Apogee Therapeutics Provides Pipeline Progress and Reports Second Quarter 2024 Financial Results
2024年8月12日 - 7:30PM
Apogee Therapeutics, Inc. (Nasdaq: APGE), a clinical-stage
biotechnology company advancing novel biologics with potential for
differentiated efficacy and dosing in the largest inflammatory and
immunology (I&I) markets, including for the treatment of atopic
dermatitis (AD), asthma, chronic obstructive pulmonary disease
(COPD) and other I&I indications, today reported pipeline
highlights and second quarter financial results.
“The first half of this year has been marked with significant
pipeline progress and a focus on further defining our strategy that
will enable us to deliver on our goal of reshaping the standard of
care for patients in I&I by developing treatments with
potential best-in-class monotherapy and combination efficacy and
improved dosing schedules,” said Michael Henderson, M.D., Chief
Executive Officer of Apogee. “A key component of that strategy is
combining several of our pipeline programs, including APG333, which
is our newly added compound targeting TSLP. TSLP is a validated
target with one compound approved for asthma without a biomarker
requirement, and which has recent clinical data demonstrating
potential for treatment of a broader respiratory disease
population, including COPD. We have strategically built a unique
portfolio of IL-13, IL-4Rα, OX40L and TLSP inhibitors that enable
multiple combinations in dermatology and respiratory diseases with
the potential for deeper and broader responses. With our continued
execution of the pipeline, our expected milestones are on track and
we have a strong cash position taking us into 2028. We look forward
to discussing our programs and additional plans for combination
approaches in further detail at our R&D Day in December this
year.”
Pipeline and Corporate Highlights and Upcoming Milestones
- First patient dosed in APG777 Phase 2 trial and on
track for Part A data in 2H 2025: APG777 is a novel,
subcutaneous (SQ) extended half-life monoclonal antibody (mAb)
targeting IL-13 – a critical cytokine in inflammation and a primary
driver of AD.
- In May, the company commenced dosing in the Phase 2 clinical
trial of APG777 in patients with moderate-to-severe AD; 16-week
proof-of-concept induction data from Part A of the trial are
expected in the second half of 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 change in
EASI score from baseline to Week 16.
- The Phase 2 APG777 trial in asthma is expected to include
APG777 as a monotherapy and APG777 in combination with APG333,
combining IL-13 and TSLP inhibition, pending Phase 1 clinical trial
data from APG333.
- Phase 1 APG990 HV clinical trial set to start ahead of
schedule in 3Q 2024: APG990 is 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 have broader impact on the
inflammatory cascade by inhibiting Type 1, Type 2 and Type 3
pathways. 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. In
addition, based on our preclinical studies, we believe APG990 can
be dosed every three to six months in maintenance, which, if our
clinical trials are successful, would represent a significant
improvement compared to first generation OX40L antibodies that are
expected to be dosed every four to twelve weeks.
- The company has received regulatory clearance in Australia and
plans to initiate a Phase 1 APG990 clinical trial in HVs in the
third quarter of 2024 with interim data expected in 2025.
- Phase 1 APG808 trial on track for 4Q 2024 interim data
readout: APG808 is a SQ extended half-life mAb targeting
IL-4Rα, a target with clinical validation across eight Type 2
allergic diseases. APG808 has similar binding affinity for IL-4Rα
as a 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).
- The company expects to share interim data from the Phase 1 HV
clinical trial in the fourth quarter of 2024.
- Pending results of the Phase 1 HV clinical trial, Apogee plans
to initiate a Phase 1b clinical trial in asthma with data expected
in the first half of 2025.
