The following was the result of discussion and collaboration between MS Money Moves and SCYNEXIS (Nasdaq: SCYX) Chief Financial Officer Eric Francois. We are thankful for his time and conscientious efforts to help us deliver SCYNEXIS shareholders insightful information.
1) Approximately when can CARES data be expected?
The CARES study has a similar design and protocol as the FURI study (i.e. emergency protocol). SCYNEXIS does not initiate or conduct the study
In FURI the main object was to see if
The CARES study has a similar design and protocol as theFURI study (i.e., open-label, uncontrolled). However, for the CARES study, SCYNEXISdoes not initiate sites but rather respond to investigators requests (emergencyprotocol approach). Considering this and other factors, it is hard for thecompany to give a specific timeline on when data will be reported. We know fromthe information available for CARES ~30 patients with documented Candida auris infections will be treatedwith oral ibrexafungerp for up to 90 days. Before SCYNEXIS can report any data,they must first enroll enough patients and assess if there is a beneficialtreatment effect.
In the FURI study, the main object was to see if oral ibrexafungerpwas safe and improved patient outcomes based on global responses. SCYNEXIS suspectsthe positive interim results recently reported will lead to increased interestin the study and ultimately helps with enrollment. Hopefully, medicalprofessionals that were on the fence about enrolling their difficult-to-treat patientsin FURI will have their concerns abated. The timeline on the next data readoutis unclear as it is highly dependent on pace of enrollment. What we do know isthat once a large enough number of patients have been dosed up to 90 days, itis likely another DRC assessment will be conducted. For your reference the 20patients included in the interim-results were evaluated at the end of October2018.
2. Following the FURI interim data, does SCYNEXIS have a clearer timeline on when or if they will file for LPAD? If not, what factors are impeding the company from filing? LPAD = Limited Population Pathway for Anti-bacterial and Anti-fungal Drugs
Two specific points regarding this matter is the lack ofprecedents and clear regulatory guidelines set-forth by the FDA. This is amatter taken very seriously by the company. At the right time, SCYNEXIS’management team will be meeting the Agency to discuss what a possible submissionwould look like and construct a timeline. Shareholders willbe updated as developments arise, and more information becomes available.
It is important to remember that LPAD is not a blanketdesignation. SCYNEXIS would have to file for ibrexafungerp to receive LPAD for eachindication. Now that some phase 3 data are in-hand and more is on the way, thecompany can start to strategize on how to secure LPAD approval where and whenappropriate.
3. Would it be possible to update the website to include more information about the details, specifications, and benefits of LPAD? I think many investors lack clarification on this.
From the sound of its management, SCYNEXIS is going to meet and act to provide investors with resources to learn more about LPAD. Until then, we located a few for you:
4. Are there any financial incentives for the studies that fall under the GAIN Act?
There are no direct/cash financial incentives associated with the GAIN Act. However, there are numerous indirect benefits.
In May 2018, SCYNEXIS announced the receipt of Qualified Infectious Disease Product (QIDP) and Fast Track designations from the FDA for multiple indications: invasive candidiasis, invasive aspergillosis, treatment of VVC and prevention of recurrent VVC. QIDP designation provides eligibility for priority review and an additional 5 years of market exclusivity in the U.S. for
5.Following the interim results for FURI can you file for compassionate care use?
SCYNEXIS could study ibrexafungerp and file for compassionate care use, but intentionally is focusing efforts on securing non-compassionate care use approvals because this pathway represents the company’s best opportunity to positively impact patient lives. Pursuing compassionate care would divert capital and manpower and with limited resources, impede the execution of ongoing clinical trials which are pivotal to commercialization of ibrexafungerp.
