CD228

Conference Call with Slides Begins at 8:30 a.m. Eastern Time Today EMERYVILLE, Calif.--(BUSINESS WIRE)-- OmniAb, Inc. (NASDAQ: OABI) today reported financial results for the three months ended March 31, 2023, and provided operating and partner program updates. “Our first quarter performance is a strong start to the year. We reached 301 active programs, with 27 in clinical development or approved for commercialization as our growing portfolio of partner programs continued to advance,” said Matt Foehr, Chief Executive Officer of OmniAb, Inc. “Innovating our technologies is part of our strategy, and we are proud to introduce OmniDeep™ at next week’s PEGS Protein Engineering Conference and Expo in Boston. OmniDeep is a suite of proprietary in silico tools that have been a part of our internal research efforts for many years and that we’ve recently expanded. These tools are now more broadly available to our partners and facilitate rapid identification of lead candidates leveraging our large multi-species antibody databases and the Biological Intelligence™ of our proprietary transgenic animals.” First Quarter 2023 Financial Results Revenue for the first quarter of 2023 was $16.9 million, compared with $9.6 million for the same period in 2022, with the increase primarily due to the recognition of a $10.0 million milestone payment related to the first commercial sale of TECVAYLI® (teclistamab) in the European Union. Research and development expense was $13.8 million for the first quarter of 2023, compared with $10.8 million for the same period in 2022, with the increase primarily due to investments in facilities, headcount, and technology innovation. General and administrative expense was $8.2 million for the first quarter of 2023, compared with $4.1 million for the same period in 2022, with the increase primarily due to higher headcount and other expenses related to being an independent publicly traded company. Net loss for the first quarter of 2023 was $6.1 million, or $0.06 per share, compared with a net loss of $6.3 million, or $0.08 per share, for the same period in 2022. As of March 31, 2023, OmniAb had cash, cash equivalents, and short-term investments of $113.6 million. The Company expects its year-end 2023 cash, cash equivalents and short-term investments balance to be slightly higher than year-end 2022. Current cash, cash equivalents and short-term investments, along with the cash the Company generates from operations, are expected to be sufficient to fund operations for the foreseeable future. On November 1, 2022, OmniAb completed a spin-off from Ligand Pharmaceuticals Incorporated (NASDAQ: LGND), resulting in OmniAb becoming an independent publicly traded company. Financial results prior to November 1, 2022, are presented on a carve-out basis derived from Ligand’s historical accounting records, as if OmniAb were an independent company. First Quarter 2023 and Recent Business Highlights In the first quarter of 2023, the Company entered into a license and revenue-sharing agreement with The Scripps Research Institute related to OmniRat®-derived programs that are being advanced by Cessation Therapeutics, Inc. In addition, subsequent to the end of the quarter, OmniAb signed a platform license agreement with Neurocrine Biosciences. Our partners’ programs continued to progress in the first quarter, including Seagen’s bispecific molecule SGN-BB228 to treat advanced melanoma and other solid tumors entering the clinic. As of March 31, 2023, the Company had 70 active partners with 27 OmniAb-derived programs in clinical development or being commercialized, and a total of 301 programs being pursued or commercialized. First quarter 2023 and recent partner highlights include the following: Batoclimab Immunovant announced that it expects to report initial results from its Phase 2 clinical trial in Graves’ disease in the second half of 2023. In addition, Immunovant is running clinical trials in generalized myasthenia gravis, thyroid eye disease and chronic inflammatory demyelinating polyneuropathy. IMVT-1402 Immunovant announced plans to initiate a Phase 1 clinical trial of its next-generation anti-FcRn, IMVT-1402, in autoimmune diseases, contingent on clearance of its Investigational New Drug application. As with batoclimab, in nonclinical studies IMVT-1402 has been observed to reduce IgG antibody levels and is designed to enable a subcutaneous route of administration delivered in a matter of seconds. Additionally, in animal studies IMVT-1402 has been observed to have minimal or no impact on albumin and LDL levels. SGN-BB228 Seagen announced initiation of a first-in-human Phase 1 clinical