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Details:
The net proceeds will be used in the clinical development of AD04 (ondansetron), which is a Serotonin 5-HT3a receptor antagonist. It is being evaluated in the clinical trial studies for patients with alcohol use disorder.
Lead Product(s): Ondansetron
Therapeutic Area: Psychiatry/Psychology Product Name: AD04
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: H.C. Wainwright & Co
Deal Size: $3.5 million Upfront Cash: Undisclosed
Deal Type: Public Offering March 01, 2024
Details:
The Company intends to use the net proceeds to support regulatory and clinical activities related to AD04 (ondansetron), a genetically targeted, serotonin-3 receptor antagonist, its lead investigational drug product for the treatment of Alcohol Use Disorder (AUD).
Lead Product(s): Ondansetron
Therapeutic Area: Psychiatry/Psychology Product Name: AD04
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: H.C. Wainwright & Co.
Deal Size: $4.0 million Upfront Cash: Undisclosed
Deal Type: Private Placement October 24, 2023
Details:
The Company intends to use the net proceeds to support regulatory and clinical activities related to AD04 (ondansetron), a genetically targeted, serotonin-3 receptor antagonist, its lead investigational drug product for the treatment of Alcohol Use Disorder (AUD).
Lead Product(s): Ondansetron
Therapeutic Area: Psychiatry/Psychology Product Name: AD04
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: H.C. Wainwright & Co.
Deal Size: $4.0 million Upfront Cash: Undisclosed
Deal Type: Private Placement October 20, 2023
Details:
The Company’s lead investigational new drug product, AD04 (ondansetron), is a genetically targeted, serotonin-3 receptor antagonist, therapeutic agent for the treatment of Alcohol Use Disorder (AUD) in heavy drinking patients.
Lead Product(s): Ondansetron
Therapeutic Area: Psychiatry/Psychology Product Name: AD04
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Adenomed
Deal Size: $83.0 million Upfront Cash: Undisclosed
Deal Type: Divestment February 01, 2023
Details:
At 30 minutes post dose, PNV-5030 reduced pain by 43% compared to the control group, while acetaminophen doses did not have a significant effect. PNV-5030 also demonstrated a 49% improvement in pain reduction over acetaminophen (APAP-25mg/kg).
Lead Product(s): PNV-5030
Therapeutic Area: Neurology Product Name: PNV-5030
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 26, 2022
Details:
In the study, PNV-6005 demonstrated statistically significant effect against both primary study endpoints, which are pre-clinical endpoints expected to indicate potential efficacy against ulcerative colitis in humans.
Lead Product(s): PNV-6005
Therapeutic Area: Gastroenterology Product Name: PNV-6005
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 06, 2022
Details:
AD04 (ondansetron) achieved statistically significant mean reduction in heavy drinking days among pre-specified group of heavy drinkers, compared to placebo, with an approximately 79% reduction from baseline drinking.
Lead Product(s): Ondansetron
Therapeutic Area: Psychiatry/Psychology Product Name: AD04
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 20, 2022
Details:
In studies of Zofran, patients were given AD04 (ondansetron) acutely at dosages up to almost 100 times dosage expected to be formulated in AD04 with the highest doses of Zofran® given intravenously which results in almost twice exposure level as oral dosing.
Lead Product(s): Ondansetron
Therapeutic Area: Psychiatry/Psychology Product Name: AD04
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 18, 2022
Details:
Phase 3 clinical study to evaluate the efficacy, safety and tolerability of AD04 (ondansetron) in patients with Alcohol Use Disorder and selected polymorphisms in the serotonin transporter and receptor genes.
Lead Product(s): Ondansetron
Therapeutic Area: Psychiatry/Psychology Product Name: AD04
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 27, 2022
Details:
Clinical trial of AD04 (Ondansetron) for treatment of AUD showed promising results in reducing frequency of drinking, quantity of drinking and heavy drinking, and no overt safety concerns (there were no statistically significant serious adverse events reported).
Lead Product(s): Ondansetron
Therapeutic Area: Psychiatry/Psychology Product Name: AD04
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 14, 2022
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