If you think about, getting ibrexafungerp commercialized as soon as possible really adds the most societal value. Once approved it’ll be available to anyone with a fungal disease that falls under the umbrella of the approved indication. If you read the press release too you will see SCYNEXIS has already had a significant impact on people’s lives. Take for example the man who was on a feeding tube prior to undergoing treatment with oral ibrexafungerp:
A 63-year-old male with a 10-year history of painful esophageal constriction and recurrent esophageal candidiasis required a percutaneous gastroenterostomy feeding tube due to the inability of the patient to swallow and eat. Multiple courses of antifungals were unsuccessful in treating this fluconazole-resistant C. glabrata infection, and the patient was enrolled in the FURI study with severe esophagitis at baseline. After 54 days of oral ibrexafungerp treatment, the infection fully resolved. The patient remained asymptomatic during the follow-up period and the feeding tube was able to be removed.SCYNEXIS Press Release Reporting FURI Interim-Results
6. Does the funding through 2020 include up to ibrexafugrep NDA filing?
In early 2019 SCYNEXIS had $51 million in the bank – this includes $6.7 million of non-dilutive funding through NOLs monetization (NJEDA program in the state of New Jersey) SCYNEXIS will continue to utilize this program in the future. The company is going to review all options to strengthen its cash balance. The primary focus though is business development and looking at potential partners that may want to team up. SCYNEXIS became a lot more visible with the Phase 2b DOVE results last summer. There are no plans to do an offering right now. SCYNEXIS feels that the stock is undervalued (and we agree considering they are a phase 3 clinical stage biotech company with a competitive product targeting an undeserved market). All in all, 2019 is shaping up to be an important year for SCYNEXIS and the team is very focused on execution
MS: Does the funding plan account for a commercial launch of ibrexafungerp?
It doesn’t include any commercialization activities. SCYNEXIS would consider going at it alone to penetrate this specialty market, however, if they find the right partner they would consider that. The company will explore all the options but doesn’t currently have the capital in place to fund a commercial launch. Members of SCYNEXIS management team have a lot of commercialization expertise.
Take SCYNEXIS President and Chief Executive Officer (CEO) Marco Taglietti, M.D. for example. Over his career, he has brought 35 different products to market in the U.S. and abroad. Chairman of the Board of Directors Guy MacDonald is a biopharmaceutical industry veteran. In addition to his role at
7. Does SCYNEXI intend on seeking accelerated approval for Invasive Refractory Infections?
This would be part of fast track process, a regulatoryadvantage included under LPAD. For this type of infections, SCYNEXIS alsobenefits from its QIDP designation.
8. Regarding the $6.7 million received from NJEDA, is SCYNEXIS eligible to receive the remaining $8.3 million capturing the full $15 million potential in a company’s lifetime?
Yes, SCYNEXIS is eligible for and intends to secure theremaining $8.3 million of non-dilutive funding available to them from NJEDA –based on current and forward NOLs, it will likely be secured over the next 2-3years.
9. Can you provide any update on where the company is in the scale up process with the liposomal IV formulation?
While oral ibrexafungerp is progressing as a potential valuable option to treat hospital-based invasive fungal infections (as shown with the recent FURI results), SCYNEXIS continues the development of the intravenous liposomal formulation of ibrexafungerp and will provide further updates in the future. The IV formulation development is not a big financial strain. Right now, SCYNEXIS is primarily focused on execution of phase 3 studies and working with the FDA to optimally navigate the registration process.
From an investor perspective, the IV option is a bonus, if you will. Of course, it is nice to have the increased versatility of dual product administration, but the oral agent is most important. Seconal (a barbiturate hypnotic with a calming effect) achieved $1.2 billion in sales without a great safety profile, yet they were first in class. Oral ibrexafungerp has blockbuster potential in its target market with a favorable safety profile signaling high monetization potential. Thus, the strategic priority is placed on getting it to market in timely and responsible manner.
10. Has Merck received any milestone payments as a result of initiation of a phase 3 study for ibrexafungrep or subsequent to the positive interim-results for FURI?
SCYNEXIS acknowledged they have some financial obligations towards Merck but stated they have not publicly disclosed the amounts and timing of payments. The company assured us they are tracking them very carefully.
11. Is SCYNEXIS considering bringing products to market through licensing to a third-party?
Management is currently busy and focused on the development and regulatory advancement of
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