Tiziana Life Sciences (NASDAQ: TLSA) stock has not rewarded patient shareholders. The TLSA share price is down nearly 35% year-to-date. And Tiziana has breached the NASDAQ's minimum bid price requirement.
To remain compliant with the exchange's listing rules, the share price must meet or exceed $1 for at least ten consecutive business days between now and 12 December 2022.
Unfortunately, the TLSA share price has been trading below a dollar since early May. If it doesn't regain the minimum bid price, Tiziana Life Sciences stock could be at risk of delisting from the NASDAQ. However, the company intends to resolve the deficiency and regain compliance with the Listing Rules.
TLSA shares have been trading on the NASDAQ exchange since 21 October 2021. Before its US IPO, Tiziana Life Sciences stock was listed on the primary market of the London Stock Exchange (LSE) on 21 January 2021, and before this, on the AIM market of the London Stock Exchange since 2014. In London, Tiziana traded under the ticker symbol TILS.
What is Tiziana Life Sciences?
Tiziana Life Sciences (NASDAQ: TLSA) is a biotech stock focused on research and development (R&D) in immunotherapy products.
The company's clinical pipeline includes Foralumab, Anti IL-6R, and Milciclib.
Foralumab is for the treatment of Crohn's and neurodegenerative diseases.
Anti Interleukin-6 Receptor mAB (Anti IL-6R) is an antibody treatment used in conjunction with Foralumab for the potential as a therapy for idiopathic pulmonary fibrosis (IPF), acute respiratory distress syndrome (ARDS), multiple myeloma, arthritis, lupus and oncology indications.
Milciclib is a Monotherapy for treating HCC, a common liver cancer.
The company was founded by Gabriele Marco Antonio Cerrone on 11 February 1998 and is headquartered in London, the United Kingdom.
Tiziana Leadership Team Changes
On July 15, 2022, Dr. Kunwar Shailubhai voluntarily resigned as CEO, CSO, and Board director, effective as of 1 August 2022.
Dr. Shailubhai resigned for personal reasons, and his resignation is not related to any disagreement with the company on any matter relating to how the company is run.
Gabriele Cerrone has been appointed as interim CEO. Gabriele Cerrone has a 37.64% share interest in the company.
Tiziana Life Sciences has also recently appointed Matthew Davis, MD, RPh, as its Chief Medical Officer and Acting Chief Scientific Officer.
How Does Tiziana Life Sciences Make Money?
Tiziana Life Sciences does not make money. The company is not profitable and has no existing revenue streams.
To fund its operations, Tiziana relies on share placings and debt financing.
Tiziana Life Sciences Stock Financials
TLSA stock has a price-to-book value (P/BV) of 1.8, above the industry average of 0.4. Tiziana Life Sciences stock does not come with a shareholder dividend.
Tiziana's R&D expenses have increased Y/Y for the past three years from $3.7m in 2019 to $5.9m in 2020 and $13.2m in 2021. Operating expenses have also increased during this time. Total losses of $23.4m in 2021 slightly improved on the $26.1m loss in 2020.
TLSA Growth Potential
Tiziana is the first company attempting to switch from traditional intravenous immunotherapy to alternative routes of immunotherapy, including oral, nasal and inhalation.
The antibody and immunotherapy markets are rapidly growing. In an analyst discussion in March, Kunwar Shailubhai stated they're expected to reach $300bn by 2025. Tiziana aims to prove that new immunotherapy methods are possible without entry through the veins (intravenous) or under the skin (subcutaneous).
The trouble with the traditional methods is that as the drug is delivered quickly, it hits the patient's bloodstream at a high level for the first few hours. This can bring toxicities, as it shocks the patient's system. With the complexities involved in intravenous and subcutaneous delivery, some patients object.
Tiziana hopes to offer alternative routes of immunotherapy via mouth, nose and breath.
Its flagship drug Foralumab is undergoing clinical trials for the following delivery methods:
An intranasal version to treat progressive multiple sclerosis
An oral version to treat Crohn's disease
A subcutaneous version to treat Type 1 diabetes
And the company is investigating an oral delivery approach for its Milciclib drug.
To improve their effectiveness, Tiziana wants to deliver these drugs to ensure localized action with a lower dose and minimal toxicity.
The company believes if it succeeds in any of these methods, it could revolutionize how immunotherapy is carried out. And this could prove particularly popular if the delivery methods can be taken at home. Namely, for nasal administration, it will offer a prefilled nasal device the patient can use at home, and for the clinical trials, the dosing will be supervised. Meanwhile, for oral administration, the company will provide take-home capsules.
In March 2022, Tiziana announced positive clinical data from a secondary progressive multiple sclerosis (MS) patient treated for six months with intranasally administered Foralumab. This validates its efforts to succeed.
On 1 August 2022, Tiziana Life Sciences announced it presented a study at Alzheimer's Association International Conference 2022 (AAIC) evaluating intranasal anti-CD3 for the potential treatment of Alzheimer's Disease.
Tiziana Life Sciences Stock Risks
The primary risk to Tiziana investors is delisting. If Tiziana Life Sciences stock is delisted from the NASDAQ, shareholders will still own their shares but will only be able to trade them over-the-counter. This is a less liquid way to trade, and in this instance, the share price could very well lose more value.
The company may opt for a share placing to help fund its ongoing R&D.
Should You Invest in Tiziana Life Sciences Stock?
Inflammatory conditions such as those Tiziana Life Sciences stock aims to combat are widespread and seriously debilitating, so a breakthrough treatment would be welcomed.
Liver cancer is often fatal, while irritable bowel disease (IBD) such as Crohn's is devastating lives. If Tiziana can offer patient relief in dealing with any of these conditions, it's likely to send the share price higher. But there are no guarantees, and the road to commercialization is long.
Nevertheless, Tiziana's technology for alternative routes of immunotherapy has been patented, with several applications pending, and is expected to allow for broad pipeline applications in the future.
As you can glean from above, Tiziana Life Sciences stock makes for a risky investment. As with many biotech stocks, future success depends on the outcome of clinical trials and taking products to market.
In July, Mayank Mamtani, an analyst at B Riley Securities, rates TLSA stock a Buy with a target share price of $3. This follows analyst Ashok Kumar of ThinkEquity, who rated TLSA stock a Buy in June with a target share price of $4.
