Rituximab

-Contineum is focused on leading the Neuroscience, Inflammation and Immunology (NI&I) field- -Successful completion of Initial Public Offering with strong syndicate of existing and new investors- SAN DIEGO--(BUSINESS WIRE)-- Contineum Therapeutics Inc. (Nasdaq: CTNM), a clinical stage biopharmaceutical company focused on discovering and developing novel, oral small molecule therapies that target biological pathways associated with specific clinical impairments for the treatment of NI&I indications, today reported financial results for the first quarter ended March 31, 2024, and highlighted recent corporate progress. “2024 has been a pivotal year of growth for Contineum, as we transitioned to a publicly traded company, expanded the development of PIPE-791 into fibrotic diseases, and nominated our third internally derived development candidate,” said Carmine Stengone, Contineum’s Chief Executive Officer. “We have an exciting year ahead of us focused on clinical execution – we have initiated a Phase 2 trial of PIPE-307 in relapse-remitting multiple sclerosis (RRMS) and expect to initiate a Phase 1b clinical trial of PIPE-791 to measure the relationship of pharmacokinetics (PK) to lung and brain receptor occupancy by positron emission tomography (PET) imaging, while our partner, J&J, announced plans to initiate a Phase 2 trial of PIPE-307 in depression in 2024. Additionally, we look forward to advancing our scientific capabilities and applying our expertise in the NI&I field to develop better drugs and deliver benefits to patients and shareholders.” First Quarter 2024 and Recent Business Highlights Significantly Extended Cash Runway Through the Completion of the Company’s Initial Public Offering. In April 2024, Contineum completed its initial public offering (IPO) resulting in net proceeds of $108.0 million, providing the Company with sufficient capital to generate multiple readouts from PIPE-791 studies in idiopathic pulmonary fibrosis (IPF) and progressive multiple sclerosis (MS) and PIPE-307 studies in depression and RRMS. Contineum’s proforma cash balance at March 31, 2024, when taking into account the net proceeds from its IPO, was $225.9 million, which is anticipated to fund operations to the end of 2027 based upon the current operating plan. Met Primary and Secondary Objectives in PIPE-791 Phase 1 Clinical Trial. In January 2024, Contineum completed a Phase 1 clinical trial of PIPE-791, a novel, brain penetrant, small molecule LPA1R receptor antagonist to support the clinical development of PIPE-791 in both IPF and progressive MS. The Phase 1 trial was a single-center, double-blind, placebo-controlled safety, tolerability, and PK trial of oral administration of PIPE-791. The primary objective of the trial was to assess the safety and tolerability of single and repeat oral doses of PIPE-791. The secondary objective of the trial was to assess the single and repeat dose PK pro PIPE-791. PIPE-791 was well-tolerated across all four single ascending dose and three multiple ascending dose cohorts. Contineum expects to initiate a Phase 1b open-label trial of PIPE-791 in the fourth quarter of 2024 to establish the relationship of PK to lung and brain receptor occupancy by PET imaging. The results of this Phase 1b trial will inform dose selection for Contineum’s planned future Phase 2 trials in IPF and progressive MS, respectively. Expanded Pipeline Through the Nomination of a Third Development Candidate, CTX-343. In January 2024, Contineum nominated and began preclinical studies for CTX-343, a peripherally restricted (unable to cross the blood-brain-barrier) LPA1R antagonist. CTX-343 represents the third internally development candidate to be generated from Contineum’s drug discovery platform. Contineum expects to submit an Investigational New Drug Application (IND) to the U.S. Food and Drug Administration for CTX-343 in 2025. Presented Positive LPA1 Expression Data on PIPE-791 at the Myelin Gordon Conference. In March 2024, Contineum presented a poster at the Myelin Gordon Conference that showed high LPA1 receptor expression in brain tissue sections derived from patients with MS. Further, that expression was enriched in lesions with activated microglia associated with chronic inflammation and disease severity further supporting clinical development of PIPE-791 in progressive MS. Strengthened Board of Directors. In March 2024, Contineum appointed commercial veteran Olivia Ware to its Board of Directors. Ms. Ware has more than twenty years of experience in pharmaceutical drug development, commercialization