c-Kit

REDWOOD CITY, Calif., March 19, 2024 (GLOBE NEWSWIRE) -- Jasper Therapeutics, Inc. (Nasdaq: JSPR) (Jasper), a biotechnology company focused on development of briquilimab, a novel antibody therapy targeting c-Kit (CD117) in mast cell driven diseases such as chronic spontaneous urticaria (CSU) and chronic inducible urticaria (CIndU), today announced that the first patient has been dosed in Jasper’s Phase 1b/2a (SPOTLIGHT) clinical study of subcutaneous briquilimab for the treatment of CIndU. The SPOTLIGHT study is evaluating a single administration, at two different dose levels, of subcutaneous briquilimab in adult patients with cold urticaria (ColdU) or symptomatic dermographism (SD). “We are excited to announce dosing of the first patient in the SPOTLIGHT study in patients with CIndU, our second clinical program evaluating briquilimab in a mast cell-mediated disease,” said Edwin Tucker, Chief Medical Officer of Jasper. “As with our BEACON study in CSU, we expect the SPOTLIGHT study to establish proof of concept for the depletion of mast cells by briquilimab in CIndU and help us to determine doses and dosing regimens for future registrational studies. We plan to provide enrollment updates as we progress through the study and anticipate reporting preliminary data in the second half of 2024.” The SPOTLIGHT study is expected to enroll approximately 15 patients across 2 dose cohorts. The primary endpoints are safety and tolerability of briquilimab with secondary endpoints focused on efficacy measures and pharmacokinetics. The study is being conducted at four sites in the EU. Jasper anticipates reporting preliminary data from the SPOTLIGHT study in the second half of 2024. “c-Kit inhibitors are a promising class of monoclonal therapeutics with demonstrated efficacy in mast cell driven diseases,” said Marcus Maurer, M.D., Professor of Dermatology and Allergy at Charité – Universitätsmedizin in Berlin. “As a potent and differentiated c-Kit inhibitor, I believe briquilimab has the potential to serve as an important treatment option for patients suffering from CIndU, and I look forward to enrolling patients into the SPOTLIGHT study and additionally into the BEACON study for CSU.” About Briquilimab Briquilimab (formerly JSP191) is a targeted aglycosylated monoclonal antibody that blocks stem cell factor from binding to the cell-surface receptor c-Kit, also known as CD117, thereby inhibiting signaling through the receptor. This inhibition disrupts the critical survival signal, leading to the depletion of the mast cells via apoptosis which removes the underlying source of the inflammatory response in mast cell driven diseases such as chronic urticaria. Jasper is currently conducting clinical studies of briquilimab as a treatment in patients with CSU or with CIndU. Briquilimab is also currently in clinical studies as a treatment for patients with LR-MDS and as a conditioning agent for cell therapies for rare diseases. To date, briquilimab has a demonstrated efficacy and safety pro more than 145 dosed participants and healthy volunteers, with clinical outcomes as a conditioning agent in severe combined immunodeficiency (SCID), AML, MDS, FA, and sickle cell disease (SCD). About Jasper Jasper is a clinical-stage biotechnology company developing briquilimab, a monoclonal antibody targeting c-Kit (CD117) as a therapeutic for chronic mast and stem cell diseases such as chronic urticaria and lower to intermediate risk MDS and as a conditioning agent for stem cell transplants for rare diseases such as SCD, FA and SCID. To date, briquilimab has a demonstrated efficacy and safety pro more than 145 dosed participants and healthy volunteers, with clinical outcomes as a conditioning agent in SCID, AML, MDS, FA, and SCD. For more information, please visit us at . Forward-Looking Statements Certain statements included in this press release that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements are sometimes accompanied by words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding briquilimab’s potential, including with respect to its potential in mast cell driven diseases such as CSU and CIndU and its potential to serve as an important treatment option for patients suffering from CIndU; Jasper’s expectations regarding its Phase 1b/2a SPOTLIGHT study of subcutaneous briquilimab in CIndU, including the expected enrollment, cohorts and site locations, the expected timing for reporting preliminary data, the expectation that the SPOTLIGHT or BEACON studies will establish proof of concept or help Jasper determine doses and dosing regimens for future registrational studies; and Jasper’s expectations regarding its BEACON study in CSU, including the expectation that Jasper will enroll additional patients in the BEACON study for CSU. