– Ongoing analysis of interim data from the Phase 2 study of ABP-450 in chronic migraine, which did not achieve its primary or secondary endpoints –
– Evaluating next-steps across the Company’s late-stage clinical pipeline for ABP-450 that targets multiple indications –
“We continue to believe in our development pipeline for ABP-450, which targets a number of indications that have well-founded scientific rationale to pursue in early- and late-stage clinical trials. Several of the late-stage clinical programs are candidates to advance into the next phase of clinical development,” commented
Recent Clinical and Corporate Highlights
- Phase 2 study of ABP-450 in episodic and chronic migraine:
- Chronic Migraine - Interim Analysis: The topline interim analysis did not achieve its primary or secondary endpoints. The Company is continuing its analysis of interim data from the study. The Phase 2 randomized, double-blind, placebo-controlled study is evaluating the efficacy and safety of ABP-450 for the prevention of chronic migraine in adults who suffer from 15 or more headache days per month and at least 8 migraine days per month. The study has enrolled a total of 492 patients across approximately 50 sites in
the United States ,Canada andAustralia . - Episodic Migraine End-of-Phase 2 Meeting with
U.S. FDA: In the first quarter of 2024, the Company held a productive end-of-Phase 2 (EOP2) meeting with theU.S. Food and Drug Administration to present the Company’s Phase 2 episodic migraine study results, which demonstrated a favorable safety profile for patients with episodic migraine and achieved key prespecified secondary endpoints, although it did not statistically separate from placebo with respect to the primary endpoint. The meeting resulted in a preliminary alignment on the design and endpoints for the proposed pivotal Phase 3 trial.
- Chronic Migraine - Interim Analysis: The topline interim analysis did not achieve its primary or secondary endpoints. The Company is continuing its analysis of interim data from the study. The Phase 2 randomized, double-blind, placebo-controlled study is evaluating the efficacy and safety of ABP-450 for the prevention of chronic migraine in adults who suffer from 15 or more headache days per month and at least 8 migraine days per month. The study has enrolled a total of 492 patients across approximately 50 sites in
- Completed
$15 Million Private Placement Agreements- In
April 2024 , the Company received the second and final installment from its definitive agreements relating to a private placement of$15 million aggregate principal amount of senior secured convertible notes (the “Notes”) with its strategic partner, Daewoong Pharmaceutical Co., LTD (“Daewoong”). Proceeds from the private placement are being used for general working capital purposes. - In connection with the receipt of the final installment of the Notes,
Seongsoo (Shawn) Park was appointed to the Company’s Board of Directors as Daewoong’s representative.
- In
About AEON Biopharma
AEON is a clinical stage biopharmaceutical company focused on developing its proprietary botulinum toxin complex, ABP-450 (prabotulinumtoxinA) injection, or ABP-450, for debilitating medical conditions, with an initial focus on the neurosciences market. ABP-450 is the same botulinum toxin complex that is currently approved and marketed for cosmetic indications by Evolus under the name Jeuveau. ABP-450 is manufactured by Daewoong in compliance with current Good Manufacturing Practice, or cGMP, in a facility that has been approved by the
Forward-Looking Statements
Certain statements in this press release may be considered forward-looking statements. Forward-looking statements generally relate to future events or AEON’s future financial or operating performance. For example, statements regarding the closing of each installment of the Private Placement, AEON’s expected capital resources and liquidity needs and the anticipated timing of AEON’s clinical results are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as "plan", "possible", "forecast", "expect", "intend", "will", "estimate", "anticipate", "believe", "predict", "potential" or "continue", or the negatives of these terms or variations of them or similar terminology. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements.
