This is a MAJOR milestoneThe filing of an Investigational New...

This is a MAJOR milestone

The filing of an Investigational New Drug (IND) for IHL-42X in a 12-month blended Phase 2/3 trial with the U.S. Food and Drug Administration (FDA) is a very significant milestone for a small biotech company likeIncannex.

IND Application: The IND application is a crucial step in the drug development process. It signifies that a biotech company has compiled sufficient preclinical data and initial safety information to support the initiation of human trials. The FDA's acceptance of the IND application allows Incannexto to proceed with Phase 2/3 clinical trials.

Phase 2/3 Trial: Combining Phase 2 and Phase 3 trials is known as a blended trial design. Phase 2 evaluates the drug's efficacy and safety in a larger patient population, while Phase 3 confirms the drug's effectiveness, monitors side effects, and compares it to existing treatments.

In a blended trial, there is a seamless transition from Phase 2 to Phase 3 without a separate break or analysis. The patients enrolled in the Phase 2 component continue into the Phase 3 component, maintaining the continuity of treatment and evaluation. Blending these phases saves time and resources, making the development process more efficient.

Unmet Medical Need: Developing a novel medication such as IHL-42X to address an unmet pharmaceutical medical need for Sleep Apnoea demonstrates the potential ofIncannex'smedication to fulfill a gap in treatment options. It suggests that there is a significant patient population that could benefit from the new therapy, which can have substantial commercial value if successful.

Alternative Remedy: If the only alternative remedy for the targeted condition is a device with sales of approximately US$9 billion per annum, it further highlights the market potential of the IHL-42x medication. This implies that there is a significant market opportunity and demand for a pharmaceutical solution, potentially a disruptive alternative leading to substantial revenue generation if the drug is approved.

FDA Collaboration: Collaborating with the FDA on the IND application and gaining their acceptance indicates regulatory progress and acknowledgment ofIncannex'sresearch and development efforts. It also provides a level of credibility and confidence to investors and stakeholders, which can positively impact the company's market cap.

Opening of an IND: for a 12-month blended Phase 2/3 trial with the FDA, especially for a novel medication targeting an unmet pharmaceutical need for Sleep Apnoea with a US$9 + BLN market opportunity, is a significant milestone forIncannex.

It demonstrates progress in;

• drug development,
• market potential, and
• regulatory recognition,

all of which IMO can have a significant impact on investors' expectations for the company's future success in the short to medium term.

"If we again observe such remarkable drug efficacy, safely administered over the 52 weeks,Incannexis confident that our product will be marketable.” CEO

The company may not feel more valuable today than yesterday, but our Market Cap has increased in value considerably overnight IMO (per the research paper below) if it were considered a takeover target.

Valuation by development stage

Valuation by development stage
On average, companies with lead products in pre-clinical development were acquired for a total transaction value of $88 million (95% CI $56–120 million).
Mean valuations rose to $354 million (95% CI $211–498 million) for
Phase 1, $683 million (95% CI $436–930 million) for

Phase 2, $1761 million (95% CI $996–2527 million) for
Phase 3, and $2469 million (95% CI $1582–3355 million) for Approved lead products.
However, the acquisition value displayed a high dispersion within development stages. Therefore, only the transitions from Pre-Clinic to Phase 1 (p < 0.001) and from Phase 2 to Phase 3 (p < 0.01) significantly differed.

Click to view the Article

Good luck to all holders