Apogee Therapeutics Provides Pipeline Progress and Reports Fourth Quarter and Full Year 2023 Financial Results
- Positive interim results from APG777 Phase 1 trial with a 75-day half-life
- Potential for improved clinical responses in atopic dermatitis
- Ahead of schedule Phase 2 trial planned for 2024
- Initiation of Phase 1 trial for APG808
- Total cash of $395.5 million at year end 2023
- Expected cash runway into 4Q 2026
- None.
Insights
The interim results from APG777's Phase 1 clinical trial depict a promising pharmacokinetic profile with an extended half-life of roughly 75 days, which is significant for the treatment of atopic dermatitis (AD). This extended half-life could reduce the frequency of dosing required, potentially improving patient compliance and quality of life. The potential for higher drug exposures during induction could lead to enhanced clinical responses, thereby possibly establishing APG777 as a best-in-class therapy. The initiation of a Phase 2 trial ahead of schedule reflects confidence in the compound's profile and could accelerate the timeline for regulatory approval and market entry.
It's important to note that the therapeutic landscape for AD is competitive, with several biologics targeting similar pathways. The comparison of APG777's expected exposure rates to lebrikizumab, another anti-IL-13 biologic, suggests that Apogee Therapeutics is positioning its candidate as a superior option. The implications for stakeholders include potential market share gains if APG777 demonstrates efficacy and safety in the upcoming trials. However, the long-term success will depend on the outcomes of the Phase 2 trial and subsequent studies, as well as the drug's reception in the market among existing therapies.
Apogee Therapeutics' financial results indicate a substantial increase in cash reserves from $151.9 million in 2022 to $395.5 million at the end of 2023, likely bolstered by a successful IPO. This positions the company well to fund its operations into the fourth quarter of 2026, providing a robust runway to advance its clinical programs without immediate need for additional capital. The increased R&D expenses, up to $68.4 million from $27.8 million the previous period, reflect the company's investment in advancing APG777 and APG808, as well as the development of its pipeline. While such increases are expected for a growing biotech firm, investors should monitor the balance between spending and the progression of clinical trials to assess the efficient allocation of capital.
General and administrative expenses have also risen, which is typical for a company transitioning from private to public status and expanding operations. The net loss has widened as a result of these increased expenses, which is not uncommon for clinical-stage biotech companies focused on R&D. Stakeholders should consider the potential future value of Apogee's pipeline against the current burn rate, keeping in mind that successful clinical outcomes could lead to strategic partnerships, licensing deals, or even buyout opportunities, which could significantly affect the company's valuation and stock performance.
Apogee Therapeutics' advancement of APG777 and APG808 signifies a strategic focus on inflammatory and immunology indications, a market with a high unmet medical need and significant commercial potential. The move to initiate a Phase 2 trial for APG777 in AD ahead of schedule could give Apogee a competitive edge, especially with an induction and maintenance dosing profile that could be more appealing to patients and healthcare providers. The potential expansion into asthma and COPD with APG808 reflects a broader strategy to target multiple Type 2 allergic diseases, leveraging IL-4Rα inhibition – a clinically validated target.
The early-stage programs targeting OX40L suggest Apogee is looking to diversify its approach and target different aspects of the inflammatory cascade, potentially providing solutions for patients who are non-responders to current treatments. The strategic focus on these areas, combined with a strong cash position, positions Apogee to potentially capture significant market share in the I&I segment. However, the company's success will hinge on clinical trial outcomes and the ability to navigate a competitive market landscape with several established players.
Positive interim results from APG777 Phase 1 healthy volunteer clinical trial exceeded objectives with approximately 75-day half-life which supports the potential for higher exposures leading to potential for improved clinical responses in induction than currently available biologic therapies and the potential for maintenance dosing of every 3- or 6-months
APG777 Phase 1 interim data support advancement of a randomized, placebo-controlled Phase 2 clinical trial in patients with moderate-to-severe atopic dermatitis in 1H 2024 ahead of schedule
Phase 1 healthy volunteer clinical trial set to start ahead of schedule for APG808, a subcutaneous extended half-life antibody targeting IL-4Rα, following receipt of regulatory clearance in February
Total cash of
SAN FRANCISCO and WALTHAM, Mass., March 05, 2024 (GLOBE NEWSWIRE) -- 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 fourth quarter and full year 2023 financial results.
