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
fourth quarter and full year 2023 financial results.
“2023 was a momentous year for Apogee with the completion of a
successful IPO, initiation of our first clinical program of APG777
in healthy volunteers and the nomination of our second pipeline
candidate, APG808,” said Michael Henderson, M.D., Chief Executive
Officer of Apogee. “Our momentum and track record of execution have
continued in 2024, and we were thrilled to disclose positive
interim results from our Phase 1 trial of APG777 today, which
demonstrated a favorable safety profile and exceeded our trial
objectives on both pharmacokinetics and pharmacodynamics. This data
readout is a key risk-reducing milestone for our APG777 program and
pipeline and supports a path forward into a Phase 2 trial for
APG777 in patients with AD in the first half of this year. Looking
ahead to the rest of the year, we continue to make progress with
APG808, for which we are set to start a Phase 1 healthy volunteer
clinical trial ahead of schedule while advancing our earlier
programs, APG990 and APG222. With each of our programs, we have the
potential to reshape the standard of care with potential
best-in-class or first-in-class therapeutic candidates for I&I
diseases.”
Pipeline Highlights and Upcoming Milestones
- Positive, interim Phase 1 results for APG777 exceeded
trial objectives and delivered ahead of schedule: APG777
is a novel, subcutaneous (SQ) extended half-life monoclonal
antibody targeting IL-13 – a critical cytokine in inflammation and
a primary driver of AD. Today, the company reported positive
interim results in the Phase 1 first-in-human study of APG777,
designed to evaluate the safety, tolerability, pharmacokinetics
(PK) and pharmacodynamics (PD) of single-ascending and
multiple-ascending doses of APG777 in healthy volunteers. Key
findings from the study include:
- Potentially best-in-class PK profile, including a half-life of
approximately 75 days, supporting:
- Testing higher exposures of drug in induction to potentially
achieve improved clinical responses
- Testing of maintenance dosing of every 3- or 6-months,
representing 2-4 injections per year compared to the current
treatment paradigm of 13-26 injections per year
- Single doses of APG777 showed deep and sustained effect on key
AD biomarkers pSTAT6 and TARC for approximately 3 months (longest
follow-up available with inhibition still ongoing at the time of
the data cut
- APG777 was well tolerated across all dose groups with a
favorable safety profile consistent with the anti-IL-13 class
- Based on these data, Apogee plans to initiate a randomized,
placebo-controlled Phase 2 clinical trial in patients with
moderate-to-severe AD in the first half of 2024; modeled induction
and maintenance dosing for the Phase 2 trial suggests APG777 could
reach exposures approximately 30-40% greater than lebrikizumab in
induction and potentially enable every 3- or 6- month maintenance
dosing
- 16-week proof-of-concept data from this Phase 2 trial is
expected in second half of 2025
- Apogee also plans to evaluate APG777 in expansion indications
including initiating a Phase 2 trial in asthma in 2025
- Phase 1 APG808 healthy volunteer clinical trial set to
start ahead of schedule: Apogee’s second program, APG808,
is novel, SQ extended half-life 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 as compared
to a first generation mAb, DUPIXENT, and has demonstrated similar
inhibition to DUPIXENT across three in vitro assays which measure
downstream functional inhibition of the IL-13/IL-4 pathway (pSTAT6
induction, inhibition of TF-1 proliferation, and inhibition of TARC
secretion). An APG808 Phase 1 healthy volunteer clinical trial is
expected to start ahead of schedule following receipt of regulatory
clearance in February and will be followed by a potential Phase 1b
trial in asthma and a Phase 2 trial in COPD (pending data from the
Phase 1 trial). Key milestones in 2024 and 2025 include:
- Interim Phase 1 PK and safety in healthy volunteers expected in
2H 2024, ahead of prior guidance
- Initial proof-of-concept data in asthma expected 1H 2025
- Proof-of-concept clinical trial in patients with COPD expected
to initiate in 2025, pending positive data from Phase 1 trial and
regulatory clearance
- Early-stage programs progressing to candidate
selection: Apogee’s earlier-stage programs, APG990 and
APG222, utilize advanced antibody engineering to target OX40L and
both IL-13 and OX40L, respectively, and are initially being
developed for the treatment of 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. With current approved biologics only
targeting two mechanisms of action (IL-13 and IL4Rα) in AD, OX40L
could represent another therapeutic option for patients, especially
the portion of patients who do not benefit from currently available
treatments.
