UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): |
(Exact name of Registrant as Specified in Its Charter)
(State or Other Jurisdiction |
(Commission File Number) |
(IRS Employer |
||
|
|
|
|
|
|
||||
|
||||
(Address of Principal Executive Offices) |
|
(Zip Code) |
||
Registrant’s Telephone Number, Including Area Code: |
|
(Former Name or Former Address, if Changed Since Last Report)
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:
Securities registered pursuant to Section 12(b) of the Act:
|
|
Trading |
|
|
|
|
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 November 12, 2024, Apogee Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended September 30, 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, regardless of any general incorporation language in such filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits. The following exhibits are being furnished or filed herewith:
Exhibit |
|
Description |
|
|
|
99.1 |
|
|
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: |
November 12, 2024 |
By: |
/s/ Michael Henderson, M.D. |
|
|
|
Michael Henderson, M.D. |
Apogee Therapeutics Provides Pipeline Progress and Reports Third Quarter 2024 Financial Results
Continued execution across all programs, including positive results up to nine months from APG777 Phase 1 trial that continue to support potential best-in-class profile
On track to report Phase 2 Part A data for APG777 in 2H 2025, interim Phase 1 data for APG808 in 4Q 2024 and interim Phase 1 data for APG990 in 1H 2025
APG333 development candidate selected and accelerating initiation of Phase 1 in late 2024 or early 2025; potential to offer best-in-class combination efficacy across multiple respiratory indications
Plans advancing for combination studies, starting with the first clinical trial of the APG777 and APG990 combination for the treatment of AD in 2025
$754 million cash, cash equivalents and marketable securities with runway into 2028
Virtual R&D Day to be held December 2, 2024 at 10am ET
San Francisco, CA and Waltham, MA, November 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 third quarter financial results.
“We continue to execute across our portfolio and advance potentially transformative therapies for patients living with I&I diseases by positioning our pipeline to achieve potential best-in-class efficacy and dosing,” said Michael Henderson, M.D., Chief Executive Officer of Apogee. “Over the past year, we demonstrated significant progress advancing three programs – soon to be four – into the clinic and our lead program, APG777, into Phase 2 trials. Importantly, we remain in a very strong cash position providing for runway into 2028 and look forward to sharing more details and progress on our pipeline and combination strategy during our R&D Day on December 2nd.”
Pipeline Highlights and Upcoming Milestones
Corporate Highlights
Third Quarter 2024 Financial Results
About Apogee
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 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 results from its clinical trials, including data from its Phase 2 trial of APG777, Phase 1 trial of APG808 and Phase 1 trial of APG990; the anticipated timing of initiation of its clinical trials, including its Phase 1 trial of APG333 and clinical trial of the APG777 and APG990 combination; its plans for current and future clinical trials; and the potential clinical benefit and half-life of APG777, Apogee’s other product candidates, and any other potential programs, including combination therapies; 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 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 June 30, 2024, filed with the SEC on August 12, 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)
|
|
SEPTEMBER 30, |
|
|
DECEMBER 31, |
|
||
Assets |
|
|
|
|
|
|
||
Current assets: |
|
|
|
|
|
|
||
Cash and cash equivalents |
|
$ |
118,780 |
|
|
$ |
118,316 |
|
Marketable securities |
|
|
407,269 |
|
|
|
277,143 |
|
Prepaid expenses and other current assets |
|
|
8,434 |
|
|
|
2,950 |
|
Total current assets |
|
|
534,483 |
|
|
|
398,409 |
|
Long-term marketable securities |
|
|
227,746 |
|
|
|
— |
|
Property and equipment, net |
|
|
1,417 |
|
|
|
377 |
|
Right-of-use asset, net |
|
|
12,126 |
|
|
|
2,217 |
|
Other non-current assets |
|
|
514 |
|
|
|
401 |
|
Total assets |
|
$ |
776,286 |
|
|
$ |
401,404 |
|
Liabilities and stockholders' equity |
|
|
|
|
|
|
||
Current liabilities: |
|
|
|
|
|
|
||
Accounts payable |
|
$ |
2,216 |
|
|
$ |
2,143 |
|
Lease liability |
|
|
2,867 |
|
|
|
1,101 |
|
Accrued expenses |
|
|
27,528 |
|
|
|
17,314 |
|
Total current liabilities |
|
|
32,611 |
|
|
|
20,558 |
|
Long-term liabilities: |
|
|
|
|
|
|
||
Lease liability, net of current |
|
|
9,273 |
|
|
|
933 |
|
Total liabilities |
|
|
41,884 |
|
|
|
21,491 |
|
Stockholders' equity: |
|
|
|
|
|
|
||
Common Stock; $0.00001 par value, 400,000,000 authorized, 58,509,583 issued and 56,899,295 outstanding as of September 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 |
|
|
969,829 |
|
|
|
503,354 |
|
Accumulated other comprehensive income |
|
|
3,270 |
|
|
|
329 |
|
Accumulated deficit |
|
|
(238,698 |
) |
|
|
(123,770 |
) |
Total stockholders’ equity |
|
|
734,402 |
|
|
|
379,913 |
|
Total liabilities and stockholders’ equity |
|
$ |
776,286 |
|
|
$ |
401,404 |
|
APOGEE THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS
(UNAUDITED)
(In thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
|
THREE MONTHS ENDED SEPTEMBER 30, |
|
|
NINE MONTHS ENDED SEPTEMBER 30, |
|
||||||||||
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
||||
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Research and development |
|
$ |
45,714 |
|
|
$ |
17,069 |
|
|
$ |
107,636 |
|
|
$ |
39,470 |
|
General and administrative |
|
|
12,972 |
|
|
|
7,236 |
|
|
|
33,353 |
|
|
|
16,378 |
|
Total operating expenses |
|
|
58,686 |
|
|
|
24,305 |
|
|
|
140,989 |
|
|
|
55,848 |
|
Loss from operations |
|
|
(58,686 |
) |
|
|
(24,305 |
) |
|
|
(140,989 |
) |
|
|
(55,848 |
) |
Other income, net: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Interest income, net |
|
|
9,668 |
|
|
|
3,465 |
|
|
|
26,061 |
|
|
|
3,598 |
|
Total other income, net |
|
|
9,668 |
|
|
|
3,465 |
|
|
|
26,061 |
|
|
|
3,598 |
|
Net loss |
|
$ |
(49,018 |
) |
|
$ |
(20,840 |
) |
|
$ |
(114,928 |
) |
|
$ |
(52,250 |
) |
Investor Contact:
Noel Kurdi
VP, Investor Relations
Apogee Therapeutics, Inc.
Noel.Kurdi@apogeetherapeutics.com
Media Contact:
Dan Budwick
1AB Media
dan@1abmedia.com