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of Jasper and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by an investor as, a guarantee, an assurance, a prediction or a definitive statement of fact or probability. Many actual events and circumstances are beyond the control of Jasper. These forward-looking statements are subject to a number of risks and uncertainties, including general economic, political and business conditions; the risk that the potential product candidates that Jasper develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all; the risk that clinical trials may not confirm any safety, potency or other product characteristics described or assumed in this press release; the risk that Jasper will be unable to successfully market or gain market acceptance of its product candidates; the risk that prior study results may not be replicated; the risk that Jasper’s product candidates may not be beneficial to patients or successfully commercialized; patients’ willingness to try new therapies and the willingness of physicians to prescribe these therapies; the effects of competition on Jasper’s business; the risk that third parties on which Jasper depends for laboratory, clinical development, manufacturing and other critical services will fail to perform satisfactorily; the risk that Jasper’s business, operations, clinical development plans and timelines, and supply chain could be adversely affected by the effects of health epidemics; the risk that Jasper will be unable to obtain and maintain sufficient intellectual property protection for its investigational products or will infringe the intellectual property protection of others; and other risks and uncertainties indicated from time to time in Jasper’s filings with the SEC, including its Annual Report on Form 10-K for the year ended December 31, 2023 and subsequent Quarterly Reports on Form 10-Q. If any of these risks materialize or Jasper’s assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. While Jasper may elect to update these forward-looking statements at some point in the future, Jasper specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Jasper’s assessments of any date subsequent to the date of this press release. Accordingly, undue reliance should not be placed upon the forward-looking statements. Contacts: Joyce Allaire (investors) LifeSci Advisors 617-435-6602 jallaire@lifesciadvisors.com Alex Gray (investors) Jasper Therapeutics 650-549-1454 agray@jaspertherapeutics.com Lauren Walker (media) Real Chemistry 646-564-2156 lbarbiero@realchemistry.com

PLYMOUTH, Mass.--( BUSINESS WIRE )--IDRx, Inc., a clinical-stage biopharmaceutical company dedicated to transforming cancer treatment with purpose-built precision therapies, today announced that it has strengthened its leadership team with the appointments of Tim Clackson, Ph.D. as Chief Executive Officer, and Brad Dahms as Chief Financial Officer and Chief Business Officer. Ben Auspitz, IDRx’s co-founder and founding CEO, and also co-founder of Forge Life Science Partners, will become Chairman of the IDRx Board of Directors. “I am thrilled to join the Company at this important stage of our development. At CTOS in November 2023, IDRx announced preliminary clinical data supporting the best-in-class potential of IDRX-42 in patients with GIST, for which a new therapy in the second line or front line has not been approved in nearly two decades,” said Dr. Clackson. “We are well-positioned to address the significant unmet need for patients with GIST, and I am humbled to be a part of such a talented team to further advance IDRX-42.” Dr. Clackson brings three decades of experience building oncology companies, including three oncology drug approvals. Dr. Clackson was most recently Chief Executive Officer of Theseus Pharmaceuticals, a clinical stage biotechnology company focused on development of precision oncology therapies, where he led the Company through its initial public offering and early clinical development for its lead product candidate for the treatment of GIST. Prior to Theseus, Dr. Clackson served as President at Xilio Therapeutics, a privately held oncology company developing tumor-selective immunotherapies, where he led the development of the Company's technology and product strategy. From 1994 to 2018, Dr. Clackson was with ARIAD Pharmaceuticals, where he held several leadership positions including President of Research & Development and Chief Scientific Officer. He played a key role in the company's evolution from early research to a global commercial oncology