflammatory cascade by
inhibiting both Type 1 and Type 2 inflammation. With current
approved biologics only targeting Type 2 inflammation (IL-13/IL4Rα)
in AD, OX40L could represent another therapeutic option for
patients, especially the portion of patients who do not benefit
from currently available treatments. APG990 has been engineered to
have differentiated attributes, including an extended half-life,
which we expect will result in a more favorable dosing schedule of
every three or six months. The company is also interested in
testing the hypothesis that combining APG990 with APG777 will
result in more extensive inhibition of the inflammatory cascade
(Type 1 and Type 2 inflammation) than either approach alone. The
company plans to present additional data on this at its R&D Day
in the fourth quarter of this year.
- Initiation of a Phase 1 APG990 trial in healthy volunteers is
expected to begin ahead of schedule and is now expected in the
second half of 2024.
- Completed $483 million upsized public
offering: In March, the company closed on an upsized
public offering of 7,790,321 shares of common stock, including the
full exercise of the underwriters’ option to purchase up to
1,016,128 additional shares, at a public offering price of $62.00
per share. The aggregate gross proceeds to Apogee from the offering
were approximately $483.0 million before deducting underwriting
discounts and commissions and other offering expenses payable by
Apogee.
First Quarter Financial Results
- Cash Position: As of March 31, 2024, Apogee
had cash, cash equivalents and marketable securities of $816.2
million. Apogee expects that its existing total cash will enable it
to fund its current operating expenses into the first quarter of
2028.
- Research & Development (R&D) Expenses:
R&D expenses for the first quarter of 2024 were $28.7 million,
compared to $8.5 million for the first quarter of 2023. R&D
expenses increased primarily due to further development of the
company’s APG777 and APG808 programs and advancement of its
pipeline into clinical trials, as well as increases in personnel
costs, including equity-based compensation expense, associated with
the growth of its R&D team.
- General and Administrative (G&A) Expenses:
G&A expenses for the first quarter of 2024 were $9.5 million,
compared to $4.2 million for the first quarter of 2023. G&A
expenses increased primarily due to increases in personnel costs,
including equity-based compensation, associated with the growth of
the company’s G&A team, as well as increased costs related to
being a public company, including for legal, IT and professional
services, and to support the growth of the business.
- Net Loss: Net loss for the first quarter of
2024 was $32.1 million, compared to $12.5 million net loss for the
first quarter of 2023 . Net loss increased primarily as a result of
higher R&D and G&A expenses as described above, partially
offset by higher interest income.
About ApogeeApogee Therapeutics is a
clinical-stage biotechnology company seeking to develop
differentiated biologics for the treatment of atopic dermatitis
(AD), chronic obstructive pulmonary disease (COPD), asthma and
other inflammatory and immunology indications with high unmet need.
Apogee’s antibody programs are designed to overcome limitations of
existing therapies by targeting well-established mechanisms of
action and incorporating advanced antibody engineering to optimize
half-life and other properties. The company’s two most advanced
programs are APG777 and APG808, which are being initially developed
for the treatment of AD, COPD, and asthma, respectively. Based on a
broad pipeline and depth of expertise, the company believes it can
deliver value and meaningful benefit to patients underserved by
today’s standard of care. For more information, please visit
www.apogeetherapeutics.com.
Forward Looking StatementsCertain statements in
this press release may constitute “forward-looking statements”
within the meaning of the federal securities laws, including, but
not limited to, statements regarding: Apogee’s expectations
regarding plans for its current and future product candidates and
programs, its plans for Apogee’s current and future clinical
trials, including a Phase 2 trial for APG777 in asthma, Phase 1
trials of APG808, and a Phase 1 trial for APG990, Apogee’s plans
for clinical trial design, the anticipated timing of the initiation
of and results from Apogee’s clinical trials, including data from
Apogee’s Phase 2 trial of APG777 and Apogee’s Phase 1 trial of
APG808, the potential clinical benefit and half-life of APG777,
APG808, APG990 and any other potential programs, Apogee’s expected
timing for future pipeline updates and expectations regarding the
time period over which Apogee’s capital resources will be
sufficient to fund Apogee’s anticipated operations. Words such as
“may,” “might,” “will,” “objective,” “intend,” “should,” “could,”
“can,” “would,” “expect,” “believe,” “design,” “estimate,”
“predict,” “potential,” “develop,” “plan” or the negative of these
terms, and similar expressions, or statements regarding intent,
belief, or current expectations, are forward-looking statements.
While Apogee believes these forward-looking statements are
reasonable, undue reliance should not be placed on any such
forward-looking statements, which are based on information
available to the company on the date of this release. These
forward-looking statements are based upon current estimates and
assumptions and are subject to various risks and uncertainties
(including, without limitation, those set forth in Apogee’s filings
with the U.S. Securities and Exchange Commission (the SEC)), many
of which are beyond the company’s control and subject to change.
