Announcement • Nov 07
Pieris Pharmaceuticals, Inc., Annual General Meeting, Dec 02, 2024 Pieris Pharmaceuticals, Inc., Annual General Meeting, Dec 02, 2024. Announcement • Apr 21
Pieris Pharmaceuticals Approves 1-for-80 Reverse Stock Split to Regain Compliance with the Minimum Bid Price Requirement Pieris Pharmaceuticals, Inc. announced that its board of directors has approved a 1-for-80 reverse stock split of the Company's common stock, par value $0.001, which will be effective at 5:00 pm Eastern Time on April 22, 2024. The Company's common stock will continue to be traded on The Nasdaq Capital Market on a split-adjusted basis beginning on April 23, 2024, under the Company's existing trading symbol ‘PIRS’. The reverse stock split is intended to regain compliance with the minimum bid price requirement of $1.00 per share of the Company's common stock for continued listing on The Nasdaq Capital Market. The new CUSIP number following the reverse stock split will be 720795202. The Company filed a Certificate of Change with the Nevada Secretary of State on April 18, 2024 to effect the reverse split. Reported Earnings • Mar 31
Full year 2023 earnings released: US$0.27 loss per share (vs US$0.45 loss in FY 2022) Full year 2023 results: US$0.27 loss per share (improved from US$0.45 loss in FY 2022). Revenue: US$42.8m (up 65% from FY 2022). Net loss: US$24.5m (loss narrowed 26% from FY 2022). Over the last 3 years on average, earnings per share has increased by 30% per year but the company’s share price has fallen by 57% per year, which means it is significantly lagging earnings. New Risk • Mar 29
New major risk - Revenue and earnings growth Earnings have declined by 8.9% 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 Less than 1 year of cash runway based on free cash flow trend (-US$47m free cash flow). Share price has been highly volatile over the past 3 months (15% average weekly change). Earnings have declined by 8.9% per year over the past 5 years. Minor Risks Shareholders have been diluted in the past year (33% increase in shares outstanding). Market cap is less than US$100m (€16.8m market cap, or US$18.1m). Reported Earnings • Nov 16
Third quarter 2023 earnings released: US$0.11 loss per share (vs US$0.13 loss in 3Q 2022) Third quarter 2023 results: US$0.11 loss per share. Revenue: US$19.5m (up 264% from 3Q 2022). Net loss: US$10.8m (loss widened 10% from 3Q 2022). Revenue is expected to decline by 81% p.a. on average during the next 3 years, while revenues in the Biotechs industry in Germany are expected to grow by 15%. Board Change • Sep 01
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 10 experienced directors. 2 highly experienced directors. Independent Director Maya Said was the last director to join the board, commencing their role in 2019. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Announcement • Jul 14
Pieris Pharmaceuticals, Inc. Announces Executive Changes Pieris Pharmaceuticals, Inc. announced on July 13, 2023, Ahmed Mousa, the Senior Vice President, Chief Business Officer, General Counsel & Corporate Secretary of the company, gave notice that he will resign from the company effective September 11, 2023 in order to become chief executive officer of Vicore Pharma Holding AB. Mr. Mousa is expected to serve as a strategic advisor to the Company for a transition period thereafter, subject to a mutual agreement of terms in the near future. Mr. Mousa’s resignation is not a result of any disagreement with the Company or any other entity or on any matter relating to the operations, policies (including accounting or financial policies) or practices of the company. Following Mr. Mousa’s departure, Stephen Yoder, the company’s chief executive officer and President will oversee corporate and business development at the company. New Risk • Jul 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: -US$49m 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 (-US$49m free cash flow). Share price has been highly volatile over the past 3 months (27% average weekly change). Earnings are forecast to decline by an average of 8.5% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$74m net loss in 3 years). Shareholders have been diluted in the past year (11% increase in shares outstanding). Market cap is less than US$100m (€12.4m market cap, or US$13.6m). Reported Earnings • May 11
