CD32B

Results of a prospective, randomized, placebo-controlled study of inhaled Leukine® in non-hospitalized patients at risk for severe COVID-19 LEXINGTON, Mass., Dec. 20, 2023 /PRNewswire/ -- Partner Therapeutics, Inc. (PTx) announced today that Open Forum Infectious Diseases recently published the results from the SCOPE study (doi.org/10.1093/ofid/ofad500.351).1 These data were also presented at IDWeek 2023. The study was a prospective, multicenter study of 600 non-hospitalized COVID-19 patients randomized to receive either inhaled Leukine® (sargramostim; yeast-derived, glycosylated recombinant human granulocyte-macrophage colony-stimulating factor [rhu GM-CSF]) or placebo. SCOPE included patients diagnosed with symptomatic mild/moderate COVID-19 who were at high risk for progression to severe disease. Of the 600 patients, 93 were vaccinated. Inhaled sargramostim, administered daily for five days, was well tolerated, no cytokine changes were observed, and adverse events were generally similar across both arms. The primary study endpoint was to determine if inhaled sargramostim could prevent progression to more severe disease as determined by any emergency room visit, hospitalization, or death by day 28. No difference was found in the primary endpoint between treatment arms. However, the sargramostim arm had a greater reduction in overall symptom score (a secondary endpoint) than the placebo arm. Results of prior studies of sargramostim in patients hospitalized with COVID-192,3 showed inhaled sargramostim plus standard of care led to greater improvement in P(A–a)O2, a measure of oxygenation, compared to standard of care alone. Exploratory analyses of a biomarker cohort (n=101, containing both vaccinated and unvaccinated patients) revealed potential immunomodulatory effects of sargramostim. Humoral and cellular immune signatures adjust to a multiplying SARS-CoV-2 viral load during the progression from mild to severe COVID-19.4,5 SCOPE investigators observed that treatment with inhaled sargramostim enhanced SARS-CoV-2 viral load clearance, modulated the humoral kinetics and magnitude against SAS-CoV-2 antigens, and suggested enhanced IgG4 expression and FcGR2B binding.2 The effect of sargramostim on humoral immune response was more pronounced in patients who have received a COVID-19 vaccination. The translational data from this study show modulation of humoral immunity with sargramostim treatment. Ila Joshi, Ph.D., Director of Biology, Pre-Clinical and Translational Research and Development at PTx observed, "The exploratory results from the biomarker cohort provide evidence of the potential for sargramostim to act as a virus-agnostic, host-directed immunomodulator. The combined effect of sargramostim and a COVID-19 vaccination observed on the humoral response, humoral kinetics, and viral load highlight a synergistic immune response against virus-specific antigens." This effort was funded by the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) under project agreement MCDC2006-012. Included references to commercial products do not constitute an endorsement by the U.S. Defense Department or the JPEO-CBRND. Leukine® is not approved to treat COVID-19. ABOUT IDWEEK IDWeek is the joint annual meeting of the Infectious Diseases Society of America, Society for Healthcare Epidemiology of America, the HIV Medicine Association, the Pediatric Infectious Diseases Society, and the Society of Infectious Diseases Pharmacists. IDWeek 2023 was held October 11-15, 2023, in Boston. ABOUT Leukine® Leukine® (sargramostim) is a glycosylated recombinant human granulocyte-macrophage colony-stimulating factor (rhu GM-CSF) produced by recombinant DNA technology in yeast. Leukine® is indicated: To shorten time to neutrophil recovery and to reduce the incidence of severe and life-threatening infections and infections resulting in death following induction chemotherapy in adult patients 55 years and older with acute myeloid leukemia. For the mobilization of hematopoietic progenitor cells into peripheral blood for collection by leukapheresis and autologous transplantation in adult patients. For the acceleration of myeloid reconstitution following autologous bone marrow or peripheral blood progenitor cell transplantation in adult and pediatric patients two years of age and older. For the acceleration of myeloid