These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by AEON and its management, are inherently uncertain. Factors that may cause actual results to differ materially from current expectations include, but are not limited to: (i) the outcome of any legal proceedings that may be instituted against AEON or others; (ii) AEON’s future capital requirements, including with respect to potential obligations pursuant to the forward purchase agreements; (iii) AEON’s ability to raise financing in the future; (iv) AEON’s ability to continue to meet continued stock exchange listing standards; (v) the possibility that AEON may be adversely affected by other economic, business, regulatory, and/or competitive factors; and (vi) other risks and uncertainties set forth in the section entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in the Company’s filings with the
Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. AEON does not undertake any duty to update these forward-looking statements.
Contacts
Investor Contact:
+1 212 915 2577
cdavis@lifesciadvisors.com
Source: AEON Biopharma
AEON BIOPHARMA, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands, except share data and par value amounts) | |||||||
Successor | Successor | ||||||
2024 | 2023 | ||||||
(Unaudited) | |||||||
ASSETS | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 1,558 | $ | 5,158 | |||
Prepaid expenses and other current assets | 940 | 1,064 | |||||
Total current assets | 2,498 | 6,222 | |||||
Property and equipment, net | 307 | 332 | |||||
Operating lease right-of-use asset | 198 | 262 | |||||
Other assets | 29 | 29 | |||||
Total assets | $ | 3,032 | $ | 6,845 | |||
LIABILITIES AND STOCKHOLDERS' DEFICIT | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 6,523 | $ | 3,388 | |||
Accrued clinical trials expenses | 984 | 5,128 | |||||
Accrued compensation | 1,338 | 943 | |||||
Forward purchase agreements liquidated damages | 3,000 | — | |||||
Other accrued expenses | 4,112 | 3,590 | |||||
Total current liabilities | 15,957 | 13,049 | |||||
Convertible notes at fair value, including related party amount of | 5,087 | — | |||||
Warrant liability | 12,000 | 1,447 | |||||
Contingent consideration liability | 168,119 | 104,350 | |||||
Embedded forward purchase agreements and derivative liabilities | 250 | 41,043 | |||||
Total liabilities | 201,413 | 159,889 | |||||
Commitments and contingencies | |||||||
Stockholders’ Deficit: | |||||||
Class A common stock, | 4 | 4 | |||||
Additional paid-in capital | 393,235 | 381,264 | |||||
Subscription receivables | — | (60,710 | ) | ||||
Accumulated deficit | (591,620 | ) | (473,602 | ) | |||
Total stockholders' deficit | (198,381 | ) | (153,044 | ) | |||
Total liabilities and stockholders' deficit | $ | 3,032 | $ | 6,845 |
AEON BIOPHARMA, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (in thousands, except share and per share data) | ||||||||
Three Months Ended | ||||||||
2024 | 2023 | |||||||
Successor | Predecessor | |||||||
Operating expenses: | ||||||||
Selling, general and administrative | $ | 4,649 | $ | 3,841 | ||||
Research and development | 5,732 | 9,205 | ||||||
Change in fair value of contingent consideration | 63,769 | — | ||||||
Total operating costs and expenses | 74,150 | 13,046 | ||||||
Loss from operations | (74,150 | ) | (13,046 | ) | ||||
Other (loss) income: | ||||||||
Change in fair value of convertible notes | (87 | ) | (4,657 | ) | ||||
Change in fair value of warrants | (20,903 | ) | — | |||||
Loss on embedded forward purchase agreements and derivative liabilities, net | (22,917 | ) | — | |||||
Other income, net | 39 | 64 | ||||||
Total other loss, net | (43,868 | ) | (4,593 | ) | ||||
Loss before taxes | (118,018 | ) | (17,639 | ) | ||||
Income taxes | — | — | ||||||
Net loss and comprehensive loss | $ | (118,018 | ) | $ | (17,639 | ) | ||
Basic and diluted net loss per share | $ | (3.17 | ) | $ | (0.13 | ) | ||
Weighted average shares of common stock outstanding used to compute basic and diluted net loss per share | 37,268,074 | 138,825,356 |
The accompanying condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in
On
Unless the context otherwise requires, the “Company,” for periods prior to the close of the Merger, refers to Old AEON, currently
Source: AEON Biopharma
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