APGE Apogee Therapeutics Inc

 

 

UNITED STATES

 

SECURITIES AND EXCHANGE COMMISSION

 

WASHINGTON, D.C. 20549

 

 

FORM 8-K 

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): March 3, 2025

 

 

Apogee Therapeutics, Inc.

(Exact Name of Registrant as Specified in Its Charter)

 

 

Delaware	001-41740	93-4958665
(State of Incorporation or Organization)	(Commission File Number)	(I.R.S. Employer Identification No.)

 

221 Crescent Street, Building 17, Suite 102b,

Waltham, MA, 02453

(Address of Principal Executive Offices, including Zip Code)

 

(650) 394-5230

(Registrant’s telephone number, including area code)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

¨	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, par value $0.00001 per share		APGE		The Nasdaq Global Market

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company ¨

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨

 

 

 

Item 2.02

Results of Operations and Financial Condition.

 

On March 3, 2025, Apogee Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the quarter and year ended December 31, 2024.

 

A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference herein. The exhibit furnished under Item 2.02 of this Current Report on Form 8-K shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Exchange Act or the Securities Act of 1933, as amended (the “Securities Act”), regardless of any general incorporation language in such filing.

 

Item 7.01

Regulation FD Disclosure.

 

On March 3, 2025, the Company issued a press release announcing positive interim Phase 1 results from its first-in-human trial of APG990. The Company will host a webcast today, Monday, March 3, 2025, at 8:30 a.m., Eastern Time, to discuss the data results.

 

A copy of the press release is furnished as Exhibit 99.2 to this Current Report on Form 8-K and is incorporated by reference herein. The exhibit furnished under Item 7.01 of this Current Report on Form 8-K shall not be deemed to be “filed” for purposes of Section 18 of the Exchange Act, or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Exchange Act or the Securities Act, regardless of any general incorporation language in such filing.

 

Item 9.01

Financial Statements and Exhibits.

 

(d) Exhibits. The following exhibits are being furnished herewith:

 

EXHIBIT INDEX

 

Exhibit No.		Description
99.1		Earnings Press Release, dated March 3, 2025
99.2		Data Press Release, dated March 3, 2025
104		Cover Page Interactive Data File (embedded within the Inline XBRL document).

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

	Apogee Therapeutics, Inc.
Date: March 3, 2025	By:	/s/ Michael Henderson, M.D.
		Michael Henderson, M.D.
		Chief Executive Officer

 

 

 

Exhibit 99.1

 

 

Apogee Therapeutics Provides Pipeline Progress and Reports Full Year 2024 Financial Results

 

Accelerated execution of Phase 2 APEX clinical trial for APG777, with Part A over-enrolled and Part B initiated ahead of schedule; topline Part A 16-week data expected mid-2025

 

APG279 (APG777 + APG990) Phase 1b head-to-head study vs. DUPIXENT supported by positive APG990 interim Phase 1 results, which exceeded trial objectives and demonstrated potential for three- and six-month dosing in combination with APG777; APG279 readout expected in second half of 2026

 

$731.1 million cash, cash equivalents and marketable securities with runway into Q1 2028

 

San Francisco and Boston, March 3, 2025 – Apogee Therapeutics, Inc. (Nasdaq: APGE), a clinical-stage biotechnology company advancing novel biologics with the potential for differentiated efficacy and dosing in the largest inflammatory and immunology (I&I) markets, including for the treatment of atopic dermatitis (AD), asthma, eosinophilic esophagitis (EoE), chronic obstructive pulmonary disease (COPD) and other I&I indications, today provided pipeline progress and reported full year 2024 financial results.

 

“We achieved significant progress across our pipeline in 2024 and are well-positioned to continue executing rapidly on our mission to bring transformative, potentially best-in-class therapies to patients with I&I diseases,” said Michael Henderson, M.D., Chief Executive Officer of Apogee. “We kicked off 2025 by over-enrolling Part A and dosing the first patient in the Part B portion of our Phase 2 APEX clinical trial for APG777 in AD, well ahead of schedule and we are on track for our critical 16-week readout for APG777 in mid-2025. Our positive readout today from the Phase 1 trial of APG990 in healthy volunteers enables our combination study of APG777 + APG990, which we have named APG279, versus DUPIXENT this year following regulatory submissions, with this important dataset expected in the second half of 2026. With a strong cash position and several meaningful catalysts expected, we are looking forward to an exciting and productive 2025.”

