Apogee Highlights Corporate Progress and Reports Second Quarter 2023 Financial Results
28 Août 2023 - 1:30PM
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) and other inflammatory and immunology (I&I)
indications, today provided a review of its pipeline of potentially
best-in-class monoclonal antibody (mAb) therapies for I&I
diseases, along with key anticipated milestones and recent business
progress. In addition, Apogee reported second quarter 2023
financial results and provided guidance on its projected operating
runway.
“We have achieved remarkable growth and progress across all
aspects of Apogee’s business in 2023 to date, marked by the
important milestones of transitioning to both a publicly traded and
clinical-stage company,” said Michael Henderson, M.D., Chief
Executive Officer of Apogee. “In the last year we have made
noteworthy progress in our mission to develop therapeutic options
for patients by advancing novel, potentially best in class
antibodies that we believe may significantly improve upon standard
of care. Our broad pipeline has the potential to overcome
limitations of existing therapies for AD, asthma and COPD. And we
have capitalized the company with an upsized IPO consisting of new
and existing top tier investors that provides sufficient funding to
support our operations through multiple clinical catalysts for our
lead programs. We have attracted an incredibly talented and
passionate team of industry leaders and experts across our board of
directors, R&D and business operations. This is an exciting
time for Apogee, and we are confident in our ability to deliver
value from our potentially best-in-class therapeutic candidates to
benefit patients living with I&I diseases.”
Pipeline Highlights and Upcoming Milestones
- Enrollment advancing in Phase 1 trial of
APG777, with initial data expected
mid-2024: In August 2023, Apogee
announced initiation of dosing of healthy volunteers for APG777, a
novel, subcutaneous (SQ) extended half-life monoclonal antibody
targeting IL-13 – a critical cytokine in inflammation and a primary
driver of AD. The Phase 1 trial is a double-blind,
placebo-controlled clinical trial designed to evaluate the safety,
tolerability and pharmacokinetics (PK) of single-ascending and
multiple-ascending doses of APG777. Apogee expects initial safety
and PK data from the Phase 1 trial in mid-2024, a potentially key
de-risking event given APG777 is targeting a validated mechanism
and has the potential to show significant differentiation compared
to leading therapies. Pending positive PK and safety data, the
company plans to advance into a randomized, placebo-controlled,
16-week Phase 2 proof-of-concept trial in moderate-to-severe
patients with AD in 2024.
- APG808 development candidate selection expected in 4Q
2023: APG808 is an SQ extended half-life
mAb program targeting IL-4Rα for the treatment of COPD. In
head-to-head preclinical assays, Apogee’s lead candidates have
demonstrated equivalent or better potency in the inhibition of
IL-4Rα signaling to the current standard-of-care.
- APG990 program progressing as a differentiated
OX40L-targeted opportunity: APG990 is an earlier-stage SQ
extended half-life mAb program designed to target OX40L, which
occurs further upstream in the inflammatory pathway than IL-13 or
IL-4Rα, which may lead to an expanded effect on the inflammatory
cascade. Targeting OX40L represents another potential treatment
approach for AD, including for patients who do not benefit from
currently available therapies. Apogee expects to select a
development candidate for its APG990 program in 2024.
- APG222 program advancing with a dual mechanism
targeting both IL-13 and OX40L: APG222 is one or more SQ
extended half-life mAbs targeting both IL-13 and OX40L, for the
potential treatment of AD and other I&I indications. By
blocking OX40L and IL-13, APG222 could simultaneously decrease
OX40L signaling, helping to rebalance the immune system and
decrease immune cell differentiation and cytokine release, and
further reduce IL-13, resulting in even less immune signaling. This
approach has the potential to prevent certain disease-related signs
and symptoms that are driven by IL-13 signaling and the downstream
inflammatory cascade.
- Multiple pipeline expansion opportunities, including
through Paragon collaboration: In addition to each
program’s initial indication, Apogee’s programs have the potential
to expand into a range of I&I diseases. The company has
identified asthma as a leading expansion opportunity for APG777
given the significant overlap with AD and the unmet need. In
addition, under a strategic collaboration agreement with Paragon
Therapeutics, Inc., Apogee plans to select and evaluate additional
targets that have the potential to overcome the limitations of
existing therapies by engineering best-in-class antibodies.