reconstitution following allogeneic bone marrow transplantation in adult and pediatric patients two years of age and older. For treatment of delayed neutrophil recovery or graft failure after autologous or allogeneic bone marrow transplantation in adult and pediatric patients two years of age and older. To increase survival in adult and pediatric patients from birth to 17 years of age acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome). Important Safety Information for Leukine® (sargramostim) Contraindications Do not administer Leukine® to patients with a history of serious allergic reaction, including anaphylaxis, to human granulocyte-macrophage colony-stimulating factor, sargramostim, yeast-derived products, or any other component of Leukine®. Warnings and Precautions Serious hypersensitivity reactions, including anaphylactic reactions, have been reported with Leukine®. If a serious allergic or anaphylactic reaction occurs, immediately discontinue Leukine® therapy, and institute medical management. Discontinue Leukine® permanently for patients with serious allergic reactions. Leukine® can cause infusion-related reactions that may be characterized by respiratory distress, hypoxia, flushing, hypotension, syncope, and/or tachycardia. Observe closely during infusion, particularly in patients with preexisting lung disease; dose adjustment or discontinuation may be needed. Leukine® should not be administered simultaneously with or within 24 hours preceding cytotoxic chemotherapy or radiotherapy or within 24 hours following chemotherapy. Edema, capillary leak syndrome, and pleural or pericardial effusions have been reported in patients after Leukine® administration. Leukine® should be used with caution in patients with preexisting fluid retention, pulmonary infiltrates, or congestive heart failure. Such patients should be monitored. Supraventricular arrhythmia has been reported in uncontrolled studies during Leukine® administration, particularly in patients with a history of cardiac arrhythmia. Use Leukine® with caution in patients with preexisting cardiac disease. If absolute neutrophil count > 20,000 cells/mm3 or if white blood cell counts > 50,000/mm3, Leukine® administration should be interrupted, or the dose reduced by half. Monitor complete blood counts with differential twice per week. Discontinue Leukine® therapy if tumor progression, particularly in myeloid malignancies, is detected during Leukine® treatment. Treatment with Leukine® may induce neutralizing anti-drug antibodies. Use Leukine® for the shortest duration needed. Avoid administration of solutions containing benzyl alcohol (including Leukine® for injection reconstituted with Bacteriostatic Water for Injection, USP [0.9 % benzyl alcohol]) to neonates and low birth weight infants. Drug Interactions Avoid the concomitant use of Leukine® and products that induce myeloproliferation. Monitor for clinical and laboratory signs of excess myeloproliferative effects. Adverse Reactions Adverse events occurring in >10% of patients receiving Leukine® in controlled clinical trials and reported at a higher frequency than in placebo patients are: In recipients of autologous bone marrow transplantation–asthenia, malaise, diarrhea, rash, peripheral edema, urinary tract disorder. In recipients of allogeneic blood and marrow transplant–abdominal pain, chills, chest pain, diarrhea, nausea, vomiting, hematemesis, dysphagia, gastrointestinal hemorrhage, pruritus, bone pain, arthralgia, eye hemorrhage, hypertension, tachycardia, bilirubinemia, hyperglycemia, increased creatinine, hypomagnesemia, edema, pharyngitis, epistaxis, dyspnea, insomnia, anxiety, high glucose, low albumin. In patients with acute myeloid leukemia–fever, weight loss, nausea, vomiting, anorexia, skin reactions, metabolic laboratory abnormalities, edema. ABOUT PARTNER THERAPEUTICS Partner Therapeutics, Inc., an integrated biotechnology company, focuses on development and commercialization of late-stage therapeutics to improve health outcomes in treatment of cancer and other serious diseases. The company believes in delivering products and supporting medical teams with the purpose of achieving superior outcomes for patients and their families. Visit . ABOUT THE JPEO-CBRND The Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) mission is to provide an integrated layered