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Enochian BioSciences' CEO Letter to Shareholders Turning the Page; A Promising Future Los Angeles

Key Takeaway: Enochian BioSciences has reported promising data from independent studies on its novel cell-gene-immunotherapy, particularly for pancreatic cancer, showing significant tumor volume reduction. The company announced plans to accelerate its Pre-IND submission to the US FDA in light of these results, with potential clinical trials expected to begin in early 2024. The CEO expressed confidence in leveraging their research platform for additional therapeutic areas, including other solid tumors and chronic infectious diseases. Recent fundraising efforts have positioned the company strongly to maximize shareholder value as it pushes forward with its initiatives.

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POSITIVE FACTORS

  • Encouraging results from independent studies show significant tumor reduction.
  • Accelerated timeline for Pre-IND submission aims for clinical trials in early 2024.
  • Strong backing from renowned researchers indicates confidence in therapeutic potential.

Full Press Release Details

Enochian BioSciences' CEO Letter to Shareholders
Turning the Page; A Promising Future
Los Angeles, April 3, 2023 (GLOBE NEWSWIRE) -(NASDAQ: ENOB)--
Jewett, Professor at the University of California, Los Angeles (UCLA) and a renowned
cancer researcher in the field of immunotherapy
said, "I have been working in this field for three
decades and designed the mouse model that we have used in my laboratory to study the Company's potential cancer therapies. The results
are some of the most impressive I have seen. The fact that we saw very similar highly statistically significant results across two independently
conducted studies is particularly encouraging, indicating reproducibility of the findings. I look forward to continuing our work together
towards clinical trials, and potentially offering hope to many who are suffering with diseases with few good treatment options."
"I am delighted to be the Senior Scientific Advisor for Enochian
BioSciences," said Dr. Richard Whitley, Distinguished Professor of Pediatrics,
Professor of Microbiology, Medicine and Neurosurgery and Loeb Eminent Scholar Chair in Pediatrics of the University of Alabama.
"I have been very impressed by the Company's resilience and the potential human impact of the recent data from the cancer
pipeline with a potential product that could have relevance for other pipelines in HIV, and perhaps other chronic infectious diseases.
I very much look forward to working with the Company as they advance the translation of their platform to potential life-saving interventions
for cancer and infectious diseases."
On behalf of the Board, Management, and scientific team, I would like to
thank two distinguished leaders in their fields, Professors Anahid Jewett, Ph.D. and Richard Whitley, MD, for their steadfast support
and belief in the promising future of the Company. In addition, we offer deep thanks to Dr. Jewett and her colleagues at UCLA for performing
the pivotal proof-of-concept studies that have allowed us to accelerate our timeline to submit a Pre-Investigational New Drug (Pre-IND)
application to the US FDA.
I would also like to thank and welcome Dr. Sadeghi to the team. He brings
deep experience and expertise as a consultant as we prepare for the IND submission, and we hope, clinical trials in early 2024.
I am pleased to be able to provide shareholders with a summary of recent
advances and what we believe is a promising future for the Company.
Proof-of-Concept Confirmed for Novel Cell-Gene-Immunotherapy for
Pancreatic Cancer and, Potentially, Other Solid Tumors
Several key, independent studies performed by Dr. Anahid Jewett have shown
remarkably promising results, demonstrating proof-of-concept. In two separate studies in humanized mice implanted with pancreatic cancer,
the volume of the tumors was reduced by an average of 77 to 87 percent following only two injections of the product. The tumor weight
was also highly statistically significantly reduced. There was also a statistically significant increase in key immunologic markers in
mice potentially validating the hypothesized mechanism of action via a strong activation of the immune response by the potential product.
Of note, the mice were evaluated only 3-4 weeks after treatment - it is possible the effect would have been even greater if the
study were conducted for a longer time. As noted above, Dr. Jewett presented the key results as part of an invited plenary lecture at
a scientific conference last week ( Link to Press Release and Link to Presentation Excerpt).
Accelerated Timeline for Pre-IND Submission, Toward Several Solid
Because of the strength of the data, we are accelerating the timeline for
a Pre-IND submission to the US FDA, which is imminent.
Because the mechanism of action could be effective against other solid
tumors, the clinical study design component of the Pre-IND submission will propose the inclusion of all solid tumors during the initial
safety and tolerability component and based on preliminary anti-cancer performance, narrowed to a few solid tumor candidates such as pancreatic,
triple-negative breast cancers, head and neck, and mesothelioma.
Each of those cancers have relatively few treatment options with poor life-expectancy.
