Topline 24-week knowledge from Part 1b trial in topics with non-alcoholic fatty liver illness (NAFLD) anticipated mid-December 2022
Interim 24-week readout from MOMENTUM Part 2 weight problems trial anticipated Q1 2023
GAITHERSBURG, Md., Nov. 10, 2022 (GLOBE NEWSWIRE) — Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical firm, immediately introduced monetary outcomes for the three and 9 months ended September 30, 2022, and offered a enterprise replace.
“We proceed heading in the right direction in our development of pemvidutide for 2 essential medical indications, weight problems and non-alcoholic steatohepatitis (NASH), and sit up for knowledge readouts from our NAFLD trial extension in mid-December 2022 and from our interim 24-week readout on roughly 160 topics from our MOMENTUM Part 2 weight problems trial in Q1 2023,” stated Vipin Okay. Garg, Ph.D., President and Chief Government Officer of Altimmune.
“We imagine that the promising reductions in liver fats content material and alanine aminotransferase (ALT) ranges noticed in our just lately accomplished 12-week Part 1b NAFLD trial ought to translate into success on the approvable NASH endpoints, together with NASH decision and fibrosis enchancment, in late-phase biopsy trials. The magnitude of the consequences on the liver mixed with significant reductions in physique weight might symbolize essential factors of differentiation from different medication in growth for NASH.”
Dr. Garg added, “Turning to our MOMENTUM weight problems trial, we imagine that the extent of weight reduction we anticipate to see at 48 weeks will likely be just like the main medication within the class. The trial is being performed in a typical weight problems inhabitants at established weight problems trial websites and employs life-style interventions which are customary in weight problems trials. We imagine the absence of dose titration, along with the favorable tolerability profile, reductions in serum lipids and reductions in liver fats content material noticed in medical trials thus far, might translate into larger ease of administration, improved adherence to remedy and larger potential for cardiovascular profit on this affected person inhabitants.”
Current Highlights and Anticipated Milestones:
Pemvidutide
HepTcell™
Monetary Outcomes for the Three Months Ended September 30, 2022
-
Altimmune had money, money equivalents and short-term investments totaling $201.9 million at September 30, 2022.
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Income was minimal for the three months ended September 30, 2022 in comparison with $0.2 million in the identical interval in 2021. The change in income quarter over quarter was primarily because of the discontinuation of growth actions for the T-COVID and NasoShield applications in 2021.
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Analysis and growth bills had been $20.3 million for the three months ended September 30, 2022, in comparison with $29.2 million in the identical interval in 2021. The bills for the quarter ended September 30, 2022 included $14.0 million in direct prices associated to growth actions for pemvidutide and $1.8 million in direct prices associated to growth actions for HepTcell.
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Common and administrative bills had been $4.5 million for the three months ended September 30, 2022, in comparison with $4.2 million in the identical interval in 2021. The change was primarily attributable to elevated inventory compensation expense.
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Web loss for the three months ended September 30, 2022 was $23.5 million, or $0.48 internet loss per share, in comparison with a internet lack of $33.5 million, or $0.81 internet loss per share, in the identical interval in 2021.
Convention Name Info:
Date: |
Thursday, November 10, 2022 |
Time: |
8:30 am Jap Time |
Webcast: |
The convention name will likely be webcast stay on Altimmune’s Investor Relations web site at https://ir.altimmune.com/traders. |
Dial-in: |
Members who wish to be a part of the decision might register right here to obtain the dial-in numbers and distinctive PIN to entry the decision. |
Following the conclusion of the decision, the webcast will likely be out there for replay on the Investor Relations web page of the Firm’s web site at www.altimmune.com. The Firm has used, and intends to proceed to make use of, the IR portion of its web site as a way of revealing materials private info and for complying with disclosure obligations below Regulation FD.
About Pemvidutide
Pemvidutide is a novel, investigational, peptide-based GLP-1/glucagon twin receptor agonist in growth for the remedy of weight problems and NASH. Activation of the GLP-1 and glucagon receptors is believed to imitate the complementary results of food regimen and train on weight reduction, with GLP-1 suppressing urge for food and glucagon rising vitality expenditure. Pemvidutide incorporates the EuPortTM area, a proprietary expertise that will increase its serum half-life for weekly dosing whereas slowing the entry of pemvidutide into the bloodstream, which can enhance its tolerability. In a 12-week Part 1b medical trial, NAFLD topics handled with pemvidutide demonstrated promising reductions in liver fats content material, serum ALT ranges and physique weight.
