Q1 2022 Inhibikase Therapeutics Inc Earnings Call

Speaker 1: The C.

Speaker 1: Five.

Multiple speakers: Greetings, welcome to Inhibikase Therapeutics' first quarter 2022 financial results conference call. At this time, all participants are in a listen-only mode, a question and answer session will follow the formal presentation. If you would like to ask a question, please press star one on your telephone keypad. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. Please note this conference is being recorded. I will now turn the conference over to Alex Lobo, [inaudible] Investor Relations. Thank you, you may begin. Thank you, Sherri. Good morning and welcome to Inhibikase Therapeutics' first quarter 2022 financial results conference call and audio one counts. With me today is Dr. Millton Werner, Chief Executive Officer, and Joseph Fratteroli, Chief Financial Officer.

Alexander Lobo: Yesterday, Inhibikase issued a press release announcing financial results for the first quarter ended March 31st, 2022. We encourage everyone to read yesterday's press release as well as Inhibikase's quarterly report on Form 10-Q for the first quarter of 2022, which is being filed with the SEC. The company's press release and quarterly report are also available on Inhibikase's website at inhibikase.com. In addition, this conference call is being webcast through the Investor Relations section of the company's website and will be archived there for future reference.

Alexander Lobo: Please note that certain information discussed on today's call is covered under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Participants are cautioned that this conference call contains time sensitive information that is accurate only as of the date of this live broadcast- May 17th, 2022. Actual results could differ materially from those stated or implied by these forward-looking statements, due to risks and uncertainties associated with the company's business. Information on potential risks and uncertainties are set forth in our most recent public filings with the SEC at sec.gov. The company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this webcast, except as may be required by applicable securities law.

Speaker 3: Information on potential risks and uncertainties are set forth in our most recent public filings with the SEC at sec.gov.

Speaker 3: The company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this webcast, except as may be required by applicable securities law.

Alexander Lobo: With that said, I would now like to turn the call over to Dr. Milton Werner. Milton, you may begin.

Milton Werner: Thanks and thank you Alex, and thank you everyone for joining Inhibkase Therapeutics' first quarter 2022 earnings call. As we kicked off the year, we have worked diligently to advance our clinical and preclinical development programs as well as extend our thought leadership in Parkinson's disease. This past month, for example, we brought together leading k-wells in the field of movement disorders to host an educational at investor event. We also participated in multiple medical conferences this past quarter, including the annual ADPD conference where we presented results from our Phase one and Phase one B studies for IkT-148009, as well as the next generation kinase inhibitor summit where we highlighted the rationale behind targeting [inaudible] for Parkinson's disease.

Speaker 4: As well as extend our thought leadership in Parkinson disease. This past month, for example, we brought together leading kwells in the field of movement disorders to host an educational at Investor event. We also participated in multiple medical conferences this past quarter, including the annual ADPD conference where we presented results from our Phase one and Phase one B studies for ikt 14, 8- 9, as well as the next generation knis inhibitor Sumit, where we highlighted the rationale behind targeting caable for parkkinginson disease.

Milton Werner: As we look ahead to the second quarter, we anticipate achieving a number of key milestones. Most importantly, we expect to dose the first patients in our  Phase 2A study for IkT-148009 for Parkinson's. In addition, we also expect filing our IND application for IkT-001Pro for stable Phase chronic myeloid leukemia or CML, as well as report preclinical data from at least one study of IkT-148009 in multiple system atrophy or MSA. Before I dive into our clinical and preclinical pipeline programs, I want to encourage everyone to watch the replay of our educational investor events that we hosted last month.

Milton Werner: Together with our key opinion leaders, we covered the current unmet need, competitive, and regulatory landscape in Parkinson's disease, as well as our development strategy for IkT-148009 as a potential therapeutic option for patients. The event can be accessed under the events and presentation section of our IR website.

Milton Werner: So now let me start with a lead program: IkT-148009. IkT-148009 is a highly selective nonreceptor [inaudible] inhibitor. As you may remember, 148009 was designed to have a predictable low toxicity profile and to have the ability to cross the blood-brain barrier and accumulate in the brain. Animal studies, including chronic toxicology studies, confirm these designs.

Speaker 4: Animal studies, including chronic toxicology studies, confirm these designs.

