Alitair Pharmaceuticals Investor Relations Communication - 3rd Quarter 2020
Alitair Pharmaceuticals Investor Relations Communication
September 10, 2020
Dear Shareholders and Stakeholders:
I hope you are faring well as we all continue to navigate life amidst the coronavirus pandemic. The Alitair team is doing fine and we hope you are too. From a business standpoint, we continue to work hard at driving the business forward although the current and recent past business environments have made capital-raising activities even more challenging than normal. Notwithstanding these setbacks, and the unprecedented impacts of the SARS-CoV-2 pandemic, we believe our product portfolio remains attractive, our target markets remain large, and the unmet medical needs remain unfulfilled. We also believe that Alitair still holds fundamental attractiveness from a therapeutic area standpoint and from a valuation standpoint.
Raising capital remains our #1 priority – Driving forward benzonatate tablets for prescription cough and erdosteine for bronchiectasis remain the keys to unlocking the value of the Alitair portfolio. Both products would launch into markets of $500 million to $1 billion. Given the differentiated profile of both products, we continue to believe that the commercial revenues would be very attractive.
After a lull (during the initial months of the pandemic) in our ability to engage potential financial firms to help us raise the required capital, we now have two initiatives in place. One is a royalty-focused deal approach for benzonatate. The other is a more traditional equity raise targeting broader product development initiatives including erdosteine and some small IP-related work. While we cannot guarantee success with either initiative, we are excited about our strategic plan to gain funding for our pipeline. As a third prong in our strategy, we are targeting some small investment to cover near-term operating costs through a “friends and family” type of capital raise. So, we now have three initiatives in place to help secure the capital required to grow Alitair and unlock value for shareholders.
Benzonatate Tablets – This is our lead asset. Benzonatate gel-caps (Pfizer and generics) in its current marketed form has become the leading treatment choice in the large 26 million patient cough market. The molecule has grown to capture over 60% of total prescriptions. However, there are safety risks caused by the dosage form and the dosage frequency is 3-4 times a day. In comparison, Alitair Benzonatate Tablets are designed to deliver the efficacy of the gel-cap, but with a projected safer profile and with the first tablet formulation with a twice-a-day dosing regimen. We believe our Benzonatate Tablets can become the leading brand in the prescription cough market in the US. We hold strong IP in support of our Benzonatate Tablets.
Bronchiectasis – We have two assets holding FDA Orphan Drug status for the treatment of bronchiectasis in both CF and non-CF patients. The lead compound here, erdosteine capsules, has an open IND with FDA and is Phase II ready. The other asset is doxofylline capsules. Both compounds have the potential to compete effectively in the 160,000-patient bronchiectasis market. As we have ready access to clinical trial material from an FDA-approved manufacturing site, we are ready to move into Phase II … once funded.
Other Pipeline Assets and Special Initiatives – As we continue to evolve as a company, we have deemphasized the narcotic cough portfolio. We have reprioritized Overdose Reduction (ODR) formulation technology as a Business Development initiative available for out-licensing. In terms of special projects, erdosteine and doxofylline are both being studied in Italy for COVID-19 patients (studies being conducted by our licensing partners). We await the full results of these clinical studies. We have not placed any probability of success on these programs as it is too early, there are too many unknowns with the SARS-CoV-2 virus, and the studies are too small to make a definitive judgement on next steps.
Enhancing Scientific Support – Gaining input and expertise from leading researchers, clinicians and frontline physicians is critical to our success. To that end, we are updating our team of Scientific Advisors. We are retaining some of our core physicians and adding several new advisors with deep experience in cough, with hands-on patient care expertise in respiratory diseases and emergency medicine, and knowledge of clinical trial design and regulatory requirements. While this initiative will not be completed until mid-4Q20, we have made good progress with leading and well-respected clinicians. While we will not release the new panel details until it is filled in its entirety, our two newest members are stellar. One heads Emergency Medicine in a large metropolitan area and is actively involved in his professional society in a key leadership role. The other is a worldwide Pulmonology expert, the founder of a Cough Center of Excellence, and is involved in the peer-review and publication process at the preeminent medical journal in his specialty area. Stay tuned for more details on our Scientific Advisors in the coming months.
Looking ahead – As stated earlier, raising additional capital is the key step for Alitair. Without additional capital, we cannot succeed, and it has been our main challenge over the past several years. However, we have good engagement with our financial partners and a growing engagement with the scientific community. We are still hopeful that we can succeed in our quest. Our focus is on benzonatate, and then, Orphan Drug product development … with narcotic cough and ODR de-emphasized. Three years ago, our Board and Executive team took the reins of the Company and we remain committed and passionate about Alitair Pharmaceuticals. We know what success would mean for patients, stakeholders, and shareholders. That is why, near-term, our #1 priority remains focused on gaining new capital. We will provide a further Investor Relations updates when major news flow develops.
James Hoyes - Chairman and CEO
FORWARD-LOOKING STATEMENTS
The information contained in this letter may contain information about the Company’s future plans and prospects that constitute forward-looking statements for purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Any statements that express or involve discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, goals, assumptions or future events or performance are not statements of historical facts and may be "forward looking statements". Forward looking statements may be identified through the use of words such as “may”, "expects/excepted", "will", "anticipates", “allows”, "estimates", "believes", “provides” or by statements indicating certain actions. "may", "could", "should" or "might" occur. Forward looking statements are based on expectations, estimates and projections at the time the statements are made that involve a number of risks and uncertainties which could cause actual results or events to differ materially from those presently anticipated. The information contained in this letter was current as of the date presented and we specifically disclaim any obligation to update any forward-looking statements, whether as a result of new information, future developments, or otherwise.