1. Investment Snapshot
2. Thesis
3. Valuation & Price Target
4. Business & Product Moat
5. People & Governance
6. Market & Macro
7. Financial Quality
8. Risk Register
9. Prediction Market
10. đť•Ź Posts
Discussion
1. Investment Snapshot
2. Thesis
3. Valuation & Price Target
4. Business & Product Moat
5. People & Governance
6. Market & Macro
7. Financial Quality
8. Risk Register
9. Prediction Market
10. đť•Ź Posts
Discussion
1. Investment Snapshot
2. Valuation
Discussion
Symbol
PLRZ
Event Date
2024-10-29
Sector
Health Care
Subsector
Health Care Equipment & Supplies
Offer Range
$4.38
Shares Offered
958.9K
4.04M
$17.7M
23.7%
Implied Upside vs Midpoint
Description
We are a development stage biotech company specializing in the development of innovative medical device hydrogels delivered in the form of nasal sprays, which form a thin hydrogel-based shield containment barrier in the nasal cavity that can provide a barrier against viruses and allergens from contacting the nasal epithelial tissue. Our proprietary Capture and Contain™, or C&C, hydrogel technology, comprised of a mixture of naturally occurring building blocks, is delivered in the form of nasal sprays, and potentially functions as a “biological mask” with a thin shield containment barrier in the nasal cavity. We are further developing certain aspects of our C&C hydrogel technology such as the bioadhesion and prolonged retention at the nasal deposition site for intranasal delivery of drugs. We refer to our additional technology, which is in an earlier stage of pre-clinical development, that is focused on nasal delivery of active pharmaceutical ingredients, or APIs, as Trap and Target™, or T&T. Our Product Candidates Our nasal hydrogels have been designed to serve as a non-invasive and fast-acting system. The hydrogels are formulated as an innovative mixture of mucoadhesive polymers (e.g., sodium alginate) which are Generally Recognized as Safe, or GRAS, by the Federal Drug Administration, or the FDA. Our mucoadhesive polymers derived from seaweed polysaccharides possess promising features as they are renewable, biodegradable, biocompatible, and environment friendly. The formulated hydrogel is sprayed into the nose to create a physical barrier with long-lasting adhesion to the mucosal membranes. Our polymers have an atomic mass much higher than the upper cell penetration limit, the polymers will simply lay on top of the cells and act as a physical barrier to viruses and allergens from contacting the nasal epithelial tissue, as opposed to penetrating the cells and causing a chemical reaction. Therefore, the C&C product candidates are not expected to be considered as drugs by the FDA but as medical devices. Our leading technologies are C&C and T&T. The C&C technology is a containment barrier against a wide range of allergen particulates and viruses. PL-14 – Nasal Allergies Blocker . We expect our PL-14 C&C technology medical device product candidate, or our PL-14 product candidate, to be regulated as a Class II medical device by the FDA under its 510(k) pathway. . Our PL-14 product candidate is scheduled to initiate preclinical safety trials in the second quarter of 2025. In addition, we expect pivotal clinical trial on our PL-14 product candidate to commence in the fourth quarter of 2025, following which we plan to submit a 510(k) application for FDA clearance. . For our PL-14 technology product candidate, we will pursue the 510(k) pathway requires a manufacturer to demonstrate substantial equivalence to an FDA-cleared device (i.e., predicate device) to a subject device (i.e., our product candidate). This process for clearing our device with the FDA entails performing a medical device analysis of the product candidates (e.g., PL-14 product candidate) description, operational principle, potential accessories and proposed intended use, for the purpose of identifying a predicate device that has already been cleared by the FDA. Through this review, we found three possible predicate devices for establishing substantial equivalence, Alzair Allergy Blocker (510(k) Number: K170848), or Alzair, NASAL EASE ALLERGY BLOCKER (510(k) Number: K132520), or Nasalease, and Bentrio Allergy Blocker (510(k) Number: K213114), or Bentrio. There is no guarantee that our PL-14 product candidate will advance in the FDA 510(k) process at the same rate as the aforementioned predicate devices or will reach commercialization. . The estimated timeline for obtaining 510(k) clearance for our PL-14 product candidate is based on the estimated time needed for the following activities: (i) GMP manufacturing of our clinical trial materials, which usually requires 9-12 months; (ii) biocompatibility preclinical studies, which usually requires 3-6 months (although these studies may be performed concurrently with the GMP manufacturing mentioned above); (iii) clinical trials, which usually requires 6-12 months; and (iv) FDA submission and clearance, which usually requires 3-12 months. Regarding FDA submission and clearance, generally 510(k) applicants can expect submission acceptance review decisions within 15 calendar days, substantive review decisions within 60 days, and final decisions within 90 days. However, the FDA’s time of review does not include time on “hold”, which includes any time spent by us responding to any FDA information requests, meaning that the total timeframe of the review process could take longer than anticipated. In the case of our predicate devices for our PL-14 product candidate, Alzai, Nasalese, and Bentrio, the FDA submission and clearance process took 86 and 140 days, respectively. PL-15 – COVID-19 and PL-16 – Influenza Blockers . We expect our PL-15 C&C technology medical device product candidate, or our PL-15 product candidate, and our PL-16 C&C technology medical device product candidate, or our PL-16 product