Q&A session related topline data Study 0205

January 04, 2024 at 11:31 am EST

On 4 January - Cessatech A/S ("Cessatech" or "the Company") releases a short Question and Answers (Q&A) overview, based all the positive feedback and questions from the release of topline data from study 0205 on 22 December 2023.

1.Can the Company elaborate on the exposure data and levels in children compared to adults?
A: The exposure observed in children in both the 0201 and 0206 study showed a 2 times higher exposure of both sufentanil and ketamine compared to adults in both the 0204 and 0205 studies at similar weight-adjusted dosing, highlighting that children are not just small adults.

2.The simulated data done in children, are these the completed 0207 and 0208 studies?
A: Not completely, but much work has been done to be able to compare the adults data from study 0205 into the modelled and simulated data in children. This will obviously make the remaining part of study 0207 and 0208 easier.

3.Can the Company explain the reduction in pain compared to placebo, in layman's terms?
A: Descriptive statistics for CT001 from the study showed a pain reduction of approximately 40% at 30 minutes compared to baseline, while placebo showed an approximate 1-2% reduction at 30 minutes.

4.Has the Company had any discussions with EMA regarding the 0205 data and process?
A: A discussion with the EMA requires advanced planning and cannot be arranged with short notice. However, the Company has engaged with regulatory experts concerning the data and the strategic approach.

5.Did you see any sedation effect in the 0205 data?
A: As the exposure in adults were 2 times lower than in children, the sedative effect previously observed in children, was only observed in a few subjects in 0205.

6.Was the dose in the sufentanil arm the same as given for CT001?
A: The sufentanil dose in CT001 and the sufentanil arms were the same, while the exposure measured in blood samples from the CT001 arm was three times lower, compared the exposure in the sufentanil arm. Despite lower exposure, a similar pain reduction was observed, due to the presence of ketamine in CT001.

7.When will secondary endpoints be communicated
A: Secondary endpoints included mainly safety and tolerability, use of rescue medication, and analysis of various efficacy results at different timepoints. These will be communicated later in more detail.

8.What does it mean that the adult data of CT001 was not superior to sufentanil?
A: The treatment effect of CT001 was not statistically significantly better than sufentanil, but on par with sufentanil. The sufentanil exposure in the sufentanil arm was 3 times higher than the sufentanil exposure in CT001, resulting in similar clinically relevant pain reduction in both arms.

9.Can you elaborate on the opioid sparing effect
A: Across the 4 main treatment arms and the 12 supportive arms in the study there was a robust finding, that the presence of ketamine reduced the amount of sufentanil exposure needed with 50% to achieve the same pain reduction as observed for sufentanil only.

10.Can you be more specific on the anticipated US launch and EU partnerships?
A: The Company will soon give a more detailed update on the planned launch of CT001 in the US and other ongoing plans regarding partnerships.

For more information about Cessatech, please contact:
Jes Trygved, CEO
Phone: +45 9387 2309
E-mail: jes.trygved@cessatech.com
www.cessatech.com

About Cessatech
Cessatech A/S is a Danish pharmaceutical company committed to developing and commercializing evidence-based and innovative medicines for children for the treatment of paediatric acute pain. Its lead asset (CT001) is an analgesic nasal spray for the treatment of acute and planned painful procedures in children. The advantages include needle-free administration, easy administration, a fast-acting therapeutic effect, and being medically approved for children. CT001 is at its pivotal stage of clinical development, and CT002 is at the early development phase.

https://news.cision.com/cessatech/r/q-a-session-related-topline-data-study-0205,c3904372

https://mb.cision.com/Main/19921/3904372/2523484.pdf

End-of-day quote NORDIC GROWTH MARKET Other stock markets 06:00:00 2024-04-25 pm EDT			5-day change	1st Jan Change
6.62 ^DKK	+1.85%		+5.08%	-8.82%

Feb. 29	Cessatech A/S Reports Earnings Results for the Full Year Ended December 31, 2023	CI
2023	Cessatech A/S Reports Earnings Results for the Third Quarter and Nine Months Ended September 30, 2023	CI

Cessatech A/S Reports Earnings Results for the Full Year Ended December 31, 2023	Feb. 29	CI
Cessatech A/S Reports Earnings Results for the Third Quarter and Nine Months Ended September 30, 2023	Nov. 16	CI
Cessatech A/S Announces the Paediatric Committee Agrees to Reduce the Number of Required Children in the Final Clinical Study with CT001 from 300 to 150 Children	23-10-25	CI
Cessatech Announces Last Participant Dosed in Pivotal Trial 0205 with Lead Candidate CT001	23-09-21	CI
Cessatech Wins EU Nod for Clinical Studies of Nasal Sedation Spray in Children; Shares Soar 21%	23-09-12	MT
Cessatech A/S Announces EMA's Paediatric Committee Agrees to Paediatric Investigational Plan for CT002 for Procedural Sedation	23-09-12	CI
Cessatech A/S Reports Earnings Results for the Second Quarter and Six Months Ended June 30, 2023	23-08-24	CI
Cessatech A/S Secures DKK 5 Million Loan Facility Agreement to Support the US Launch of its Lead Program CT001	23-08-17	CI
Cessatech A/S and Ventis Pharma Announce US Partnership for CT001	23-06-27	CI
Cessatech A/S Reports Earnings Results for the First Quarter Ended March 31, 2023	23-04-29	CI
Cessatech A/S Appoints Martin Olin as the Chairman of the Board	23-03-23	CI
Cessatech A/S Reports Earnings Results for the Fourth Quarter Ended December 31, 2022	23-03-01	CI
Cessatech A/S Reports Earnings Results for the Full Year Ended December 31, 2022	23-02-28	CI
Cessatech A/S Auditor Raises 'Going Concern' Doubt	23-02-27	CI
Cessatech A/S Reports Earnings Results for the Third Quarter and Nine Months Ended September 30, 2022	22-11-18	CI
Cessatech to Raise $2 Million in Rights Offer	22-11-14	MT
Cessatech Reports Successful Outcome of Pharmacokinetic Trial in Children of Lead Candidate	22-09-23	CI
Cessatech A/S Reports First Patient Dosed in Pivotal Trial of Lead Product Candidate	22-09-05	CI
Cessatech A/S Reports Earnings Results for the Second Quarter and Six Months Ended June 30, 2022	22-08-19	CI
Cessatech A/S Announces Pivotal Trial 0205 Has Obtained Regulatory Approval	22-06-30	CI
Cessatech Reports Last Patient Dosed in Pharmacokinetic Trial in Children of Lead Candidate	22-05-16	CI
Cessatech A/S Reports Earnings Results for the First Quarter Ended March 31, 2022	22-04-19	CI
Cessatech A/S Announces Board Changes	22-03-17	CI
Cessatech Reports Successful Outcome of Bioavailability Trial 0204 with CT001	22-03-08	CI
Cessatech A/S Reports Earnings Results for the Fourth Quarter Ended December 31, 2021	22-02-24	CI

Cessatech A/S

Equities

CESSA

DK0061411964

Q&A session related topline data Study 0205

Latest news about Cessatech A/S

Chart Cessatech A/S

Company Profile

Income Statement Evolution