Zafgen Reports Fourth Quarter and Full Year 2014 Financial Results
Quarter and Full Year Highlighted by Further Progress in Advancing Beloranib Clinical Development Program
Company to Report Data from Ongoing Clinical Trials in Late 2015/Early 2016
Enters 2015 with
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Initiated a first Phase 3 trial through the bestPWS (Beloranib Efficacy Safety and Tolerability in PWS) clinical trial in patients with a rare genetic disorder, Prader-Willi syndrome (PWS), which began randomized treatment in
September 2014
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Initiated a Phase 2b clinical trial (ZAF-203) to establish the long-term weight loss benefits of MetAP2 inhibitor treatment with beloranib in patients with severe obesity complicated by type 2 diabetes, which began randomized treatment in
December 2014
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Announced positive results from a Phase 2a clinical trial of beloranib in patients with hypothalamic injury-associated obesity (HIAO), a rare condition that is also a difficult-to-treat severe form of obesity, in
January 2015
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Two U.S. patents owned by
Zafgen have issued during 2014 and 2015 that relate to methods of treating obesity using dosing regimens of beloranib, and one U.S. patent issued in 2014 that relates to compositions of beloranib
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Added to the NASDAQ Biotechnology Index (Nasdaq:NBI) in
December 2014
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Raised approximately
$230 million through a successful initial public offering (IPO) inJune 2014 and a follow-on public offering inJanuary 2015
"We are very pleased with our accomplishments for the fourth quarter of 2014 and moreover, the year as a whole, which has been one of the most productive in our Company's history. We have made substantial progress in the clinical development of beloranib in multiple indications, all in continued support of our mission of bringing life-changing treatment options to patients affected by obesity and obesity-related disorders," said Dr.
"With promising data in hand from our recent Phase 2a proof of concept trial (ZAF-221) in patients with HIAO, we look forward to readouts from our bestPWS (ZAF-311) Phase 3 study in Prader-Willi syndrome, and our Phase 2b trial (ZAF-203) in patients with severe obesity complicated by type 2 diabetes," said
"We were pleased to have completed our IPO in
Fourth Quarter and Full Year 2014 Financial Results
Cash and
As of
In
Net Loss
The Company reported a net loss for the fourth quarter of 2014 of
Research and Development Expenses
Research and development expenses for the fourth quarter of 2014 were
General and Administrative Expenses
General and administrative expenses for the fourth quarter of 2014 were
2015 Financial Guidance
The Company expects that its cash and cash equivalents and marketable securities balance will be greater than
Conference Call Information
About Beloranib
Beloranib is a novel, first-in-class injectable small molecule therapy with a unique mechanism of action that reduces hunger while stimulating the use of stored fat as an energy source. Beloranib is a potent inhibitor of MetAP2, an enzyme that modulates the activity of key cellular processes that control metabolism. MetAP2 inhibitors work, at least in part, by directing MetAP2 binding to cellular stress mediators, and, thus, reducing the tone of signals that drive lipid synthesis by the liver and fat storage throughout the body. In this manner, MetAP2 inhibition increases metabolism of fat as an energy source.
About Prader-Willi Syndrome
Prader-Willi syndrome (PWS), the most common known genetic cause of life-threatening obesity, results in constant and unrelenting hunger that drives patients with PWS to engage in problematic hunger-related behaviors and to gain excessive weight. As a result, many of those affected with PWS become morbidly obese and suffer significant mortality. Currently, there is no cure for this disease. Although the cause of PWS is complex, it results from a deletion or loss of function of a cluster of genes on the 15th chromosome. PWS typically causes low muscle mass and function, short stature, incomplete sexual development, and a chronic feeling of hunger that, when coupled with a metabolism that utilizes drastically fewer calories than normal, can lead to excessive eating and life-threatening obesity. PWS occurs in males and females equally and in all races, with the same incidence around the world. Prevalence estimates have ranged from 1:8,000 to 1:50,000.