candidate, which provide a barrier to COVID-19 and influenza from contacting the nasal epithelial tissue, respectively, to be regulated as a Class II medical device under a De Novo Classification request. For the clinical studies planned for PL-15 & PL-16 which will include human subjects; the Investigational Device Exemptions, or IDE, regulation describes three types of device studies: significant risk, nonsignificant risk, and exempt studies. During the first quarter following the closing of this offering, the company intends to schedule a pre-submission meeting with the FDA to determine the IDE regulation type of device studies for PL-15 & PL-16. Our proposed 12-month interval from the scheduled FDA pre-sub meeting to the planned IDE clinical trial initiation should provide ample time to fulfill the necessary tasks for the IDE filing, such as 1) reporting previous studies to support the IDE, 2) preparing IDE required design and manufacturing control documentation, 3) conducting bench and biocompatibility tests to support safety of the device prior to starting the a human study, and 4) obtaining clinical protocol and ethics committee approvals as well as FDA IDE approval to start the clinical trial. Once IDE has been initiated, Polyrizon will comply with FDA Guidance “Changes or Modifications During the Conduct of a Clinical Investigation”, 2001. . Our PL-15 product candidate is scheduled to initiate preclinical safety trials in the second quarter of 2025, and subject to securing additional financing, we intend to initiate feasibility clinical trials in the third quarter of 2026 and pivotal clinical trials in the second quarter of 2027. Following these trials, we plan to submit De Novo Classification requests for each product candidate. Our PL-16 product candidate is scheduled to initiate preclinical safety trials in the second quarter of 2025, and subject to securing additional financing, we intend to initiate feasibility clinical trials in the first quarter of 2026 and pivotal clinical trials in the third quarter of 2026. Following these trials, we plan to submit De Novo Classification requests for each product candidate. . Upon a review similar to the one performed for our PL-14 product candidate, we found that there were no potential predicate devices in the FDA’s database matching the proposed intended uses of our PL-15 and PL-16 product candidates. Because of this, we will pursue a De Novo Classification request for each product candidate. This pathway involves demonstrating that the product candidates provide a reasonable assurance of safety and effectiveness. During the first quarter following the closing of this offering, we intend to submit a Q-submission (Pre-submission) for each product candidate and request a pre-submission meeting with FDA’s Center for Devices and Radiological Health, or CDRH, to confirm the potential for this regulatory path. . The estimated timeline for marketing authorization via De Novo Classification grant for our PL-15 and PL-16 product candidates is based on taking similar steps as the steps described above for obtaining 510(k) clearance for our PL-14 product candidate. We estimate a longer period of time for the entire grant process for each of these product candidates due to possibly extended clinical trials requested by the FDA and also due to a longer review timeframe. In the event the FDA does not agree with our regulatory assessments regarding the C&C product candidates (510(k) for our PL-14 product candidate, and Class II De Novo pathway for our PL-15 and PL-16 product candidates), it may require us to go through a lengthier, more rigorous examination than we had expected (such as Premarket approval, or PMA, which is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. If we are required to pursue a PMA, the introduction of our product candidates into the market could be delayed significantly. Trap and Target™ Product Candidates In contrast to our C&C product candidates, the hydrogel in our T&T product candidates is formulated differently in order to provide for sustained release of the API. The content of the hydrogel (quantity and quality) in the T&T product candidates is formulated differently than the content of C&C product candidates, and therefore enable different functions: physical barrier for the C&C product candidates and API sustained release for the T&T product candidates. It is through these differences that we rationalize the different regulatory treatment of our C&C and T&T product candidates. The T&T platform technology is designed to allow a long residence time and an intimate contact with the mucosal tissue for a targeted delivery of medicines. We expect that our T&T platform product candidates will be regulated as a combination-product consisting of a nasal sprayer and formulation consisting of a hydrogel and a generic API, which we intend to pursue under the FDA’s 505(b)(2) pathway. We aim to conduct feasibility studies for our T&T platform product candidates with corticosteroids, benzodiazepines and naloxone, beginning in the fourth quarter of 2024, through the first quarter of 2026. Pre-clinical studies will follow and are expected to begin in the second quarter of 2026. Phase I clinical trials for the leading T&T technology product candidate are planned for the fourth quarter of 2027. Both pre-clinical studies and Phase I clinical trials are subject to securing additional financing. In addition, we plan to start an initial testing to explore the potential of our SCI-160 platform when combined with the T&T technology, in the first quarter of 2025. --- We are an Israeli corporation, incorporated in January 2005. Our principal executive offices are located at 5 Ha-Tidhar Street, Raanana, 4366507, Israel. Our telephone number is +972-9-3740120. Our website address is www.polyrizon-biotech.com.