company, and its subsequent acquisition by Takeda. He led the multi-disciplinary R&D team that internally discovered and developed five clinical-stage product candidates, including ICLUSIG® (ponatinib), approved for patients with treatment-resistant Ph+ leukemias; ALUNBRIG® (brigatinib), approved for ALK+ non-small cell lung cancer (NSCLC); and EXKIVITY™, approved for Exon20 insertion+ NSCLC. Prior to ARIAD, Dr. Clackson was a postdoctoral research fellow at Genentech. He received his Ph.D. in Biology from the University of Cambridge, and his B.A. in Biochemistry from the University of Oxford. Dr. Clackson serves as a Director on the Board of Elevation Oncology and previously served as a. Director on the Boards of Forma Therapeutics (acquired by Novo Nordisk) and the Massachusetts Biotechnology Council (MassBio). “Tim brings an impressive track record of clinical execution with multiple drug approvals and Brad brings a wealth of experience strategically growing and financing companies,” said Mr. Auspitz. “We welcome their leadership as we continue to build the company and advance IDRX-42 with the goal of bringing a new therapy to GIST patients for whom current therapies continue to be limited by drug resistance and toxic side effects from available treatments.” Mr. Dahms was most recently Chief Financial Officer of Theseus Pharmaceuticals, where he led capital raises totaling approximately $230 million, including Theseus’ $180 million initial public offering. Mr. Dahms oversaw financial operations, information technology, business development, and investor/public relations. He led the sale of the Company to Concentra Biosciences. Prior to Theseus, Mr. Dahms served as Chief Financial Officer of Selecta Biosciences, Inc., where he oversaw financial operations, information technology, investor relations, and business development activities. He led Selecta through several significant financing and strategic transactions, including a $730 million licensing agreement for its lead program. Previously, Mr. Dahms was a Senior Vice President in the Healthcare Group at Cantor Fitzgerald & Co., focused on providing strategic and financial advice to life sciences companies. Prior to Cantor, Mr. Dahms held several other investment banking roles, including at RBC Capital Markets in the Healthcare Group, and at J.P. Morgan. Mr. Dahms earned a B.S. in Economics, with honors, from The Ohio State University. “I look forward to working with Tim, Ben, and the team at IDRx to grow the Company with the backbone of IDRX-42,” said Mr. Dahms. “The opportunity in GIST is large and unmet, and we have multiple paths to evaluate as we scale the Company for the benefit of patients and our investors.” About GIST Gastrointestinal stromal tumors (GIST) are the most common subtype of soft tissue sarcoma. Approximately 80% of cases arise from gain of function mutations in the KIT receptor tyrosine kinase, driving the malignancy through constitutive activation of aberrant signaling. Resistance mutations in KIT emerge in ~90% of patients treated with imatinib, the current standard of care for GIST. In unresectable or metastatic GIST, clinical benefits from existing treatments can vary by mutation type. About the IDRx Pipeline IDRX-42 is a potent, oral, highly selective KIT inhibitor targeting all major categories of activating and resistance mutations in patients with KIT-mutant GIST (including variants in exons 9, 11, 13 and 17). IDRX-42 is currently being evaluated in a first-in-human Phase 1/1b study, and clinical data to date suggest this therapy may represent a best-in-class therapy for GIST. IDRx is also developing IDRX-73, a highly selective inhibitor of exon-13-mutant KIT, which could provide future optionality in clinical development. An investigational new drug (IND) application for IDRX-73 was recently cleared by the FDA. About IDRx IDRx is a clinical-stage biopharmaceutical company dedicated to transforming cancer care with intelligently designed precision therapies. IDRx aims to address the limitations of today’s precision cancer medicines with highly potent and selective targeted therapies to stop key tumor escape mechanisms and prolong response to therapy. IDRx’s lead program is IDRX-42, designed to inhibit key genetic drivers and drug-resistant mutations of KIT in gastrointestinal stromal tumor (GIST). IDRx's pipeline also includes a second KIT inhibitor, IDRX-73. Founded in 2021, IDRx’s leadership team has extensive experience in drug development and collectively has been involved in the discovery, development, and commercialization of more than 10 approved drugs. To learn more, please visit www.idrx.com and follow us on LinkedIn .