 

Pipeline Highlights and Upcoming Milestones

 

·

Company continues to execute on APG777 monotherapy program in AD as well as initial expansion indications in asthma and EoE: APG777 is a novel, subcutaneous (SQ), extended half-life monoclonal antibody (mAb) targeting IL-13 – a critical cytokine in inflammation and a primary driver of AD.

 

o

At its December 2024 R&D Day, the company reported updated data from its Phase 1 APG777 trial, out to 12 months, including a half-life of 77 days, which continue to support a potentially best-in-class profile. In the updated dataset, safety was consistent with prior results, and APG777 demonstrated a favorable pharmacodynamic (PD) profile showing near complete inhibition of pSTAT6 for up to 12 months after a single administration and sustained TARC inhibition.

 

o

The data support Apogee’s ongoing Phase 2 clinical trial of APG777 in AD and support the potential for improved clinical responses from greater exposures in induction and maintenance dosing of every three- and six- months. In February 2025, the company announced that Part A of the trial had exceeded enrollment expectations and the first patient was dosed in Part B – both milestones completed ahead of schedule.

 

§

The company expects to report 16-week topline data from the Part A portion of the trial mid-2025.

 

o

Apogee plans to initiate a Phase 1b trial in asthma the first half of 2025 followed by a Phase 2b trial in asthma in the second half of 2025 with data expected in 2026.

 

 

 

o

The company also plans to initiate a Phase 2 trial in EoE in 2026.

 

	·	APG279 (APG777 + APG990) Phase 1b head-to-head study against DUPIXENT now supported by positive, interim Phase 1 results for APG990 and completion of a combination toxicology study: APG990 is a novel, SQ, half-life extended monoclonal antibody (mAb), and the combination with APG777 offers the potential for improved clinical responses over monotherapy across a variety of I&I diseases while Apogee’s approach of coformulating two extended half-life mAbs holds the potential for best-in-class dosing. Today, the company reported positive interim results in the Phase 1 first-in-human study of APG990, which is designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of single-ascending doses (SAD) of APG990 in healthy volunteers. Key findings from the study include:

	o	PK profile includes half-life of approximately 60 days; PK profile supports the potential for a single 2 mL co-formulated injection of APG279 administered every three- and six- months in maintenance.

	o	APG990 was well tolerated across all dose groups with a favorable safety profile.

·

Based on these data, Apogee plans to initiate its first combination trial in 2025 – a Phase 1b trial designed to evaluate the safety, PK, PD and efficacy of APG279 against DUPIXENT in patients with moderate-to-severe AD, with interim readout expected in the second half of 2026.

 

	·	Progress in respiratory indications continues with planned combination approach of APG777 + APG333: APG333 is a novel, SQ extended half-life mAb targeting thymic stromal lymphopoietin (TSLP), a key driver of Type 2 and Type 3 inflammation in eosinophilic and non-eosinophilic conditions.

	o	A Phase 1 trial of APG333 in healthy volunteers is underway, with data expected in the second half of 2025.

o

Apogee plans to evaluate APG777 and APG333 monotherapies in respective Phase 1b trials in patients with asthma in 2025 to support advancement into future combination trials in asthma and COPD.

 

	·	Positive interim data for APG808 Phase 1 trial reported, supporting the potential for two- to three-month dosing and demonstrating deep and sustained inhibition of biomarkers: APG808 is a novel SQ extended half-life mAb targeting IL-4Rα, a target with clinical validation across eight Type 2 allergic diseases. APG808 has similar binding affinity for IL-4Rα as a first generation mAb, DUPIXENT, and has demonstrated similar inhibition to DUPIXENT across three in vitro assays that measure downstream functional inhibition of the IL-13/IL-4 pathway.

	o	At its December 2024 R&D Day, the company reported interim data from all four SAD cohorts in the Phase 1 healthy volunteer trial. APG808 demonstrated a potential best-in-class PK profile, including a half-life of approximately 55 days, and single doses of APG808 demonstrated deep and sustained effect on PD markers out to ~3 months (which was the longest follow-up available at the time of data cut). APG808 was well tolerated in the study.

o

Apogee is also evaluating APG808 in a Phase 1b trial in patients with asthma, with data expected in the first half of 2025.

