– 4 improvement candidates in medical research with knowledge anticipated this 12 months, persevering with speedy progress of antiviral pipeline –
– Interim Part 1b proof-of-concept knowledge, together with preliminary efficacy measures, anticipated in fall 2025 for ABI-5366 and ABI-1179, long-acting helicase-primase inhibitor candidates for recurrent genital herpes –
SOUTH SAN FRANCISCO, Calif., March 20, 2025 (GLOBE NEWSWIRE) — Meeting Biosciences, Inc. ASMB, a biotechnology firm creating modern therapeutics concentrating on critical viral ailments, as we speak reported monetary outcomes for the 12 months ended December 31, 2024, and up to date highlights.
“We’re well-positioned to ship necessary medical knowledge on 4 of our novel antiviral candidates in 2025, together with proof-of-concept efficacy knowledge anticipated this fall from the Part 1b research of ABI-5366 and ABI-1179 for recurrent genital herpes,” mentioned Jason Okazaki, chief govt officer and president of Meeting Bio. “We anticipate that the speedy progress throughout our medical pipeline we noticed in 2024 will proceed this 12 months, reinforcing the distinctive execution of our R&D group and our dedication to altering the therapy paradigm for people dwelling with critical viral ailments.”
Fourth Quarter 2024 and Current Highlights
- Recurrent genital herpes
- Optimistic Part 1a interim knowledge launched for ABI-1179
- ABI-1179 was well-tolerated, with noticed half-life and publicity supporting the potential for once-weekly oral dosing at a low dose
- Optimistic Part 1a interim knowledge launched for ABI-1179
- Hepatitis delta virus (HDV)
- Initiated dosing within the Part 1a research for ABI-6250, an oral, small molecule entry inhibitor candidate for continual HDV an infection
- Hepatitis B virus (HBV)
- Optimistic Part 1b interim knowledge launched for ABI-4334, a next-generation extremely potent capsid meeting modulator candidate for continual HBV (cHBV) an infection
- ABI-4334 was well-tolerated, with an noticed half-life supporting once-daily oral dosing
- Within the preliminary 150 mg dose cohort, a imply decline in HBV DNA of two.9 log10 IU/mL was noticed in a inhabitants of predominately hepatitis B e antigen (HBeAg) unfavorable individuals
- Optimistic Part 1b interim knowledge launched for ABI-4334, a next-generation extremely potent capsid meeting modulator candidate for continual HBV (cHBV) an infection
- Transplant-associated herpesviruses
- Superior ABI-7423, an oral broad-spectrum non-nucleoside polymerase inhibitor candidate concentrating on transplant-associated herpesviruses, into IND/CTA-enabling research
- Partnership with Gilead Sciences, Inc. (Gilead)
- Acquired roughly $20.1 million fairness funding and $10 million in accelerated funding from Gilead to advance medical improvement applications
Anticipated Milestones and Occasions
- Recurrent genital herpes (ABI-5366 and ABI-1179)
- In fall 2025, interim efficacy, security and pharmacokinetic (PK) Part 1b knowledge for ABI-5366 and ABI-1179
- Meeting Bio plans to run each research concurrently and to guage weekly (and, for ABI-5366, month-to-month) oral dosing in individuals with recurrent genital herpes over a 28-day dosing interval
- HDV (ABI-6250)
- In Q3 2025, knowledge from a Part 1a research in wholesome individuals for ABI-6250
- Biomarker of ABI-6250 goal engagement will probably be assessed along with security and PK measures
- HBV (ABI-4334)
- Within the first half of 2025, efficacy, security and PK knowledge from the remaining 400 mg once-daily oral dosing cohort in a Part 1b research for ABI-4334 in individuals with cHBV an infection
ABI-1179 was contributed by Gilead below the collaboration between Meeting Bio and Gilead. ABI-5366, ABI-1179, ABI-6250, ABI-4334 and ABI-7423 are investigational product candidates that haven’t been accepted wherever globally, and their security and efficacy haven’t been established.
