• AVITA jumps after providing bullish guidance
  • Anatara up after holding AGM this morning
  • Imugene doses first patient in its Phase 1b clinical trial using azer-cel


AVITA up on bullish sales forecast

Regenerative medicine biotech, AVITA Medical (ASX:AVH) jumped 24% this morning after providing a bullish guidance for Q4 FY23.

AVITA said its commercial revenue for Q4 will come in between $15.3 to $16.3 million, reflecting a big lower bound of 64% and upper bound of 73% growth over the pcp.

For the full year FY23, revenue is expected to be in the range of $51 to $53 million, reflecting a lower bound of 50% and upper bound of 56% growth over the pcp.

Gross margin for the full year is expected to be in the range of 83% to 85%.

AVITA’s flagship product is the RECELL System, a technology platform approved by the FDA for the treatment of thermal burn wounds, and for repigmentation of skin cells harnessed from the patient’s own skin.

Using the RECELL device, a clinician prepares and delivers autologous skin cells from pigmented skin to stable depigmented areas, offering a safe and effective treatment for vitiligo.

AVITA said it’s well funded after securing a debt financing facility for up to $90 million in October.

Together with the cash on hand of $60.1 million as of September 30, the company believes it has sufficient capital to meet its goals and to reach profitability during 2025.


Anatara rises after AGM

Gastrointestinal-focused biotech, Anatara Lifesciences (ASX:ANR), also jumped 15% after holding its AGM this morning.

Exec chair Dr David Brookes told shareholders the recent company news flow has been dominated by the completion of Stage 1 of the GaRP-IBS trial.

“As you are aware from the ASX updates, the results were considered very encouraging and the interim analysis of Stage 1 successfully met all the intended objectives,” Brookes said.

Anatara’s GaRP product is a microbiome-targeted medicine that has been designed to address the primary underlying factors associated with chronic gastrointestinal conditions such as irritable bowel syndrome (IBS) and inflammatory bowel disease (IBD).

“The immediate project for advancement is our Gastrointestinal ReProgramming to become a product for wide-ranging indications via the completion of the IBS trial,” said Brookes.


Imugene’s Phase 1b clinical trial using azer-cel

Meanwhile, Imugene (ASX:IMU) rose 15% this morning after dosing of the first patient in its Phase 1b clinical trial using Azer-cel (an allogeneic off-the-shelf CD19 CAR T, a type of cell therapy).

Azer-cel is currently being studied in an ongoing multi-centre Phase 1b CAR T clinical trial in patients with blood cancer called non-Hodgkin’s lymphoma (NHL).

This Phase 1b trial is a precursor to a Phase 2 registrational trial (subject to FDA agreement) in 2024.

The Azer-cel clinical drug is being supplied from Imugene’s state-of-the-art manufacturing facility in North Carolina.

“It is a great credit to our team that the Phase 1b study has been initiated and the first patient dosed, in under three months since acquiring the technology,” said Imugene CEO, Leslie Chong.


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