- APG333, a novel SQ half-life extended anti-TSLP
antibody, added to portfolio earlier in the year, with supporting
third-party evidence of broad potential of target inhibition in
asthma and COPD: APG333 is a fully-human mAb targeting
thymic stromal lymphopoietin (TSLP). TSLP is an epithelial
cell-derived cytokine that has emerged as an attractive validated
target for the treatment of I&I indications, with the potential
to be used in combination with other mAbs for potentially greater
efficacy in broader populations. TSLP plays important roles in Type
2 and Type 3 inflammation, particularly in both eosinophilic and
non-eosinophilic inflammation. TSLP inhibition has been clinically
validated, with one approved product on the market for the
treatment of severe asthma without biomarker or phenotype
restrictions. Based on its mechanism, TSLP inhibition could offer
treatment to the approximately 40% of severe asthma patients with
low Type 2 inflammation.
- The company plans to nominate a development candidate by the
end of 2024 and initiate a Phase 1 APG333 clinical trial in healthy
volunteers (HV) in 2025.
- Pending Phase 1 data, the company has the opportunity to
combine APG333 with APG777, combining IL-13 and TSLP inhibition, to
drive potential best-in-class efficacy in respiratory
indications.
- Potential to expand patient reach with best-in-class
efficacy and dosing with planned APG777 and APG990 combination
approach, combining IL-13 and OX40L inhibition: Apogee
plans to develop APG777 and APG990 together as a potential
first-in-class coformulation combining deep and sustained
inhibition of Type 2 inflammation via APG777’s inhibition of IL-13
with broader inhibition of Type 1-3 inflammation through APG990’s
inhibition of OX40L. These combined mechanisms offer the potential
for improved clinical responses over monotherapy across a variety
of I&I diseases while our approach of coformulating two
extended half-life mAbs holds the potential for best-in-class
dosing.
- The company plans to initiate the first clinical trial of the
APG777 and APG990 combination in 2025.
- Expanded board of directors: In May, drug
development expert Lisa Bollinger, M.D., joined Apogee’s board of
directors. Dr. Bollinger has over 30 years of experience in drug
development, with deep regulatory experience gained within both the
U.S. FDA and multinational biotechnology and pharmaceutical
companies, and most recently served as Vice President, Regulatory
Affairs, Global Regulatory Affairs and Clinical Safety at Merck,
where she led the general medicine therapeutic area in regulatory
affairs.
- Apogee Therapeutics 2024 Virtual R&D Day to be held
in December: The company plans to highlight progress
across its pipeline and showcase its path to reshaping the standard
of care in I&I by bringing forward monotherapy and combination
treatments that offer the potential for best-in-class efficacy and
improved dosing.
Second Quarter Financial Results
- Cash Position: As of June 30, 2024, Apogee had
cash, cash equivalents and marketable securities of $789.6 million.
Apogee expects that its existing 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 second quarter of 2024 were $33.2 million,
compared to $13.9 million for the second quarter of 2023. R&D
expenses increased primarily due to further development of the
company’s APG777, APG808 and APG990 and APG333 programs and
advancement of its pipeline into clinical trials, preclinical
testing of potential combinations, 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 second quarter of 2024 were $10.9 million,
compared to $4.9 million for the second 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 second quarter of
2024 was $33.8 million, compared to the net loss for the second
quarter of 2023 which was $18.9 million. 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 advancing novel biologics with
potential for differentiated efficacy and dosing in the largest
inflammatory and immunology (I&I) markets, including for the