12 months Finish 2024 Monetary Outcomes
- Money, money equivalents and marketable securities had been $112.1 million as of December 31, 2024, in comparison with $95.0 million as of September 30, 2024, and $130.2 million as of the 12 months ended December 31, 2023. The corporate’s money place is projected to fund operations into mid-2026.
- Revenues from collaborative analysis had been $28.5 million for the 12 months ended December 31, 2024, in comparison with $7.2 million in 2023. The rise is primarily as a consequence of recognizing a full 12 months of income in 2024 below the collaboration with Gilead.
- Analysis and improvement bills had been $55.9 million for the 12 months ended December 31, 2024, in comparison with $48.9 million in 2023. The rise is attributable to having extra candidates in improvement in 2024.
- Common and administrative bills had been $18.0 million for the 12 months ended December 31, 2024, in comparison with $22.9 million in 2023. The lower is primarily as a consequence of decreases in authorized and non-cash stock-based compensation expense.
- Internet loss attributable to frequent stockholders was $40.2 million, or $6.69 per fundamental and diluted share, for the 12 months ended December 31, 2024, in comparison with $61.2 million, or $13.38 per fundamental and diluted share, in 2023.
About Meeting Biosciences
Meeting Biosciences is a biotechnology firm devoted to the event of modern small-molecule therapeutics designed to alter the trail of significant viral ailments and enhance the lives of sufferers worldwide. Led by an completed crew of leaders in virologic drug improvement, Meeting Bio is dedicated to enhancing outcomes for sufferers combating the intense, continual impacts of herpesvirus, hepatitis B virus (HBV) and hepatitis delta virus (HDV) infections. For extra data, go to assemblybio.com.
Ahead-Trying Statements
The data on this press launch accommodates forward-looking statements which can be topic to sure dangers and uncertainties that might trigger precise outcomes to materially differ. These dangers and uncertainties embrace: Meeting Bio’s skill to take care of monetary assets essential to proceed its analysis actions, medical research and different enterprise operations; Meeting Bio’s skill to comprehend the potential advantages of its collaboration with Gilead Sciences, Inc., together with all monetary elements of the collaboration and fairness investments; Meeting Bio’s skill to provoke and full medical research involving its therapeutic product candidates, together with research contemplated by Meeting Bio’s collaboration with Gilead, within the at the moment anticipated timeframes or in any respect; security and efficacy knowledge from medical or nonclinical research might not warrant additional improvement of Meeting Bio’s product candidates; medical and nonclinical knowledge introduced at conferences might not differentiate Meeting Bio’s product candidates from different corporations’ candidates; outcomes of nonclinical research is probably not consultant of illness habits in a medical setting and is probably not predictive of the outcomes of medical research; and different dangers recognized once in a while in Meeting Bio’s reviews filed with the U.S. Securities and Alternate Fee (the SEC). You’re urged to contemplate statements that embrace the phrases might, will, would, may, ought to, would possibly, believes, hopes, estimates, initiatives, potential, expects, plans, anticipates, intends, continues, forecast, designed, aim or the unfavorable of these phrases or different comparable phrases to be unsure and forward-looking. Meeting Bio intends such forward-looking statements to be coated by the protected harbor provisions contained in Part 27A of the Securities Act of 1933, as amended, and Part 21E of the Securities Alternate Act of 1934, as amended. Extra details about Meeting Bio’s dangers and uncertainties are extra absolutely detailed below the heading “Danger Components” in Meeting Bio’s filings with the SEC, together with its most up-to-date Annual Report on Kind 10-Okay, Quarterly Studies on Kind 10-Q and Present Studies on Kind 8-Okay. Besides as required by legislation, Meeting Bio assumes no obligation to replace publicly any forward-looking statements, whether or not on account of new data, future occasions or in any other case.
Contacts
Investor and Company:
Shannon Ryan
SVP, Investor Relations, Company Affairs and Alliance Administration
(415) 738-2992
[email protected]
Media:
Sam Brown Inc.
