Full Press Release Details
Apogee Therapeutics Highlights Pipeline Progress
and Reports First Quarter 2024 Financial Results
2 clinical trial of APG777, a subcutaneous half-life extended monoclonal antibody targeting IL-13, in patients with moderate-to-severe
atopic dermatitis, with 16-week proof-of-concept data from Part A of the trial expected in 2H 2025
dosed in Phase 1 healthy volunteer clinical trial of APG808, a subcutaneous half-life extended monoclonal antibody targeting IL-4R ,
for the treatment of chronic obstructive pulmonary disease and other inflammatory diseases with interim Phase 1 data expected in 2H 2024
development candidate for APG990, a subcutaneous half-life extended monoclonal antibody targeting OX40L, with a Phase 1 trial in healthy
volunteers expected to initiate in 2H 2024
cash equivalents and marketable securities with runway into 2028
SAN FRANCISCO, CA and
WALTHAM, MA, May 13, 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 first quarter financial results.
"I am proud of the continued momentum our team has achieved this
quarter, executing against our goals and successfully bringing our programs forward ahead of schedule," said Michael Henderson,
MD, Chief Executive Officer of Apogee. "We continue to maintain that pace of progress with the selection of our development candidate
for APG990 and now plan to initiate a Phase 1 trial in healthy volunteers by the end of the year. We commenced dosing of the first healthy
participants in our second clinical program, APG808, and expect an interim readout in the second half of this year. Following that readout,
we're planning a Phase 1b readout for APG808 in asthma to follow in the first half of 2025 that is designed to determine the doses to
then take into a Phase 2 trial in COPD in the same year. We are on track to dose the first patient in the APG777 Phase 2 trial in patients
with moderate-to-severe AD in the first half of this year. Additionally, on the heels of our successful interim Phase 1 APG777 data readout,
we raised $483 million in an upsized public offering providing capital into 2028."
Pipeline and Corporate Highlights and Upcoming Milestones
First Quarter Financial Results
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, COPD, and asthma, 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: Apogee's
expectations regarding plans for its current and future product candidates and programs, its plans for Apogee's current and future
clinical trials, including a Phase 2 trial for APG777 in asthma, Phase 1 trials of APG808, and a Phase 1 trial for APG990, 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 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 Annual Report on 10-K for the year period
ended December 31, 2023, filed with the SEC on March 5, 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
(In thousands, except unit/share data)
| MARCH 31, | DECEMBER 31, | |||||||
| 2024 | 2023 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 485,457 | $ | 118,316 | ||||
| Marketable securities | 330,739 | 277,143 | ||||||
| Prepaid expenses and other current assets | 4,412 | 2,950 | ||||||
| Total current assets | 820,608 | 398,409 | ||||||
| Property and equipment, net | 699 | 377 | ||||||
| Right-of-use asset, net | 1,951 | 2,217 | ||||||
| Other non-current assets | 401 | 401 | ||||||
| Total assets | $ | 823,659 | $ | 401,404 | ||||
| Liabilities and stockholders' equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | 4,302 | $ | 2,143 | |||||
| Lease liability | 1,141 | 1,101 | ||||||
| Accrued expenses | 16,108 | 17,314 | ||||||
| Total current liabilities | 21,551 | 20,558 | ||||||
| Long-term liabilities: | ||||||||
| Lease liability, net of current | 630 | 933 | ||||||
| Total liabilities | 22,181 | 21,491 | ||||||
| Stockholders' Equity: | ||||||||
| Common Stock; $0.00001 par value, 400,000,000 authorized, 58,456,027 issued and 56,367,802 outstanding as of March 31, 2024; 400,000,000 authorized, 50,655,671 issued and 48,338,769 outstanding as of December 31, 2023 | 1 | - | ||||||
| Additional paid-in capital | 957,518 | 503,354 | ||||||
| Accumulated other comprehensive (loss) income | (177 | ) | 329 | |||||
| Accumulated deficit | (155,864 | ) | (123,770 | ) | ||||
| Total stockholders' equity | 801,478 | 379,913 | ||||||
| Total liabilities and stockholders' equity | $ | 823,659 | $ | 401,404 |
APOGEE THERAPEUTICS, INC.
CONSOLIDATED STATEMENT OF OPERATIONS
(In thousands, except share and per share data)
| THREE MONTHS ENDED MARCH 31, | ||||||||
| 2024 | 2023 | |||||||
| Operating expenses: | ||||||||
| Research and development | $ | 28,716 | $ | 8,455 | ||||
| General and administrative | 9,465 | 4,203 | ||||||
| Total operating expenses | 38,181 | 12,658 | ||||||
| Loss from operations | (38,181 | ) | (12,658 | ) | ||||
| Other income, net: | ||||||||
| Interest income, net | 6,087 | 133 | ||||||
| Total other income, net | 6,087 | 133 | ||||||
| Net loss | $ | (32,094 | ) | $ | (12,525 | ) |
VP, Investor Relations
Apogee Therapeutics, Inc.