New Risk • May 15
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -kr.26m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-kr.26m free cash flow). Revenue is less than US$1m. Minor Risks Shareholders have been diluted in the past year (22% increase in shares outstanding). Market cap is less than US$100m (kr201.9m market cap, or US$21.6m). Announcement • May 13
Initiator Pharma A/S, Annual General Meeting, May 29, 2026 Initiator Pharma A/S, Annual General Meeting, May 29, 2026, at 10:00 Romance Standard Time. Location: office of dla piper denmark, oslo plads 2, 2100 copenhagen oe, denmark, Denmark New Risk • May 11
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -kr.26m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-kr.26m free cash flow). Earnings are forecast to decline by an average of 7.4% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (kr.25m net loss in 2 years). Shareholders have been diluted in the past year (22% increase in shares outstanding). Market cap is less than US$100m (kr230.0m market cap, or US$24.8m). Breakeven Date Change • Feb 23 The 2 analysts covering Initiator Pharma previously expected the company to break even in 2026. New consensus forecast suggests the company will make a profit of kr.22.0m in 2026.
New Risk • Feb 23
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 8.1% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Earnings are forecast to decline by an average of 8.1% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Shareholders have been diluted in the past year (22% increase in shares outstanding). Market cap is less than US$100m (kr234.1m market cap, or US$25.8m). Breakeven Date Change • Aug 25
Forecast breakeven date pushed back to 2026 The 2 analysts covering Initiator Pharma previously expected the company to break even in 2025. New consensus forecast suggests the company will make a profit of kr.21.5m in 2026. Average annual earnings growth of 80% is required to achieve expected profit on schedule. New Risk • Aug 24
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -kr.12m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-kr.12m free cash flow). Earnings are forecast to decline by an average of 7.7% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Shareholders have been diluted in the past year (22% increase in shares outstanding). Market cap is less than US$100m (kr246.4m market cap, or US$25.9m). New Risk • Jul 04
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 22% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Earnings are forecast to decline by an average of 1.5% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Share price has been volatile over the past 3 months (12% average weekly change). Shareholders have been diluted in the past year (22% increase in shares outstanding). Market cap is less than US$100m (kr276.4m market cap, or US$28.9m). Announcement • May 23
Initiator Pharma A/S Elects Göran Ando as Members of the Board Initiator Pharma A/S held its annual general meeting on May 23, 2025 and elected Göran Ando as members of the board of directors unanimously. Announcement • May 20
Initiator Pharma A/S has filed a Follow-on Equity Offering in the amount of SEK 56.15836 million. Initiator Pharma A/S has filed a Follow-on Equity Offering in the amount of SEK 56.15836 million.
Security Name: Shares
Security Type: Common Stock
Securities Offered: 14,039,590
Price\Range: SEK 4
Transaction Features: Rights Offering New Risk • May 19
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of Swedish stocks, typically moving 12% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Earnings are forecast to decline by an average of 3.7% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Share price has been volatile over the past 3 months (12% average weekly change). Market cap is less than US$100m (kr219.0m market cap, or US$22.6m). Announcement • May 07
Initiator Pharma A/S, Annual General Meeting, May 23, 2025 Initiator Pharma A/S, Annual General Meeting, May 23, 2025, at 10:00 Romance Standard Time. Location: at the office of dla piper denmark, oslo plads 2, 2100 copenhagen oe Denmark New Risk • Mar 04
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 0.3% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Earnings are forecast to decline by an average of 0.3% per year for the foreseeable future. Revenue is less than US$1m. Minor Risk Market cap is less than US$100m (kr370.5m market cap, or US$35.2m). New Risk • Mar 03
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -kr.11m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-kr.11m free cash flow). Revenue is less than US$1m. Minor Risk Market cap is less than US$100m (kr401.4m market cap, or US$37.6m). New Risk • Jan 13
New major risk - Financial data availability The company has not reported any financial data. This is considered a major risk. With no or incomplete audited reported financial data, it is virtually impossible to assess the company's investment potential. Currently, the following risks have been identified for the company: Major Risk No financial data reported. Minor Risks Shareholders have been diluted in the past year (7.1% increase in shares outstanding). Market cap is less than US$100m (kr407.0m market cap, or US$36.3m). Breakeven Date Change • Nov 29
Forecast breakeven date pushed back to 2025 The 2 analysts covering Initiator Pharma previously expected the company to break even in 2024. New consensus forecast suggests the company will make a profit of kr.35.0m in 2025. Average annual earnings growth of 33% is required to achieve expected profit on schedule. New Risk • Aug 27
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 6.8% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-kr.16m free cash flow). Earnings are forecast to decline by an average of 27% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Shareholders have been diluted in the past year (6.8% increase in shares outstanding). Market cap is less than US$100m (kr440.0m market cap, or US$43.2m). Buy Or Sell Opportunity • Jul 09
Now 20% undervalued Over the last 90 days, the stock has risen 8.5% to kr9.20. The fair value is estimated to be kr11.54, however this is not to be taken as a buy recommendation but rather should be used as a guide only. New Risk • Jul 01