trial of SGN-BB228 in advanced melanoma and other solid tumors. SGN-BB228 is a first-in-class CD228-targeted costimulatory antibody Anticalin bispecific delivering potent and conditional 4-1BB costimulation to intratumoral T cells. This fully human IgG4 monoclonal antibody is designed to provide a potent signal between tumor-reactive cytotoxic T cells and CD228-expressing tumor cells, improving and constraining T cell-mediated cytotoxicity in tumors, potentially expanding the therapeutic window for 4-1BB agonism. Sugemalimab CStone announced submission of a supplemental biologics application (sBLA) to China’s National Medical Products Administration for sugemalimab in combination with chemotherapy as a first-line treatment of unresectable locally advanced, recurrent or metastatic esophageal squamous cell carcinoma. The sBLA application is based on the GEMSTONE-304 study, which met its primary endpoints in January 2023. CStone reported publication of GEMSTONE-201 study results for sugemalimab monotherapy in the treatment of relapsed/refractory extranodal NK/T-cell lymphoma and announced it expects a decision on its pending new drug application in the second half of 2023 in mainland China. CStone also announced a decision on its supplemental new drug application for first-line treatment in gastric adenocarcinoma/gastroesophageal junction adenocarcinoma is expected in the second half of 2023 or the first half of 2024 in mainland China. CStone announced that it will regain rights for the development and commercialization of sugemalimab outside of Greater China from EQRx. CStone will now lead the regulatory process for the Marketing Authorization Applications by the European Medicines Agency and the Medicines and Healthcare products Regulatory Agency in the United Kingdom. OmniAb will be highlighting some of its new technology at the 19th Annual PEGS Boston Conference and Expo, including a presentation on its OmniDeep platform at 1:10 p.m. Eastern time on Wednesday, May 17, 2023. OmniDeep is a suite of in silico tools for therapeutic discovery and optimization that are woven throughout OmniAb’s various technologies and capabilities. These tools include structural modeling, molecular dynamics simulations, large multi-species antibody databases, AI, machine learning, deep learning models and more. OmniDeep facilitates rapid identification of candidates with the right affinity, specificity and developability pro to make drug development more effective and efficient. The Company also expects that multiple partners will be presenting data from programs developed with OmniAb technology at the American Society of Clinical Oncology Annual Meeting taking place June 2-6. Conference Call and Webcast OmniAb management will host a conference call with slides today beginning at 8:30 a.m. Eastern time to discuss this announcement and answer questions. To participate via telephone, please dial (888) 886-7786 using the conference ID 36818707. Slides, as well as the live and replay webcast of the call, are available at . About OmniAb® OmniAb, Inc.’s discovery platform provides pharmaceutical industry partners access to diverse antibody repertoires and high-throughput screening technologies to enable discovery of next-generation therapeutics. At the heart of the OmniAb platform is the Biological Intelligence™ (BI) of our proprietary transgenic animals, including OmniRat®, OmniChicken® and OmniMouse® that have been genetically modified to generate antibodies with human sequences to facilitate development of human therapeutic candidates. OmniFlic® (transgenic rat) and OmniClic® (transgenic chicken) address industry needs for bispecific antibody applications though a common light chain approach, and OmniTaur™ features unique structural attributes of cow antibodies for complex targets. We believe the OmniAb animals comprise the most diverse host systems available in the industry and they are optimally leveraged through computational antigen design and immunization methods, paired with high-throughput single B cell phenotypic screening and mining of next-generation sequencing datasets with custom algorithms to identify fully human antibodies with superior performance and developability characteristics. An established core competency focused on ion channels and transporters further differentiates our technology and creates opportunities in emerging target classes. OmniAb antibodies have been leveraged across modalities, including bispecific antibodies, antibody-drug conjugates and others. The OmniAb suite of technologies span from BI-powered repertoire generation to cutting-edge antibody discovery and optimization