chemical, biological, radiological, and nuclear defense capabilities to the Joint Force across combined Joint All-Domain Operations. JPEO-CBRND's goal is to enable the Joint Force to fight and win unencumbered by a CBRN environment. To learn more about JPEO-CBRND, visit: , or follow JPEO-CBRND on social media @JPEOCBRND. References: 1 Joshi I, Garner F, Roychowdhury DF, et al. Inhaled Sargramostim (rhu GM-CSF) Leads to Enhanced SARS-CoV-2 Virus-Specific Immune Response and Viral Clearance: Results of the Biomarker Cohort of a Randomized, Double-Blind, Placebo-Controlled Phase 2b Trial in Non-Hospitalized Patients with COVID-19. Open Forum Infectious Diseases. 2023;10(Supplement 2). doi:10.1093/ofid/ofad500.351 2 Paine R, Chasse R, Halstead ES, et al. Inhaled Sargramostim (Recombinant Human Granulocyte-Macrophage Colony-Stimulating Factor) for COVID-19-Associated Acute Hypoxemia: Results of the Phase 2, Randomized, Open-Label Trial (iLeukPulm) [published online ahead of print, 2022 Dec 2]. Mil Med. 2022;188(7-8):e2629-e2638. doi:10.1093/milmed/usac362 3 Bosteels C, Van Damme KFA, De Leeuw E, et al. Loss of GM–CSF–Dependent Instruction of Alveolar Macrophages in COVID–19 Provides a Rationale for Inhaled GM–CSF Treatment. Cell Rep Med. 2022:100833. doi: 10.1016/j.xcrm.2022.100833 4 Galipeau Y, Greig M, Liu G, Driedger M, Langlois MA. Humoral Responses and Serological Assays in SARS-CoV-2 Infections. Front Immunol. 2020;11:610688. Published 2020 Dec 18. doi:10.3389/fimmu.2020.610688 5 Zhou X, Ye Q. Cellular Immune Response to COVID-19 and Potential Immune Modulators. Front Immunol. 2021;12:646333. Published 2021 Apr 30. doi:10.3389/fimmu.2021.646333 SOURCE Partner Therapeutics, Inc.

LUND, SWEDEN / ACCESSWIRE / June 13, 2023 / BioInvent International (STO:BINV) Abstract for the ongoing clinical trial with BI-1206 in combination with rituximab has been accepted to the ICML and showcases the study design and status, and summarizes the early clinical results generated so far in the dose escalation phase. Lund, Sweden - June 13, 2023 - 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 announces that an abstract reporting the clinical pro its lead drug candidate BI-1206, the novel anti-FcgRIIB antibody, has been accepted at the International Conference of Malignant Lymphoma (ICML) Annual Meeting 2023. The conference is taking place in Lugano, Switzerland, June 13-17, 2023. In the ongoing Phase 1/2a study of BI-1206 in combination with rituximab for the treatment of non-Hodgkin's lymphoma (NHL), the dose escalation phase of intravenously (IV) administered BI-1206 has been completed and the recommended IV Phase 2 dose (RP2D) has been identified. A subcutaneous (SC) formulation is being developed in parallel to the IV and the first results will be available during H1 2023. The SC formulation should allow a great deal of flexibility in dosing and regimen to assure the best development of BI-1206. All patients in the ongoing study of BI-1206 have previously been treated with one or multiple rituximab containing treatments and classified as refractory or relapsed. In the IV dose escalation cohort, responses have been observed across the dose range of 30-100 mg, including 4 complete responders (CR), 3 partial responders (PR) and 4 cases of stable disease (SD) out of 15 evaluable patients. Among the CR population, responses have been long-lasting, three of them lasting years after end of treatment, while the 4th is still on treatment. As of June 12th, 2023, the median duration of complete response was 2.5 years, with three patients still ongoing. No maximum tolerated dose has been defined, and Phase 2a dose expansion cohort is currently enrolling patients. The details of the abstract are as follows: Abstract title: Phase 1/2a Clinical Trial of BI-1206, a Monoclonal Antibody to CD32b (FcyRIIB), in Combination with Rituximab in Subjects with Indolent B-Cell Lymphoma Authors: M. Jerkeman , P. Abrisqueta Costa , H. E. Hagberg , J. M. Sancho Cia , M. Bastos-Oreiro, D. Stevens , J. B Cohen , R. Cordoba Mascunano, E. Domingo Domenech, I. Fernández Román, S. Novelli Canales, M. Borggren , B. Frendeus, I. Karlsson, L. Mårtensson, S. Patel, I. Teige, J. E. Wallin, A. Mc Allister Publication Nr. OT16 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 four drug candidates in five ongoing clinical programs in Phase 1/2 trials for the treatment of hematological cancer and solid tumors, respectively. 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 drug 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 Twitter: @BioInvent. 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. Attachments BioInvent Announces Abstract Presentation of BI-1206 at the 17th International Conference of Malignant Lymphoma 2023 SOURCE: BioInvent International View source version on accesswire.com:

Continues to Advance Preparations for Potential U.S. Commercial Launch of Teplizumab Ahead of November 17th FDA User Fee Goal Date RED BANK, N.J., Nov. 3, 2022 /PRNewswire/ -- Provention Bio, Inc. (Nasdaq: PRVB), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated disease, today reported financial results for the third quarter ended September 30, 2022 and provided a business update. "Throughout the third quarter, we have continued to interact with the FDA in support of our resubmitted, breakthrough therapy designated, teplizumab BLA for the delay of clinical type 1 diabetes in at-risk individuals," stated Ashleigh Palmer, Chief Executive Officer & Co-Founder, Provention Bio. "As we approach our upcoming November 17th FDA action date, we are pleased to report that we have received both the FDA's proposed labelling and post-marketing requirements and commitments, and that these are generally consistent with our expectations. In parallel, we have been advancing our planning and preparations for the potential commercial launch of teplizumab and our recently announced co-promotion agreement, which allows us to leverage the expertise, capabilities, and commercial resources of Sanofi. Finally, we were able to strengthen our balance sheet by raising additional capital during the third quarter." Third Quarter 2022 and Recent Corporate Highlights: Entered into Agreement with Sanofi to Support Potential U.S. Launch of Teplizumab On October 6, 2022, the Company announced that it entered a co-promotion agreement with Sanofi U.S. for the potential launch of Provention's lead investigational drug candidate, teplizumab. Teplizumab is currently under review by the U.S. Food and Drug Administration (FDA), for the delay of clinical type 1 diabetes (T1D) in at-risk individuals, with a user fee goal date of November 17, 2022. The Company also granted Sanofi, in consideration of a non-refundable, one-time payment of $20.0 million, an exclusive, one-time right of first negotiation (ROFN) to obtain exclusive global rights to commercialize teplizumab for T1D in humans, subject to certain retained rights of the Company to engage in discussions with third parties with respect to certain transactions. Sanofi may exercise the ROFN until June 30, 2023, with an option to extend within 2023 under certain conditions. The Company received the $20.0 million payment in October from Sanofi. Simultaneously with their entry into the co-promotion agreement, the Company and Sanofi entered into a Securities Purchase Agreement (the Purchase Agreement). Pursuant to the Purchase Agreement, if teplizumab is approved by the FDA, Sanofi has agreed to purchase $35.0 million of the Company's common stock at a premium over the daily volume-weighted average per share price for the five consecutive trading days prior to the closing date. The closing date will be at Provention's discretion and would occur no later than February 16, 2023. Senior Leadership Addition On September 19, 2022, the Company announced the appointment of Sarah O'Brien as Chief People Officer. Sarah brings more than 20 years of experience building strong employee culture and leading human resources within the biotech sector. She most recently served as Chief People Officer at Ardelyx, and has also served in prior senior leadership roles at Ohana Bioscience, Relay Therapeutics, Novartis, and Sobi, Inc. $125.0 Million Term Loan Facility with Hercules Capital On August 31, 2022, the Company entered into a term loan facility with Hercules Capital, Inc. The term loan facility provides for up to $125.0 million of term loans in the aggregate, available to be funded in up to five tranches. The first tranche in an amount equal to $25.0 million was drawn at closing. The Company may draw the second tranche in an amount equal to $40.0 million upon approval of teplizumab, subject to certain conditions. The third and