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -kr.19m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-kr.19m free cash flow). Earnings are forecast to decline by an average of 5.5% per year for the foreseeable future. Revenue is less than US$1m. Minor Risk Market cap is less than US$100m (kr518.6m market cap, or US$48.9m). New Risk • May 12
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 5.5% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Earnings are forecast to decline by an average of 5.5% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Less than 1 year of cash runway based on current free cash flow (-kr.19m). Market cap is less than US$100m (kr486.8m market cap, or US$44.9m). New Risk • May 10
New major risk - Revenue and earnings growth Earnings have declined by 33% per year over the past 5 years. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are declining over an extended period, then in most cases the share price will decline over time unless the company can turn around its fortunes. A trend of falling earnings can be very difficult to turn around. If the company is well already established it may also be a sign the company has matured and is in decline. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Earnings have declined by 33% per year over the past 5 years. Revenue is less than US$1m. Minor Risk Market cap is less than US$100m (kr486.8m market cap, or US$44.9m). New Risk • Feb 23
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 7.0% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risk Revenue is less than US$1m. Minor Risks Less than 1 year of cash runway based on current free cash flow (-kr.28m). Shareholders have been diluted in the past year (7.0% increase in shares outstanding). Market cap is less than US$100m (kr480.9m market cap, or US$46.6m). Announcement • Jan 10
Initiator Pharma A/S to Report Fiscal Year 2023 Final Results between Apr 29, 2024 and May 03, 2024 Initiator Pharma A/S announced that they will report fiscal year 2023 final results at 9:00 AM, Central European Standard Time on between Apr 29, 2024 and May 03, 2024 Announcement • Jan 08
Initiator Pharma A/S Expands Its Position to Broader Sexual Health Franchise and Intends Business Development Efforts Initiator Pharma A/S announced that the company will expand the position of the company to a broader Sexual Health Franchise including both male Erectile Dysfunction (ED) and Female Sexual Dysfunction (FSD) indications. Initiator Pharma will be in San Francisco to present the company at business and investor meetings during the 42nd Annual J.P. Morgan Healthcare Conference January 8 to 11. In September 2023 Initiator announced that the drug candidates, pudafensine and IP2018, had showed significant efficacy in preclinical models for Female Sexual Dysfunction (F SD) and that the company was reviewing the potential to extend the clinical indications for the drug candidates, to include FSD. During the fourth quarter 2023 a strategic review of the FSD opportunity has been completed. Based on the data obtained in the preclinical models, and a commercial assessment, the management and board of directors have decided to build on the strong data obtained from the Phase II clinical trials in male ED and expand the position of Initiator Pharma to a broader Sexual Health Franchise, offering great life cycle management and significant revenue and earning opportunities. Initiator will present its extended opportunity at business and investor meetings in connection with the 42nd Annual J.p. Morgan Healthcare Conference in San Francisco. The commercial potential within the FSD area is considered to be very attractive. The total female sexual dysfunction treatment market size is expected to grow by USD 7.76 billion from 2022 to 2027, at a CAGR of 34.28%, according to Technavio Research. Initiator Pharma's analysis of its FSD commercial opportunity, executed by the well-reputed marketing and pricing strategy firm Global Life Sciences in the UK, has conservatively concluded that a product for underserved women suffering from FSD/HSDD (Female sexual dysfunction/Hypo-Sexual Desire Disorder) has the potential to reach peak sales of USD 2 billion. Initiator Pharma will capture the FSD opportunity in a de-risked way complementing the clinical development of the company's current programs within ED, where Initiator Pharma has already successfully completed phase 2a and 2b trials for its two lead drug candidates, respectively. Female sexual dysfunction (FSD) includes a range of issues such as hypo-sexual desire disorder (low libido), difficulty achieving arousal, pain during intercourse, and inability to reach orgasm. Female hypo-sexual desire disorder (HSDD) in the US occurs in 10% of women, independent of age. FSD can profoundly affect the individual's quality of life and relationships due to the distress, low self- esteem, and anxiety it causes. There are medical treatment options for young women with FSD, but despite the current options, a large unmet need is to restore the desire for an intimate relationship with the partner. Initiator Pharma will investigate the potential for its products with a priority on postmenopausal women with FSD, where there currently is no available treatment option. Pudafensine and IP2018 offer the potential as first-line treatment options in postmenopausal generalized, acquired HSDD - where it would be positioned as the first approved therapy. Both products offer the potential of clear differentiation from current FSD drugs, with the key differentiators: Non-hormonal mechanism of action. Clean safety/tolerability, with drug interaction or contraindication issues (as shown in completed trials in men no Erectile Dysfunction). Convenient, improved efficacy to Addyi and Vyleesi (currently only approved for use in HSDD in premenopausal women). Announcement • Nov 10
Initiator Pharma A/S, Annual General Meeting, May 24, 2024 Initiator Pharma A/S, Annual General Meeting, May 24, 2024. New Risk • Oct 06