offering a highly efficient and customizable end-to-end solution for the growing discovery needs of the global pharmaceutical industry. For more information, please visit . Forward-Looking Statements OmniAb cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. Words such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or continue” and similar expressions, are intended to identify forward-looking statements. The forward-looking statements are based on our current beliefs and expectations and include, but are not limited to: the growth prospects of our business; continued innovation around, and the expected performance of, our technologies; the ability to add new partners and programs; scientific presentations and clinical and regulatory events of our partners and the timing thereof; expected cash runway; and the future balance of cash, cash equivalents and short-term investments. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in our business, including, without limitation: our future success is dependent on acceptance of our technology platform by new and existing partners, as well as on the eventual development, approval and commercialization of products developed by our partners for which we have no control over the development plan, regulatory strategy or commercialization efforts; biopharmaceutical development is inherently uncertain; risks arising from changes in technology; the competitive environment in the life sciences and biotechnology platform market; our failure to maintain, protect and defend our intellectual property rights; difficulties with performance of third parties we will rely on for our business; regulatory developments in the United States and foreign countries; unstable market and economic conditions, including adverse developments with respect to financial institutions and associated liquidity risk, may have serious adverse consequences on our business, financial condition and stock price; we may use our capital resources sooner than we expect; and other risks described in our prior press releases and filings with the SEC, including under the heading “Risk Factors” in the our annual report on Form 10-K and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Partner Information The information in this press release regarding partnered products and programs comes from information publicly released by our partners. [Tables Follow] OMNIAB, INC. CONDENSED CONSOLIDATED AND COMBINED BALANCE SHEETS (Unaudited) (in thousands, except share and per share data) March 31, 2023 December 31, 2022 ASSETS Current assets: Cash and cash equivalents $ 22,906 $ 33,390 Short-term investments 90,699 54,875 Accounts receivable, net 1,819 30,290 Prepaid expenses and other current assets 5,657 6,395 Total current assets 121,081 124,950 Intangible assets, net 164,355 167,242 Goodwill 83,979 83,979 Property and equipment, net 19,307 19,979 Operating lease right-of-use assets 20,979 21,483 Other long-term assets 3,340 3,579 Total assets $ 413,041 $ 421,212 LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable $ 2,485 $ 2,971 Accrued expenses and other current liabilities 3,909 5,557 Income tax payable 3,486 3,485 Current contingent liabilities 2,471 4,022 Current deferred revenue 6,886 8,207 Current operating lease liabilities 2,440 1,780 Total current liabilities 21,677 26,022 Long-term contingent liabilities 3,683 4,089 Deferred income taxes, net 20,400 21,341 Long-term operating lease liabilities 23,418 24,016 Long-term deferred revenue 3,017 4,325 Other long-term liabilities 44 46 Total liabilities 72,239 79,839 Stockholders' equity: Preferred stock, $0.0001 par value; 100,000,000 shares authorized at March 31, 2023 and December 31, 2022; no shares issued and outstanding at March 31, 2023 and December 31, 2022 — — Common stock, $0.0001 par value; 1,000,000,000 shares authorized at March 31, 2023 and December 31, 2022; 115,584,520 and 115,218,229 shares issued and outstanding at March 31, 2023 and December 31, 2022, respectively 12 12 Additional paid-in capital 335,631 330,100 Accumulated other comprehensive income 7 9 Retained earnings 5,152 11,252 Total stockholders’ equity 340,802 341,373 Total liabilities and stockholders’ equity $ 413,041 $ 421,212 OMNIAB, INC. CONDENSED CONSOLIDATED AND COMBINED STATEMENTS OF OPERATIONS (Unaudited) (in thousands, except per share data) Three Months Ended March 31, 2023 2022 Revenues: License and milestone revenue $ 12,646 $ 4,101 Service revenue 3,958 5,259 Royalty revenue 315 263 Total revenues 16,919 9,623 Operating expenses: Research and development 13,759 10,772 General and administrative 8,195 4,112 Amortization of intangibles 3,369 3,405 Other operating expense (income), net 49 (443 ) Total operating expenses 25,372 17,846 Loss from operations (8,453 ) (8,223 ) Other income: Interest income 1,324 — Total other income 1,324 — Loss before income taxes (7,129 ) (8,223 ) Income tax benefit 1,029 1,941 Net loss $ (6,100 ) $ (6,282 ) Net loss per share, basic and diluted $ (0.06 ) $ (0.08 ) Weighted-average shares outstanding, basic and diluted 99,158 82,612