Recent Corporate Highlights
- Appointed Mark C. McKenna as Chairman of the
Board: In August, Apogee expanded its
board with the appointment of Mark C. McKenna, former Chairman,
President and CEO of Prometheus Biosciences, Inc. which was
acquired by Merck & Co., Inc. in June 2023 for approximately
$10.8 billion, representing the largest pre-Phase 3 biopharma
acquisition to date. Mr. McKenna’s knowledge and successful track
record in the I&I space as well as his significant development,
commercial and executive management experience contributed to the
Apogee board of directors’ selection decision.
- Designated Matt Batters as General Counsel:
Also in August, Matt Batters was appointed as General Counsel. He
was previously General Counsel at Arvinas, Inc., a biotech focused
on oncology and neurological diseases where he built its legal team
as it moved from a private, preclinical company to a public
company, led the alliance management team in supporting Arvinas’s
strategic collaborations, and, before becoming its General Counsel,
also led its business development activities. Previously, Mr.
Batters was a Senior Director on the legal team at Alexion
Pharmaceuticals (now part of AstraZeneca) where he supported the
business development function, and was responsible for structuring
and negotiating Alexion’s licensing, collaborations and M&A
activities. Prior to Alexion, Mr. Batters was a corporate associate
at DLA Piper and Skadden, Arps, Slate, Meagher & Flom, where he
advised pharmaceutical and biotechnology clients on global
corporate governance, capital raising and securities matters, as
well as complex licenses, collaborations, and M&A
transactions.
- Completed $345 million upsized Initial Public Offering
(IPO): In July, the
company completed its upsized IPO and sold 20,297,500 shares of
common stock, which included the full exercise of the underwriters’
option to purchase additional shares at a price to
the public of $17.00 per share. The aggregate gross proceeds to
Apogee from the offering before deducting underwriting discounts
and commissions and other offering expenses were approximately $345
million.
- Strengthened team with Board of Directors and
Management Appointments: In June, Apogee
further strengthened its leadership team with the appointments of
Jennifer Fox and William “BJ” Jones, seasoned financial and
commercial executives, respectively, to its board. In addition,
Rebecca Dabora, Ph.D., an expert in chemistry, manufacturing and
controls (CMC), was appointed Chief Technical
Officer.
Second Quarter Financial Results
- Cash Position: As of June 30, 2023, Apogee had
a cash balance of $125.1 million. We expect that the Company’s
existing cash, together with the gross proceeds from the upsized
IPO of approximately $345 million will enable it to fund its
current operating expenses and capital expenditure requirements
into the fourth quarter of 2026.
- Research & Development (R&D) Expenses:
R&D expenses for the second quarter of 2023 were $13.9 million,
compared to $1.4 million for the second quarter of 2022. R&D
expenses increased primarily due to APG777 and APG808 program
advancements and increases in personnel costs, including
share-based compensation expense associated with the growth of
R&D team.
- General and Administrative (G&A) Expenses:
G&A expenses for the second quarter of 2023 were $4.9 million,
compared to $0.4 million for the second quarter of 2022. The
increase of $4.5 million was primarily attributable to the increase
in personnel costs associated with increased headcount and legal
and other professional services conducted to support the growth of
the business.
- Net Loss: Net loss for the second quarter of
2023 was $18.9 million, compared to the net loss for the second
quarter of 2022 which was $1.8 million.