treatment of atopic dermatitis (AD), asthma, chronic obstructive
pulmonary disease (COPD) and other I&I indications. 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. APG777, the company’s most advanced program,
is being initially developed for the treatment of AD, which is the
largest and one of the least penetrated I&I markets. With four
validated targets in its portfolio, Apogee is seeking to achieve
best in class efficacy and dosing through monotherapies and
combinations of its novel antibodies. 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 plans for its
current and future product candidates and programs, its plans for
current and future clinical trials, including a Phase 2 trial for
APG777 in asthma, a Phase 1b trial of APG808 in asthma, a Phase 1
trial for APG990, and a Phase 1 trial for APG333; 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, APG333 and any other potential programs, including
combination therapies; 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 Form 10-K for the year ended December 31, 2023, filed
with the SEC on March 5, 2024, Quarterly Report on 10-Q for the
quarterly period ended March 31, 2024, filed with the SEC on May
13, 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) |
|
|
|
|
JUNE 30,2024 |
|
|
DECEMBER 31,2023 |
|
Assets |
|
|
|
|
|
Current assets: |
|
|
|
|
|
Cash and cash equivalents |
$ |
307,299 |
|
|
$ |
118,316 |
|
Marketable securities |
|
368,929 |
|
|
|
277,143 |
|
Prepaid expenses and other current assets |
|
5,625 |
|
|
|
2,950 |
|
Total current assets |
|
681,853 |
|
|
|
398,409 |
|
Long-term marketable
securities |
|
113,395 |
|
|
|
— |
|
Property and equipment, net |
|
714 |
|
|
|
377 |
|
Right-of-use asset, net |
|
4,227 |
|
|
|
2,217 |
|
Other non-current assets |
|
468 |
|
|
|
401 |
|
Total assets |
$ |
800,657 |
|
|
$ |
401,404 |
|
Liabilities and
stockholders' equity |
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
Accounts payable |
$ |
5,527 |
|
|
$ |
2,143 |
|
Lease liability |
|
1,682 |
|
|
|
1,101 |
|
Accrued expenses |
|
17,408 |
|
|
|
17,314 |
|
Total current liabilities |
|
24,617 |
|
|
|
20,558 |
|
Long-term liabilities: |
|
|
|
|
|
Lease liability, net of
current |
|
2,401 |
|
|
|
933 |
|
Total liabilities |
|
27,018 |
|
|
|
21,491 |
|
Commitments and contingencies
(Note 9) |
|
|
|
|
|
Stockholders' equity: |
|
|
|
|
|
Common Stock; $0.00001 par value, 400,000,000 authorized,
58,481,214 issued and 56,676,465 outstanding as of June 30,
2024; 400,000,000 authorized, 50,655,671 issued and 48,338,769
outstanding as of December 31, 2023 |
|
1 |
|
|
|
— |
|
Additional paid-in capital |
|
963,607 |
|
|
|
503,354 |
|
Accumulated other comprehensive (loss) income |
|
(289 |
) |
|
|
329 |
|
Accumulated deficit |
|
(189,680 |
) |
|
|
(123,770 |
) |
Total stockholders’ equity |
|
773,639 |
|
|
|
379,913 |
|
Total liabilities and
stockholders’ equity |
$ |
800,657 |
|
|
$ |
401,404 |
|
APOGEE THERAPEUTICS, INC.CONDENSED
CONSOLIDATED STATEMENT OF
OPERATIONS(UNAUDITED) |
|
|
THREE MONTHS ENDED JUNE 30, |
|
|
SIX MONTHS ENDED JUNE 30, |
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
Research and development |
$ |
33,206 |
|
|
$ |
13,946 |
|
|
$ |
61,922 |
|
|
$ |
22,401 |
|
General and administrative |
|
10,916 |
|
|
|
4,939 |
|
|
|
20,381 |
|
|
|
9,142 |
|
Total operating expenses |
|
44,122 |
|
|
|
18,885 |
|
|
|
82,303 |
|
|
|
31,543 |
|
Loss from operations |
|
(44,122 |
) |
|
|
(18,885 |
) |
|
|
(82,303 |
) |
|
|
(31,543 |
) |
Other income, net: |
|
|
|
|
|
|
|
|
|
|
|
Interest income, net |
|
10,306 |
|
|
|
— |
|
|
|
16,393 |
|
|
|
133 |
|
Total other income, net |
|
10,306 |
|
|
|
— |
|
|
|
16,393 |
|
|
|
133 |
|
Net loss |
$ |
(33,816 |
) |
|
$ |
(18,885 |
) |
|
$ |
(65,910 |
) |
|
$ |
(31,410 |
) |
Investor Contact:Noel KurdiVP, Investor
RelationsApogee Therapeutics,
Inc.Noel.Kurdi@apogeetherapeutics.com
Media Contact:Dan Budwick1AB
Mediadan@1abmedia.com
Apogee Therapeutics (NASDAQ:APGE)
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