COMPANY TO HOST AN INVESTOR CONFERENCE CALL TODAY, WEDNESDAY, MAY 10, 2023, AT 8:00 AM EDT Enrollment for elarekibep (PRS-060/AZD1402) Phase 2a study for asthma continues to progress with topline clinical data anticipated by mid-2024; successful safety review completed for 10 mg dose cohort PRS-220, inhaled Anticalin protein for idiopathic pulmonary fibrosis (IPF), continues in Phase 1 study with topline results expected H2 2023 PRS-400, inhaled Anticalin protein for muco-obstructive respiratory disease, advances toward anticipated development candidate nomination H2 2023 New preclinical data to be presented at the American Thoracic Society (ATS) 2023 International Conference in May 2023 for both PRS-220 and PRS-400 BOSTON, MA / ACCESSWIRE / May 10, 2023 / Pieris Pharmaceuticals, Inc. (NASDAQ:PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin® technology platform for respiratory diseases, cancer, and other indications, reported financial results for the quarter ended March 31, 2023, and provided a business update. "We continue to be excited by the potential of our inhaled biologics pipeline to reshape the treatment paradigm for patients living with uncontrolled asthma and other chronic respiratory diseases. Our top priority remains the study completion and clinical data read out from the elarekibep Phase 2a study in asthma, which is benefitting from increased operational resources from our partner, AstraZeneca," said Stephen S. Yoder, President and CEO of Pieris. "Pieris continues to make measured investments in PRS-220 and PRS-400 while also expecting additional progress across partnered programs through our capital-efficient collaborations with Boston Pharmaceuticals, Genentech, Seagen and Servier." Respiratory Pipeline: Elarekibep and AstraZeneca Collaboration: Enrollment is ongoing in the multi-center, placebo-controlled Phase 2a study of dry powder inhaler-formulated elarekibep, an IL-4 receptor alpha (IL-4Rα) inhibitor being developed for the treatment of moderate-to-severe asthma. Topline results measuring placebo-adjusted FEV1 improvement at four weeks, the study's primary efficacy endpoint, are expected by the middle of 2024. AstraZeneca previously communicated to the Company that completion of the Phase 2a study remains an important priority and that additional resources have been provided to achieve study completion. This includes a commitment to adding several new countries and a significant number of additional clinical sites, bringing the anticipated total number to more than 100 sites. As part of this commitment, AstraZeneca is on track to add three new geographies and related sites in the current quarter. Together with the previously announced protocol amendments, which are positively impacting study screening, we anticipate this will enable the achievement of the enrollment targets and timelines. In addition, the safety review of the 10 mg dose cohort in mild controlled asthmatics was successfully completed, which provides additional data supporting the elarekibep safety pro enables doses greater than 3 mg to be evaluated in the future, if needed. Previously reported elarekibep Phase 1 results demonstrated reduced fractional exhaled nitric oxide (FeNO) levels in mild asthma patients, and a favorable safety profile. Elarekibep is further validated by dupilumab, an FDA-approved inhibitor of IL-4Rα that has demonstrated reduced levels of FeNO and clinical efficacy in uncontrolled, moderate-to-severe asthma. Furthermore, dupilumab Phase 3 study results have shown efficacy in chronic obstructive pulmonary disease (COPD). Pieris retains co-development and U.S. co-commercialization rights for elarekibep, which are exercisable following completion of the ongoing Phase 2a study. PRS-220: Pieris continues clinical development of PRS-220, a potential best-in-class inhaled Anticalin protein targeting connective tissue growth factor (CTGF) for the treatment of IPF, a disease with a large unmet medical need, and other fibrotic lung diseases. Preclinically, PRS-220 demonstrated superior on-target potency compared to pamrevlumab, an intravenously infused CTGF antagonist in late-stage clinical development. The Company believes inhaled administration