Milton Werner: We are currently evaluating IkT-148009 in a Phase 1B extension study. The trial is a three-to-one randomized placebo-controlled dose-escalation trial that is evaluating the safety tolerability in pharmacokinetics of seven-day dosing of IkT-148009 at three escalating dose levels and patients with mild to moderately advanced Parkinson's disease. The study is also assessing motor and nonmotor function and gut motility and plans to measure [inaudible] aggregate clearance as exploratory endpoints. The study is also assessing motor and nonmotor function and gut motility and plans to measure [inaudible] aggregate clearance as exploratory endpoints.

Speaker 4: The trial is a three-to-one randomized placebo-controlled dose-escalation trial that is evaluating the safety tolerability in pharmacokinetics of seven-day dosing of IkT-148009 at three escalating dose levels and patients with mild to moderately advanced Parkinson's disease.

Speaker 4: The study is also assessing motor and nonmotor function and gut motility and plans to measure [inaudible] aggregate clearance as exploratory endpoints.

Milton Werner: In March, we presented data from the first cohort of the study at the Alzheimer's and Parkinson's disease conference or ADPD conference. Data from this cohort suggested that the safety and tolerability profile in patients closely met out of older, healthy volunteers from our phase I and study. Pharmacokinetics of IkT-148009 in volunteers and subjects was also similar, further suggesting the pharmacology of 148009 is consistent across patient groups and penetrates the central nervous system. We have dosed six of eight patients in the second cohort and expect to complete this cohort in the second quarter. We expect to present additional data from the study and comment on the measures of the effects on Parkinson's disease at a medical meeting later this year.

Speaker 4: Data from this cohort suggested that the safety and tolerability profile in patients closely met out of older, healthy volunteers from our phasal and study. pharmsaccokinetics of ikt Fortune to nine in volunteers and subjects was also similar. Further suggesting: the pharmacology of Fortune to nine is consistent across patient groups. Penetrate centrial nervous system. We have dosed six of a patients in the second cohort and expect to complete this cohort in the second quarter. We expect to present additional data from the study and comments on the measures of the effects on Parkinson disease at a medical meeting later this year.

Milton Werner: While the trial is still blinded, we cannot draw any conclusions about the potential benefit of IkT-148009 based on the dosing of a small number of patients for seven days at different doses. We have determined that IkT-148009 does not worsen the patients' Parkinson's disease when dosed for seven days and that the pharmacology of Ikt-148009 patients is similar to that of a healthy subject of the same age.

Milton Werner: Based on these outcomes, we continue to believe that the results seen thus far in our Phase I and Phase II studies support the safety and therapeutic potential of 148009 as a disease-modifying treatment for Parkinson's, and we are working diligently to advance 148009 into a Phase III study.

Milton Werner: The Phase IIA study, dubbed the 201 trial will be a three-to-one randomized double-blind 12-week dosing trial that will evaluate the safety and tolerability of three doses of 148009 and up to one hundred and twenty patients diagnosed with Parkinson's who have not yet progressed to the need for symptomatic treatment. The trial will also measure a hierarchy of motor and non-motor function using patient and clinician-reported outcomes inside and outside of the brain at a secondary endpoint. And we'll evaluate whether treatment before 148009 leads to a reduction or clearance of pathogenic [inaudible] aggregates as exploratory endpoints. We are currently in the process of activating clinical sites and look forward to announcing dosing the first patients in the second quarter.

Speaker 4: Diagnosis with parkin tennmises who have not yet progressed to the need for symptomatic treatment.

Speaker 4: The trial will also measure a hierarchy of motor and non-motorve function using patient and clinician reported outcomes inside and outside of the brain at a secondary endpoint.

Speaker 4: And we'll evaluate whether treatment before two to nine leads to a reduction or clearance of pathogenic opicon aggregates as exploratory endpoints.

Speaker 4: We are currently in the process of activating clinical sites and look forward to anncing ghosting the first patients in the second quarter.

Milton Werner: Turning now to our preclinical efforts, we are dancing two programs that leverage our work in year generation.

Milton Werner: The first is IkT-001Pro, our pro drug formulation of ammonium methylate, which we have designed as a potentially safer, better-tolerated treatment for massive sensitive cancers such as stable Phase chronic myeloid leukemia.