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of Swedish stocks, typically moving 9.8% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risk Revenue is less than US$1m. Minor Risks Less than 1 year of cash runway based on current free cash flow (-kr.29m). Share price has been volatile over the past 3 months (9.8% average weekly change). Market cap is less than US$100m (kr515.3m market cap, or US$47.1m). Announcement • Sep 20
Initiator Pharma A/S Announces Indication Expansion - Clinical Drug Candidates Active in Models of Female Sexual Dysfunction Initiator Pharma A/S 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. During the last two years, Initiator Pharma has internally investigated its phase II drug candidates, pudafenedine and IP2018, currently developed in two types of male Erectile Dysfunction, in preclinical models for Female sexual dysfunction (FSD). Significant efficacy has been shown for both pudafensine andIP2018 in the animal models tested for FSD. The tested models are highly relevant and offer a way to predict efficacy in the clinical setting. Based on these promising findings, the board and leadership team are reviewing the potential for extending the previous efforts in male erectile dysfunction (ED) also to include FSD. In ED significant clinical efficacy has been shown in phase II trials, and Initiator Pharma is developing a strategy to tackle sexual health disorders covering both female and male sexual dysfunctions. The strategic review will include the data generated to establish the best development plan, positioning and commercialization strategy for these two assets going forward. The review will be executed in Fourth Quarter, 2023, from both a commercial and clinical perspective, to best capture and optimize the large potential value offered by these two assets. New Risk • Aug 27
New minor risk - Financial position The company has less than a year of cash runway based on its current free cash flow. Free cash flow: -kr.29m This is considered a minor risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risk Revenue is less than US$1m. Minor Risks Less than 1 year of cash runway based on current free cash flow (-kr.29m). Share price has been volatile over the past 3 months (11% average weekly change). Market cap is less than US$100m (kr387.7m market cap, or US$35.1m). Announcement • Jul 21
Initiator Pharma A/S Announces Positive Results from Pudafensine Phase I Pharmacokinetic Trial Initiator Pharma A/S 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. The Phase I study is an open-labeled randomized study of 12 healthy subjects evaluating current and new oral solid dosage formulations of pudafensine. The study demonstrated that the new oral solid dosing formulations provide relevant drug bioavailability and pharmacokinetic drug release profiles supporting the future treatment settings in Phase II and III trials. The reported adverse events were of mild severity and only potentially related to treatment. Announcement • Jun 30
Initiator Pharma A/S Completes Recruitment in Phase IIb Trial with Pudafensine (IP2015) Initiator Pharma A/S announced that it has completed recruitment of all planned patients for its Phase IIb clinical trial with pudafensine (IP2015). Results are expected in Fourth Quarter 2023. The primary objective of the Phase IIb trial is to investigate the effects of repeat single oral doses of pudafensine on male subjects with severe or moderate erectile dysfunction (ED) on the ability to develop and maintain an erection, with weekly assessments during a 4-week treatment period. The Phase IIb trial is a randomized, double-blind, placebo-controlled, parallel dosing group trial studying the efficacy and safety of high and low doses of pudafensine as well as placebo in patients suffering from severe to moderate ED. The study is conducted at the MAC clinical sites in the UK. All planned 120 patients have been recruited and the last patients are undergoing the final dosing regimen, and the efficacy and safety assessments are being conducted as planned. Data analysis will be initiated after last patient last visit, and results are scheduled to be provided in Fourth Quarter 2023. Announcement • Jun 06
Initiator Pharma A/S Reports Dose-Dose-Dose-dependent Significant Erectile Dysfunction of IP 2018 in the Placebo-Controlled Phase IIa Clinical Trial of Erectile Dysfunction Initiator Pharma A/S announced positive, statistically significant, and dose-dependent clinical observations related to efficacy in psychogenic erectile dysfunction (ED) and no observations of serious or critical adverse events in the Phase IIa clinical trial of IP2018 in patients with mild to moderate ED. The Phase IIa trial is a randomized, double-blind, placebo-controlled, 3-way crossover trial studying the efficacy and safety of a low and a high dose of IP2018 as well as a placebo in young, depressed patients who have erectile dysfunction. The primary objective of this study was to investigate the effects of IP2018 on penile rigidity and tumescence using a visual sexual stimulation test. Twenty-four patients with mild to moderate depression and erectile dysfunction completed the study. The high dose of IP2018 in single oral administration increased penile tumescence (p=0.04) and duration of rigidity (p=0.025) in a statistically significant way, sufficient for intercourse. The effect of IP2018 on erectile function was dose-dependent. The study demonstrated promising, clinically relevant efficacy data related to ED, supporting a new treatment paradigm for this patient segment. In addition, no safety observations of concern have been reported. Headache and gastrointestinal adverse events of mild character were the most common. IP2018 is developed to treat psychogenic erectile dysfunction (ED), which is the inability to achieve or maintain an erection during sexual intercourse due to psychological factors. Up to 68% of patients undergoing treatment for depressive disorder also suffer from sexual dysfunction. The patient segment thus represents a clear unmet medical need. IP2018 has the potential to help these patients and significantly increase their quality of life. In addition, IP2018 broadens the scope of Initiator Pharma pipeline, including first-in-class treatments for psychogenic and organic ED, IP2018 and pudafensine (IP2015), respectively. Breakeven Date Change • Feb 17