First quarter 2023 earnings released: US$0.18 loss per share (vs US$0.069 loss in 1Q 2022) First quarter 2023 results: US$0.18 loss per share (further deteriorated from US$0.069 loss in 1Q 2022). Revenue: US$1.94m (down 82% from 1Q 2022). Net loss: US$13.2m (loss widened 158% from 1Q 2022). Revenue is forecast to stay flat during the next 3 years compared to a 20% growth forecast for the Biotechs industry in Germany. Over the last 3 years on average, earnings per share has fallen by 4% per year but the company’s share price has fallen by 35% per year, which means it is performing significantly worse than earnings. Announcement • May 05
Pieris Pharmaceuticals, Inc. Announces Successful Completion of Safety Review for 10 Mg Dose of Phase 2A Trial of Elarekibep (Prs-060/Azd1402) Pieris Pharmaceuticals, Inc. announced the successful safety review of the 10 mg dry powder dose safety cohort from the ongoing multi-center, placebo-controlled phase 2a study of dry powder inhaler-formulated elarekibep (PRS-060/AZD1402). The successful review of the 10 mg dose provides additional data supporting the elarekibep safety profile and enables doses of 10 mg or less to be evaluated in future clinical trials. Elarekibep is an IL-4 receptor alpha inhibitor under development in collaboration with AstraZeneca for the treatment of moderate-to-severe asthma. Pieris previously announced the successful completion of the safety review for the 1 mg and 3 mg doses, triggering the efficacy portion of the study, which is ongoing at the 3 mg dose. Upon completion of the phase 2a study and availability of topline data, which Pieris expects to be reported by mid-2024, the Company will have a co-development option for this program with AstraZeneca. For this safety review, 13 asthma patients, controlled on standard of care (medium dose inhaled corticosteroids with long-acting beta agonists), received elarekibep twice daily over four weeks to establish the safety profile and pharmacokinetics of the dry powder formulation of elarekibep at the 10 mg dose. Following completion of enrollment and observation, AstraZeneca evaluated, compared to placebo, the incidence of adverse events, changes in laboratory markers (immuno-biomarkers, clinical chemistry, and hematology), and forced expiratory volume in one second. Reported Earnings • Mar 30
Full year 2022 earnings released: US$0.45 loss per share (vs US$0.71 loss in FY 2021) Full year 2022 results: US$0.45 loss per share (improved from US$0.71 loss in FY 2021). Revenue: US$25.9m (down 18% from FY 2021). Net loss: US$33.3m (loss narrowed 27% from FY 2021). Revenue is expected to decline by 41% p.a. on average during the next 3 years, while revenues in the Biotechs industry in Germany are expected to grow by 22%. Over the last 3 years on average, earnings per share has fallen by 6% per year whereas the company’s share price has fallen by 10% per year. Announcement • Jan 11
Pieris Pharmaceuticals Announces $5 Million Milestone from Seagen for Initiation of Phase 1 Trial of Cd228 X 4-1Bb Bispecific Molecule (Mabcalin Sgn-Bb228 (Prs-346) Pieris Pharmaceuticals, Inc. announced that the Company has achieved a $5 million milestone from Seagen. The milestone is based on dosing the first patient in a Seagen-sponsored phase 1 study of SGN-BB228 (PRS-346), a novel bispecific antibody-Anticalin molecule (Mabcalin™) that is designed to provide a potent costimulatory bridge between tumor-specific T cells and CD228 expressing tumor cells. The Seagen-sponsored (NCT05571839) open-label phase 1 study is evaluating the safety and tolerability of SGN-BB228 in patients with advanced melanoma and other solid tumors. Secondary endpoints in the study include pharmacokinetics and antitumor activity. This program is one of three ongoing immuno-oncology programs with Seagen and preclinical data were recently presented at the Society for Immunotherapy of Cancer's (SITC) Annual Meeting in Boston. Pieris has an opt-in option to a U.S. co-promotion for one program in the collaboration. Board Change • Nov 16
