Apogee Highlights Corporate Progress and Reports Third Quarter 2023 Financial Results
13 Novembre 2023 - 1:30PM
Apogee Therapeutics, Inc. (Nasdaq: APGE), a clinical-stage
biotechnology company advancing differentiated biologics for the
treatment of atopic dermatitis (AD), asthma, chronic obstructive
pulmonary disease (COPD) and other inflammatory and immunology
(I&I) indications, today provided business updates and reported
third quarter 2023 financial results.
“I am proud of our team’s execution during the third quarter and
2023 overall. We continue to deliver against our operating plan,
advancing our lead program, APG777 for AD, into a first-in-human
healthy volunteer study ahead of schedule while progressing our
portfolio of potentially best-in-class biologics designed to
significantly improve therapeutic options for patients across the
largest markets in I&I”, said Michael Henderson, M.D., Chief
Executive Officer of Apogee. “We expect to report initial PK and
safety data from the Phase 1 trial for APG777 in mid-2024, a
potentially key de-risking milestone, which we believe could
demonstrate our potential benefit relative to the current standard
of care, including optimized exposures, low variability, and
extended half-life. Alongside the advancements in APG777, we are
excited to announce the selection of a development candidate for
our second program, APG808, and remain on track to enter the clinic
in healthy volunteers in 2024 followed by a Phase 2 trial in
COPD.
Pipeline Highlights and Upcoming Milestones
- Dosing underway in Phase 1 trial of
APG777: 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. The
Phase 1 trial is a randomized, 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 initiated dosing of healthy volunteers
ahead of schedule in August 2023. The Phase 1 clinical trial
objectives are to:
- Establish safety and PK;
- Set Phase 2 induction regimen to achieve at least equivalent
exposures as lebrikizumab, a first-generation IL-13 antibody;
and
- Support testing of maintenance dosing regimens of every 2 or 3
months while maintaining the minimal concentration of APG777 at a
similar level to lebrikizumab
Apogee expects initial safety and PK data from the Phase 1 trial
in mid-2024, a potentially key de-risking milestone given APG777 is
targeting a validated mechanism. The goal of the Phase 1 trial is
to support potential dosing every 2 to 3 months compared to the
current standard of care of every 2 to 4 weeks. Apogee believes
this potential for significant differentiation compared to leading
therapies may contribute to a best-in-class profile for APG777.
Pending positive PK and safety data, the company plans to advance
into a randomized, double-blind, placebo-controlled, 16-week Phase
2 proof-of-concept trial in moderate-to-severe patients with AD in
2024 with data expected in the second half of 2025.
- Finalized nomination of APG808 development
candidate in 4Q 2023:
APG808 is an SQ extended half-life mAb targeting IL-4Rα, a target
with clinical validation across eight Type 2 allergic diseases.
APG808 has similar binding femtomolar affinity for IL-4Rα as 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). Additionally, in Apogee’s head-to-head studies of
APG808 and DUPIXENT in non-human primates, APG808 showed a
significantly longer half-life than DUPIXENT. In these preclinical
studies, APG808’s half-life was up to 26 days, as compared to 12
days for DUPIXENT. Based on these preclinical studies, we believe
that the longer half-life could support dosing either every 6 weeks
or every 2 months in the clinic, which, if future clinical trials
are successful, would represent a significant improvement compared
to DUPIXENT which is currently being investigated with every 2-week
dosing in COPD. APG808 remains on track to enter the clinic in
healthy volunteers in 2024 followed by a Phase 2 trial in COPD
(pending data from the Phase 1 trial and following the submission
of an IND to support the Phase 2 trial).
Recent Corporate Highlights
- 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.
- Presented preclinical data for
APG777: In October, at the 2023 European
Academy of Dermatology and Venereology (EADV) Congress held in
Berlin, Germany, Apogee presented preclinical data that highlighted
the potential advantages of APG777 over current therapeutic agents
targeting IL-13, including half-life.
- Expanded board of directors and leadership
team: In August, healthcare veteran and former Chairman,
President and CEO of Prometheus Biosciences, Mark C. McKenna, was
appointed Chairman of the Apogee board of directors. Matt Batters
also joined Apogee in August as General Counsel, a role he most
recently served in at Arvinas, Inc.
Upcoming Investor Events
Apogee plans to participate in the following upcoming
events:
- Stifel 2023 Healthcare Conference, November 14, New York,
NY
- Jefferies London Healthcare Conference, November 15, London,
UK
- Evercore ISI 6th Annual HealthCONx Conference, November 28,
Miami, FL
Third Quarter Financial Results
- Cash Position: As of September 30, 2023,
Apogee had a total cash balance of $422.9 million. Apogee expects
that its existing cash 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 third quarter of 2023 were $17.1 million,
compared to $9.9 million for the third quarter of 2022. R&D
expenses increased primarily due to further development of the
company’s APG777 and APG808 programs and advancement of its
pipeline, as well as increases in personnel costs, including
share-based compensation expense, associated with the growth of its
R&D team.