and healthcare management, playing key roles in the launch of several commercial drugs including Rituxan®, Herceptin®, Avastin® and Lucentis®. Ms. Ware also serves as a member of the board of directors of Arcellx, Inc. and Revance Therapeutics, Inc. Ms. Ware holds an A.B. in Psychology from Davidson College and an M.B.A. in Finance and Marketing from the University of North Carolina at Chapel Hill. First Quarter 2024 Financial Results Cash, Cash Equivalents and Marketable Securities. As of March 31, 2024, Contineum had cash, cash equivalents and marketable securities of $117.9 million, compared to $125.2 million at the end of 2023. Research and Development Expenses. Research and development expenses were $7.8 million for the three months ended March 31, 2024, compared to $3.6 million for the three months ended March 31, 2024. The increase of $4.2 million for the three months ended March 31, 2024, compared to the three months ended March 31, 2023 was primarily driven by a $2.9 million increase in expenses related to research and development expenses for the Company’s product candidates and a $0.6 million increase in expenses related to personnel costs due to increased headcount to support increased development activities. General and Administrative Expenses. General and administrative expenses were $2.2 million for the three months ended March 31, 2024, compared to $1.5 million for the three months ended March 31, 2023. The increase of $0.7 million for the three months ended March 31, 2024, compared to the three months ended March 31, 2023 was primarily driven by $0.5 million increase in consulting expenses and $0.1 million increase in personnel costs. About Contineum Therapeutics Contineum Therapeutics (Nasdaq: CTNM) is a clinical stage biopharmaceutical company focused on discovering and developing novel, oral small molecule therapies for NI&I indications with high unmet need. Contineum is focused on targeting biological pathways associated with specific clinical impairments, that Contineum believes, once modulated, may demonstrably impact the course of disease. Contineum has a pipeline of internally-developed programs to address multiple NI&I disorders. PIPE-791 is an LPA1 receptor antagonist which recently completed a Phase 1 healthy volunteer clinical trial to support ongoing clinical development for IPF and progressive MS. PIPE-307, a selective inhibitor of the M1 receptor, is currently in a Phase 2 clinical trial for RRMS, and a Phase 2 trial in depression is planned to initiate in 2024. Contineum is developing PIPE-307 in collaboration with Johnson & Johnson Innovative Medicines. Contineum is headquartered in San Diego, CA. For more information, please visit Forward-Looking Statements Certain statements contained in this press release, other than historical information, constitute forward-looking statements within the meaning of the federal securities laws. Forward-looking statements include, but are not limited to, statements regarding the Company’s clinical trial and product development plans and timelines, the indications and market opportunities for its drug candidates and its business strategies and plans. These statements involve known and unknown risks, uncertainties and other important factors that are in some cases beyond the Company’s control and may cause its actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These risks and uncertainties, include, but are not limited to, the following: the Company is heavily dependent on the success of PIPE-791 and PIPE-307, both of which are in the early stages of clinical development, and neither of these drug candidates may progress through clinical development or receive regulatory approval; the results of earlier preclinical studies and clinical trials, including those conducted by third parties, may not be predictive of future results; the Company has incurred significant operating expenses since inception and it expects that its operating expenses will continue to significantly increase for the foreseeable future; the Company’s license agreement with an affiliate of Johnson & Johnson may not result in the successful development of PIPE-307; and the Company may be unable to obtain, maintain and enforce intellectual property protection for its technology and drug candidates. Additional risks and uncertainties that could affect the Company’s business, operations and results are included under the captions, “Risk Factors” and "Management’s Discussion and Analysis of Financial Condition and Results of Operations” in its most recent filing on Form 10-Q