• AdAlta says Phase 1 extension trial of AD-214 in IPF on track for final readout in Q1 2024
  • Biotech has active partner pipeline to enable progression of AD-214 into Phase 2 trial
  • $1.65m capital raising backed by supportive institutional and large shareholder base fully approved at EGM


Special Report: 1AD’s Phase 1 extension trial of its lead asset AD-214 in Idiopathic Pulmonary Fibrosis (IPF) remains on track for final readout in Q1 2024 with half of participants receiving their final dose.

And in a case of no new is good news for clinical-stage biopharmaceutical development company AdAlta (ASX:1AD), there has been no new findings in the Phase 1 extension study of multiple 10mg/kg doses of AD-214, which continues to meet its milestones.

Speaking at 1AD’s extraordinary general meeting (EGM) following a recent capital raise, chairman Paul MacLeman says in 2023 heading into 2024 1AD has been focused on realising the value of AD-214 in fibrotic disease.

MacLeman says the company is working to secure partners to provide the necessary non-dilutive capital to advance AD-214 to Phase 2 clinical studies in patients with IPF, a debilitating and fatal respiratory disease with currently no good treatment options.

He says success on this front enables 1AD to progress its i-CAR and i-PET immuno-oncology programs and investing in its trademarked i-body platform and pipeline.


‘Go where traditional antibody and small molecule drugs cannot’

1AD’s proprietary i-body® platform is being used to discover and develop next generation protein therapeutics.

An i-body is a unique human protein combining advantages of tiny antibody-like molecules to go places that traditional antibodies can’t and solve therapeutic challenges which have so far defeated antibody therapies.

“AdAlta’s purpose is to go where traditional antibody and small molecule drugs cannot, using our i-body technology to target next generation protein and cell therapeutic products,” MacLeman says.

1AD’s internal pipeline has a particular focus on a very important class of drug targets known as G protein-coupled receptors (GPCRs) that are targeted by around one-third of all approved drugs.

With only two approved antibody drugs in this class, GPCR mediated diseases are clearly hard for antibodies to address a sweet spot for the 1AD i-bodies.

Today, 1AD’s GPCR targeted pipeline focusses on fibrotic and inflammatory disease and cancer.

AD-214 was the first drug 1AD developed using the i-body platform, starting back in 2015 and since then it has invested around $45 million in developing that product to the end of Phase 1.


Partners to progress to Phase 2 trials  

MacLeman says 1AD is actively working with potential partners, strategic or financial, to support and fund a capital-efficient Phase 2 clinical program assessing the efficacy and safety of AD-214 in patients with IPF.

“We continue to maintain and curate a robust pipeline of potential licensing partners who are eagerly anticipating the results of the Phase I extension study,” he says.

“We will provide in person updates to these partners in San Francisco in early January at the Biotech Showcase attached to the JP Morgan Healthcare Conference.

“We are also actively marketing an opportunity to invest in the AD-214 asset to a select group of qualified North Asia and North American strategic and financial investors.

“In support of this initiative, a global clinical research organization or CRO has indicated a willingness to invest a material portion of their fees in the clinical study should they be selected as the study CRO.”


Oversubscribed placement raises $1.65m

In November 1AD announced it had accepted commitments from sophisticated and professional investors to raise $1.65 million in an oversubscribed placement offer.

The final $450,000 of subscriptions, together with half the options associated with the first $1.2 million of subscriptions remained subject to shareholder approval, which was received at an EGM today where all resolutions passed with more than 93% support.

MacLeman says proceeds from the capital raise will be used to:

  • Complete final analysis of the healthy volunteer cohort of the ongoing Phase 1 extension study of AD 214;
  • Progress partnering and/or licensing discussions for the AD-214 product to help move AD-214 into Phase 2 studies and beyond;
  • Evaluating synergistic external technology and product collaboration and transaction opportunities to expand and accelerate 1AD’s product pipeline;
  • General working capital with any remaining funds.

“We are blessed with a strong and supportive institutional and large shareholder base who support our long-term goals,” MacLeman says.

“I want to make it clear that every dollar of shareholder funds is precious.

“Realising the value of AD-214 is our number one priority, and it is the focus and purpose of the placement offer being finalised.”

CEO and managing director Tim Oldman recently told Stockhead multiple opportunities are opening for the company as it finishes 2023 in the “best place we’ve ever been”.

“For us 2024 will most definitely be transformational,” Oldham says.



This article was developed in collaboration with AdAlta, a Stockhead advertiser at the time of publishing.


This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.