Provention Bio, Inc. (Nasdaq: PRVB), a clinical-stage biopharmaceutical company dedicated to intercepting and preventing immune-mediated disease, today reported financial results for the second quarter ended June 30, 2020 and provided a business update.
"In the past few months, we have achieved tremendous progress in support of our efforts to advance teplizumab toward the market for the delay or prevention of insulin-dependent type 1 diabetes (T1D) in presymptomatic patients," stated Ashleigh Palmer, CEO, Provention Bio. "New data presented at the American Diabetes Association conference from the "At-Risk" TN-10 study strengthened the value proposition for teplizumab, with long-term data now showing that teplizumab delays the onset of insulin-dependent T1D by approximately three years versus placebo, adding one year to the two-year delay presented in 2019. In addition, treatment with teplizumab significantly reversed the decline of C-peptide levels, providing further evidence of the disease-modifying potential of teplizumab."
"We remain laser focused on submitting the clinical module of our rolling BLA submission in Q3 2020 and completing the remaining modules in Q4 2020. We are pleased to report today that we have successfully completed the commercial-scale drug substance process performance qualification (PPQ) campaign, a key gating factor for our chemistry, manufacturing and controls (CMC) module. We strengthened our financial position with a successful financing in June, which resulted in net cash proceeds of $103.3 million. We continue to scale our organization in preparation for a potential commercial launch and we are well-positioned to execute our strategy to bring teplizumab to the T1D community as soon as possible."
Second Quarter 2020 and Recent Corporate Highlights:
Successfully Completed Commercial-Scale PPQ Runs
The Company reported today that it has recently completed three, back-to-back, commercial-scale, drug substance process performance qualification (PPQ) batches at AGC Biologics, the Company's contract manufacturer. The batches will serve as the foundation of the chemistry, manufacturing and controls (CMC) module for the BLA submission, which the company expects to complete in the fourth quarter of 2020.
Extended TN-10 Follow-up Data Now Shows That Teplizumab Delays the Onset of Insulin-Dependent Type 1 Diabetes in Presymptomatic Diabetes Patients by A Median of Approximately Three Years Versus Placebo
In June, extended follow-up data from the pivotal "At-Risk" TN-10 study conducted by TrialNet was presented at the American Diabetes Association (ADA) 80th Scientific Sessions. The follow-up data demonstrates that one course of teplizumab is now shown to delay insulin-dependence in presymptomatic T1D patients by a median of approximately three years compared to placebo. At the same meeting in 2019, the study demonstrated a median delay of two years to the onset of insulin-dependence in presymptomatic patients. Additionally, teplizumab was shown to significantly reverse the decline of C-peptide levels, suggesting not just a delay in the destruction of beta cells but also restoration of insulin production by dysfunctional beta cells.
Appointed Heidy Abreu King-Jones as Chief Legal Officer
In August 2020, Provention appointed Heidy Abreu King-Jones as Chief Legal Officer. Heidy brings nearly 12 years of corporate counsel and law firm experience in the biotechnology and pharmaceutical sectors, including the development of compliance programs for rare disease launches.
Added Key Roles to Commercial, Sales, Regulatory and Medical Affairs Functions
In recent months, Provention has continued to scale its organization to support a potential commercial launch of teplizumab. This includes recent hires in leadership positions across the Market Access, Sales, Analytics & Forecasting, Medical Affairs, and Regulatory Affairs teams. The new team members bring extensive, relevant experience in rare disease launches in the biotechnology sector.
Appointed Nancy Wysenski to the Board of Directors
In May 2020, Provention announced the appointment of Nancy Wysenski, a seasoned pharmaceutical executive with rare disease and commercialization experience, to the Company's Board of Directors. Ms. Wysenski brings tremendous value to the Provention team, with more than 30 years of leadership in biotechnology and pharmaceuticals, including having served as the Chief Commercial Officer of Vertex Pharmaceuticals.
Announced Publication of Proof-of-Concept Data for a Preclinical Prototype of Coxsackievirus B Vaccine
In a paper published in Science Advances in May 2020, a preclinical prototype of Provention's polyvalent coxsackievirus B vaccine, PRV-101, was shown to be well-tolerated, immunogenic and protective against coxsackievirus B infections and diabetes in relevant animal models. Provention is developing PRV-101 as a potential vaccine for acute coxsackievirus infection and for the potential prevention of T1D and celiac disease. These results provide a solid scientific basis for human trials with PRV-101, which the Company expects to initiate in the second half of 2020.
Financial Highlights:
In June 2020, the Company completed a public follow-on offering of 7,590,000 shares, including 990,000 shares sold pursuant to the full exercise of the underwriters' option to purchase additional shares, at a price of $14.50 per share, resulting in aggregate net cash proceeds from the sale of the shares, after deducting underwriting discounts and offering expenses, of $103.3 million. In addition, during the second quarter of 2020 and prior to the follow-on offering the Company generated $9.9 million of net proceeds from the sale of common stock under its at-the-market program. As a result, Provention had cash, cash equivalents and marketable securities of $172.2 million as of June 30, 2020.
Net loss for the second quarter 2020 was $22.1 million, or $0.45 per basic and diluted share, compared to a net loss of $12.0 million, or $0.32 per basic and diluted share, for the same period in 2019. The increase in net loss was primarily attributable to teplizumab related CMC costs, BLA preparation costs, precommercial costs, and medical affairs expenses.
Cash-based operating expenses were $21.5 million for the three months ended June 30, 2020 and included teplizumab CMC expenses of $7.5 million and $4.8 million of precommercial expenses. Provention expects to utilize $44 million to $52 million of cash for its operating needs in the second half of 2020.
About Provention Bio, Inc.:
Provention Bio, Inc. (Nasdaq: PRVB) is a biopharmaceutical company leveraging a transformational drug development strategy focused on the prevention or interception of immune-mediated disease. Provention's mission is to source, transform and develop therapeutic candidates targeting the high morbidity, mortality and escalating costs of autoimmune diseases. Provention's diversified portfolio includes teplizumab, a pre-commercial-stage candidate that has been shown to delay the onset of insulin-dependent type 1 diabetes (T1D) in at-risk patients during the presymptomatic phase of the disease. The Company's portfolio includes additional clinical product development candidates that have demonstrated proof-of-mechanism and/or proof-of-concept in other autoimmune diseases, including celiac disease and lupus.
