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Pieris Pharmaceuticals(PIRS) - 2024 Q3 - Quarterly Report
PIRSPieris Pharmaceuticals(PIRS)2024-11-13 21:02

Financial Performance - For the three months ended September 30, 2024, the company reported a revenue of 15,569,000,comparedto15,569,000, compared to 6,000 for the same period in 2023, representing a significant increase[16]. - The net loss for the three months ended September 30, 2024, was (2,887,000),comparedtoanetlossof(2,887,000), compared to a net loss of (10,752,000) for the same period in 2023, indicating an improvement in financial performance[16]. - The company experienced a comprehensive loss of (2,767,000)fortheninemonthsendedSeptember30,2024,comparedto(2,767,000) for the nine months ended September 30, 2024, compared to (20,044,000) for the same period in 2023, reflecting a reduction in overall losses[16]. - The basic and diluted loss per share for the three months ended September 30, 2024, was (2.19),comparedto(2.19), compared to (8.70) for the same period in 2023, showing a decrease in loss per share[16]. - For the nine months ended September 30, 2024, the net loss was 11.369millioncomparedtoanetlossof11.369 million compared to a net loss of 19.959 million for the same period in 2023, representing a 43.5% improvement[22]. - The company reported net cash used in operating activities of 8.330millionfortheninemonthsendedSeptember30,2024,comparedto8.330 million for the nine months ended September 30, 2024, compared to 34.150 million for the same period in 2023, indicating a significant reduction in cash burn[22]. - Cash and cash equivalents at the end of the period were 19.363million,comparedto19.363 million, compared to 32.894 million at the end of the same period in 2023[22]. - The company has an accumulated deficit of 326.3millionasofSeptember30,2024,andexpectstocontinueincurringoperatinglossesfortheforeseeablefuture[31].−Thetotalstockholders′equityatSeptember30,2024,was326.3 million as of September 30, 2024, and expects to continue incurring operating losses for the foreseeable future[31]. - The total stockholders' equity at September 30, 2024, was 16.268 million, down from 30.510millionatSeptember30,2023,reflectingadecreaseof46.630.510 million at September 30, 2023, reflecting a decrease of 46.6%[19]. Merger and Strategic Initiatives - The company is in the process of a merger with Palvella Therapeutics, which is expected to enhance its market position and operational capabilities[5]. - The anticipated benefits from the merger include potential cost savings and capital preservation through workforce reduction and restructuring activities[7]. - The company entered into a merger agreement with Palvella Therapeutics, Inc., which will result in Palvella becoming a wholly-owned subsidiary of the company[28]. - The merger is expected to close in the fourth quarter of 2024, subject to stockholder approval[143]. - Upon the closing of the Merger, pre-Merger Pieris stockholders will own approximately 18% and pre-Merger Palvella stockholders will own approximately 82% of the combined company on a pro forma basis[140]. - The Merger Agreement includes a termination fee of 1.0 million payable by Pieris to Palvella and 2.0millionpayablebyPalvellatoPierisunderspecifiedcircumstances[146].−ThegrossproceedsfromthePIPEFinancingareexpectedtobeapproximately2.0 million payable by Palvella to Pieris under specified circumstances[146]. - The gross proceeds from the PIPE Financing are expected to be approximately 78.9 million, before estimated expenses[147]. - The Exchange Ratio for the Merger assumes a valuation for Palvella equal to 95millionandavaluationforPierisequalto95 million and a valuation for Pieris equal to 21 million, with adjustments based on Pieris' net cash at closing[159]. - Pieris plans to amend its articles of incorporation to increase the number of authorized common stock shares and change its name to "Palvella Therapeutics, Inc."[141]. Research and Development - The company has discontinued all research and development efforts and is reducing discretionary expenditures to maximize potential milestones from partnered programs with Pfizer and Boston Pharmaceuticals[32]. - The company announced the discontinuation of all research and development activities on March 27, 2024, which is expected to significantly lower future research and development costs[193]. - Research and development expenses for the three months ended September 30, 2024 were 446,000,downfrom446,000, down from 9.6 million in the same period in 2023, indicating a decrease of approximately 95.4%[202]. - The company has not generated any revenues from product sales to date and does not expect to do so in the foreseeable future, with revenues primarily coming from license and collaboration agreements[188]. Revenue Recognition and Contracts - Revenue is recognized when a customer obtains control of promised goods or services, with the company applying a five-step process to determine revenue recognition[52]. - The company evaluates the probability of achieving variable consideration in contracts, which may include milestone payments, and re-evaluates this probability each reporting period[55]. - The company classifies payments received under collaborative arrangements as revenue and payments made as a reduction of revenue in the period earned[51]. - The Company recognized total revenue of 19,520,000forthethreemonthsendedSeptember30,2023,and19,520,000 for the three months ended September 30, 2023, and 41,511,000 for the nine months ended September 30, 2023[79]. - The Company has not generated revenue from product sales but has generated revenue from contracts with customers, including upfront payments and milestone payments[79]. - The Company recognized all remaining revenue of 12.5millionundertheGenentechcollaborationaftertheexpirationofallperformanceobligations[83].−TheCompanyiseligibletoreceivevariousresearch,development,commercial,andsalesmilestonesunderthePfizerAgreements,withuncertaintyregardingachievementduetothenatureofclinicaldevelopment[89].CostManagementandExpenditures−Thecompanyincurredapproximately12.5 million under the Genentech collaboration after the expiration of all performance obligations[83]. - The Company is eligible to receive various research, development, commercial, and sales milestones under the Pfizer Agreements, with uncertainty regarding achievement due to the nature of clinical development[89]. Cost Management and Expenditures - The company incurred approximately 7.5 million in severance costs and related termination benefits in 2023 due to a workforce reduction of approximately 70%[25]. - The company expects to pay approximately 4.3millionofterminationbenefitsthroughtheendof2024,withtheremaindertobepaidin2025[26].−Thecompanyexpectsgeneralandadministrativecoststobesignificantlylowerthanhistoricalamountsduetoaleanerorganizationandtheeliminationofresearchanddevelopmentspendinggoingforward[194].−GeneralandadministrativeexpensesforthethreemonthsendedSeptember30,2024were4.3 million of termination benefits through the end of 2024, with the remainder to be paid in 2025[26]. - The company expects general and administrative costs to be significantly lower than historical amounts due to a leaner organization and the elimination of research and development spending going forward[194]. - General and administrative expenses for the three months ended September 30, 2024 were 3.6 million, a reduction from 11.1millioninthesameperiodin2023,representingadecreaseofabout67.611.1 million in the same period in 2023, representing a decrease of about 67.6%[195]. Shareholder Information - The company had 1,320,240 shares of common stock issued and outstanding as of September 30, 2024, an increase from 1,236,688 shares as of December 31, 2023[117]. - The company did not sell any shares under the ATM Program for the nine months ended September 30, 2024, while it sold 24.3 million shares for gross proceeds of 20.3 million under the program in the same period of 2023[128]. - As of September 30, 2024, there are 333,145 shares remaining and available for grant under the 2020 Employee, Director and Consultant Equity Incentive Plan[124]. - The company has reserved 9,375 shares of common stock for issuance under the 2023 Employee Stock Purchase Plan[125].