- Candidate nomination for APG990 anticipated in 2024 and Phase 1
initiation in healthy volunteers in 2025
- Apogee plans to provide more detailed updates on its earlier
pipeline programs and combination strategy in an R&D Day in Q4
2024 to support its vision of future I&I therapeutics
Fourth Quarter and Full Year 2023 Financial
ResultsCash Position: Cash, cash
equivalents and marketable securities were $395.5 million as of
December 31, 2023, compared to $151.9 million as of December 31,
2022. Based on current operating plans, Apogee expects its existing
cash, cash equivalents and marketable securities will enable the
company to fund its operating expenses into 4Q 2026.
R&D Expenses: Research and development
(R&D) expenses were $29.0 million for the quarter ended
December 31, 2023, and $68.4 million for the year ended December
31, 2023, compared to $12.2 million for the quarter ended December
31, 2022, and $27.8 million for the period from February 4, 2022
(inception) to December 31, 2022. R&D expenses increased
primarily due to further development of Apogee’s APG777 and APG808
programs and advancement of its pipeline, as well as increases in
personnel costs, including equity-based compensation expense,
associated with the growth of its R&D team.
G&A Expenses: General and administrative
(G&A) expenses were $8.2 million for the quarter ended December
31, 2023, and $24.6 million for the year ended December 31, 2023,
compared to $1.9 million for the quarter ended December 31, 2022,
and $2.9 million for the period from February 4, 2022 (inception)
to December 31, 2022. G&A expenses increased primarily due to
increases in personnel costs, including equity-based compensation,
and legal and professional services, all of which were the result
of the expansion of Apogee’s operations to support the growth in
its business and the cost of operating as a public company.
Net Loss: Net loss was $31.7 million for the
quarter ended December 31, 2023, and $84.0 million for the year
ended December 31, 2023, compared to a net loss of $14.0 million
for the quarter ended December 31, 2022 and $39.8 million for the
period from February 4, 2022 (inception) to December 31, 2022. Net
loss increased primarily as a result of higher R&D and G&A
operating 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 and COPD, 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: the efficacy, safety,
tolerability, PK and PD profile of APG777, the potential dosing
regimen of APG777, the potential superiority of APG777 compared to
current therapies, Apogee’s expectations regarding plans for
Apogee’s current and future product candidates and programs,
Apogee’s plans for Apogee’s current and future clinical trials,
including a Phase 2 trial for APG777, 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, the potential clinical benefit and
half-life of APG777, APG808, APG990, APG222 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 Quarterly
Report on 10-Q for the quarterly period ended September 30, 2023,
filed with the SEC on November 13, 2023, 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. |
CONSOLIDATED BALANCE SHEETS |
(In thousands, except unit/share data) |
|
|
|
|
|
|
|
DECEMBER 31, |
|
DECEMBER 31, |
|
2023 |
|
2022 |
Assets |
|
|
|
|
|
Current assets: |
|
|
|
|
|
Cash and cash equivalents |
$ |
118,316 |
|
|
$ |
151,890 |
|
Marketable securities |
|