Forecast breakeven date pushed back to 2024 The analyst covering Initiator Pharma previously expected the company to break even in 2023. New forecast suggests the company will make a profit of kr.75.0m in 2024. Average annual earnings growth of 98% is required to achieve expected profit on schedule. Announcement • Feb 08
Initiator Pharma A/S to Report Fiscal Year 2022 Results on May 01, 2023 Initiator Pharma A/S announced that they will report fiscal year 2022 results on May 01, 2023 Announcement • Dec 21
Initiator Pharma A/S Ready to Start Phase I Pharmacokinetics Study for New IP2015 Formulations Initiator Pharma A/S announced that it will initiate a Phase I pharmacokinetic study in healthy subects evaluating new oral solid dosage forms enabling a bridging between previous data sets into new future clinical studies for IP2015. The Phase I study will be an open labelled randomized study in 12 healthy subjects evaluating current and new oral solid dosage formulations of IP2015. It was approved by the British Regularotory Authorities, MHRA and the Ethics Committee and is expected to start in the beginning of 2023 and provide draft phamacokinetic data in Second Quarter 2023. The study will also strengthen the intellectual property rights (IPR) portfolio for the entire IP2015 program. Board Change • Nov 16
No independent directors Following the recent departure of a director, there are no independent directors on the board. The company's board is composed of: No independent directors. 6 non-independent directors. Director Gunilla Ekstrom was the last director to join the board, commencing their role in 2022. The company's lack of independent directors is a risk according to the Simply Wall St Risk Model. Announcement • Nov 05
Initiator Pharma A/S Provides an Update on Its Clinical Programs Initiator Pharma A/S announced an update on its ongoing and planned clinical studies. 22 out of 24 patients have beenare expected to ongoing Phase IIa study in the IP2018 trial program. The two last patients enrolled in the be included shortly so read-outs of the are expected no later than second quarter of 2023. A protocol amendment has been submitted to regulatory authorities for the ongoing Phase IIb study in the IPED2015 program in order to optimize patient recruitment without compromising the relevance of data readouts at completion of the trial. A pharmacokinetic study will be initiated in the IPTN2021 program to support the future clinical development program in neuropathic pain, with the aim of generating more data as a guidance to priorities going forward in the program and to enhance the IP position relating to the program. Initiator Pharma confirms that the above activities are fully financed through the capital raise closed during summer 2022 and that the proceeds raised during the summer of 2022 will be sufficient to fund all currently planned activities to the end of 2024. Initiator Pharma's pipeline consists of three clinical programs - the IP2018 and IPED2015 programs for treatment of Erectile Dysfunction of psychogenic and organic origin, respectively, and the orphan drug program IPTN2021 developed for neuropathic pain. Furthermore, Initiator Pharma has entered an exclusive option agreement for a Phase II/III ready pharmaceutical asset for an undisclosed pain indication, which currently is under evaluation. IP2018 is a monoamine reuptake inhibitor developed for the treatment of psychogenic Erectile Dysfunction (ED) mainly caused by anxiety and depression, targeting both the serotonin and the dopamine system. A clinical Phase IIa study in 24 depressed ED patients is being conducted at the MAC Phase I unit in Manchester, UK. Recruitment to the study has been somewhat slower than expected. 22 out of the total 24 patients in the trial have this far been enrolled. The clinical trial could still be completed before the end of the year, given that the last two patients are successfully enrolled in the near future, but it might run into the first quarter of 2023. Announcement • Sep 22
Initiator Pharma A/S Reports the Final Analysis of Positive Efficacy Data from the IPTN2021 Program Phase I Study Initiator Pharma A/S announced that the final dataset and study- report analysis have been obtained in the IPTN2021 program. The IPTN2021 program is a clinical Phase I study in healthy subjects dosed with the drug IP2015 and challenged with a pain-inducing ingredient (capsaicin). The final analysis confirms the statistically significant effects on pain measures that were observed in the analysis of the first data read-out from the study presented in May 2022. The objective of the study in healthy subjects was to validate and demonstrate that the effect of IP2015 in preclinical animal models can be translated into pain relief in the human setting. The pain assessments in the study covered a range of pain measures, e.g., allodynia and hyperalgesia, and has provided Initiator Pharma with supportive data that will help guide the continued development and design of the IPTN2021 program. The Phase I study was a randomized, double#blind, placebo#controlled study in 24 healthy male subjects, investigating the effects on pain measures (hyperalgesia, allodynia, and subjects pain rating) of single doses of IP2015, pregabalin as an active control, and placebo. The pain was induced by intradermal capsaicin. As previously communicated and still evident, IP2015 demonstrated a statistically significant effect on allodynia (p=0.049) and showed a dose-dependent effect on the measured pain parameters. Pregabalin (p=0.083) and IP2015 (p=0.051) tended to reduce hyperalgesia, although the effects on hyperalgesia were not statistically significant compared to placebo-treated subjects. In the assessment of subjective pain ratings, the mean values for IP2015 showed 2- and 5-fold higher effects compared to pregabalin and placebo, respectively. In support of these positive results, IP2015 demonstrated data in the Quantitative Sensory Test pain assessments related to pain in line with the primary pain assessments provided above. In the heat detection and thermal sensory (warm) threshold tests, respectively, statistically significant outcomes were detected for IP2015 when tested within test subjects. In addition as communicated before, there were no observations of unexpected adverse events, and IP2015 demonstrated a supportive safety profile compared to pregabalin. IP2015 is a monoamine reuptake inhibitor, preferentially inhibiting dopamine reuptake followed by serotonin uptake, and with markedly less effect on noradrenaline uptake in vivo. IP2015 is also in clinical development for the treatment of erectile dysfunction. Pregabalin is currently recommended as first-line medication against a number of neuropathic pain indications and binds to a subunit (2-subunit) of voltage-gated calcium channels and reduces presynaptic release of neurotransmitters. Announcement • May 23