and in other filings that it makes with the SEC from time to time. These documents are available on the Company’s website at under the Investor section and on the SEC’s website at . Accordingly, readers should not rely upon forward-looking statements as predictions of future events. Except as required by applicable law, the Company undertakes no obligation to update publicly or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. Contineum Therapeutics, Inc. Condensed Balance Sheets (Unaudited) (in thousands) March 31, 2024 December 31, 2023 Assets Cash, cash equivalents and marketable securities $ 117,907 $ 125,190 Prepaid expenses and other current assets 1,804 2,516 Property and equipment, net 756 678 Other long-term assets 2,623 1,283 Operating lease right-of-use assets 474 719 Total assets $ 123,564 $ 130,386 Liabilities, convertible preferred stock and stockholders' deficit Current liabilities $ 6,234 $ 5,484 Long-term liabilities 339 218 Convertible preferred stock 192,620 192,620 Total stockholders' deficit (75,629 ) (67,936 ) Total liabilities, convertible preferred stock and stockholders' deficit $ 123,564 $ 130,386 Contineum Therapeutics, Inc. Condensed Statement of Operations (Unaudited) (in thousands) Three Months Ended March 31, 2024 2023 Operating expenses: Research and development $ 7,778 $ 3,632 General and administrative 2,152 1,483 Total operating expenses 9,930 5,115 Loss from operations (9,930 ) (5,115 ) Interest income 1,636 401 Interest expense — (92 ) Change in fair value of preferred stock warrant liability (117 ) — Other expense, net (6 ) (18 ) Net loss (8,417 ) (4,824 ) Other comprehensive income (loss): Unrealized gain (loss) on marketable securities (166 ) 67 Comprehensive loss $ (8,583 ) $ (4,757 ) Net loss per share, basic and diluted $ (3.55 ) $ (2.12 ) Weighted average shares of common stock outstanding, basic and diluted 2,369,067 2,277,555

First data for the SC arm: 1 complete response (CR), 2 partial response (PR), 1 stable disease (SD) out of 4 evaluable patients. Further updates from the IV arm; a fifth CR has been observed, adding to a total of 5 CR, 1 PR and 6 SD out of 17 evaluable patients. Data to be presented at the European Hematology Association, June 13-16, 2024. BI-1206 is developed to re-establish the clinical effect of existing cancer treatments such as rituximab and is evaluated as both intravenous (IV) and subcutaneous (SC) administration. Phase 2a trial plans to include a triple combination with BI-1206, rituximab and acalabrutinib. LUND, SE / ACCESSWIRE / May 14, 2024 / BioInvent International AB ("BioInvent") (Nasdaq Stockholm:BINV), a biotech company focused on the discovery and development of novel and first-in-class immune-modulatory antibodies for cancer immunotherapy, today announced that promising clinical data for BI-1206 in relapsed/refractory (R/R) non-Hodgkin lymphoma (NHL), dosed in combination with rituximab, will be presented in a poster at the European Hematology Association congress held in Madrid, Spain from June 13-16, 2024. "We are pleased to share further validating Phase 1/2a data for BI-1206 in NHL during EHA. There is a high unmet need to develop treatments that can overcome resistance and improve the durability of responses to rituximab, an essential part of NHL treatment. We believe BI-1206 has the potential to meet this need," said Martin Welschof, Chief Executive Officer of BioInvent. "To identify the best options and meet the needs of clinicians and patients, we are evaluating BI-1206 administration as both IV and SC. IV dosing so far has produced response rates of a 35% ORR (overall response rate), 29% CRR (cumulative response rate) and 71% DCR (disease control rate), and we see promising early efficacy data from the subcutaneous dosing. In addition, we report an ORR of 56% in the subset of patients with follicular lymphoma (FL). Based on these encouraging results, we plan to initiate a Phase 2a study arm where the BTK inhibitor, acalabrutinib (Calquence®), will be added to the rituximab and BI-1206 combination, which should further increase response rates." BI-1206 is also being developed for the treatment of solid tumors and data will be presented at ASCO 2024. Abstract summary: Title: Safety And Preliminary Efficacy Of BI-1206, An Antibody To CD32B (FcγRIIB), Given In Combination With Rituximab In Subjects With Indolent B-Cell Non-Hodgkin Lymphoma Abstract#: P1135 Session: Indolent and mantle-cell non-Hodgkin lymphoma Date: June 14, 2024 Time: 6 - 7 pm CEST Overview: While anti-CD20 antibodies such as rituximab are a