 

 

 

Full Year 2024 Financial Results

 

·

Cash Position: Cash, cash equivalents and marketable securities were $731.1 million as of December 31, 2024, compared to $395.5 million as of December 31, 2023. Based on current operating plans, Apogee expects its existing cash, cash equivalents and marketable securities will enable the company to fund its operating expenses into the first quarter of 2028.

 

·

R&D Expenses: Research and development (R&D) expenses were $167.9 million for the year ended December 31, 2024, compared to $68.4 million for the year ended December 31, 2023. R&D expenses increased primarily due to continued development of the company’s APG777, APG990/APG777 + APG990, and APG333/APG777 + APG333 programs and advancement of its pipeline into clinical trials, as well as increases in personnel related expenses including equity-based compensation expense, associated with the growth of its R&D team.

 

·

G&A Expenses: General and administrative (G&A) expenses were $49.0 million for the year ended December 31, 2024, compared to $24.6 million for the year ended December 31, 2023. G&A expenses increased primarily due to increases in personnel related expenses including equity-based compensation expenses, primarily driven by increased headcount and an increase in the fair value of equity awards granted. These increases are the result of the company’s expansion of operations to support the growth in its business and the costs of operating as a public entity.

 

·

Net Loss: Net loss was $182.1 million for the year ended December 31, 2024, compared to a net loss of $84.0 million for the year ended December 31, 2023. Net loss increased primarily as a result of higher R&D and G&A expenses as described above, partially offset by higher interest income.

 

About Apogee

 

Apogee Therapeutics is a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&I markets, including for the treatment of AD, asthma, EoE, 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 https://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; the anticipated timing of the initiation of its clinical trials, including the Phase 1b trial of APG279 (the combination of APG777 and APG990), the Phase 1b and 2b trials of APG777 in asthma, the Phase 2 trial of APG777 in EoE, and the Phase 1b trial of APG333 in asthma; the expected timing of and results from its clinical trials, including data from its Phase 2 trial of APG777, Phase 1b trial of APG279, Phase 1 trial of APG333, Phase 1b trial of APG808, the potential combination of APG777 and APG333; planned clinical trial designs; its plans for current and future clinical trials; the potential clinical benefit and half-life of APG777, APG990, APG333, APG808, Apogee’s other product candidates, including combination therapies, and any other potential programs; its expected timing for future pipeline updates and expectations regarding the time period over which Apogee’s capital resources will be sufficient to funds its 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, 2024, filed with the SEC on November 12, 2024, and subsequent disclosure documents the company 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.

 

CONSOLIDATED BALANCE SHEETS

(In thousands, except unit/share data)

 

		DECEMBER 31, 2024				DECEMBER 31, 2023
Assets
Current assets:
Cash and cash equivalents		$	141,789			$	118,316
Marketable securities			378,864				277,143
Prepaid expenses and other current assets			9,060				2,950
Total current assets			529,713				398,409
Long-term marketable securities			210,416				—
Property and equipment, net			1,959				377
Right-of-use asset, net			11,365				2,217
Other non-current assets			498				401
Total assets		$	753,951			$	401,404
Liabilities and stockholders' equity
Current liabilities:
Accounts payable		$	1,071			$	2,143
Lease liability			3,234				1,101
Accrued expenses			24,255				17,314
Total current liabilities			28,560				20,558
Long-term liabilities:
Lease liability, net of current			8,597				933
Total liabilities			37,157				21,491
Stockholders' equity:
Common Stock; $0.00001 par value, 400,000,000 authorized, 59,478,725 issued and 58,062,898 outstanding as of December 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			1,021,794				503,354
Accumulated other comprehensive income			915				329
Accumulated deficit			(305,916	)			(123,770	)
Total stockholders’ equity			716,794				379,913
Total liabilities and stockholders’ equity		$	753,951			$	401,404

 

 

APOGEE THERAPEUTICS, INC.

 

CONSOLIDATED STATEMENTS OF OPERATIONS

(In thousands)

 

		YEAR ENDED DECEMBER 31,
		2024				2023
Operating expenses:
Research and development		$	167,865			$	68,424
General and administrative			49,005				24,579
Total operating expenses			216,870				93,003
Loss from operations			(216,870	)			(93,003	)
Other income, net:
Interest income, net			34,742				9,018
Total other income, net			34,742				9,018
Net loss before taxes			(182,128	)			(83,985	)
Provision for income taxes			(18	)			—
Net loss after taxes		$	(182,146	)		$	(83,985	)

 

 

 

Investor Contact:

Noel Kurdi

VP, Investor Relations

Apogee Therapeutics, Inc.

