Zafgen Reports Second Quarter 2018 Operating and Financial Results
Phase 1 clinical trial for ZGN-1258 for Prader-Willi syndrome (PWS) expected to begin in the fourth quarter 2018
Multiple ZGN-1258 nonclinical studies accepted for presentation at upcoming
Initiated 1.8 mg dosing arm in ZGN-1061 Phase 2 clinical trial for type 2 diabetes; results from additional arm expected early 2019
Company to host conference call today at
“2018 is an important year of execution on our plan for our novel second-generation MetAP2 pipeline,” said
Recent Corporate and Program Highlights
Zafgenprogressed investigational new drug (IND) enabling studies for ZGN-1258, with Prader-Willi syndrome (PWS) as an initial indication. An IND allowance and initiation of a Phase 1 clinical trial for ZGN-1258 are anticipated in the fourth quarter of 2018.
Zafgenand the Foundation for Prader-Willi Research(FPWR), a nonprofit organization founded to eliminate the challenges of PWS through the advancement of research and therapeutic development, launched a co-sponsored four-year natural history study, named PATH for PWS (Paving the way for Advances in Treatments & Health for PWS), to advance understanding of the medical history of and medical events in people with PWS. PATH for PWS is a non-interventional, observational study to evaluate occurrences of serious medical events in PWS, intended to inform development and clinical trial design for potential new treatments for PWS, including ZGN-1258, Zafgen’s new, second-generation program for PWS designed to decrease hyperphagia, change the way the body metabolizes fat, and reduce fat mass.
Zafgenreports today that multiple nonclinical studies will be presented at the FPWR Annual Conference which begins October 4, 2018, covering the following topics:
- ZGN-1258 effects on food intake and body weight in mouse models of hyperphagia and obesity
- ZGN-1258 effects on other behavioral manifestations commonly observed in PWS, such as low physical activity, anxiety, and obsessive-compulsive behaviors in mouse models
- ZGN-1258 nonclinical differentiation on safety measures
- PATH for PWS natural history study design
- Data from the Phase 2 clinical trial and two supportive nonclinical studies for ZGN-1061 were presented as late-breaker abstracts at the
American Diabetes Association(ADA) 78th Scientific Sessions in Orlando, Floridain June 2018: Zafgenannounced positive full results from the initial part of its 12-week Phase 2 clinical trial of ZGN-1061 designed to demonstrate proof-of-concept efficacy and safety in patients with type 2 diabetes and establish a minimally effective dose. The clinical trial met all of its primary endpoints at a minimally effective dose of 0.9 mg dose, and 12-week data demonstrated a favorable safety and tolerability profile, with no treatment-related serious adverse events and no cardiovascular (CV) safety signals observed.
- Nonclinical data on treatment with both ZGN-1061 and liraglutide suggest that combination therapy with these glucose-lowering agents may yield additive improvement in glycemic control and weight loss, demonstrating the effect of two complementary mechanisms – MetAP2 inhibition and GLP-1.
- From nonclinical data in a nonalcoholic steatohepatitis (NASH) model,
Zafgenobserved that ZGN-1061 markedly reduced liver weight, NAS score and markers of liver damage. These NASH-related data, combined with previous gene expression data and clinical liver fat content data from Zafgen’s first-generation MetAP2 inhibitor, suggest potential clinical value in treating liver-specific metabolic conditions.
- As previously announced, based on the safety and tolerability results of the interim analysis for the ZGN-1061 Phase 2 proof-of-concept clinical trial detailed in March 2018, Zafgen opted to explore the higher end of the potential therapeutic range of ZGN-1061 by adding a 1.8 mg dose arm to the clinical trial. Patient dosing was initiated during the second quarter of 2018 and will run in parallel with completion of long-term toxicology studies for ZGN-1061. Results from this additional arm are expected in early 2019.
July 2, 2018, Zafgenclosed an underwritten public offering of 9.2 million shares of its common stock at a price to the public of $7.50per share, including 1.2 million shares pursuant to the underwriters' exercise in full of their option to purchase additional common shares. The offering resulted in total gross proceeds of $69.0 millionand net proceeds of approximately $64.6 million, after deducting the underwriting discounts and commissions and other estimated offering costs.
May 2018, Zafgenexpanded its executive leadership team with the appointment of Brian McVeighas Chief Business Officer (CBO). Mr. McVeigh brings over 25 years of pharmaceutical and biotech industry experience at GlaxoSmithKline (GSK) including 15 years of extensive experience in buy-side and sell-side business development deal making and investment management.
June 2018, industry veteran and healthcare policy expert Dr. Wendy Everettjoined Zafgen’s board of directors.
Zafgenjoined the Russell 2000 Index on June 25, 2018. The Annual Russell US Index reconstitution captures the largest US stocks as of May 11, 2018ranking them by total market capitalization.
Second Quarter 2018 Financial Results
“The completion of our recent public offering of common stock has provided the Company with additional capital to advance the Company’s pipeline through multiple value-creating milestones,” said
The Company reported a net loss for the second quarter of 2018 of
The weighted average common shares (basic and diluted) outstanding used to compute net loss per share were 27,565,064 for the second quarter of 2018 compared to 27,407,408 for the same quarter of 2017.
Research and Development Expenses
Research and development expenses for the second quarter of 2018 were
General and Administrative Expenses
General and administrative expenses for the second quarter of 2018 were
2018 Financial Guidance
The Company expects that its cash, cash equivalents and marketable securities balance will be greater than
Conference Call Information
Safe Harbor Statement
Various statements in this release concerning
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Condensed Consolidated Statements of Operations
(In thousands, except share and per share data)
|Three Months Ended June 30,||Six Months Ended June 30,|
|Research and development||12,209||10,528||24,642||20,205|
|General and administrative||3,351||3,008||6,620||6,596|
|Total operating expenses||15,560||13,536||31,262||26,801|
|Loss from operations||(15,560||)||(13,536||)||(31,262||)||(26,801||)|
|Other income (expense):|
|Foreign currency transaction (losses) gains, net||(73||)||(5||)||(136||)||95|
|Total other (expense) income, net||(215||)||189||(469||)||443|
|Net loss per share, basic and diluted||$||(0.57||)||$||(0.49||)||$||(1.15||)||$||(0.96||)|
|Weighted average common shares outstanding, basic and diluted||27,565,064||27,407,408||27,553,394||27,379,122|
Condensed Consolidated Balance Sheets
(In thousands, except share and per share data)
|June 30,||December 31,|
|Cash and cash equivalents||$||40,745||$||40,777|
|Tax incentive receivable||895||946|
|Prepaid expenses and other current assets||1,289||1,927|
|Total current assets||78,033||104,925|
|Tax incentive receivable||938||-|
|Property and equipment, net||472||528|
|Liabilities and Stockholders' Equity|
|Notes payable, current||1,818||-|
|Total current liabilities||9,276||7,293|
|Notes payable, long-term||18,502||20,000|
|Preferred stock; $0.001 par value per share; 5,000,000 shares authorized as of June 30, 2018 and December 31, 2017; no shares issued and outstanding as of June 30, 2018 and December 31, 2017||-||-|
|Common stock, $0.001 par value per share; 115,000,000 shares authorized as of June 30, 2018 and December 31, 2017; 27,578,989 and 27,489,457 shares issued and outstanding as of June 30, 2018 and December 31, 2017, respectively||28||27|
|Additional paid-in capital||373,308||367,825|
|Accumulated other comprehensive loss||(6||)||(58||)|
|Total stockholders' equity||52,022||78,217|
|Total liabilities and stockholders' equity||$||79,800||$||105,510|
Source: Zafgen, Inc.