Initiator Pharma A/S Reports Positive Efficacy Data Outcome of the Iptn2021 Program Phase I Study to Assess Pain-Reducing Effects Initiator Pharma A/S announced that analysis of the first data read-out has been obtained in the IPTN2021 program clinical Phase I study in healthy subjects dosed with the drug substance IP2015, and challenged with a pain-inducing ingredient (capsaicin). Initiator Pharma has received topline from the Phase I study,and the first statistical evaluations have been made. The study is a randomized, double-blind, placebo-controlled study in 24 healthy male subjects, investigating the effects on pain measures (hyperalgesia, allodynia, and subjects pain rating) of single doses of IP2015, pregabalin as active control, and placebo. The pain was induced by intradermal capsaicin. IP2015 demonstrated a statistical significant effect on allodynia (p=0.049) and showed a dose-dependent effect on the measured pain parameters. Pregabalin (p=0.083) and IP2015 (p=0.051) tended to reduce hyperalgesia, although the effects on hypoalgesia were not statistically significant compared to placebo-treated subjects. In addition, there were no observations of unexpected adverse events. Further analysis of incoming data is in progress. A final report is expected in the third quarter of 2022 and the company plans to update the market at that time. IP2015 is a monoamine reuptake inhibitor, preferentially inhibiting dopamine reuptake followed by serotonin uptake, and with markedly less effect on noradrenaline uptake in vivo. IP2015 is also in clinical development for treatment of erectile dysfunction. Pregabalin is currently recommended as first-line medication against a number of neuropathic pain indications and binds to a subunit (2- subunit) of voltage-gated calcium channels and reduce presynaptic release of neurotransmitters. Board Change • Apr 27
No independent directors Following the recent departure of a director, there are no independent directors on the board. The company's board is composed of: No independent directors. 5 non-independent directors. Director Annette Colin was the last director to join the board, commencing their role in 2021. The company's lack of independent directors is a risk according to the Simply Wall St Risk Model. Announcement • Apr 15
Initiator Pharma A/S announced that it expects to receive SEK 19.999995 million in funding from Adrigo Asset Management AB, Linc AB Initiator Pharma A/S announced a private placement of 2,666,666 common shares at a price of SEK 7.5 per share for gross proceeds of SEK 19,999,995 on April 13, 2022. The transaction will include participation from returning investors Adrigo Asset Management AB and Linc AB for 1,333,333 shares each. As a part of the transaction, investors will collectively acquire 5.7% stake in the company. Post closing, the total number of shares issued by the company will increase from 43,772,462 shares to 46,439,128 shares. All shares to be issued in the transaction will be subject to a lock-up period of 90 days. The transaction has been approved by the board of directors of the company, and is subject to shareholders' approval. Announcement • Apr 06
Initiator Pharma A/S Signs Option Agreement for Late-Stage Drug Candidate Initiator Pharma A/S announced that it has signed an exclusive option agreement for a Phase 2/3 ready drug asset for an undisclosed pain indication. Initiator Pharma intends to continue the evalution of the drug candidate. A key task is to design a regulatory and clinical development plan that fulfills the Target Product Profile for the undisclosed pain indication, that can be completed in a time and cost-efficient manner. The drug candidate has through previously conducted clinical studies already been de-risked to a high extent, demonstrating exploratory clinical efficacy in the selected indication. Initiator Pharma will disclose more information about the asset and development after having completed evaluation during the option period ending 31 December 2022. This pain asset fits well into Initiator Pharma's business strategy of creating company and shareholder value by developing attractive drug candidates to value inflection points in a cost-efficient manner. The exclusive option agreement contains no upfront or initial milestone payments. If Initiator Pharma Chooses to exercise the option it triggers a signing payment, two late-stage development milestones; i) Positive Phase 3 result and ii) Market approval, and a low single digit percentage on Initiator Pharma's revenues on this asset only. Announcement • Feb 16
Initiator Pharma A/S Appoints Christina Guldberg as Senior Director, Clinical Development and Outcomes Research, Effective on March 1, 2022 Initiator Pharma A/S announced the appointment of Christina Guldberg as Senior Director, Clinical Development and Outcomes Research (Rare Diseases), a new position designed to strengthen the company's clinical development and Orphan drug capabilities. Christina Guldberg will assume her position on March 1, 2022. Christina Guldberg comes from the position as Director Clinical Outcomes at Orphazyme A/S which she has held since 2017. She has a vast pharma experience in drug development and clinical development with a focus on rare diseases including companies like uniQure, Zealand Pharma, Novo Nordisk and Ferring Pharmaceuticals. Announcement • Jan 22