Actual results could be materially different. Risks and
uncertainties include: global macroeconomic conditions and related
volatility, expectations regarding the initiation, progress, and
expected results of Apogee’s preclinical studies, clinical trials
and research and development programs; expectations regarding the
timing, completion and outcome of Apogee’s clinical trials; the
unpredictable relationship between preclinical study results and
clinical study results; the timing or likelihood of regulatory
filings and approvals; liquidity and capital resources; and other
risks and uncertainties identified in Apogee’s Annual Report on
10-K for the year period ended December 31, 2023, filed with the
SEC on March 5, 2024, and subsequent disclosure documents we may
file with the SEC. Apogee claims the protection of the Safe Harbor
contained in the Private Securities Litigation Reform Act of 1995
for forward-looking statements. Apogee expressly disclaims any
obligation to update or alter any statements whether as a result of
new information, future events or otherwise, except as required by
law.
APOGEE THERAPEUTICS, INC. |
CONDENSED CONSOLIDATED BALANCE SHEETS |
(UNAUDITED) |
(In thousands, except unit/share data) |
|
|
|
|
|
|
|
|
MARCH 31, |
|
DECEMBER 31, |
|
2024 |
|
2023 |
Assets |
|
|
|
|
|
Current assets: |
|
|
|
|
|
Cash and cash equivalents |
$ |
485,457 |
|
|
$ |
118,316 |
|
Marketable securities |
|
330,739 |
|
|
|
277,143 |
|
Prepaid expenses and other current assets |
|
4,412 |
|
|
|
2,950 |
|
Total current assets |
|
820,608 |
|
|
|
398,409 |
|
Property and equipment,
net |
|
699 |
|
|
|
377 |
|
Right-of-use asset, net |
|
1,951 |
|
|
|
2,217 |
|
Other non-current assets |
|
401 |
|
|
|
401 |
|
Total assets |
$ |
823,659 |
|
|
$ |
401,404 |
|
Liabilities and
stockholders' equity |
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
Accounts payable |
$ |
4,302 |
|
|
$ |
2,143 |
|
Lease liability |
|
1,141 |
|
|
|
1,101 |
|
Accrued expenses |
|
16,108 |
|
|
|
17,314 |
|
Total current liabilities |
|
21,551 |
|
|
|
20,558 |
|
Long-term liabilities: |
|
|
|
|
|
Lease liability, net of
current |
|
630 |
|
|
|
933 |
|
Total liabilities |
|
22,181 |
|
|
|
21,491 |
|
Stockholders’ Equity: |
|
|
|
|
|
Common Stock; $0.00001 par value, 400,000,000 authorized,
58,456,027 issued and 56,367,802 outstanding as of March 31, 2024;
400,000,000 authorized, 50,655,671 issued and 48,338,769
outstanding as of December 31, 2023 |
|
1 |
|
|
|
- |
|
Additional paid-in capital |
|
957,518 |
|
|
|
503,354 |
|
Accumulated other comprehensive (loss) income |
|
(177 |
) |
|
|
329 |
|
Accumulated deficit |
|
(155,864 |
) |
|
|
(123,770 |
) |
Total stockholders’ equity |
|
801,478 |
|
|
|
379,913 |
|
Total liabilities and
stockholders’ equity |
$ |
823,659 |
|
|
$ |
401,404 |
|
|
|
|
|
|
|
|
|
APOGEE THERAPEUTICS, INC. |
CONDENSED CONSOLIDATED STATEMENT OF
OPERATIONS |
(UNAUDITED) |
(In thousands, except share and per share data) |
|
|
|
|
|
|
|
THREE MONTHS ENDED MARCH 31, |
|
2024 |
|
2023 |
Operating expenses: |
|
|
|
|
|
Research and development |
$ |
28,716 |
|
|
$ |
8,455 |
|
General and administrative |
|
9,465 |
|
|
|
4,203 |
|
Total operating expenses |
|
38,181 |
|
|
|
12,658 |
|
Loss from operations |
|
(38,181 |
) |
|
|
(12,658 |
) |
Other income, net: |
|
|
|
|
|
Interest income, net |
|
6,087 |
|
|
|
133 |
|
Total other income, net |
|
6,087 |
|
|
|
133 |
|
Net loss |
$ |
(32,094 |
) |
|
$ |
(12,525 |
) |
|
|
|
|
|
|
|
|
Investor Contact:Noel KurdiVP, Investor
RelationsApogee Therapeutics,
Inc.Noel.Kurdi@apogeetherapeutics.com
Media Contact:Dan Budwick1AB
dan@1abmedia.com
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