For example, the 5-year survival rate for pancreatic cancer is only 10 percent.
We are targeting submission of the IND application for early 2024 towards
potentially starting clinical trials soon after that.
Basic Platform and Product Design Leveraged for Other Pipelines Such
as Infectious Diseases, Including HIV
The second proof-of-concept study was performed with what we believe will
be the key product design components that we intend to advance towards clinical studies. Important features of that design provide the
backbone of our overall approach to use cells from other persons, with or without gene-modification, to renew and stimulate a stronger
immune response than the patient could without treatment.
We have a similar approach to HIV which could apply to other chronic infectious
disease conditions. Therefore, we can potentially leverage the design, development, production, and regulatory processes of the oncology
platform for HIV pipelines, and, perhaps, for additional infectious diseases.
Private Placement and Non-Dilutive Opportunities
As of March 31, 2023, we raised approximately $2.5 million of additional
funds through a private placement of restricted shares. The Chair of the Board, Ren Sindlev, led the round with $1 million, demonstrating
his confidence in the Company.
We have identified a total of up to $27 million from three non-dilutive
grant opportunities covering IND-enabling (Pre-IND to IND) and clinical (post IND) costs. There is, of course, no guarantee of being awarded
any of the grants. But we believe the strength of the data puts the Company in a strong position.
Conclusion: Turning the Page for a Promising Future While Working
to Maximize Shareholder Value
Despite significant challenges that would have derailed many companies,
our strategic plan to focus on our most promising platform has allowed us to significantly de-risk our cancer immune oncology program
and be in a strong position now. We have made substantial scientific and product development advances over the past 10 months. This was
accomplished while substantially reducing operating costs - including, at my request, a decrease in my compensation as CEO - towards
maximizing shareholder value.
The progress with a platform that has key attributes that could potentially
be leveraged for products to treat solid tumors, HIV and, perhaps, other infectious diseases is particularly encouraging. Such an approach
could open possibilities to partner, sell or sub-license individual pipelines towards further potential maximization of shareholder value.
Indeed, as previously announced, we have already sub-licensed a novel aspect of one of our HIV pipelines to potentially enhance the effectiveness
of a CAR-T therapy already in clinical trials.
Recent fundraising through a private placement of approximately $2.5 million
and the identification of potential non-dilutive grant opportunities totaling up to $27 million are encouraging and, yet again, offer
the possibility to maximize shareholder value.
Thank you for taking the time to read this update. We look forward to your
continued support as we work towards life-saving scientific advances and a promising new future for the Company.
The Hon. Mark Dybul, MD
Chief Executive Officer, Enochian BioSciences Inc.
Forward-Looking Statements
Statements in this press release that are not strictly
historical in nature are forward-looking statements. These statements are only predictions based on current information and expectations
and involve a number of risks and uncertainties, including but not limited to the success or efficacy of our pipeline. All statements
other than historical facts are forward-looking statements, which can be identified by the use of forward-looking terminology such as
"believes," "plans," "expects," "aims," "intends," "potential,"
or similar expressions. Actual events or results may differ materially from those projected in any of such statements due to various uncertainties,
including as set forth in Enochian BioSciences' most recent Annual Report on Form 10-K filed with the SEC. Readers are cautioned
not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements
are qualified in their entirety by this cautionary statement, and Enochian BioSciences Inc. undertakes no obligation to revise or update
this shareholder letter to reflect events or circumstances after the date hereof.
Source: Enochian Biosciences Inc.

Frequently Asked Questions

What is Enochian BioSciences' recent progress in cancer therapy?

The company has confirmed proof-of-concept results for a novel therapy that reduced tumor volume significantly in studies.

When will Enochian submit their IND application?

Enochian aims to submit their IND application in early 2024 to initiate clinical trials.

How has Enochian BioSciences secured funding recently?

The company raised approximately $2.5 million through a private placement and identified up to $27 million in non-dilutive grant opportunities.

What are the potential applications of their cancer platform?

The platform could also be utilized for treatment options in HIV and other chronic infectious diseases.

Who are the key scientific advisors at Enochian?

Professors Anahid Jewett and Richard Whitley are significant scientific advisors, enhancing the company's research efforts.

Last updated: Apr 3, 2023