Initiator Pharma A/S Initiates Dosing in the IPTN2021 Program Phase I Study to Assess Pain Reducing Effects Initiator Pharma A/S announced that the first subject has been dosed with the drug substance IP2015 in the IPTN2021 program clinical Phase I study in healthy subjects challenged with pain inducing ingredient (capsaicin). The dosing in Initiator Pharma's Phase I study has started as planned and according to the Authority and Ethics Committee approved study protocol. The study is a randomised, double#blind, placebo#controlled study to investigate the pharmacodynamic effects of IP2015 in 24 healthy male subjects using the intradermal capsaicin model. The study is carried out in collaboration with MAC Clinical Research, UK, as a single site study. Pending current and future Covid-19 restrictions, first results are expected sometimes during the second quarter 2022. Announcement • Dec 18
Initiator Pharma A/S Announces an Update on its Clinical Programs Initiator Pharma A/S announced an update on its clinical programs IPED2015, IP2018 and IPTN2021 for erectile dysfunction and neuropathic pain. All programs are progressing according to plan, although full patient inclusion in the IP2018 Phase 2a trial is expected to occur in the first part of 2022. IPED2015 Program: The patient recruitment rate in the ongoing Phase 2b trial with the drug substance IP2015 is progressing according to plan. Inclusion and dosing of patients should be completed in H2 2022, pending the development of the Covid-19 pandemic. The Phase 2b trial received CTA approval from the MHRA in UK and the Ethics Committee in June 2021, and the first patient was dosed in September 2021. The Phase 2b study is a randomized, double-blind, parallel-group, repeat single oral dose study of IP2015 or placebo in otherwise healthy organic erectile dysfunction patients. The plan is to include 120 patients in the study divided into 3 parallel arms receiving a higher (also used in the first Phase 2a study) and a lower dose of IP2015 and placebo, respectively. The treatment consists of 4 dosings over four weeks with frequent assessments of erectile dysfunction, safety, and pharmacokinetics. IP2018 Program: The patient recruitment rate in the ongoing Phase 2a study with the drug substance IP2018 has increased significantly since Initiator in July 2021 obtained approval from the regulatory authorities to modify certain inclusion criteria. However, recruitment rate is still impacted by the Covid-19 pandemic, especially the patient segment targeted in this trial seems to be significantly impacted. The patient recruitment is expected to be completed in the first part of 2022. The Phase 2a trial is a randomised, double-blind, placebo-controlled, 3-way crossover trial (placebo, high dose IP2018 and low dose IP2018) studying the efficacy and safety of IP2018 in 24 patients depressed, erectile dysfunction patients. The primary objective of the study is to investigate the effects of IP2018 on penile rigidity and tumescence using visual sexual stimulation test. The study is conducted at the MAC unit in Manchester, UK. IPTN2021 Program: Initiator received CTA approval from the MHRA in UK and the Ethics Committee in November 2021 for a Phase 1 study, with the drug substance IP2015, targeting the orphan drug indication trigeminal neuralgia. Subject inclusion and dosing is expected to commence in the beginning of 2022. The planned Phase 1 study in the IPTN2021 program is a pain challenge in healthy subjects challenged with pain inducing ingredient (capsaicin) with the objective to generate PK/PD understanding of the drug substance IP2015 in the pain setting. The trial is designed as a randomised, double#blind, placebo#controlled, 4-way crossover study with 2 dose levels of IPTN2021, placebo and pregabalin. The trial will be carried out in collaboration with MAC Clinical Research, UK, as a single site study. Announcement • Nov 27
Initiator Pharma A/S Receives CTA Approval for Iptn2021 Program Phase I Study to Assess Pain Reducing Effects Initiator Pharma A/S announced that it has received approval of a Clinical Trials Application for its planned Phase I study in the IPTN2021 program with the drug substance IP2015 in healthy subjects challenged with pain inducing ingredient (capsaicin). Initiator Pharma’s Clinical Trial Application (CTA) for its planned Phase I study in healthy male subjects has been approved by the Medicines & Healthcare products Regulatory Agency, MHRA, UK as well as the local Ethics Committee. Subject inclusion and dosing is expected to commence in January 2022. The study will be carried out in collaboration with MAC Clinical Research, UK, as a single site study. Initiator Pharma A/S, a clinical-stage pharma company, announced that it has received approval of a Clinical Trials Application for its planned Phase I study in the IPTN2021 program with the drug substance IP2015 in healthy subjects challenged with pain inducing ingredient (capsaicin). Initiator Pharma’s Clinical Trial Application (CTA) for its planned Phase I study in healthy male subjects has been approved by the Medicines & Healthcare products Regulatory Agency, MHRA, UK as well as the local Ethics Committee. Subject inclusion and dosing is expected to commence in January 2022. The study will be carried out in collaboration with MAC Clinical Research, UK, as a single site study. IP2015: IP2015 is the drug substance used in the IPTN2021 trial. It is a monoamine reuptake inhibitor preferentially inhibiting dopamine and serotonin reuptake. IP2015 is superior to duloxetine in the rat formaldehyde pain model and the rat sciatic chronic constriction injury (CCI) model. Moreover, safety of IP2015 is superior compared to duloxetine, and no risk for drug interactions has been detected. IP2015 is also the active pharmaceutical ingredient used in the IPED2015 program, that is currently undergoing Phase IIb testing in 120 patients for organic erectile dysfunction. Announcement • Sep 25