“2023 was a momentous year for Apogee with the completion of a successful IPO, initiation of our first clinical program of APG777 in healthy volunteers and the nomination of our second pipeline candidate, APG808,” said Michael Henderson, M.D., Chief Executive Officer of Apogee. “Our momentum and track record of execution have continued in 2024, and we were thrilled to disclose positive interim results from our Phase 1 trial of APG777 today, which demonstrated a favorable safety profile and exceeded our trial objectives on both pharmacokinetics and pharmacodynamics. This data readout is a key risk-reducing milestone for our APG777 program and pipeline and supports a path forward into a Phase 2 trial for APG777 in patients with AD in the first half of this year. Looking ahead to the rest of the year, we continue to make progress with APG808, for which we are set to start a Phase 1 healthy volunteer clinical trial ahead of schedule while advancing our earlier programs, APG990 and APG222. With each of our programs, we have the potential to reshape the standard of care with potential best-in-class or first-in-class therapeutic candidates for I&I diseases.”
Pipeline Highlights and Upcoming Milestones
- Positive, interim Phase 1 results for APG777 exceeded trial objectives and delivered ahead of schedule: APG777 is a novel, subcutaneous (SQ) extended half-life monoclonal antibody targeting IL-13 – a critical cytokine in inflammation and a primary driver of AD. Today, the company reported positive interim results in the Phase 1 first-in-human study of APG777, designed to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single-ascending and multiple-ascending doses of APG777 in healthy volunteers. Key findings from the study include:
- Potentially best-in-class PK profile, including a half-life of approximately 75 days, supporting:
- Testing higher exposures of drug in induction to potentially achieve improved clinical responses
- Testing of maintenance dosing of every 3- or 6-months, representing 2-4 injections per year compared to the current treatment paradigm of 13-26 injections per year
- Single doses of APG777 showed deep and sustained effect on key AD biomarkers pSTAT6 and TARC for approximately 3 months (longest follow-up available with inhibition still ongoing at the time of the data cut
- APG777 was well tolerated across all dose groups with a favorable safety profile consistent with the anti-IL-13 class
- Based on these data, Apogee plans to initiate a randomized, placebo-controlled Phase 2 clinical trial in patients with moderate-to-severe AD in the first half of 2024; modeled induction and maintenance dosing for the Phase 2 trial suggests APG777 could reach exposures approximately 30
-40% greater than lebrikizumab in induction and potentially enable every 3- or 6- month maintenance dosing - 16-week proof-of-concept data from this Phase 2 trial is expected in second half of 2025
- Apogee also plans to evaluate APG777 in expansion indications including initiating a Phase 2 trial in asthma in 2025
- Potentially best-in-class PK profile, including a half-life of approximately 75 days, supporting:
- Phase 1 APG808 healthy volunteer clinical trial set to start ahead of schedule: Apogee’s second program, APG808, is novel, SQ extended half-life mAb targeting IL-4Rα, a target with clinical validation across eight Type 2 allergic diseases. APG808 has similar binding and femtomolar affinity for IL-4Rα as compared to a first generation mAb, DUPIXENT, and has demonstrated similar inhibition to DUPIXENT across three in vitro assays which measure downstream functional inhibition of the IL-13/IL-4 pathway (pSTAT6 induction, inhibition of TF-1 proliferation, and inhibition of TARC secretion). An APG808 Phase 1 healthy volunteer clinical trial is expected to start ahead of schedule following receipt of regulatory clearance in February and will be followed by a potential Phase 1b trial in asthma and a Phase 2 trial in COPD (pending data from the Phase 1 trial). Key milestones in 2024 and 2025 include:
- Interim Phase 1 PK and safety in healthy volunteers expected in 2H 2024, ahead of prior guidance
- Initial proof-of-concept data in asthma expected 1H 2025
- Proof-of-concept clinical trial in patients with COPD expected to initiate in 2025, pending positive data from Phase 1 trial and regulatory clearance
- Early-stage programs progressing to candidate selection: Apogee’s earlier-stage programs, APG990 and APG222, utilize advanced antibody engineering to target OX40L and both IL-13 and OX40L, respectively, and are initially being developed for the treatment of 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. With current approved biologics only targeting two mechanisms of action (IL-13 and IL4Rα) in AD, OX40L could represent another therapeutic option for patients, especially the portion of patients who do not benefit from currently available treatments.