fourth tranches will be available to the Company in an aggregate amount of up to $35.0 million, subject to satisfaction of certain conditions, including achievement of certain milestones. The availability of the fifth tranche of up to $25.0 million is subject to the approval of the lenders. $60.0 Million Private Placement in July 2022 On July 7, 2022, the Company entered into a Securities Purchase Agreement with certain institutional purchasers, pursuant to which the Company sold, in a private placement, 13,318,535 shares of common stock and 13,318,535 warrants to acquire additional shares of common stock for aggregate gross proceeds of approximately $60.0 million, based on an offering price of $4.505 for each share plus one warrant (the July 2022 Private Placement). The warrants expire five years from the closing date of the transaction, have an exercise price of $6.00 per share and were immediately exercisable upon issuance, subject to other limitations on exercise as described in the warrants. Net proceeds from the transaction were $57.2 million after deducting fees for the placement agent of $2.4 million and other offering expenses of $0.4 million. PROTECT Phase 3 Trial Evaluating Teplizumab in Patients with Recent Onset of Type 1 Diabetes The Company is currently evaluating teplizumab in patients with newly diagnosed, insulin-dependent T1D in the Phase 3 PROTECT study. The Company reached target enrollment during the third quarter of 2021 and expects to report top-line data from the PROTECT study in the second half of 2023. PREVAIL-2 Phase 2a Trial Evaluating PRV-3279 in Systemic Lupus Erythematosus In the first quarter of 2022, the Company initiated a Phase 2a trial in Systemic Lupus Erythematosus (SLE) of PRV-3279, an investigational DART® (bispecific antibody-based molecule) targeting the B-cell surface proteins CD32B and CD79B. The PREVAIL-2 study is a Phase 2a proof-of-concept (POC) study in moderate-to-severe SLE patients induced into response with a short course of corticosteroids, and then monitored for relapse, after randomization to either PRV-3279 or placebo treatment. This study design enables the withdrawal of most concomitant medications and clear POC evaluation. The ongoing challenges of the COVID-19 pandemic have affected the PREVAIL-2 study enrollment, primarily due to resource constraints at the clinical site level and subdued patient interest in participating in clinical trials of immune modulatory agents. The Company continues to expect to report top-line results of the PREVAIL-2 study in the second half of 2024. PROACTIVE Phase 2b Study of Ordesekimab (AMG 714/PRV-015) in Non-Responsive Celiac Disease The Company is conducting a Phase 2b dose-finding, placebo-controlled study of ordesekimab (AMG 714/PRV-015), an investigational anti-interleukin-15 monoclonal antibody in adults with non-responsive celiac disease. The study currently expects to enroll 220 adult celiac patients not responding to gluten-free diet. The Company expects top-line results from the PROACTIVE study by the end of 2023. PRV-101 Coxsackievirus B Vaccine (CVB) Provention is developing PRV-101 for the prevention of CVB-triggered autoimmune damage to pancreatic beta cells that may progress to T1D and damage to intestinal cells that may lead to celiac disease. In the first quarter of 2022, the Company announced results from the final analysis of the PROVENT (PROtocol for coxsackievirus VaccinE in healthy voluNTeers) study, a first-in-human study of PRV-101, a polyvalent inactivated coxsackievirus B (CVB) vaccine candidate targeting all key CVB strains associated with type 1 diabetes autoimmunity. In this final analysis, 6 months following the final administered dose of the vaccine, PRV-101 met the primary safety endpoint and also showed durability of viral neutralizing antibody (VNT) responses. The Company continues to seek and evaluate partnership opportunities to further the clinical development of PRV-101. Third Quarter 2022 Financial Results Cash Position: Provention ended the third quarter of 2022 with $186.5 million of cash, cash equivalents and marketable securities. 