Noel.Kurdi@apogeetherapeutics.com

 

Media Contact:

Dan Budwick

1AB Media

dan@1abmedia.com

 

 

Exhibit 99.2

 

 

Apogee Therapeutics Announces Positive Interim Phase 1 Results from the APG990 Healthy Volunteer Trial, Unlocking Potential Maintenance Dosing Every Three and Six Months for APG279 (APG777 + APG990)

 

Interim Phase 1 results for APG990, a novel half-life extended OX40L antibody, exceeded trial objectives and demonstrated an approximately 60-day half-life

 

APG279 (APG777 + APG990) Phase 1b head-to-head study vs. DUPIXENT supported by successful completion of preclinical combination toxicology studies and positive APG990 interim Phase 1 results; trial planned to initiate this year with readout expected in second half of 2026

 

Webcast to be held today at 8:30 a.m. ET

 

SAN FRANCISCO and BOSTON, March 3, 2025 -- 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, eosinophilic esophagitis (EoE), chronic obstructive pulmonary disease (COPD) and other I&I indications, today announced positive interim Phase 1 results from its first-in-human trial of APG990.

 

APG990 interim Phase 1 pharmacokinetic (PK) data showed a half-life of approximately 60 days across doses tested. These PK data support the possibility of every three- and six-month maintenance dosing of APG990 with as little as 50 mg, which when considered with APG279 (APG777 + APG990) coformulation data, provides the potential for dosing the combination two to four times per year with a single 2 mL coformulated injection. The combination also offers the potential for improved clinical outcomes by addressing the heterogeneity of AD given preclinical data demonstrating deep Type 2 inhibition from APG777 and broad Type 1-3 inhibition from APG990.

 

“We’re pleased to report findings from our third clinical program today, APG990, which demonstrated extended PK and a favorable tolerability profile, supporting its potential as a first-in-class combination with APG777 for the treatment of AD and other inflammatory diseases that could address multiple inflammation pathways,” said Michael Henderson, M.D., Chief Executive Officer of Apogee. “The interim results as well as the supportive preclinical combination toxicology studies are an important step forward in our combination plans for the program, suggesting strong potential for compatibility with APG777 and supporting our planned APG777 and APG990 coformulated combination approach, which we have named APG279. With the potential to broadly inhibit Type 1, Type 2 and Type 3 inflammation, APG279 could offer patients a more effective treatment option, while minimizing side effects seen with other available therapies. Based on these findings, we plan to initiate a head-to-head Phase 1b trial of the combination against DUPIXENT this year.”

 

 

APG990 is a novel, subcutaneous (SQ), half-life-extended monoclonal antibody (mAb) that targets OX40L, which is positioned further upstream in the inflammatory pathway than IL-13, allowing for a broader impact on the inflammatory cascade by inhibiting Type 1, Type 2, and Type 3 pathways. Apogee’s approach of coformulating two extended half-life mAbs, APG279, holds the potential for best-in-class dosing and efficacy across AD and broader I&I diseases.

 

The APG990 Phase 1 clinical trial is a double-blind, placebo-controlled, first-in-human, single-ascending dose trial evaluating the safety, tolerability and PK of APG990 in 40 healthy adult participants. Key results include:

	·	APG990 demonstrated a potential best-in-class PK profile, including a half-life of approximately 60 days, supporting the potential for every three- and six-month maintenance dosing.

	o	PK profile supports the potential for a single 2 mL coformulated injection of APG279 (APG777 + APG990) administered every three- and six- months.

	·	APG990 was well tolerated across all five cohorts, with doses up to 1,200mg.

	o	The most common (≥10%) treatment-emergent adverse events (TEAEs) were headache.

	§	53% of participants observed at least one TEAE.

	o	There were no Grade 3 TEAEs related to study drug or severe adverse events. No adverse events led to study discontinuation.

§

There have been no cases of pyrexia or chills.

 

In addition, preclinical studies of the combination of APG777 and APG990 showed potential for enhanced pharmacologic responses relative to individual agents, and exhibited no safety findings at any dose level, including the highest dose tested of 150 mg/kg per agent in a 3-month combination toxicology study.

