- Scientific trial software clearances acquired for a Part 1a/1b trial for ABI-5366 concentrating on recurrent genital herpes, and a Part 1b trial for ABI-4334 in persistent HBV an infection; each research on monitor to provoke by mid-2024
- ABI-5366 interim Part 1a first-in-human knowledge anticipated in Q3 2024 and ABI-4334 interim Part 1b knowledge anticipated by finish of 12 months
SOUTH SAN FRANCISCO, Calif., Could 08, 2024 (GLOBE NEWSWIRE) — Meeting Biosciences, Inc. ASMB, a biotechnology firm creating progressive therapeutics concentrating on severe viral ailments, at present reported monetary outcomes and up to date highlights for the primary quarter ended March 31, 2024.
“We’re happy that we now have regulatory clearance to provoke trials evaluating our promising investigational therapies ABI-5366 and ABI-4334 and stay up for sharing interim knowledge from these research later this 12 months,” stated Jason Okazaki, chief govt officer and president of Meeting Bio. “These clearances are a big step towards our aim of reaching key medical inflection factors for a number of packages in our antiviral pipeline by 12 months finish. Our continued medical progress displays the power and agility of our extremely skilled group and our singular focus of enhancing remedy choices for these residing with severe viral ailments.”
First Quarter 2024 and Latest Highlights
- Two medical trial functions acquired clearance to proceed:
- ABI-5366, a long-acting herpes simplex virus (HSV) helicase-primase inhibitor candidate, for initiation of Part 1a/1b medical research in each wholesome volunteers and in people with recurrent genital herpes
- ABI-4334, a next-generation, extremely potent capsid meeting modulator candidate, for initiation of a Part 1b research in people with persistent hepatitis B virus (HBV) an infection
- An summary highlighting preclinical knowledge for ABI-6250, an oral, small molecule HBV/hepatitis delta virus (HDV) entry inhibitor candidate, has been accepted for poster presentation on the European Affiliation for the Research of the Liver (EASL) CongressTM 2024, June 5-8, 2024
Anticipated 2024 Milestones
- ABI-5366 and ABI-4334 research anticipated to provoke by mid-2024:
- ABI-5366 Part 1a interim medical knowledge anticipated in Q3 2024 and interim Part 1b knowledge anticipated within the first half of 2025
- ABI-4334 Part 1b interim medical knowledge anticipated by the top of 2024
- Two further candidates are anticipated to enter the clinic by the top of 2024:
- ABI-1179, a long-acting HSV helicase-primase inhibitor contributed by Gilead Sciences, Inc. (Gilead) below the collaboration between Meeting Bio and Gilead
- ABI-6250, a small molecule orally-bioavailable HDV entry inhibitor
First Quarter 2024 Monetary Outcomes
- Money, money equivalents and marketable securities have been $113.0 million as of March 31, 2024, in comparison with $130.2 million as of December 31, 2023. Meeting Bio’s money place is projected to fund operations into the second half of 2025.
- Revenues from collaborative analysis have been $5.8 million for the three months ended March 31, 2024. There was no income acknowledged for a similar interval in 2023. Income for the three months ended March 31, 2024 consists of quantities acknowledged below the collaboration with Gilead.
- Analysis and growth bills have been $11.9 million for the three months ended March 31, 2024, in comparison with $14.5 million for a similar interval in 2023. Elevated bills associated to the event of ABI-1179 and ABI-6250 have been greater than offset by financial savings from the discontinuation of ABI-H3733 and vebicorvir in addition to decreased worker and contractor-related bills.
- Common and administrative bills have been $4.6 million for the three months ended March 31, 2024, in comparison with $5.0 million for a similar interval in 2023. The lower is primarily on account of a lower in non-cash stock-based compensation expense.
- Internet loss attributable to frequent stockholders was $9.1 million, or $1.66 per primary and diluted share, for the three months ended March 31, 2024, in comparison with $19.0 million, or $4.46 per primary and diluted share, for a similar interval in 2023.
The investigational merchandise and investigational product candidates referenced right here haven’t been accepted wherever globally, and their security and efficacy haven’t been established.