Milton Werner: We are conducting the necessary stability studies for IND submission for the IND submission package and expect to submit the investigation on the drug application this quarter. Following receipt of a study made letter and other discussions with the FDA, we intend to commence [inaudible] studies in accordance with the 505-B2 regulatory pathway.

Milton Werner: Finally, we are continuing our preclinical work evaluating 148009 for the potential treatment of multiple system atrophy. As you may remember, MSA is a rare, rapidly progressive, neurodegenerative movement disorder that affects both the central and autonomic nervous systems.

Milton Werner: As you may remember, MSA is a rare, rapidly progressive, neurodegenerative movement disorder that affects both the central and autonomic nervous systems.

Milton Werner: Similar to Parkinson's, MSA is characterized by pathological [inaudible] aggregation which may lead to cell dysfunction and degeneration in neurons. MSA affects approximately twenty thousand people in the US and there are currently no approved treatments to slow or halt progression of this disease.

Milton Werner: These preclinical studies are evaluating whether inhibition of [inaudible] could have a therapeutic benefit in MSA and we expect to report data in at least one of two animal models in the second quarter of 2022.

Milton Werner: Preliminary readouts from one animal model study indicates that therapeutic administration of IkT-148009 has a beneficial effect. Depending on the full results from these model studies and subject to agreement with the FDA and equivalent regulatory bodies in the European Union, we may advance 148009 into a Phase IIA clinical study in the fourth quarter of 2022.

Milton Werner: Now, let me turn the call over to our CFO, Joe Fratterolli to review the financials. Joe? 

Joseph Fratteroli: Thank you, Milton. Let me review our financials for the three months ended March 31, 2022. For the first quarter of 2022, we reported a net loss of approximately $4.7 million, or 18 cents net loss per share, compared to a net loss of approximately $2.6 million or 26 cents net loss per share for the first quarter of 2021.

Joseph Fratteroli: Research and development expenses were approximately $3 million for the first quarter of 2022, compared to approximately $2.4 million for the first quarter of 2021. The increase was driven by a $2.1 million increase in non-grant-related research, offset by a decrease of $1.2 million in grant-related research expenditures and also a decrease of 0.4 million in non-cash stock compensation expense.

Joseph Fratteroli: Non-grant-related research was extended primarily in connection with the company's Phase I Parkinson's disease clinical trial. Selling, general, and administrative expenses were approximately $1.7 million for the first quarter 2022 compared to approximately $1.6 million from the same period in 2021. The increase was primarily due to increased headcount, resulting in increased compensation expenses of 0.2 million. Increased legal fees, Board fees, investor relation, and consulting fees of 0.1 million and a net increase of 0.2 million for the normal operating expenses, offset by decreased non-cash stock-based compensation expenses of 0.4 million. As of March 31, 2022, Inhibikase had approximately $36.6 million in cash and cash equivalents. We expect that our existing cash and cash equivalents will be sufficient to fund operating expenses and capital expenditure requirements into the third quarter of 2023. That concludes our financial statements. I'd like to hand the call back over to Milton for closing remarks.

Milton Werner: Thank you, Joe. We remain very excited about our progress and goals for the second quarter and anticipate achieving multiple milestones across our clinical and preclinical programs as we seek to significantly improve the lives of patients suffering from devastating neurogenic diseases. We expect to initiate a Phase IIA study for 148009, the application for 001Pro, and the report data from at least one preclinical [inaudible] program in this quarter. And despite the challenges posed by the current market conditions, we believe where taken together all of these efforts will position us for success in the long-term. To our shareholders, we continue to appreciate your unwavering support and we will continue to work tirelessly to drive shareholder value and improve patient outcomes. I would now like to open the call to questions. Operator?

Operator: Thank you. If you would like to ask question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press start two if you would like to remove your question from the queue, and for a participant using speaker equipment, it may be necessary to pick up your handset before pressing the star key.

Operator: Once again, that is star one on your telephone keypad. We will just pause for a brief moment to see if any questions come in.

Operator: Okay, there are no questions at this time. That would conclude today's conference. You may disconnect your lines at this time and thank you for your participation.

Speaker 2: You may disconnect your lines at this time and thank you for your participation.

Speaker 1: Pr V.

Speaker 1: The.