will deliver high lung exposure, optimal pulmonary target engagement and superior clinical outcomes, while offering convenience of at-home administration. The Company is dosing healthy volunteers in a Phase 1 study with PRS-220 and expects to report results in the second half of this year. On May 21, 2023, preclinical data will be presented at the ATS 2023 International Conference, including data demonstrating that inhaled PRS-220 significantly reduced collagen deposition in a silica-induced lung fibrosis mouse model. Pieris continues to benefit from a meaningful grant from the Bavarian government, which supports early-stage development of this program. PRS-400: Pieris continues its preclinical advancement of PRS-400, an inhaled anti-Jagged-1 Anticalin therapeutic program with transformative potential in a wide range of respiratory diseases driven by mucus hypersecretion. PRS-400 was designed to allow patients to exit the vicious cycle of mucus hypersecretion, infection and airway obstruction, while avoiding inhibition of healthy, normal mucus production outside of the lungs. On May 22, 2023, preclinical data will be presented at the ATS 2023 International Conference demonstrating that PRS-400 reduced inflammation-driven goblet cell metaplasia and mucus hypersecretion in a therapeutic disease model. PRS-400 is advancing toward development candidate nomination in the second half of this year. Immuno-Oncology Pipeline: Pieris' immuno-oncology pipeline continues to progress in a cost-efficient manner with the benefit of its partners. The Company believes that multiple opportunities exist to generate value from this portfolio based on promising data generated to date. In April, clinical results from the Company's clinical study of cinrebafusp alfa (PRS-343) in 2L+ HER2-positive gastric cancer were presented at the American Association for Cancer Research annual meeting, including an unconfirmed 100% objective response rate and promising emerging durability pro the five patients enrolled into the study prior to study discontinuation of enrollment for strategic reasons. Pieris is considering a range of transactions to facilitate program continuation, from an immuno-oncology focused spinout to a traditional partnering transaction. Boston Pharmaceuticals continues to advance BOS-342 (also known as PRS-342), a 4-1BB/GPC3 bispecific Mabcalin™ (antibody-Anticalin protein) compound, toward the clinic, with Phase 1 expected to begin in the coming months. Pieris and Servier continue to progress the escalation portion of the Phase 1/2 study of PRS-344/S095012, a 4-1BB/PD-L1 bispecific Mabcalin compound for the treatment of solid tumors, for which Pieris holds full U.S. rights. As previously announced, Seagen initiated a Phase 1 study for SGN-BB228 (also known as PRS-346), triggering a $5 million milestone payment to Pieris. SGN-BB228 is a first-in-class CD228/4-1BB bispecific antibody-Anticalin compound designed to provide a potent costimulatory bridge between tumor-specific T cells and CD228-expressing tumor cells. Pieris and Seagen continue to collaborate on two other undisclosed bispecific programs. Fiscal Year End Financial Update: Cash Position - Cash, cash equivalents, and investments totaled $48.4 million for the quarter ended March 31, 2023, compared to a cash and cash equivalents balance of $59.2 million for the year ended December 31, 2022. The decrease was due to funding operations in the first quarter of 2023. The Company believes operations are sufficiently funded for more than the next 12 months. R&D Expense - R&D expenses were $13.4 million for the quarter ended March 31, 2023, compared to $14.1 million for the quarter ended March 31, 2022. The decrease was due primarily to lower clinical costs for cinrebafusp alfa and lower personnel costs, license fees and software costs. These lower costs were partially offset by higher overall program costs for PRS-220 and higher preclinical costs for discovery-stage programs, both partnered and proprietary. G&A Expense - G&A expenses were $4.0 million for the quarter ended March 31, 2023, compared to $4.4 million for the quarter ended March 31, 2022. The period-over-period decrease was driven primarily by lower professional services, consulting and insurance costs. Other Income - For the quarter ended March 31, 2023, $2.0 million of grant income was recorded with respect to PRS-220, compared to $2.1 million for the quarter ended March 31, 2022, indicating that costs incurred on PRS-220 were comparable for both periods. Interest income was $0.4 million for the quarter ended March 31, 2023, given the impact of rising interest rates compared