Initiator Pharma Includes the First Patient in Phase 2B Study with Iped2015 in Erectile Dysfunction Patients Initiator Pharma A/S announced that it has dosed the first patient in the Phase 2b study in Erectile Dysfunction (ED) patients with the drug candidate IPED2015. The study is carried out in collaboration with MAC Clinical Research, UK, at multiple centers across UK. The Phase 2b study is a randomized, double-blind, parallel-group, repeat single oral dose study of IPED2015 or placebo in otherwise healthy organic Erectile Dysfunction patients. The plan is to include 120 patients in the study divided into 3 parallel arms receiving a higher (also used in the first Phase IIa study) and a lower dose of IPED2015 and placebo, respectively, and treatment for 4 weeks with frequent assessments of erectile dysfunction, safety and pharmacokinetics. The aim is to report results from the study in H2 2022. IPED2015 is a small molecule that preferentially binds to the dopamine transporters (DAT), and potently inhibits DAT, the noradrenaline transporter (NAT), and the sodium-dependent serotonin transporters (SERT). By binding to DAT IPED2015 increases dopamine in the brain and induces erection in rats. IPED2015 also has a direct effect in erectile tissue, where it leads to relaxation of erectile smooth muscle. IPED2015 has successfully been through a Phase 2a Proof-of-Concept study. Results from the study support the goal of further developing an oral formulation of IPED2015 for the treatment of moderate and severe erectile dysfunction in patients who do not respond to current therapies. Announcement • Jun 02
Initiator Pharma Receives Approval for Phase 2a Study with IP2018 Initiator Pharma A/S announced that it has received approval from the Medicines and Healthcare products Regulatory Agency, MHRA, UK and the Ethics Committee for optimizing the study execution of its Phase 2a study with IP2018. As previously communicated the recruitment rate for the randomised, double-blind, placebo-controlled, 3-way crossover trial studying the efficacy and safety of IP2018 in depressed, Erectile Dysfunction (ED) Patients has been slow due to the ongoing Covid-19 pandemic. In order to mitigate the situation and ensure a successful completion of the trial Initiator Pharma has obtained approval from the regulatory authorities to modify certain inclusion criteria. Furthermore, the high vaccination ratio and the forthcoming reopening of the British society, the recruitment rate is expected to increase. The primary objective of the study is to investigate the effects of IP2018 on penile rigidity and tumescence using visual sexual stimulation test. The study is conducted in 24 patients at the MAC Phase I unit in Manchester, UK. IP2018 is a monoamine reuptake inhibitor and inhibits the synaptic reuptake of serotonin, noradrenaline, and dopamine. IP2018 preferentially inhibits serotonin followed by dopamine reuptake, while it has markedly less effect on the noradrenaline reuptake. IP2018 has antidepressive effect in animal models for depression and effect on erectile function. There is solid preclinical data package, a phase I study, and a positive emission tomography (PET) study showing binding in patients to the serotonin reuptake and dopamine reuptake transporter. Breakeven Date Change • May 28
Forecast to breakeven in 2023 The analyst covering Initiator Pharma expects the company to break even for the first time. New forecast suggests the company will make a profit of kr.68.3m in 2023. Average annual earnings growth of 96% is required to achieve expected profit on schedule. Announcement • Apr 27
Initiator Pharma A/S Files its Clinical Trial Application for its Planned Phase II Study in Erectile Dysfunction Patients with IPED2015 Initiator Pharma A/S announced that it has filed its Clinical Trial Application (CTA) for its planned Phase II study in Erectile Dysfunction patients with IPED2015 to the Medicines & Healthcare products Regulatory Agency, MHRA, UK as well as the Ethics Committee. Pending the Covid-19 situation, an approval to initiate the patient recruitment and dosing is expected sometime in the late summer. The study will be carried out in collaboration with MAC Clinical Research, UK, at multiple centers across UK. Is New 90 Day High Low • Mar 04
New 90-day high: kr5.58 The company is up 27% from its price of kr4.40 on 03 December 2020. The Swedish market is up 10.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is down 3.0% over the same period. Is New 90 Day High Low • Feb 02
New 90-day low: kr4.18 The company is down 6.0% from its price of kr4.45 on 03 November 2020. The Swedish market is up 14% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is up 2.0% over the same period. Announcement • Dec 12
Initiator Pharma A/S Announces Management Changes Initiator Pharma A/S announced the appointment of Dr. Allan Wehnert as SVP, Head of Clinical and R&D Strategy and Portfolio Management, and the formation of a Scientific and Clinical Advisory Board (SCAB). Dr. Allan Wehnert joins Initiator Pharma as Senior Vice President, Clinical and R&D Strategy and Portfolio Management. Allan Wehnert has close to 30 years of experience from leading positions in the pharmaceutical industry. His career in the industry began at Janssen followed by close to 20 years at Lundbeck where he has led Clinical Research and R&D project management, and been head of business development and portfolio management within CNS disease areas. Initiator Pharma'sScientific and Clinical Advisory Board (SCAB) has been initiated by engaging Sexual Medicine experts Dr. Irwin Goldstein, and Mrs. Sue Goldstein. Irwin Goldstein was a faculty member at Boston University School of Medicine (BUSM) for 25 years where he was Professor of Urology and Gynecology and founding Director of the former Institute for Sexual Medicine at BUSM. He is the director of San Diego Sexual Medicine, where he maintains his clinical practice, Director of Sexual Medicine at Alvarado Hospital and Clinical Professor of Surgery at University of California at San Diego. Mrs. Sue Goldstein is an AASECT certified sexuality educator and certified clinical research coordinator. She serves as clinical research manager and program coordinator for San Diego Sexual Medicine, where she is site manager for clinical trials, responsible for educational programs and coordinates with the Sexual Medicine program at Alvarado Hospital. Announcement • Dec 11
