Full Press Release Details
Apogee Therapeutics Provides Pipeline Progress
and Reports Fourth Quarter and Full Year 2023 Financial Results
Positive interim results from APG777 Phase 1
healthy volunteer clinical trial exceeded objectives with approximately 75-day half-life which supports the potential for higher exposures
leading to potential for improved clinical responses in induction than currently available biologic therapies and the potential for maintenance
dosing of every 3- or 6-months
APG777 Phase 1 interim data support advancement
of a randomized, placebo-controlled Phase 2 clinical trial in patients with moderate-to-severe atopic dermatitis in 1H 2024 ahead of schedule
Phase 1 healthy volunteer clinical trial set
to start ahead of schedule for APG808, a subcutaneous extended half-life antibody targeting IL-4R , following receipt of regulatory
clearance in February
Total cash of $395.5 million at year end 2023
with expected cash runway into 4Q 2026
San Francisco, CA and Waltham, MA, March 5, 2024 -
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
Pipeline Highlights and Upcoming Milestones
Fourth Quarter and Full Year 2023 Financial Results
Cash 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
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.
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), 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 Statements
Certain 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
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
| 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 | ) |
VP, Investor Relations