to a de minimis amount of interest income in the quarter ended March 31, 2022 Net Loss - Net loss was $13.2 million or $(0.45) per share for the quarter ended March 31, 2023, compared to a net loss of $5.1 million or $(0.07) per share for the quarter ended March 31, 2022. Conference Call: Pieris management will host a conference call beginning at 8:00 AM EDT on Wednesday, May 10, 2023, to discuss the first quarter 2023 financial results and provide a corporate update. Individuals can join the call by dialing 866-682-6100 (Toll Free US & Canada) or +1 862-298-0702 (International) at least five minutes prior to the start of the call. Alternatively, a listen-only audio webcast of the call can be accessed here. A replay will be available on the Investors section of the Company's website, . About Pieris Pharmaceuticals: Pieris is a clinical-stage biotechnology company that combines leading protein engineering capabilities and deep understanding into molecular drivers of disease to develop inhaled medicines that drive local biology to produce superior clinical outcomes for patients. Our pipeline is focused on inhalable Anticalin proteins to treat respiratory diseases and locally-activated bispecifics for immuno-oncology. Proprietary to Pieris, Anticalin proteins are a novel class of therapeutics validated in the clinic and by strong partnerships with leading pharmaceutical companies. For more information, visit . Forward-looking Statements: This press release contains forward-looking statements as that term is defined in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things, our expected cash runway; our product candidates clinical and therapeutic potential in their intended indications; the advancement of our proprietary and co-development programs into and through the clinic, including the achievement of enrollment targets and timelines, and the expected timing for reporting data, including through participation in conferences; the receipt of royalty and/or milestone payments provided for in our collaboration agreements; making IND filings or achieving other milestones related to our programs, including elarekibep, PRS-220, PRS-400, PRS-344/S095012, SGN-BB228 and BOS-342; the therapeutic potential and safety pro our Anticalin platform; the potential addressable market for our product candidates; our continued progress in the area of co-stim bispecifics and inhaled therapeutics; and the advancement and funding of our developmental programs generally. Actual results could differ from those projected in any forward-looking statement due to numerous factors. Such factors include, among others, the amounts of anticipated funding actually received for our continued development programs and our actual reductions in spending as compared to anticipated cost reductions; our ability to raise the additional funding, including through partnership transactions, that we will need to continue to pursue; our business and product development plans; the inherent uncertainties associated with developing new products or technologies, including in collaboration with other parties, and operating as a development stage company; our ability to develop, complete clinical trials for, obtain approvals for and commercialize any of our product candidates, including our ability to recruit and enroll patients in our studies; the fact that data and results from preclinical and clinical studies may not necessarily be indicative of future results; competition in the industry in which we operate; delays or disruptions due to COVID-19 or geopolitical issues, including the conflict in Ukraine; and market conditions. These forward-looking statements are made as of the date of this press release, and we assume no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Investors should consult all of the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents we the Securities and Exchange Commission (SEC) available at including, without limitation, the Company's most recent Annual Report on Form 10-K, the Company's Quarterly Reports on Form 10-Q, and subsequent filings with the SEC. Investor Relations Contact: Pieris Pharmaceuticals, Inc. Investors@pieris.com Joe Patneaude Kendall Investor Relations Joe@kendalIir.com PIERIS PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (unaudited, in thousands) March 31, 2023 December 31, 2022 Assets: Cash and cash equivalents $ 39,742 $ 38,635 Short term investments 8,637 20,534 Accounts receivable 1,055 5,810 Prepaid expenses and other current assets 11,071 8,445 Total current assets 60,505 73,424 Property and equipment, net 16,706 16,992 Operating lease right-of-use assets 3,796 