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 12 experienced directors. No highly experienced directors. Independent Director Maya Said was the last director to join the board, commencing their role in 2019. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Reported Earnings • Nov 03
Third quarter 2022 earnings released: US$0.13 loss per share (vs US$0.24 loss in 3Q 2021) Third quarter 2022 results: US$0.13 loss per share (improved from US$0.24 loss in 3Q 2021). Revenue: US$5.37m (up 32% from 3Q 2021). Net loss: US$9.74m (loss narrowed 41% from 3Q 2021). Revenue is expected to decline by 17% p.a. on average during the next 3 years, while revenues in the Biotechs industry in Germany are expected to grow by 21%. Over the last 3 years on average, earnings per share has fallen by 7% per year but the company’s share price has fallen by 33% per year, which means it is performing significantly worse than earnings. Announcement • Nov 02
Pieris Pharmaceuticals, Inc. Announces Dosing of First Subject in Phase 1 Trial of Inhaled CTGF Inhibitor PRS-220 Pieris Pharmaceuticals, Inc. announced that the first subject has been dosed in the phase 1 study of PRS-220, an oral inhaled Anticalin protein targeting connective tissue growth factor (CTGF) for the treatment of idiopathic pulmonary fibrosis (IPF) and other forms of fibrotic lung disease. The phase 1 dose escalation study will evaluate the safety, tolerability, and pharmacokinetics of PRS-220 in heathy volunteers. IPF affects over three million patients worldwide and approximately 130,000 patients in the United States. Median survival is three to five years from the time of diagnosis, with standard of care conferring only modest benefit. CTGF, a protein localized in the extracellular matrix, is a driver of fibrotic tissue remodeling as a consequence of an aberrant wound healing process. Over-expression of this target in lung tissue is observed in patients suffering from IPF, and clinical data indicate inhibition of CTGF reduces the decline in lung function among these patients. Direct administration of PRS-220 to the lung via inhalation should achieve high local concentrations, and hence a more effective inhibition of CTGF than systemically administered interventions. Reported Earnings • Aug 05
Second quarter 2022 earnings released: US$0.14 loss per share (vs US$0.25 loss in 2Q 2021) Second quarter 2022 results: US$0.14 loss per share (up from US$0.25 loss in 2Q 2021). Revenue: US$3.70m (up 13% from 2Q 2021). Net loss: US$10.3m (loss narrowed 33% from 2Q 2021). Over the next year, revenue is expected to shrink by 45% compared to a 31% growth forecast for the industry in Germany. Over the last 3 years on average, earnings per share has fallen by 6% per year but the company’s share price has fallen by 30% per year, which means it is performing significantly worse than earnings. Announcement • Aug 05
Pieris Pharmaceuticals, Inc. Announces Tim Demuth Steps Down as Senior Vice President and Chief Medical Officer, Effective September 30, 2022 On August 4, 2022, Pieris Pharmaceuticals, Inc. (together with its wholly-owned subsidiary, Pieris Pharmaceuticals GmbH, the Company) announced that Tim Demuth, M.D., Ph.D. has mutually agreed with the Company to step down effective September 30, 2022. Dr. Demuth had served as Pieris’ Senior Vice President and Chief Medical Officer. Reported Earnings • May 13
First quarter 2022 earnings released: US$0.069 loss per share (vs US$0.074 loss in 1Q 2021) First quarter 2022 results: US$0.069 loss per share. Revenue: US$11.0m (down 30% from 1Q 2021). Net loss: US$5.10m (loss widened 22% from 1Q 2021). Over the next year, revenue is forecast to grow 72%, compared to a 37% growth forecast for the industry in Germany. Announcement • May 02
Pieris Pharmaceuticals, Inc., Annual General Meeting, Jun 22, 2022 Pieris Pharmaceuticals, Inc., Annual General Meeting, Jun 22, 2022, at 08:00 US Eastern Standard Time. Agenda: To elect three directors to serve a three-year term expiring in 2025; to approve an amendment to the Company’s 2020 Employee, Director and Consultant Equity Incentive Plan, or the 2020 Plan, to add 3,000,000 shares for issuance under the 2020 Plan; to ratify the appointment of Ernst & Young LLP as the Company’s independent registered public accounting firm for the fiscal year ending December 31, 2022; and to consider other matters. Board Change • Apr 27