About HepTcell
HepTcell is a novel, investigational, immunotherapeutic comprised of 9 artificial peptides representing conserved hepatitis B (HBV) sequences formulated with IC31®, a TLR9-based adjuvant from Valneva SE. The HBV-directed peptides are designed to drive T cell responses in opposition to all HBV genotypes in direction of a practical remedy for continual HBV in sufferers of various genetic backgrounds.
About Altimmune
Altimmune is a clinical-stage biopharmaceutical firm targeted on the event of novel peptide-based therapeutics for the remedy of weight problems and liver illnesses. The corporate’s lead product candidate, pemvidutide, is a GLP-1/glucagon twin receptor agonist that’s being developed for the remedy of weight problems and NASH. As well as, Altimmune is growing HepTcell™, an immunotherapeutic designed to attain a practical remedy for continual hepatitis B. For extra info, please go to www.altimmune.com.
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Ahead-Trying Assertion
Any statements made on this press launch regarding future monetary or enterprise efficiency, situations, plans, prospects, tendencies, or methods and different monetary and enterprise issues, together with with out limitation, the timing of key milestones for our medical property, the timing of the info readout of the NAFLD trial, diabetic topic trial, drug-drug interplay trial and the Part 2 weight problems medical trial of pemvidutide, the timing of the info readouts for the Part 2 medical trial of HepTcell, and the prospects for regulatory approval, use, commercializing or promoting any product or drug candidates, are forward-looking statements inside the that means of the Non-public Securities Litigation Reform Act of 1995. As well as, when or if used on this press launch, the phrases “might,” “might,” “ought to,” “anticipate,” “imagine,” “estimate,” “anticipate,” “intend,” “plan,” “predict” and comparable expressions and their variants, as they relate to Altimmune, Inc. (the “Firm”) might determine forward-looking statements. The Firm cautions that these forward-looking statements are topic to quite a few assumptions, dangers, and uncertainties, which change over time. Essential elements which will trigger precise outcomes to vary materially from the outcomes mentioned within the ahead wanting statements or historic expertise embody dangers and uncertainties, together with dangers regarding: potential impacts from the continuing battle in Ukraine and COVID-19, reminiscent of delays in regulatory overview, manufacturing and provide chain interruptions, entry to medical websites, enrollment, antagonistic results on healthcare techniques and disruption of the worldwide economic system; the reliability of the outcomes of research regarding human security and attainable antagonistic results ensuing from the administration of the Firm’s product candidates; the Firm’s means to fabricate medical trial supplies on the timelines anticipated; and the success of future product developments, together with the success of future medical trials. Additional info on the elements and dangers that would have an effect on the Firm’s enterprise, monetary situations and outcomes of operations are contained within the Firm’s filings with the U.S. Securities and Change Fee, together with below the heading “Threat Elements” within the Firm’s annual report on Kind 10-Okay for the fiscal 12 months ended December 31, 2021 and our different filings with the SEC, which can be found at www.sec.gov.
Investor & Media Contacts:
Wealthy Eisenstadt
Chief Monetary Officer
Cellphone: 240-654-1450
[email protected]
ALTIMMUNE, INC.