3,705 Other non-current assets 1,251 1,369 Total Assets $ 82,258 $ 95,490 Liabilities and stockholders' equity: Accounts payable $ 5,833 $ 4,154 Accrued expenses 10,354 11,605 Deferred revenue, current portion 26,688 20,284 Total current liabilities 42,875 36,583 Deferred revenue, net of current portion 11,727 18,734 Operating lease liabilities 12,198 12,244 Total Liabilities 66,800 67,561 Total stockholders' equity 15,458 27,929 Total liabilities and stockholders' equity $ 82,258 $ 95,490 PIERIS PHARMACEUTICALS, INC CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited, in thousands, except per share data) Three months ended March 31, 2023 2022 Revenues $ 1,936 $ 10,988 Operating expenses Research and development 13,424 14,066 General and administrative 4,023 4,379 Total operating expenses 17,447 18,445 Loss from operations (15,511) (7,457) Interest income 357 (3) Grant income 2,028 2,130 Other income (expense), net (57) 229 Net loss $ (13,183) $ (4,977) Basic and diluted net loss per share $ (0.18) $ (0.07) Basic and diluted weighted average shares outstanding 74,519 73,711 SOURCE: Pieris Pharmaceuticals, Inc. 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BOTHELL, Wash.--( BUSINESS WIRE )-- Seagen Inc. (Nasdaq: SGEN) today announced the presentation of 17 abstracts at the upcoming 2023 American Society of Clinical Oncology (ASCO) Annual Meeting taking place June 2-6, 2023, in Chicago. Data will be presented across Seagen's portfolio of approved medicines and pipeline agents in a range of cancer types and in earlier lines of therapy. “Seagen has worked towards revolutionizing cancer care for 25 years by linking scientific innovation to meaningful impacts in patients’ lives,” said Roger Dansey, M.D., President, Research and Development and Chief Medical Officer at Seagen. “Our data presented at ASCO demonstrate continued progress in our efforts to discover and develop transformative medicines.” Highlights include new data from a robust clinical development program in bladder cancer with trials across multiple lines of treatment and into earlier stages of disease for muscle-invasive and non-muscle invasive forms of bladder cancer. Long-term follow-up data from a clinical trial of PADCEV ® (enfortumab vedotin-ejfv) (EV-103 dose-escalation and Cohort A) will be featured in an oral presentation on Monday, June 5. The EV-103 dose-escalation/Cohort A study is evaluating PADCEV, developed in partnership with Astellas, in combination with Merck’s anti-PD-1 therapy KEYTRUDA ® (pembrolizumab) as first-line treatment in patients with locally advanced or metastatic urothelial carcinoma who are ineligible to receive cisplatin-based chemotherapy. Merck is known as MSD outside the United States and Canada. Updated Phase 1 data will be presented for SGN-B6A, a wholly-owned, first-in-class vedotin ADC directed to integrin beta-6, a novel target that is highly expressed in multiple solid tumors. Additionally, initial data will be presented from studies evaluating Seagen’s approved medicines in potential new cancer types. Data from a Phase 2 basket study of TUKYSA ® (tucatinib) and trastuzumab in previously treated HER2-positive metastatic biliary tract cancer will be featured in an oral presentation on Friday, June 2. Key data presentations for Seagen include: Presentations of Company-Sponsored Trials Abstract Title Abstract # Presentation Time Lead Author Enfortumab Vedotin Study EV-103 dose escalation/cohort A: Long-term outcome of enfortumab vedotin + pembrolizumab in first-line (1L) cisplatin-ineligible locally advanced or metastatic urothelial carcinoma (la/mUC) with nearly 4 years of follow-up 4505 Oral Monday, June 5 11:30 a.m. - 2:30 p.m. CT S. Gupta Enfortumab vedotin in the previously treated advanced head and neck cancer (HNC) cohort of EV-202 6017 Poster Discussion Monday, June 5 1:15 - 4:15 p.m. CT P. Swiecicki A first-in-human trial of intravesical enfortumab vedotin (EV), an antibody-drug conjugate (ADC), in patients with non-muscle invasive bladder cancer (NMIBC): Interim results of a phase 1 study (EV-104) 4596 Poster Saturday, June 3 8:00 - 11:00 a.m. CT A. Kamat Study EV-103: Neoadjuvant treatment with enfortumab vedotin monotherapy in cisplatin-ineligible patients (pts) with muscle invasive bladder cancer (MIBC): Updated results for Cohort H 4595 Poster Saturday, June 3 8:00 - 11:00 a.m. CT T. Flaig Enfortumab vedotin (EV) with or without pembrolizumab (P) in cisplatin-ineligible patients with previously untreated locally advanced or metastatic urothelial cancer (la/mUC): Additional 3-month follow-up on Cohort K data 4568 Poster Saturday, June 3 8:00 - 11:00 a.m. CT