Insufficient new directors There is 1 new director who has joined the board in the last 3 years. The company's board is composed of: 1 new director. 11 experienced directors. No highly experienced directors. Independent Director Maya Said was the last director to join the board, commencing their role in 2019. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Reported Earnings • Mar 03
Full year 2021 earnings: EPS in line with analyst expectations despite revenue beat Full year 2021 results: US$0.71 loss per share (down from US$0.68 loss in FY 2020). Revenue: US$31.4m (up 7.1% from FY 2020). Net loss: US$45.7m (loss widened 23% from FY 2020). Revenue exceeded analyst estimates by 23%. Over the next year, revenue is forecast to grow 125%, compared to a 64% growth forecast for the pharmaceuticals industry in Germany. Over the last 3 years on average, earnings per share has fallen by 12% per year but the company’s share price has increased by 3% per year, which means it is well ahead of earnings. Announcement • Jan 05
Pieris Pharmaceuticals, Inc. Announces Successful Completion of Safety Milestone and Initiation of Efficacy Portion of Phase 2A Trial of PRS-060/AZD1402 Pieris Pharmaceuticals, Inc. announced the successful completion of the sponsor safety review of part 1a of the multi-center, placebo-controlled phase 2a study of dry powder inhaler-formulated PRS-060/AZD1402. PRS-060/AZD1402 is an IL-4 receptor alpha inhibitor under development in collaboration with AstraZeneca for the treatment of moderate-to-severe asthma. Completion of part 1a allows the start of enrollment for part 2a (efficacy of the low and medium doses) and part 1b (safety of the high dose) of the study. In part 1a of the study, 31 asthma patients, controlled on standard of care (medium dose inhaled corticosteroids (ICS) with long-acting beta agonists (LABA)), received PRS-060/AZD1402 twice daily over four weeks to establish the safety profile and pharmacokinetics of the dry powder formulation of PRS-060/AZD1402. The safety review following completion of part 1a included an evaluation, compared to placebo, of the incidence of adverse events, changes in laboratory markers (immuno-biomarkers, clinical chemistry, and hematology), and forced expiratory volume in one second (FEV1). AstraZeneca is now expected to begin enrollment of part 2a of the study to evaluate efficacy, safety, and pharmacokinetics of PRS-060/AZD1402 administered twice daily to asthma patients, uncontrolled on medium dose ICS/LABA, that have a blood eosinophil count of = 150 cells/µL and FeNO = 25 ppb in two active arms and a placebo arm. Following a four-week run-in period, patients will be dosed and monitored over four weeks. FEV1 improvement compared to placebo will be the primary endpoint in this portion of the study. AstraZeneca is also now expected to begin enrollment of part 1b of the study to evaluate the safety of the high dose in asthma patients controlled on standard of care who will receive PRS-060/AZD1402 twice daily over four weeks. Upon completion of the phase 2a study and availability of topline data, which Pieris aims to announce this year, the Company will have 30 days to opt into co-development of the program with AstraZeneca. Reported Earnings • Nov 04
Third quarter 2021 earnings released: US$0.24 loss per share (vs US$0.26 loss in 3Q 2020) The company reported a solid third quarter result with improved revenues and control over costs, although losses increased. Third quarter 2021 results: Revenue: US$4.06m (up 38% from 3Q 2020). Net loss: US$16.5m (loss widened 16% from 3Q 2020). Over the last 3 years on average, earnings per share has fallen by 21% per year but the company’s share price has increased by 6% per year, which means it is well ahead of earnings. Board Change • Nov 02
Insufficient new directors There is 1 new director who has joined the board in the last 3 years. The company's board is composed of: 1 new director. 7 experienced directors. No highly experienced directors. Independent Director Maya Said was the last director to join the board, commencing their role in 2019. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Reported Earnings • Aug 08