- First PAH Patient Dosed in Ongoing Registrational Phase 3 PROSERA Study - - Inclusion of Japan in Phase 3 PROSERA Study Following CTN Acceptance by PMDA - - Cash, cash equivalents and marketable securities totaled $296 million at year-end 2023 - SAN DIEGO--(BUSINESS WIRE)-- Gossamer Bio, Inc. (Nasdaq: GOSS), a clinical-stage biopharmaceutical company focused on the development and commercialization of seralutinib for the treatment of pulmonary arterial hypertension (PAH), today announced its financial results for the fourth quarter and year ended December 31, 2023, and provided a business update. “We were thrilled to enroll the first patient in the registrational PROSERA Study last year, and we are pleased with the pace of site activations and enrollment into the study,” said Faheem Hasnain, Chairman, Co-Founder and CEO of Gossamer Bio. “This advancement marks a significant milestone in Gossamer’s journey, and it was made possible due to the tireless efforts of the Gossamer team. We are excited to be one step closer to bringing seralutinib to patients. “Additionally, we believe Gossamer is one of the first companies to take advantage of new Japanese regulatory guidelines, formally issued at the end of last year, to allow for the inclusion of Japanese subjects in our global registrational study of seralutinib without performing a pharmacokinetic bridging study. Subject to final results, PROSERA could form the basis of a Japanese New Drug Application, accelerating the potential commercial availability of seralutinib to PAH patients in Japan and unlocking a valuable geographic market for Gossamer. “Beyond PAH, we remain excited about the potential of seralutinib to treat patients living with other forms of pulmonary hypertension, including pulmonary hypertension associated with interstitial lung disease, or PH-ILD. Patients with PH-ILD are in desperate need of safe and efficacious therapies, with just one therapy approved in the US and no approved therapies available in the rest of the world. We believe seralutinib holds great promise for these patients, and our team is eagerly working through a clinical development plan.” Seralutinib (GB002): Inhaled PDGFR, CSF1R and c-KIT Inhibitor The first PAH patient in the ongoing Phase 3 PROSERA Study was dosed in the fourth quarter of 2023. The Phase 3 PROSERA Study is a global registrational clinical trial in patients with Functional Class II and III PAH. The primary endpoint is change in six-minute walk distance (6MWD) from baseline at week 24. Topline results from the PROSERA Study are expected in the fourth quarter of 2025. The Pharmaceuticals and Medical Devices Agency of Japan, or PMDA, allowed inclusion of Japanese clinical trial sites in the ongoing Phase 3 PROSERA Study. Subject to final clinical trial results, PROSERA could form the basis of a commercial marketing application in Japan. Financial Results for Quarter and Full Year Ended December 31, 2023 Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities as of December 31, 2023, were $296.4 million. As a result, we expect our current cash, cash equivalents and marketable securities will be sufficient to fund operating and capital expenditures into the first half of 2026. Research and Development (R&D) Expenses: For the quarter ended December 31, 2023, R&D expenses were $30.0 million compared to R&D expenses of $41.5 million for the same period in 2022. R&D expenses for the full year ended December 31, 2023, were $135.3 million compared to $170.9 million for the full year ended December 31, 2022. General and Administrative (G&A) Expenses: For the quarter ended December 31, 2023, G&A expenses were $9.1 million compared to $12.8 million for the same period in 2022. G&A expenses for the full year ended December 31, 2023, were $38.5 million compared to $47.6 million for the full year ended December 31, 2022. Net Loss: Net loss for the three months ended December 31, 2023, was $48.1 million, or $0.21 per share, compared to a net loss of $55.8 million, or $0.59 per share, for the same period in 2022. Net loss for the full year ended December 31, 2023, was $179.8 million, or $1.18 per share compared to a net loss of $229.4 million, or $2.71 per share, for the full year ended December 31, 2022. About Gossamer Bio Gossamer Bio is a clinical-stage biopharmaceutical company focused on the development and commercialization of seralutinib for the treatment of pulmonary arterial hypertension. Its goal is to be an industry leader in, and to enhance the lives of patients suffering from, pulmonary hypertension. Forward-Looking Statements Gossamer cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on the Company’s current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding: the anticipated timing of a data readout from our Phase 3 PROSERA Study; expectations on commencing a clinical development program in PH-ILD; the ability to commercial marketing application in Japan pending clinical data; and the expected timeframe for funding our operating plan with current cash, cash equivalents and marketable securities. The inclusion of forward-looking statements should not be regarded as a representation by Gossamer that any of its plans will be achieved. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in Gossamer’s business, including, without limitation: potential delays in the commencement, enrollment and completion of clinical trials; disruption to our operations from pandemics, including clinical trial delays; the Company’s dependence on third parties in connection with product manufacturing, research and preclinical and clinical testing; the results of preclinical studies and early clinical trials are not necessarily predictive of future results; the success of Gossamer’s clinical trials and preclinical studies for seralutinib; regulatory developments in the United States and foreign countries; unexpected adverse side effects or inadequate efficacy of seralutinib that may limit its development, regulatory approval and/or commercialization, or may result in clinical holds, recalls or product liability claims; Gossamer’s ability to obtain and maintain intellectual property protection for seralutinib; Gossamer’s ability to comply with its obligations in collaboration agreements with third parties or the agreements under which it licenses intellectual property rights from third parties; unstable market and economic conditions and adverse developments with respect to financial institutions and associated liquidity risk may adversely affect our business and financial condition and the broader economy and biotechnology industry; Gossamer may use its capital resources sooner than it expects; and other risks described in the Company’s prior press releases and the Company’s filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in the Company’s 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 Gossamer undertakes 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. GOSSAMER BIO, INC. CONDENSED CONSOLIDATED FINANCIAL STATEMENT DATA (UNAUDITED; IN THOUSANDS, EXCEPT SHARE AND PER SHARE DATA) Three months ended December 31, Year ended December 31, STATEMENTS OF OPERATIONS DATA: 2023 2022 2023 2022 Operating expenses: Research and development $ 29,970 $ 41,508 $ 135,304 $ 170,919 In process research and development 10,000 15 10,000 65 General and administrative 9,057 12,834 38,455 47,609 Total operating expenses 49,027 54,357 183,759 218,593 Loss from operations (49,027 ) (54,357 ) (183,759 ) (218,593 ) Other income (expense) Interest income 310 594 1,997 1,583 Interest expense (3,239 ) (3,457 ) (13,511 ) (13,880 ) Other income, net 3,808 1,456 15,456 1,512 Total other income (expense), net 879 (1,407 ) 3,942 (10,785 ) Net loss $ (48,148 ) $ (55,764 ) $ (179,817 ) $ (229,378 ) Net loss per share, basic and diluted $ (0.21 ) $ (0.59 ) $ (1.18 ) $ (2.71 ) Weighted average common shares outstanding, basic and diluted 225,409,315 94,280,553 152,621,669 84,574,869 BALANCE SHEET DATA: December 31, 2023 December 31, 2022 Cash, cash equivalents, and marketable securities $ 296,425 $ 255,678 Working capital 254,921 212,650 Total assets 311,916 272,450 Total liabilities 249,147 260,373 Accumulated deficit (1,212,040 ) (1,032,223 ) Total stockholders' equity 62,769 12,077