About Meeting Biosciences
Meeting Biosciences is a biotechnology firm devoted to the event of progressive small-molecule therapeutics designed to vary the trail of great viral ailments and enhance the lives of sufferers worldwide. Led by an completed group of leaders in virologic drug growth, Meeting Bio is dedicated to enhancing outcomes for sufferers combating the intense, persistent 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 comprises forward-looking statements which might be topic to sure dangers and uncertainties that might trigger precise outcomes to materially differ. These dangers and uncertainties embody: Meeting Bio’s skill to understand the potential advantages of its collaboration with Gilead Sciences, Inc., together with all monetary facets 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 present anticipated timeframes or in any respect; security and efficacy knowledge from medical or nonclinical research might not warrant additional growth of Meeting Bio’s product candidates; medical and nonclinical knowledge offered at conferences might not differentiate Meeting Bio’s product candidates from different firms’ candidates; outcomes of nonclinical research is probably not consultant of illness conduct in a medical setting and is probably not predictive of the outcomes of medical research; and different dangers recognized infrequently in Meeting Bio’s studies filed with the U.S. Securities and Change Fee (the SEC). You might be urged to think about statements that embody the phrases might, will, would, may, ought to, would possibly, believes, hopes, estimates, tasks, potential, expects, plans, anticipates, intends, continues, forecast, designed, aim or the adverse 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 Change Act of 1934, as amended. Extra details about Meeting Bio’s dangers and uncertainties are extra totally detailed below the heading “Threat Components” in Meeting Bio’s filings with the SEC, together with its most up-to-date Annual Report on Type 10-Ok, Quarterly Stories on Type 10-Q and Present Stories on Type 8-Ok. 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. | |||||||||
| CONDENSED CONSOLIDATED BALANCE SHEETS | |||||||||
| (In 1000’s aside from share quantities and par worth) | |||||||||
| March 31, | December 31, | ||||||||
| 2024 | 2023 | ||||||||
| (Unaudited) | |||||||||
| ASSETS | |||||||||
| Present belongings | |||||||||
| Money and money equivalents | $ | 18,749 | $ | 19,841 | |||||
| Marketable securities | 94,227 | 110,406 | |||||||
| Accounts receivable from collaboration | 43 | 43 | |||||||
| Pay as you go bills and different present belongings | 4,149 | 3,497 | |||||||
| Complete present belongings | 117,168 | 133,787 | |||||||
| Property and gear, internet | 367 | 385 | |||||||
| Working lease right-of-use belongings | 2,036 | 2,339 | |||||||
| Different belongings | 312 | 312 | |||||||
| Complete belongings | $ | 119,883 | $ | 136,823 | |||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||||||
| Present liabilities | |||||||||
| Accounts payable | $ | 727 | $ | 461 | |||||
| Accrued analysis and growth bills | 2,059 | 885 | |||||||
| Different accrued bills | 2,051 | 5,744 | |||||||
| Deferred income from a associated occasion – short-term | 32,771 | 30,915 | |||||||
| Working lease liabilities – short-term | 1,145 | 1,220 | |||||||
| Complete present liabilities | 38,753 | 39,225 | |||||||
| Deferred income from a associated occasion – long-term | 47,738 | 55,379 | |||||||
| Working lease liabilities – long-term | 791 | 1,122 | |||||||
| Complete liabilities | 87,282 | 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 March 31, 2024 and December 31, 2023; 5,482,752 shares issued and excellent as of March 31, 2024 and December 31, 2023 | 5 | 5 | |||||||
| Further paid-in capital | 827,660 | 826,921 | |||||||
| Amassed different complete loss | (239 | ) | (81 | ) | |||||
| Amassed deficit | (794,825 | ) | (785,748 | ) | |||||
| Complete stockholders’ fairness | 32,601 | 41,097 | |||||||
| Complete liabilities and stockholders’ fairness | $ | 119,883 | $ | 136,823 | |||||
| ASSEMBLY BIOSCIENCES, INC. | |||||||||
| CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS | |||||||||
| (In 1000’s aside from share and per share quantities) | |||||||||
| (Unaudited) | |||||||||
| Three Months Ended March 31, | |||||||||
| 2024 | 2023 | ||||||||
| Collaboration income from a associated occasion | $ | 5,785 | $ | — | |||||
| Working bills | |||||||||
| Analysis and growth | 11,879 | 14,547 | |||||||
| Common and administrative | 4,635 | 5,012 | |||||||
| Complete working bills | 16,514 | 19,559 | |||||||
| Loss from operations | (10,729 | ) | (19,559 | ) | |||||
| Different earnings | |||||||||
| Curiosity and different earnings, internet | 1,652 | 609 | |||||||
| Complete different earnings | 1,652 | 609 | |||||||
| Internet loss | $ | (9,077 | ) | $ | (18,950 | ) | |||
| Different complete loss | |||||||||
| Unrealized (loss) acquire on marketable securities | (158 | ) | 290 | ||||||
| Complete loss | $ | (9,235 | ) | $ | (18,660 | ) | |||
| Internet loss per share, primary and diluted | $ | (1.66 | ) | $ | (4.46 | ) | |||
| Weighted common frequent shares excellent, primary and diluted | 5,483,313 | 4,251,037 | |||||||