CONSOLIDATED BALANCE SHEETS
(In hundreds, besides share and per share knowledge)
|
September 30, |
|
December 31, |
||||
|
|
2022 |
|
|
|
2021 |
|
|
(Unaudited) |
|
|
|
|||
ASSETS |
|
|
|
|
|
||
Present property: |
|
|
|
|
|
||
Money and money equivalents |
$ |
127,465 |
|
|
$ |
190,301 |
|
Restricted money |
|
34 |
|
|
|
34 |
|
Whole money, money equivalents and restricted money |
|
127,499 |
|
|
|
190,335 |
|
Quick-term investments |
|
74,362 |
|
|
|
— |
|
Accounts receivable |
|
633 |
|
|
|
429 |
|
Earnings tax and R&D incentive receivables |
|
3,720 |
|
|
|
5,410 |
|
Pay as you go bills and different present property |
|
4,790 |
|
|
|
7,952 |
|
Whole present property |
|
211,004 |
|
|
|
204,126 |
|
Property and gear, internet |
|
1,172 |
|
|
|
1,448 |
|
Intangible property, internet |
|
12,419 |
|
|
|
12,419 |
|
Different property |
|
682 |
|
|
|
872 |
|
Whole property |
$ |
225,277 |
|
|
$ |
218,865 |
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
|
|
||
Present liabilities: |
|
|
|
|
|
||
Accounts payable |
$ |
1,419 |
|
|
$ |
2,034 |
|
Contingent consideration |
|
— |
|
|
|
6,090 |
|
Accrued bills and different present liabilities |
|
14,323 |
|
|
|
10,152 |
|
Whole present liabilities |
|
15,742 |
|
|
|
18,276 |
|
Different long-term liabilities |
|
4,506 |
|
|
|
1,454 |
|
Whole liabilities |
|
20,248 |
|
|
|
19,730 |
|
Commitments and contingencies (Notice 14) |
|
|
|
|
|
||
Stockholders’ fairness: |
|
|
|
|
|
||
Frequent inventory, $0.0001 par worth; 200,000,000 shares licensed; 49,161,637 and 40,993,768 shares issued and excellent as of September 30, 2022 and December 31, 2021, respectively |
|
5 |
|
|
|
4 |
|
Extra paid-in capital |
|
566,551 |
|
|
|
497,342 |
|
Accrued deficit |
|
(356,224 |
) |
|
|
(293,171 |
) |
Accrued different complete loss, internet |
|
(5,303 |
) |
|
|
(5,040 |
) |
Whole stockholders’ fairness |
|
205,029 |
|
|
|
199,135 |
|
Whole liabilities and stockholders’ fairness |
$ |
225,277 |
|
|
$ |
218,865 |
|
ALTIMMUNE, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(Unaudited)
(In hundreds, besides share and per share knowledge)
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
Three Months Ended |
|
9 Months Ended |
||||||||||||
|
September 30, |
|
September 30, |
||||||||||||
|
|
2022 |
|
|
|
2021 |
|
|
|
2022 |
|
|
|
2021 |
|
Revenues |
$ |
2 |
|
|
$ |
158 |
|
|
$ |
42 |
|
|
$ |
1,133 |
|
Working bills: |
|
|
|
|
|
|
|
|
|
|
|
||||
Analysis and growth |
|
20,262 |
|
|
|
29,206 |
|
|
|
51,359 |
|
|
|
54,356 |
|
Common and administrative |
|
4,492 |
|
|
|
4,156 |
|
|
|
13,329 |
|
|
|
11,636 |
|
Impairment loss on construction-in-progress |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
8,070 |
|
Whole working bills |
|
24,754 |
|
|
|
33,362 |
|
|
|
64,688 |
|
|
|
74,062 |
|
Loss from operations |
|
(24,752 |
) |
|
|
(33,204 |
) |
|
|
(64,646 |
) |
|
|
(72,929 |
) |
Different revenue (expense): |
|
|
|
|
|
|
|
|
|
|
|
||||
Curiosity expense |
|
(64 |
) |
|
|
(33 |
) |
|
|
(191 |
) |
|
|
(67 |
) |
Curiosity revenue |
|
1,053 |
|
|
|
13 |
|
|
|
1,402 |
|
|
|
88 |
|
Different revenue (expense), internet |
|
50 |
|
|
|
(286 |
) |
|
|
185 |
|
|
|
(293 |
) |
Whole different revenue (expense), internet |
|
1,039 |
|
|
|
(306 |
) |
|
|
1,396 |
|
|
|
(272 |
) |
Web loss earlier than revenue taxes |
|
(23,713 |
) |
|
|
(33,510 |
) |
|
|
(63,250 |
) |
|
|
(73,201 |
) |
Earnings tax profit |
|
197 |
|
|
|
— |
|
|
|
197 |
|
|
|
— |
|
Web loss |
|
(23,516 |
) |
|
|
(33,510 |
) |
|
|
(63,053 |
) |
|
|
(73,201 |
) |
Different complete revenue — unrealized (loss) acquire on short-term investments |
|
(143 |
) |
|
|
(2 |
) |
|
|
(263 |
) |
|
|
4 |
|
Complete loss |
$ |
(23,659 |
) |
|
$ |
(33,512 |
) |
|
$ |
(63,316 |
) |
|
$ |
(73,197 |
) |
Web loss per share, primary and diluted |
$ |
(0.48 |
) |
|
$ |
(0.81 |
) |
|
$ |
(1.37 |
) |
|
$ |
(1.79 |
) |
Weighted-average widespread shares excellent, primary and diluted |
|
49,286,535 |
|
|
|
41,370,768 |
|
|
|
45,881,547 |
|
|
|
40,843,905 |
|