Initiator Pharma A/S announces First patient dosed in Phase 2a trial with IP2018 Initiator Pharma A/S announced that the first patient was dosed in its Phase 2a clinical trial with IP2018 to treat psychogenic sexual dysfunction. IP2018 is Initiator Pharma's second Phase 2 asset and is complementary to IPED2015 for which positive Phase 2a data on Organic Erectile dysfunction was reported earlier this year. Initiator Pharma has received a commitment from Innovation Fund Denmark to support the clinical development of IP2018. IP2018 is being developed for the treatment of sexual dysfunction in patients with major depressive disorder and patients with psychogenic Erectile Dysfunction (ED) of other causes. It is a unique drug candidate that targets a clear unmet medical need and IP2018 is differentiated from all existing anti-depressants and drugs for psychogenic ED. Up to 68% of patients with major depressive disorder suffer from sexual dysfunction, highlighting a significant unmet medical need. The Phase 2a trial is a randomized, double-blind, placebo-controlled, 3-way crossover trial studying the efficacy and safety of IP2018 in young, depressed patients with ED. The primary objective of the trial is to investigate the effects of IP2018 on penile rigidity and tumescence using a visual sexual stimulation test. The trial will be conducted on 24 patients at the MAC Phase I unit in Manchester, UK by MAC Clinical Research. Pending the Covid-19 situation the trial is planned to be executed within the next 9 months, and top-line data from the trial is expected end of H1 2021. The company has a commitment from Innovation Fund Denmark to fund the trial with up to 3.8 MDKK through the Innobooster grant. In connection with the company's latest rights issue of units and directed issue of units in June 2020, warrants of series TO 2 were issued. The exercise period for the warrants started on November 24 and runs until December 15, 2020. Upon full exercise of warrants, Initiator Pharma will receive approximately SEK 16.4 million before issue costs. The proceeds from the warrant exercise will primarily be used to develop IP2018 through the clinical phase 2a trial and generation of Proof-of-Concept. IP2018 strengthens the company's project portfolio. Obtaining Proof-of-Concept will position IP2018 as a new type of treatment for the large number of depressive patients who, due to serious side effects, do not want or can use the medicines available on the market. In addition to Innovation Fund Denmark's investment and the ongoing exercise of warrants, Initiator Pharma recently signed a financing agreement with UK's large independent clinical development organization, MAC Clinical Research. The agreement, that is worth up to 23 MSEK, secures funding of the continued Phase 2 clinical development of the company's lead candidate drug IPED2015 in organic erectile dysfunction (ED). Announcement • Nov 27
Initiator Pharma A/S announced that it expects to receive SEK 23 million in funding from MAC Clinical Research Ltd Initiator Pharma A/S (NGM:INIT) announced that it has entered into a convertible credit agreement for gross proceeds of SEK 23 million on November 25, 2020. The transaction will include participation from new investor MAC Clinical Research. The transaction is subject to the approval of the shareholders of the company at the extraordinary general meeting to be held before January 15, 2021. Announcement • Nov 25
Initiator Pharma Secures Funding for IPED2015 clinical Phase 2b study Initiator Pharma A/S announced that it has secured funding of the continued Phase 2 clinical development of IPED2015 in organic erectile dysfunction (ED), through a convertible credit agreement worth up to 23 MSEK with the UK's independent clinical development organization, MAC Clinical Research. The agreement gives MAC Clinical Research the right to convert the credit into Initiator Pharma shares up to approximately 23 MSEK at a share price of 7.5 SEK upon the full completion of a planned Phase 2b study. Within the agreement, MAC Clinical Research (MAC) will take on the cost, up to 23 MSEK, for conducting a clinical Phase 2b intercourse study for IPED2015 in patients suffering from organic erectile dysfunction, not responding to the currently marketed drugs in the PDE5i class (e.g. Viagra®, Cialis®,Levitra®). Upon the full completion of the study, MAC has the right to convert the accrued debt into Initator Pharma shares at a share price of 7.5 SEK, equivalent to a premium of more than 70% compared to the share price at the day of signing the agreement. Upon conversion MAC will become a shareholder of Initiator Pharma on equal terms to the existing shareholders with no specific asset rights, milestones or ownership to IPED2015. Should MAC choose not to convert, following the full completion of the study, it must notify Initiator Pharma that it prefers to have the accrued debt repaid in cash. In this case, or if the study for any reason is terminated before its completion, the accrued debt will convert into a three year loan with an annual interest rate of 1%. The Phase 2b study will be conducted by MAC at multiple sites in the UK and is planned to be initiated in H1 2021 pending the development of Covid-19 situation. The final design of the study is still pending and requires approval from MHRA. Initiator Pharma and MAC are utilizing the learnings from the previous Phase 2a Proof-of-Concept study to design a Phase 2b intercourse study that also will have EIIRF-questionares as clinical end point. The study is expected to be completed in the second half of 2022. Is New 90 Day High Low • Oct 16
New 90-day low: kr4.69 The company is down 14% from its price of kr5.46 on 17 July 2020. The Swedish market is up 7.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is down 1.0% over the same period. Is New 90 Day High Low • Oct 01
New 90-day low: kr4.99 The company is down 15% from its price of kr5.86 on 03 July 2020. The Swedish market is up 11% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is up 11% over the same period. Announcement • Jun 22
Initiator Pharma A/S has completed a Composite Units Offering. Initiator Pharma A/S has completed a Composite Units Offering.
Security Name: Units
Security Type: Equity/Derivative Unit
Securities Offered: 710,203
Price\Range: SEK 9.8
Security Name: Shares
Security Type: Common Stock
Securities Offered: 1,420,406
Security Name: Warrants
Security Type: Equity Warrant
Securities Offered: 2,130,609
Transaction Features: Rights Offering