cornerstone of NHL care, approximately 15% of patients are refractory to treatment and 25% relapse within 3 years after treatment. The inhibitory Fc receptor CD32b (FcγRIIB) promotes resistance by triggering tumor cells to internalize and destroy rituximab. BI-1206 has been designed as an anti-FcγRIIB mAb to block rituximab internalization. Methods: BioInvent conducted a Phase 1/2a trial in several R/R B-cell NHL subtypes to evaluate safety and tolerability of BI-1206 in combination with rituximab. Dose expansion is ongoing for the IV formulation since the recommended Phase 2 dose (RP2D) of IV BI-1206 has been established. Phase 1 dose escalation is still ongoing for the SC formulation. Safety and Efficacy Results (May 2024): Safety: Thrombocytopenia and elevated transaminase levels were the most frequent treatment-emergent adverse events (TEAEs). The events resolved with a median duration of 4 days without any clinical complication. DLTs were not observed with intravenous (IV) dosing after pre-treatment with corticosteroids. Efficacy: In the FL subset of 16 evaluable patients (IV+SC), an ORR of 56% and CRR of 38% were observed. SC administration: In the SC dosing arm, in 4 evaluable patients, 1 complete response (CR), 2 partial response (PR) and 1 stable disease (SD) were observed. The full poster will be posted to the company's website shortly after the presentation in June. About BI-1206 The anti-FcyRIIB antibody BI-1206 is being evaluated in two separate tracks: for the treatment of NHL and solid tumors. It blocks a receptor class found on tumor cells as well as on certain immune cells, including macrophages. By selectively blocking this receptor, the aim is to improve the efficacy and/or overcome resistance from targeted therapies for hematologic cancers (including rituximab) and solid tumors (including agents that target PD-1/PD-L1). FcγRIIB is overexpressed in several forms of NHL and overexpression has been associated with poor prognosis in difficult-to-treat forms of NHL, such as mantle cell lymphoma. By blocking the receptor FcγRIIB on tumor cells, BI-1206 is expected to recover and enhance the activity of rituximab, or other anti-CD20 monoclonal antibodies, in the treatment of several forms of NHL. The combination of the two drugs could provide a new and important option for patients suffering from NHL and represents a substantial commercial opportunity. An SC formulation is being developed in parallel to the IV and patient recruitment to the Phase 1 part with BI-1206 SC as well as to the Phase 2a expansion cohorts with BI-1206 IV is ongoing. About BioInvent BioInvent International AB (Nasdaq Stockholm: BINV) is a clinical-stage biotech company that discovers and develops novel and first-in-class immuno-modulatory antibodies for cancer therapy, with currently five drug candidates in six ongoing clinical programs in Phase 1/2 trials for the treatment of hematological cancer and solid tumors. The Company's validated, proprietary F.I.R.S.T™ technology platform identifies both targets and the antibodies that bind to them, generating many promising new immune-modulatory candidates to fuel the Company's own clinical development pipeline and providing licensing and partnering opportunities. The Company generates revenues from research collaborations and license agreements with multiple top-tier pharmaceutical companies, as well as from producing antibodies for third parties in the Company's fully integrated manufacturing unit. More information is available at . Follow on the social media platform X: @BioInvent. Calquence® is a registered trademark of the AstraZeneca group of companies. BioInvent International AB (publ) Co. Reg. No. Org nr: 556537-7263 Visiting address: Ideongatan 1 Mailing address: 223 70 LUND Phone: +46 (0)46 286 85 50 The press release contains statements about the future, consisting of subjective assumptions and forecasts for future scenarios. Predictions for the future only apply as the date they are made and are, by their very nature, in the same way as research and development work in the biotech segment, associated with risk and uncertainty. With this in mind, the actual outcome may deviate significantly from the scenarios described in this press release. This information is information that BioInvent International is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 2024-05-14 16:00 CEST. Attachments BioInvent to Present Additional Promising Phase 1/2a Data at EHA 2024 for BI-1206 with rituximab in NHL SOURCE: BioInvent International View the original press release on accesswire.com