Hannah Hurdle
(805) 338-4752
[email protected]
ASSEMBLY BIOSCIENCES, INC. | ||||||||
CONSOLIDATED BALANCE SHEETS | ||||||||
(In 1000’s apart from share quantities and par worth) | ||||||||
As of December 31, | ||||||||
2024 | 2023 | |||||||
ASSETS | ||||||||
Present property | ||||||||
Money and money equivalents | $ | 38,344 | $ | 19,841 | ||||
Marketable securities | 73,735 | 110,406 | ||||||
Accounts receivable from collaboration | — | 43 | ||||||
Pay as you go bills and different present property | 3,424 | 3,497 | ||||||
Complete present property | 115,503 | 133,787 | ||||||
Property and gear, internet | 284 | 385 | ||||||
Working lease right-of-use property | 3,069 | 2,339 | ||||||
Different property | 312 | 312 | ||||||
Complete property | $ | 119,168 | $ | 136,823 | ||||
LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
Present liabilities | ||||||||
Accounts payable | $ | 585 | $ | 461 | ||||
Accrued analysis and improvement bills | 2,273 | 885 | ||||||
Different accrued bills | 6,862 | 5,744 | ||||||
Deferred income from a associated occasion – short-term | 37,622 | 30,915 | ||||||
Working lease liabilities – short-term | 461 | 1,220 | ||||||
Complete present liabilities | 47,803 | 39,225 | ||||||
Deferred income from a associated occasion – long-term | 35,378 | 55,379 | ||||||
Working lease liabilities – long-term | 2,628 | 1,122 | ||||||
Complete liabilities | 85,809 | 95,726 | ||||||
Commitments and contingencies | ||||||||
Stockholders’ fairness | ||||||||
Most popular inventory, $0.001 par worth; 5,000,000 shares approved; no shares issued or excellent | — | — | ||||||
Widespread inventory, $0.001 par worth; 150,000,000 shares approved as of December 31, 2024 and December 31, 2023; 7,457,240 and 5,482,752 shares issued and excellent as of December 31, 2024 and December 31, 2023, respectively | 7 | 5 | ||||||
Extra paid-in capital | 859,488 | 826,921 | ||||||
Collected different complete loss | (211 | ) | (81 | ) | ||||
Collected deficit | (825,925 | ) | (785,748 | ) | ||||
Complete stockholders’ fairness | 33,359 | 41,097 | ||||||
Complete liabilities and stockholders’ fairness | $ | 119,168 | $ | 136,823 | ||||
ASSEMBLY BIOSCIENCES, INC. | ||||||||
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS | ||||||||
(In 1000’s apart from share and per share quantities) | ||||||||
12 months Ended December 31, | ||||||||
2024 | 2023 | |||||||
Collaboration income ($28,520 and $4,430 from a associated occasion) | $ | 28,520 | $ | 7,163 | ||||
Working bills | ||||||||
Analysis and improvement | 55,933 | 48,900 | ||||||
Common and administrative | 18,007 | 22,909 | ||||||
Complete working bills | 73,940 | 71,809 | ||||||
Loss from operations | (45,420 | ) | (64,646 | ) | ||||
Different earnings | ||||||||
Curiosity and different earnings, internet | 5,573 | 3,451 | ||||||
Complete different earnings | 5,573 | 3,451 | ||||||
Loss earlier than earnings taxes | (39,847 | ) | (61,195 | ) | ||||
Revenue tax expense | 330 | 33 | ||||||
Internet loss | $ | (40,177 | ) | $ | (61,228 | ) | ||
Different complete loss | ||||||||
Unrealized (loss) achieve on marketable securities | (130 | ) | 722 | |||||
Complete loss | $ | (40,307 | ) | $ | (60,506 | ) | ||
Internet loss per share, fundamental and diluted | $ | (6.69 | ) | $ | (13.38 | ) | ||
Weighted common frequent shares excellent, fundamental and diluted | 6,004,560 | 4,577,371 | ||||||
Momentum17.95
Progress–
High quality–
Worth73.84
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