2021 At-the-market (ATM) Program: Provention sold 7,263,808 shares of its common stock for aggregate net proceeds of $33.6 million, net of $1.1 million in sales commissions and other offering expenses, under the Company's 2021 ATM Program during the third quarter of 2022. As of September 30, 2022, the Company had approximately $100.9 million of available capacity under the 2021 ATM Program. July 2022 Private Placement: Provention received net proceeds of $57.2 million upon the completion of the July 2022 Private Placement, after deducting fees for the placement agent of $2.4 million and other offering expenses of $0.4 million. Term Loan Facility: The Company entered into a Loan and Security Agreement with Hercules Capital, Inc. for up to $125.0 million of term loans in the aggregate, available to be funded in up to five tranches. The first tranche, equal to $25.0 million, was drawn on the closing date which provided the Company with net proceeds of $23.7 million, net of transaction costs. Interest expense was $0.3 million for the third quarter of 2022. Collaboration Revenue: The Company recognized collaboration revenue of $0.8 million during the third quarter of 2022, compared to $0.7 million for the third quarter of 2021, under its License Agreement with Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. Research & Development (R&D): R&D expenses were $16.3 million for the third quarter of 2022, compared to $17.7 million for the third quarter of 2021. The decrease was driven by lower costs for the Company's teplizumab program, including the PROTECT study, as target enrollment was reached in August 2021. R&D cost decreases were partially offset by increased costs for the PROACTIVE Phase 2b study (PRV-015) and the PREVAIL-2 Phase 2a study (PRV-3279). General & Administrative (G&A): G&A expenses were $13.5 million for the third quarter of 2022, compared to $10.0 million for the third quarter of 2021. The increase in G&A expenses is related primarily to an increase in the Company's pre-commercial activities and associated costs as the company continues to prepare for the potential commercial launch of teplizumab. Net Loss: Net loss for the third quarter of 2022 was $28.6 million, or $0.34 per basic and diluted share, compared to a net loss of $27.0 million, or $0.43 per basic and diluted share, for the third quarter of 2021. Cash Based Operating Expenses: Cash-based operating expenses for the third quarter of 2022 were $26.4 million, which exclude non-cash, stock-based compensation expense of $3.3 million and depreciation expense of $0.1 million. Financial Guidance: The Company expects its cash-based operating expenses to be in the range of $40 million to $45 million for the fourth quarter of 2022, reflecting an increase in program spend as well as preparation for the potential commercial launch of teplizumab, assuming FDA approval in November. Based on the Company's current business plans, management believes that its cash, cash equivalents and marketable securities on hand as of September 30, 2022, together with the $20.0 million received in October 2022 under the Sanofi Co-Promotion Agreement, will be sufficient to fund the Company's operating requirements for at least the next 12 months from the issuance of the Company's financial statements for the quarter ended September 30, 2022. If the Company's teplizumab BLA resubmission is approved by the FDA, factors that could impact its cash runway include, but are not limited to, the success of the Company's potential commercial launch, changes to estimated costs of commercialization, including the Company's commitments under the Sanofi Co-Promotion Agreement, and potential milestone payments that may be triggered under the Company's current agreements, including with MacroGenics. Conference Call and Webcast Information: Provention Bio will discuss these business updates and third quarter financial results via conference call today at 8:00 am ET. To access the call, please dial 1-888-347-7861 (domestic) or 1-412-902-4247 (international) ten minutes prior to the start time and ask to be connected to the "Provention Bio Call." An audio webcast will also be available on the "Events and Webcasts" page of the Investors section of the Company's website, . An archived webcast will be available on the Company's website approximately two hours after the conference call. About Provention Bio, Inc.: Provention Bio, Inc. (Nasdaq: PRVB) is a biopharmaceutical company focused on advancing the development of investigational therapies that may intercept and prevent debilitating and