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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Apogee Therapeutics Inc | NASDAQ:APGE | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 56.80 | 56.50 | 59.99 | 15 | 13:31:52 |
“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-4Rα, 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
About ApogeeApogee 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 StatementsCertain 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 BALANCE SHEETS(UNAUDITED)(In thousands, except unit/share data) | |||||||
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 |
APOGEE THERAPEUTICS, INC.CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS(UNAUDITED) | |||||||||||||||
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 | ) |
Investor Contact:Noel KurdiVP, Investor RelationsApogee Therapeutics, Inc.Noel.Kurdi@apogeetherapeutics.com
Media Contact:Dan Budwick1AB Mediadan@1abmedia.com
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