277,143 |
|
|
|
— |
|
Prepaid expenses and other current assets |
|
2,950 |
|
|
|
165 |
|
Total current assets |
|
398,409 |
|
|
|
152,055 |
|
Property and equipment,
net |
|
377 |
|
|
|
— |
|
Right-of-use asset, net |
|
2,217 |
|
|
|
— |
|
Other non-current assets |
|
401 |
|
|
|
— |
|
Total assets |
$ |
401,404 |
|
|
$ |
152,055 |
|
Liabilities, preferred
units and stockholders' equity/members’ deficit |
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
Accounts payable |
$ |
2,143 |
|
|
$ |
418 |
|
Lease liability |
|
1,101 |
|
|
|
— |
|
Accrued expenses |
|
17,314 |
|
|
|
9,562 |
|
Total current liabilities |
|
20,558 |
|
|
|
9,980 |
|
Long-term liabilities: |
|
|
|
|
|
Lease liability, net of
current |
|
933 |
|
|
|
— |
|
Total liabilities |
|
21,491 |
|
|
|
9,980 |
|
Commitments and contingencies
(Note 9) |
|
|
|
|
|
Series A Preferred Units; no
units authorized, issued and outstanding at
December 31, 2023; 20,000,000 units authorized, issued
and outstanding as of December 31, 2022 |
|
— |
|
|
|
28,971 |
|
Series B Preferred Units; no
units authorized, issued and outstanding at
December 31, 2023; 45,089,212 units authorized, issued
and outstanding as of December 31, 2022 |
|
— |
|
|
|
148,496 |
|
Stockholders’ equity/members’
deficit: |
|
|
|
|
|
Common Units; no units authorized, issued and outstanding at
December 31, 2023; 5,000,000 units authorized, issued and
outstanding as of December 31, 2022 |
|
— |
|
|
|
2,251 |
|
Incentive Units; no units authorized, issued and outstanding at
December 31, 2023; 12,412,473 units authorized, 9,648,374
issued and 1,625,086 outstanding as of
December 31, 2022 |
|
— |
|
|
|
2,142 |
|
Preferred Stock; 10,000,000 authorized, $0.00001 par value, no
shares issued and outstanding at December 31, 2023; No
shares authorized, issued and outstanding at
December 31, 2022 |
|
— |
|
|
|
— |
|
Common Stock; 400,000,000 authorized, $0.00001 par value,
50,655,671 issued and 48,338,769 outstanding as of
December 31, 2023; No shares authorized, issued and
outstanding at December 31, 2022 |
|
— |
|
|
|
— |
|
Additional paid-in capital |
|
503,354 |
|
|
|
— |
|
Accumulated other comprehensive income |
|
329 |
|
|
|
— |
|
Accumulated deficit |
|
(123,770 |
) |
|
|
(39,785 |
) |
Total stockholders’ equity/members’ deficit |
|
379,913 |
|
|
|
(35,392 |
) |
Total liabilities, preferred
units and stockholders’ equity/members’ deficit |
$ |
401,404 |
|
|
$ |
152,055 |
|
|
|
|
|
|
|
|
|
APOGEE THERAPEUTICS, INC. |
CONSOLIDATED STATEMENTS OF OPERATIONS |
(In
thousands) |
|
|
|
|
PERIOD FROM |
|
YEAR ENDED |
|
FEBRUARY 4, 2022 |
|
DECEMBER 31, |
|
(INCEPTION) TO |
|
2023 |
|
DECEMBER 31, 2022 |
Operating expenses: |
|
|
|
|
|
Research and development |
$ |
68,424 |
|
|
$ |
27,786 |
|
General and administrative |
|
24,579 |
|
|
|
2,941 |
|
Total operating expenses |
|
93,003 |
|
|
|
30,727 |
|
Loss from operations |
|
(93,003 |
) |
|
|
(30,727 |
) |
Other income (expense),
net: |
|
|
|
|
|
Interest income, net |
|
9,018 |
|
|
|
92 |
|
Other financing expense, net: |
|
— |
|
|
|
(9,150 |
) |
Total other income (expense), net |
|
9,018 |
|
|
|
(9,058 |
) |
Net loss |
$ |
(83,985 |
) |
|
$ |
(39,785 |
) |
|
|
|
|
|
|
|
|
Investor Contact:Noel KurdiVP, Investor
RelationsApogee TherapeuticsNoel.kurdi@apogeetherapeutics.com
Media Contact:Dan Budwick1AB
dan@1abmedia.com
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