 

“Today’s results are highly encouraging, further validating our approach to create fully optimized antibodies with the potential to improve patients’ lives. With good tolerability at doses up to 1,200mg and a half-life of approximately 60 days, APG990 demonstrated the potential for quarterly or less frequent dosing and was supportive of it as a combination partner with APG777. Looking ahead to our planned combination approach, we continue to believe that APG990’s broad inhibition across Type 1, 2, and 3 inflammation, coupled with APG777’s deep and sustained inhibition of Type 2 inflammation, could potentially result in a safe and effective treatment option for people living with atopic dermatitis and other inflammatory diseases,” said Carl Dambkowski, M.D., Chief Medical Officer of Apogee. “We would like to extend our gratitude to the participants, investigators, and site staff whose partnership made this study a success, driving progress toward innovative I&I treatments for patients in need.”

 

 

Based on these results, the company plans on submitting an Investigational New Drug application or foreign equivalent for APG279. Following clearance, the company plans to initiate a Phase 1b clinical trial in moderate-to-severe AD of APG279 against DUPIXENT in 2025, with data expected in the second half of 2026.

 

Webcast Details

 

Apogee Therapeutics’ live webcast of the APG990 interim Phase 1 results will begin today at 8:30 a.m. ET. The live webcast can be accessed via this link or the Investors section on the Company’s website at https://investors.apogeetherapeutics.com/news-events/events. A replay of the webcast will be available following the call.

 

About APG990

 

APG990 is a novel, SQ, half-life extended mAb targeting OX40L, initially being developed for AD. OX40L is located further upstream in the inflammatory pathway than IL-13 or IL-4Rα and targeting it could potentially have broader impact on the inflammatory cascade by inhibiting Type 1, Type 2 and Type 3 pathways. AD is a heterogeneous disease and varies by age, severity and ethnicity. With current approved biologics in AD only targeting the type 2 inflammatory pathway, OX40L could represent another therapeutic option for patients, especially the portion of patients who do not benefit from currently available treatments. In our head-to-head preclinical assays, APG990 has demonstrated similar or improved potency to amlitelimab. In addition, based on our interim Phase 1 APG990 studies, we believe APG990 can be dosed every three- and six- months in maintenance, which, if our clinical trials are successful, would represent a significant improvement compared to first generation OX40L antibodies that are expected to be dosed every four to twelve weeks. The company plans to develop APG279 (APG777 and APG990), together as a potential first-in-class combination for the treatment of AD and other I&I diseases by combining deep and sustained inhibition of Type 2 inflammation via APG777’s inhibition of IL-13 with broader inhibition of Type 1-3 inflammation through APG990’s inhibition of OX40L.

 

About Apogee

 

Apogee Therapeutics is a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&I markets, including for the treatment of AD, asthma, EoE, 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 https://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; plans for and expected timing of

regulatory filings, including the Investigational New Drug application for APG279 (the APG777 and

APG990 combination); the anticipated timing of initiation of its Phase 1b clinical trial of the APG279; planned clinical trial designs; its plans for current and future clinical trials; the anticipated timing of results from its clinical trials, including data from its Phase 1b clinical trial of APG279 ; the potential clinical benefit, safety and half-life of APG777, APG990, and APG279, Apogee’s other product candidates, including combination therapies, and any other potential programs; programs; the potential dosing schedules for APG990 and APG279; and its expected timing for future pipeline updates. 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, 2024, filed with the SEC on November 12, 2024, and subsequent disclosure documents Apogee 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.

 

Investor Contact:

Noel Kurdi

VP, Investor Relations

Apogee Therapeutics, Inc.

noel.kurdi@apogeetherapeutics.com

 

Media Contact:

Dan Budwick

1AB

dan@1abmedia.com

 

 

v3.25.0.1

Cover	Mar. 03, 2025
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Mar. 03, 2025
Entity File Number	001-41740
Entity Registrant Name	Apogee Therapeutics, Inc.
Entity Central Index Key	0001974640
Entity Tax Identification Number	93-4958665
Entity Incorporation, State or Country Code	DE
Entity Address, Address Line One	221 Crescent Street
Entity Address, Address Line Two	Building 17
Entity Address, Address Line Three	Suite 102b
Entity Address, City or Town	Waltham
Entity Address, State or Province	MA
Entity Address, Postal Zip Code	02453
City Area Code	650
Local Phone Number	394-5230
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock, par value $0.00001 per share
Trading Symbol	APGE
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	false

---