T. Friedlander EV-203: Phase 2 trial of enfortumab vedotin in patients with previously treated advanced urothelial carcinoma in China e16574 Online Abstract Q. Li Enfortumab Vedotin Trials in Progress KEYNOTE-905/EV-303: A phase 3 study to evaluate the efficacy and safety of perioperative pembrolizumab or pembrolizumab plus enfortumab vedotin (EV) for muscle-invasive bladder cancer (MIBC) (ENCORE) TPS4601 Poster Saturday, June 3 8:00 - 11:00 a.m. CT A. Necchi Tucatinib Tucatinib and trastuzumab for previously treated HER2-positive metastatic biliary tract cancer (SGNTUC-019): A phase 2 basket study 4007 Oral Friday, June 2 2:45 - 5:45 p.m. CT Y. Nakamura Real-world patient characteristics and treatment patterns associated with tucatinib therapy in patients with HER2+ metastatic breast cancer 1051 Poster Sunday, June 4 8:00 - 11:00 a.m. CT C. Anders HER2 testing in the MOUNTAINEER trial: Analysis of treatment response based on central HER2 assessment using IHC/ISH and NGS 3528 Poster Monday, June 5 8:00 - 11:00 a.m. CT J. Strickler Tucatinib Trials in Progress HER2CLIMB-05: Phase 3 study of tucatinib or placebo in combination with trastuzumab and pertuzumab as maintenance therapy for HER2+ metastatic breast cancer (trial in progress) TPS1115 Poster Sunday, June 4 8:00 - 11:00 a.m. CT E. Hamilton MOUNTAINEER-03: Phase 3 study of tucatinib, trastuzumab, and modified FOLFOX6 as first line treatment in HER2+ metastatic colorectal cancer (trial in progress) TPS3631 Poster Monday, June 5 8:00 - 11:00 a.m. CT T. Bekaii-Saab Early-Stage/Pipeline SGN-B6A, an integrin beta-6 (ITGB6)-targeted antibody-drug conjugate (ADC), in patients with advanced solid tumors: Updated results from a phase 1 study (SGNB6A-001) 3024 Poster Saturday, June 3 8:00 - 11:00 a.m. CT A. Hollebecque Early-Stage/Pipeline Trials in Progress Phase 1 study of SGN-BB228, an investigational CD228 x 4-1BB costimulatory antibody anticalin bispecific, in patients with advanced melanoma and other solid tumors (SGNBB228-001: trial in progress) TPS9597 Poster Saturday, June 3 1:15 - 4:15 p.m. CT J. Henry Presentations of Investigator-Sponsored Trials Abstract Title Abstract # Presentation Time Lead Author Enfortumab Vedotin Real-world use, dose intensity, and adherence to an antibody-drug conjugate (ADC) in metastatic urothelial cancer (mUC) e16567 Online Abstract R. Mamtani Tucatinib UCLA B-13: A phase 1b trial evaluating the safety of ribociclib, tucatinib, and trastuzumab in patients with metastatic, HER2+ breast cancer and a multicenter, randomized, open-label, phase 2 study of preoperative treatment with ribociclib, trastuzumab, tucatinib, with or without fulvestrant versus docetaxel, carboplatin, trastuzumab, and pertuzumab in HR+/HR-, HER2+ breast cancer TPS1116 Poster Sunday, June 4 8:00 - 11:00 a.m. CT N. McAndrew Disitamab Vedotin Disitamab vedotin, a novel humanized anti-HER2 antibody-drug conjugate (ADC) combined with toripalimab in patients with locally advanced or metastatic urothelial carcinoma: an open-label phase 1b/2 study 4566 Poster Saturday, June 3 8:00 - 11:00 a.m. CT X. Sheng About Seagen Seagen Inc. is a global biotechnology company that discovers, develops and commercializes transformative cancer medicines to make a meaningful difference in people’s lives. Seagen is headquartered in the Seattle, Washington area, and has locations in California, Canada, Switzerland and the European Union. For more information on our marketed products and robust pipeline, visit www.seagen.com and follow @SeagenGlobal on Twitter. Forward-Looking Statements Certain statements made in this press release are forward looking, such as those, among others, relating to the therapeutic potential of PADCEV ® (enfortumab vedotin-ejfv), TUKYSA ® (tucatinib), disitamab vedotin, and the company’s other products and product candidates, including their potential efficacy, safety and therapeutic uses, and Seagen’s pipeline. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include without limitation the difficulty and uncertainty of pharmaceutical product development, including the risks that the company may experience delays in its clinical trials or otherwise experience failures or setbacks in its clinical development programs due to lack of efficacy, adverse events or other factors, and that adverse regulatory actions may occur. More information about the risks and uncertainties faced by Seagen is contained under the caption “Risk Factors” included in the company’s Annual Report on Form 10-K for the year ended December 31, 2022, filed with the Securities and Exchange Commission. Seagen disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.