INITIATOR PHARMA: Q3 2023 REPORT

Regulatory

Business highlights in Q3 2023

  • In July the company announced that it has obtained positive data from a Phase I drug formulation and pharmacokinetics study in healthy subjects evaluating optimized oral solid dosage forms of pudafensine (IP2015), enabling a smooth and efficient bridging between previous data sets into new future clinical studies for pudafensine.
  • In August the company announced that the European Patent Office (“EPO”) has granted the company’s patent application for the product candidate IP2018, targeting monoamine reuptake transporters.
  • In September the company announced that the drug candidates, pudafensine and IP2018, have shown significant efficacy in preclinical models for Female Sexual Dysfunction (FSD). Based on the findings, the company is reviewing the potential to extend the clinical indications for the drug candidates to include FSD.

Business highlights after this reporting period

  • In October the company announced positive results from its Phase IIb clinical trial with pudafensine (IP2015) for the treatment of erectile dysfunction (ED). The study data analysis has demonstrated statistically significant and clinically relevant efficacy in ED-related endpoints and no observations of critical adverse events. The positive results, both regarding efficacy and safety, support further development of pudafensine aiming at registration and launch in this patient group with significant unmet medical need.

Financial Highlights

Third Quarter (2023-07-01 – 2023-10-30)
Net revenue were TDKK 0 (0)
Operating loss, EBIT was TDKK -5,191 (-6,689)
Earnings per share before and after dilution was DKK –0.09 (-0.13)
Cash: TDKK 21,781 (39,112)
Solidity: 36% (72%)
First Nine Months (2023-01-01 – 2023-09-30)
Net revenues were TDKK 0 (0)
Operating loss, EBIT was TDKK -22,750 (-35,263)
Earnings per share before and after dilution was DKK –0.46 (-0.68)

Solidity: equity divided by assets.

The Board of Directors have decided that interim reports will be published in English only.

Link to the full report
https://www.initiatorpharma.com/en/investors/reports-and-presentations/

For additional information about Initiator Pharma, please contact:

Claus Elsborg Olesen, CEO
Telephone: +45 6126 0035
E-mail: [email protected]

About Initiator Pharma

Initiator Pharma A/S is a Danish clinical stage emerging pharma company developing innovative drugs that target key unmet medical needs within the central and peripheral nervous system. Initiator Pharma’s pipeline consists of two clinical stage assets – pudafensine (IP2015) and IP2018 – and two preclinical assets. The company is currently conducting a Phase IIb trial with pudafensine (IP2015) in erectile dysfunction of organic origin, and successfully completed a Phase I proof of principle trial in neuropathic pain in 2022. With IP2018 the company has reported positive, statistically significant, and dose-dependent clinical observations related to efficacy in psychogenic erectile dysfunction (ED) in a Phase IIa clinical trial of IP2018 in patients with mild to moderate ED.

Initiator Pharma is listed on Nasdaq First North Growth Market (ticker: INIT). Redeye AB is the company’s Certified Adviser. For more information, please visit www.initiatorpharma.com.

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