Provention Bio Reports Second Quarter 2020 Financial Results and Provides Business Update
Provention Bio, Inc. (Nasdaq: PRVB) reported its Q2 2020 financial results, highlighting significant progress in advancing teplizumab to combat insulin-dependent type 1 diabetes (T1D). Notable developments include data showing that teplizumab delays T1D onset by approximately three years, and the completion of commercial-scale drug production. The company secured $103.3 million in funding and aims to submit the clinical module of its BLA by Q3 2020. However, the net loss for Q2 was $22.1 million, reflecting increased operational costs as they prepare for a potential product launch.
- Teplizumab demonstrated an extended delay in T1D onset by approximately three years, improving from two years previously reported.
- Successfully completed commercial-scale drug substance process performance qualification (PPQ), aiding BLA submission.
- Secured $103.3 million in net proceeds from a public follow-on offering.
- Net loss increased to $22.1 million in Q2 2020, up from $12.0 million in Q2 2019, primarily due to operational expenses.
- Projected cash utilization for the second half of 2020 is between $44 million and $52 million.
OLDWICK, N.J., Aug. 6, 2020 /PRNewswire/ -- 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
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
Net loss for the second quarter 2020 was
Cash-based operating expenses were
Conference Call and Webcast Information:
Provention Bio will discuss these results via conference call today at 8:00 am ET. To access the call, please dial 1-888-567-1603 (domestic) or 1-862-298-0702 (international) five 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, www.proventionbio.com. An archived webcast will be available on the Company's website approximately two hours after the conference call and will be available for seven days following the call.
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.
Forward Looking Statements:
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995, including but not limited to, statements relating to the Company's studies, planned submissions and timelines for the rolling BLA submission for teplizumab, the potential health benefits of, and commercialization efforts for teplizumab, planned research and development efforts for the Company's investigational product candidates and the Company's planned financial investments and cash runway. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimate," "expect," and "intend," among others. These forward-looking statements are based on Provention'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 delays in, or failure to obtain FDA approvals or clearances and noncompliance with FDA regulations; 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; dependence upon third parties; substantial competition; our need for additional financing and the risks listed under "Risk Factors" in our annual report on Form 10-K for the year ended December 31, 2019, our quarterly reports on form 10-Q, 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. The information set forth herein speaks only as of the date hereof.
Investor Contact:
Sam Martin, Argot Partners
sam@argotpartners.com
212-600-1902
Media:
Lori Rosen, LDR Communications
lori@ldrcommunications.com
917-553-6808
Provention Bio, Inc. | ||||||||||||
Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||
2020 | 2019 | 2020 | 2019 | |||||||||
Statement of Operations Data: | ||||||||||||
Operating expenses: | ||||||||||||
Research and development | $ | 15,032 | $ | 10,550 | $ | 24,122 | $ | 20,572 | ||||
General and administrative | 7,764 | 1,707 | 11,539 | 2,944 | ||||||||
Total operating expenses | 22,796 | 12,257 | 35,661 | 23,516 | ||||||||
Loss from operations | (22,796) | (12,257) | (35,661) | (23,516) | ||||||||
Interest income | 151 | 253 | 434 | 540 | ||||||||
Loss before income tax benefit | (22,645) | (12,004) | (35,227) | (22,976) | ||||||||
Income tax benefit | 523 | — | 523 | — | ||||||||
Net loss | $ | (22,122) | $ | (12,004) | $ | (34,704) | $ | (22,976) | ||||
Net loss per common share, basic and diluted | $ | (0.45) | $ | (0.32) | $ | (0.72) | $ | (0.61) | ||||
Weighted average common shares outstanding, basic and diluted | 49,199 | 37,363 | 48,449 | 37,362 | ||||||||
June 30, | December 31, | |||||||||||
Balance Sheet Data: | ||||||||||||
Cash, cash equivalents and marketable securities | $ | 172,155 | $ | 85,373 | ||||||||
Total assets | $ | 175,755 | $ | 85,996 | ||||||||
Total liabilities | $ | 11,979 | $ | 3,840 | ||||||||
Accumulated deficit | $ | (113,765) | $ | (79,061) | ||||||||
Total stockholders' equity | $ | 163,776 | $ | 82,156 | ||||||||
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SOURCE Provention Bio, Inc.
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