life-threatening immune-mediated diseases. The Biologics License Application (BLA) for teplizumab, its lead investigational drug candidate, for the delay of progression to Stage 3 clinical type 1 diabetes in at-risk individuals has been filed by the U.S. Food and Drug Administration (FDA) and has a user fee goal date of November 17, 2022. The Company's pipeline includes additional clinical-stage product candidates that have demonstrated in pre-clinical or clinical studies proof-of-mechanism and/or proof-of-concept in other autoimmune diseases, including celiac disease and lupus. Visit for more information and follow us on Twitter: @ProventionBio. Internet Posting of Information: Provention Bio, Inc. uses its website, , as a means of disclosing material nonpublic information and for complying with its disclosure obligations under Regulation F.D. Such disclosures will be included on the Company's website in the "News" section. Accordingly, investors should monitor this portion of the Company's website, in addition to following its press releases, SEC filings and public conference calls and webcasts. Forward Looking Statements: Certain statements in this press release are forward-looking, including but not limited to, statements relating to our product pipeline and delivery of key catalysts throughout the course of the next 24 months; the Company's planned regulatory interactions; the medical need in at-risk T1D patients, the potential approval of teplizumab and therapeutic effects and safety of teplizumab in at-risk T1D patients; the FDA's review and potential approval of teplizumab and potential regulatory and commercialization timeline; the potential impact of FDA decisions on PK comparability and the BLA resubmission for at-risk patients on the PROTECT study; the potential impact of the co-promotion agreement with Sanofi on the teplizumab launch; anticipated timing for the Phase 2a trial of PRV-3279; anticipated enrollment in the PROACTIVE study; anticipated timing of top-line results for our product candidates; our current expectations regarding the ability of our cash, cash equivalents and marketable securities to fund our current operating requirements for at least the next 12 months; and expected cash-based operating expenses for the fourth quarter of 2022. These statements may be identified by the use of forward-looking words such as "will," "may," "believe," "plans," and "expect," among others. These forward-looking statements are based on the Company's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to additional delays in or failure to obtain FDA approvals for teplizumab or in the development plans for the Company's other Company product candidates and the potential for noncompliance with FDA regulations and requirements; any inability to successfully work with the FDA to find a satisfactory solution to address its concerns in a timely manner or at all, including during the FDA's review of the teplizumab BLA resubmission; any inability of the BLA resubmission or our response to FDA requests to satisfactorily address other matters cited in the CRL including relating to PK comparability, product quality, the safety update required by the FDA or any other FDA requirements for an approval of teplizumab; the potential impacts of COVID-19 on our business and financial results; changes in law, regulations, or interpretations and enforcement of regulatory guidance; uncertainties of patent protection and litigation; the Company's dependence upon third parties; substantial competition; the Company's need for additional financing and the risks listed under "Risk Factors" in the Company's quarterly report on Form 10-Q for the third quarter ended September 30, 2022 and any subsequent filings with the Securities and Exchange Commission. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval, and commercialization of new products. Provention does not undertake an obligation to update or revise any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by applicable law. The information set forth herein speaks only as of the date hereof. Investor Contact: Kristen Kelleher, Manager, Investor Relations [email protected] Brendan Strong, Argot Partners [email protected] 212-600-1902 Media Contact: Kaelan Hollon VP, Corporate Communications [email protected] 202-421-4921 SOURCE Provention Bio, Inc.