About Apogee
Apogee Therapeutics is a clinical-stage biotechnology company
seeking to develop differentiated biologics for the treatment of
atopic dermatitis (AD), chronic obstructive pulmonary disease
(COPD) 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 properties, including half-life extension. 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, our expectations regarding plans for our current
and future product candidates and programs, plans for our current
and future clinical trials, plans for clinical trial design, the
anticipated timing of the initiation of and results from our
clinical trials, potential clinical benefit and half-life of
APG777, APG808, APG990, APG222, and any other potential programs,
potential additional indications for APG777, the anticipated timing
for selection of development candidates and our other programs and
expectations regarding the time period over which our capital
resources will be sufficient to fund our 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 our preclinical studies, clinical
trials and research and development programs; expectations
regarding the timing, completion and outcome of our 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 our Registration
Statement on Form S-1, as amended, declared effective by the SEC on
July 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, LLC |
|
CONDENSED CONSOLIDATED BALANCE SHEETS |
(UNAUDITED) |
(In thousands) |
|
|
|
|
|
|
|
|
|
|
JUNE 30,2023 |
|
|
DECEMBER 31, 2022 |
|
|
|
|
|
|
|
|
|
|
Assets |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash |
|
$ |
125,069 |
|
|
$ |
151,890 |
|
Prepaid expenses and other current assets |
|
|
5,598 |
|
|
|
165 |
|
Total current assets |
|
|
130,667 |
|
|
|
152,055 |
|
Total assets |
|
$ |
130,667 |
|
|
$ |
152,055 |
|
|
|
|
|
|
|
|
|
|
Liabilities, preferred
units and members’ deficit |
|
|
|
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
|
|
Accounts
payable |
|
$ |
11,148 |
|
|
$ |
418 |
|
Accrued expenses |
|
|
6,467 |
|
|
|
9,562 |
|
Total current liabilities |
|
|
17,615 |
|
|
|
9,980 |
|
Total liabilities |
|
|
17,615 |
|
|
|
9,980 |
|
Commitments and
contingencies |
|
|
|
|
|
|
|
|
Series A Preferred Units;
20,000,000 units authorized, issued and outstanding as of
June 30, 2023 and December 31, 2022; liquidation of $20,000
value as of June 30, 2023 and December 31, 2022 |
|
|
28,971 |
|
|
|
28,971 |
|
Series B Preferred Units;
45,089,212 units authorized, issued and outstanding as of
June 30, 2023 and December 31, 2022; liquidation of $149,000
value as of June 30, 2023 and December 31, 2022 |
|
|
148,496 |
|
|
|
148,496 |
|
Members’ deficit: |
|
|
|
|
|
|
Common Units; 5,000,000 units authorized, issued and outstanding as
June 30, 2023 and December 31, 2022 |
|
|
2,251 |
|
|
|
2,251 |
|
Incentive Units; 16,537,557 units authorized, 14,270,275 issued and
2,481,543 outstanding as of June 30, 2023; 12,412,473 units
authorized, 9,648,374 issued and 1,625,086 outstanding as of
December 31, 2022 |
|
|
4,529 |
|
|
|
2,142 |
|
Accumulated deficit |
|
|
(71,195 |
) |
|
|
(39,785 |
) |
Total members’ deficit |
|
|
(64,415 |
) |
|
|
(35,392 |
) |
Total liabilities, preferred
units and members’ deficit |
|
$ |
130,667 |
|
|
$ |
152,055 |
|
|
|
APOGEE THERAPEUTICS, LLC |
|
CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS AND
COMPREHENSIVE LOSS |
(UNAUDITED) |
(In thousands) |
|
|
|
THREE MONTHS ENDEDJUNE 30, |
|
SIX MONTHS ENDEDJUNE 30, |
|
|
PERIOD FROMFEBRUARY 4, 2022(INCEPTION) TO JUNE
30, |
|
|
|
|
2023 |
|
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
13,946 |
|
|
$ |
1,448 |
|
|
$ |
22,401 |
|
$ |
5,693 |
|
General and administrative |
|
|
4,939 |
|
|
|
368 |
|
|
|
9,142 |
|
|
428 |
|
Total operating expenses |
|
|
18,885 |
|
|
|
1,816 |
|
|
|
31,543 |
|
|
6,121 |
|
Loss from operations |
|
|
(18,885 |
) |
|
|
(1,816 |
) |
|
|
(31,543 |
) |
|
(6,121 |
) |
Other income (expense), net: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
— |
|
|
|
— |
|
|
|
133 |
|
|
— |
|
Total other income (expense),
net |
|
|
— |
|
|
|
— |
|
|
|
133 |
|
|
— |
|
Net loss and comprehensive
loss |
|
$ |
(18,885 |
) |
|
$ |
(1,816 |
) |
|
$ |
(31,410 |
) |
$ |
(6,121 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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Investor Contacts:
Noel KurdiVP, Investor RelationsApogee
TherapeuticsNoel.kurdi@apogeetherapeutics.com
Alex StrausTHRUST Strategic Communicationsalex@thrustsc.com
Media Contact:
Dan Budwick1AB Mediadan@1abmedia.com
Apogee Therapeutics (NASDAQ:APGE)
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