- Candidate nomination for APG990 anticipated in 2024 and Phase 1 initiation in healthy volunteers in 2025
- Apogee plans to provide more detailed updates on its earlier pipeline programs and combination strategy in an R&D Day in Q4 2024 to support its vision of future I&I therapeutics
Fourth Quarter and Full Year 2023 Financial Results
Cash Position: Cash, cash equivalents and marketable securities were
R&D Expenses: Research and development (R&D) expenses were
G&A Expenses: General and administrative (G&A) expenses were
Net Loss: Net loss was
About Apogee
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 and COPD, 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: the efficacy, safety, tolerability, PK and PD profile of APG777, the potential dosing regimen of APG777, the potential superiority of APG777 compared to current therapies, Apogee’s expectations regarding plans for Apogee’s current and future product candidates and programs, Apogee’s plans for Apogee’s current and future clinical trials, including a Phase 2 trial for APG777, 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, the potential clinical benefit and half-life of APG777, APG808, APG990, APG222 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 Quarterly Report on 10-Q for the quarterly period ended September 30, 2023, filed with the SEC on November 13, 2023, 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. | |||||||
| CONSOLIDATED BALANCE SHEETS | |||||||
| (In thousands, except unit/share data) | |||||||
| DECEMBER 31, | DECEMBER 31, | ||||||
| 2023 | 2022 | ||||||
| Assets | |||||||
| Current assets: | |||||||
| Cash and cash equivalents | $ | 118,316 | $ | 151,890 | |||
| Marketable securities | 277,143 | — | |||||
| Prepaid expenses and other current assets | 2,950 | 165 | |||||
| Total current assets | 398,409 | 152,055 | |||||
| Property and equipment, net | 377 | — | |||||
| Right-of-use asset, net | 2,217 | — | |||||
| Other non-current assets | 401 | — | |||||
| Total assets | $ | 401,404 | $ | 152,055 | |||
| Liabilities, preferred units and stockholders' equity/members’ deficit | |||||||
| Current liabilities: | |||||||
| Accounts payable | $ | 2,143 | $ | 418 | |||
| Lease liability | 1,101 | — | |||||
| Accrued expenses | 17,314 | 9,562 | |||||
| Total current liabilities | 20,558 | 9,980 | |||||
| Long-term liabilities: | |||||||
| Lease liability, net of current | 933 | — | |||||
| Total liabilities | 21,491 | 9,980 | |||||
| Commitments and contingencies (Note 9) | |||||||
| Series A Preferred Units; no units authorized, issued and outstanding at December 31, 2023; 20,000,000 units authorized, issued and outstanding as of December 31, 2022 | — | 28,971 | |||||
| Series B Preferred Units; no units authorized, issued and outstanding at December 31, 2023; 45,089,212 units authorized, issued and outstanding as of December 31, 2022 | — | 148,496 | |||||
| Stockholders’ equity/members’ deficit: | |||||||
| Common Units; no units authorized, issued and outstanding at December 31, 2023; 5,000,000 units authorized, issued and outstanding as of December 31, 2022 | — | 2,251 | |||||
| Incentive Units; no units authorized, issued and outstanding at December 31, 2023; 12,412,473 units authorized, 9,648,374 issued and 1,625,086 outstanding as of December 31, 2022 | — | 2,142 | |||||
| Preferred Stock; 10,000,000 authorized, | — | — | |||||
| Common Stock; 400,000,000 authorized, | — | — | |||||
| Additional paid-in capital | 503,354 | — | |||||
| Accumulated other comprehensive income | 329 | — | |||||
| Accumulated deficit | (123,770 | ) | (39,785 | ) | |||
| Total stockholders’ equity/members’ deficit | 379,913 | (35,392 | ) | ||||
| Total liabilities, preferred units and stockholders’ equity/members’ deficit | $ | 401,404 | $ | 152,055 | |||
| APOGEE THERAPEUTICS, INC. | |||||||
| CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||
| (In thousands) | |||||||
| PERIOD FROM | |||||||
| YEAR ENDED | FEBRUARY 4, 2022 | ||||||
| DECEMBER 31, | (INCEPTION) TO | ||||||
| 2023 | DECEMBER 31, 2022 | ||||||
| Operating expenses: | |||||||
| Research and development | $ | 68,424 | $ | 27,786 | |||
| General and administrative | 24,579 | 2,941 | |||||
| Total operating expenses | 93,003 | 30,727 | |||||
| Loss from operations | (93,003 | ) | (30,727 | ) | |||
| Other income (expense), net: | |||||||
| Interest income, net | 9,018 | 92 | |||||
| Other financing expense, net: | — | (9,150 | ) | ||||
| Total other income (expense), net | 9,018 | (9,058 | ) | ||||
| Net loss | $ | (83,985 | ) | $ | (39,785 | ) | |
Investor Contact:
Noel Kurdi
VP, Investor Relations
Apogee Therapeutics
Noel.kurdi@apogeetherapeutics.com
Media Contact:
Dan Budwick
1AB
dan@1abmedia.com
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