Second quarter 2021 earnings released: US$0.25 loss per share (vs US$0.095 loss in 2Q 2020) The company reported a poor second quarter result with increased losses, weaker revenues and weaker control over costs. Second quarter 2021 results: Revenue: US$3.29m (down 71% from 2Q 2020). Net loss: US$15.5m (loss widened 213% from 2Q 2020). Over the last 3 years on average, earnings per share has fallen by 25% per year but the company’s share price has only fallen by 12% per year, which means it has not declined as severely as earnings. Reported Earnings • May 19
First quarter 2021 earnings released: US$0.074 loss per share (vs US$0.065 loss in 1Q 2020) The company reported a solid first quarter result with improved revenues and control over costs, although losses increased. First quarter 2021 results: Revenue: US$15.6m (up 18% from 1Q 2020). Net loss: US$4.17m (loss widened 16% from 1Q 2020). Over the last 3 years on average, earnings per share has fallen by 20% per year but the company’s share price has fallen by 32% per year, which means it is performing significantly worse than earnings. Reported Earnings • Apr 01
Full year 2020 earnings released: US$0.68 loss per share (vs US$0.56 loss in FY 2019) The company reported a poor full year result with increased losses, weaker revenues and weaker control over costs. Full year 2020 results: Revenue: US$29.3m (down 37% from FY 2019). Net loss: US$37.2m (loss widened 32% from FY 2019). Over the last 3 years on average, earnings per share has fallen by 17% per year but the company’s share price has fallen by 25% per year, which means it is performing significantly worse than earnings. Announcement • Mar 31
Pieris Pharmaceuticals, Inc. announced that it expects to receive $10.000002 million in funding from AstraZeneca PLC Pieris Pharmaceuticals, Inc. (NasdaqCM:PIRS) announced a private placement of 3,584,230 common stocks at a price of $2.79 per share for gross proceeds of $10,000002 on March 31, 2021. The transaction will included participation from AstraZeneca PLC (LSE:AZN). Announcement • Mar 26
Pieris Pharmaceuticals, Inc. announced that it has received $13.008671 million in funding Pieris Pharmaceuticals, Inc. (NasdaqCM:PIRS) announced that it has entered into a subscription agreement with Seagen Inc. (NasdaqGS : SGEN) for a private placement of 3,706,174 common shares at a price of $3.51 per share for gross proceeds of $13,008,671 on March 24, 2021. Is New 90 Day High Low • Mar 10
New 90-day low: €1.99 The company is down 19% from its price of €2.47 on 10 December 2020. The German market is up 9.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is up 3.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is €1.39 per share. Is New 90 Day High Low • Dec 11
New 90-day high: €2.47 The company is up 4.0% from its price of €2.38 on 11 September 2020. The German market is up 2.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is down 8.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is per share. Reported Earnings • Nov 07
Third quarter 2020 earnings released: US$0.26 loss per share The company reported a poor third quarter result with increased losses and weaker revenues and control over expenses. Third quarter 2020 results: Revenue: US$2.94m (down 81% from 3Q 2019). Net loss: US$14.3m (loss widened 451% from 3Q 2019). Over the last 3 years on average, earnings per share has fallen by 3% per year but the company’s share price has fallen by 21% per year, which means it is performing significantly worse than earnings. Analyst Estimate Surprise Post Earnings • Nov 07
Revenue misses expectations Revenue missed analyst estimates by 80%. Over the next year, revenue is expected to shrink by 32% compared to a 312% growth forecast for the Biotechs industry in Germany. Is New 90 Day High Low • Sep 23
New 90-day low: €1.94 The company is down 31% from its price of €2.82 on 25 June 2020. The German market is up 3.0% 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. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is per share. 