Full Press Release Details
Provides Pipeline Progress and Reports Second Quarter 2024 Financial Results
Continued advancement
of pipeline and execution towards expected milestones, including APG777 16-week proof-of-concept data from the Phase 2 Part A trial
in 2H 2025, APG808 interim Phase 1 data in 4Q 2024, and APG990 Phase 1 trial initiation in healthy volunteers accelerated to 3Q 2024
subcutaneous half-life extended anti-TSLP antibody, added to portfolio to provide for potential best-in-class combination efficacy across
multiple respiratory indications, expected to enter the clinic in 2025
combination studies of 777 + 990 (IL-13 and OX40L) and 777 + 333 (IL-13 and TSLP), with the potential for greater efficacy across I&I
diseases, starting with the first clinical trial of the APG777 and APG990 combination in 2025
cash, cash equivalents and marketable securities with runway into 2028
SAN FRANCISCO, CA and WALTHAM, MA,
August 12, 2024 - 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-4R , 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
Second Quarter Financial Results
Apogee 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 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 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
(In thousands, except
| 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 |
CONSOLIDATED STATEMENT OF OPERATIONS
| 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 | ) |
VP, Investor Relations
Apogee Therapeutics, Inc.