- General and Administrative (G&A) Expenses:
G&A expenses for the third quarter of 2023 were $7.2 million,
compared to $0.6 million for the third quarter of 2022. G&A
expenses increased primarily due to increases in personnel costs,
including share-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 third quarter of
2023 was $20.8 million, compared to the net loss for the third
quarter of 2022 which was $19.7 million.
About Apogee
Apogee Therapeutics is a clinical-stage biotechnology company
seeking to develop differentiated biologics for the treatment of
atopic dermatitis (AD), asthma, 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 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.
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 and any other potential 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 Quarterly Report of 10-Q for the quarterly period ended June
30, 2023, filed with the SEC on August 28, 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.CONDENSED
CONSOLIDATED BALANCE SHEETS(UNAUDITED)(In
thousands, except unit/share data) |
|
|
|
SEPTEMBER
30, |
|
DECEMBER
31, |
|
|
2023 |
|
2022 |
Assets |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
188,269 |
|
|
$ |
151,890 |
|
Marketable securities |
|
|
234,585 |
|
|
|
- |
|
Prepaid expenses and other current assets |
|
|
3,567 |
|
|
|
165 |
|
Total current assets |
|
|
426,421 |
|
|
|
152,055 |
|
Total assets |
|
$ |
426,421 |
|
|
$ |
152,055 |
|
Liabilities, preferred
units and stockholders’ equity/members’ deficit |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
1,208 |
|
|
$ |
418 |
|
Accrued expenses |
|
|
15,970 |
|
|
|
9,562 |
|
Total current liabilities |
|
|
17,178 |
|
|
|
9,980 |
|
Total liabilities |
|
|
17,178 |
|
|
|
9,980 |
|
Commitments and
contingencies |
|
|
|
|
|
|
Series A Preferred Units; no
units authorized, issued and outstanding at September 30, 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 September 30, 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
September 30, 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
September 30, 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 September 30, 2023; No shares
authorized, issued and outstanding at December 31, 2022 |
|
|
- |
|
|
|
- |
|
Common Stock; 400,000,000 authorized, $0.00001 par value,
50,674,296 issued and 48,017,621 outstanding as of September 30,
2023; No shares authorized, issued and outstanding at December 31,
2022 |
|
|
- |
|
|
|
- |
|
Additional paid-in capital |
|
|
501,143 |
|
|
|
- |
|
Accumulated other comprehensive income |
|
|
135 |
|
|
|
- |
|
Accumulated deficit |
|
|
(92,035 |
) |
|
|
(39,785 |
) |
Total stockholders’ equity/members’ deficit |
|
|
409,243 |
|
|
|
(35,392 |
) |
Total liabilities, preferred
units and stockholders’ equity/members’ deficit |
|
$ |
426,421 |
|
|
$ |
152,055 |
|
|
APOGEE THERAPEUTICS, INC.CONDENSED
CONSOLIDATED STATEMENT OF
OPERATIONS(UNAUDITED)(In thousands) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
THREE MONTHS ENDED SEPTEMBER 30, |
|
NINE MONTHSENDED SEPTEMBER 30, |
|
PERIOD FROMFEBRUARY 4, 2022(INCEPTION) TO |
|
|
2023 |
|
2022 |
|
2023 |
|
SEPTEMBER 30, 2022 |
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
17,069 |
|
|
$ |
9,885 |
|
|
$ |
39,470 |
|
|
$ |
15,578 |
|
General and administrative |
|
|
7,236 |
|
|
|
622 |
|
|
|
16,378 |
|
|
|
1,050 |
|
Total operating expenses |
|
|
24,305 |
|
|
|
10,507 |
|
|
|
55,848 |
|
|
|
16,628 |
|
Loss from
operations |
|
|
(24,305 |
) |
|
|
(10,507 |
) |
|
|
(55,848 |
) |
|
|
(16,628 |
) |
Other income
(expense), net: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
3,465 |
|
|
|
— |
|
|
|
3,598 |
|
|
|
— |
|
Other financing expense |
|
|
— |
|
|
|
(9,150 |
) |
|
|
— |
|
|
|
(9,150 |
) |
Total other income (expense), net |
|
|
3,465 |
|
|
|
(9,150 |
) |
|
|
3,598 |
|
|
|
(9,150 |
) |
Net loss |
|
$ |
(20,840 |
) |
|
$ |
(19,657 |
) |
|
$ |
(52,250 |
) |
|
$ |
(25,778 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Investor Contact:
Noel KurdiVP, Investor RelationsApogee
TherapeuticsNoel.kurdi@apogeetherapeutics.com
Media Contact:
Dan Budwick1AB Mediadan@1abmedia.com
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