About Hypothalamic Injury-Associated Obesity (HIAO)
When the hypothalamus, a small area of the brain responsible for many hormonal and metabolic functions including the desire to eat, is injured, a syndrome of intractable weight gain can ensue, resulting in severe obesity and a poor quality of life. This rare and complicated medical condition occurs in affected individuals most commonly due to a benign central nervous system tumor called craniopharyngioma, which presents as a mass in or near the hypothalamus. When the tumor is treated with surgical resection and radiation therapy, the hypothalamus often becomes severely damaged and/or dysfunctional, which can result in loss of appetite control and reduction in metabolic rate. Craniopharyngioma-associated obesity incidence estimates have ranged from 0.13 to 0.17 per 100,000 per year. Other comparably located tumors such as pituitary macroadenoma, medulloblastoma, and pineal germinoma, affect a smaller number of patients, but patients with these tumors can have a similar clinical presentation with respect to obesity. Rarely, this form of obesity also has been reported in cases of head trauma or stroke leading to injury to the hypothalamus.
About
Safe Harbor Statement
Various statements in this release concerning
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| Consolidated Statements of Operations and Comprehensive Loss | |||
| (In thousands, except share and per share data) | |||
| (Unaudited) | |||
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Year Ended |
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| 2014 | 2013 | 2012 | |
| (in thousands, except per share data) | |||
| Revenue | $ -- | $ -- | $ -- |
| Operating expenses: | |||
| Research and development | 27,391 | 9,561 | 11,544 |
| General and administrative | 8,141 | 4,219 | 2,247 |
| Total operating expenses | 35,532 | 13,780 | 13,791 |
| Loss from operations | (35,532) | (13,780) | (13,791) |
| Other income (expense): | |||
| Interest income | 28 | -- | -- |
| Foreign currency transaction gains (losses), net | (104) | (247) | 8 |
| Interest expense | (870) | -- | (97) |
| Total other income (expense), net | (946) | (247) | (89) |
| Net loss | (36,478) | (14,027) | (13,880) |
| Accretion of redeemable convertible preferred stock to redemption value | (92) | (213) | (67) |
| Net loss attributable to common stockholders | $ (36,570) | $ (14,240) | $ (13,947) |
| Net loss per share attributable to common stockholders, basic and diluted | $ (3.00) | $ (19.53) | $ (19.65) |
| Weighted average common shares outstanding, basic and diluted | 12,189,155 | 729,001 | 709,678 |
| Comprehensive loss: | |||
| Net loss | $ (36,478) | $ (14,027) | $ (13,880) |
| Other comprehensive loss: | |||
| Unrealized loss on marketable securities | (35) | -- | -- |
| Total other comprehensive loss | (35) | -- | -- |
| Total comprehensive loss | $ (36,513) | $ (14,027) | $ (13,880) |
| Zafgen, Inc. | ||
| Consolidated Statements of Operations and Comprehensive Loss (continued) | ||
| (In thousands, except share and per share data) | ||
| (Unaudited) | ||
| Three Months Ended | ||
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| 2014 | 2013 | |
| Revenue | $ -- | $ -- |
| Operating expenses: | ||
| Research and development | 7,345 | 2,523 |
| General and administrative | 3,319 | 1,238 |
| Total operating expenses | 10,664 | 3,761 |
| Loss from operations | (10,664) | (3,761) |
| Other income (expense): | ||
| Interest income | 26 | -- |
| Interest expense | (212) | -- |
| Foreign currency transaction gains (losses), net | (81) | (85) |
| Total other income (expense), net | (267) | (85) |
| Net loss | (10,931) | (3,846) |
| Accretion of redeemable convertible preferred stock to redemption value | -- | (53) |
| Net loss attributable to common stockholders | $ (10,931) | $ (3,899) |
| Net loss per share attributable to common stockholders, basic and diluted | $ (0.48) | $ (5.35) |
| Weighted average common shares outstanding, basic and diluted | 22,783,817 | 729,391 |
| Comprehensive loss: | ||
| Net loss | $ (10,931) | $ (3,846) |
| Other comprehensive loss: | ||
| Unrealized loss on investments | (35) | -- |
| Total other comprehensive loss | (35) | -- |
| Total comprehensive loss | $ (10,966) | $ (3,846) |
| Zafgen, Inc. | ||
| Selected Consolidated Balance Sheets | ||
| (In thousands, except share and per share data) | ||
| (Unaudited) | ||
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| 2014 | 2013 | |
| Assets | ||
| Current assets: | ||
| Cash and cash equivalents | $ 58,103 | $ 35,517 |
| Marketable securities | 57,359 | -- |
| Tax incentive receivable | 391 | 1,617 |
| Prepaid expenses and other current assets | 1,345 | 224 |
| Total current assets | 117,198 | 37,358 |
| Property and equipment, net | 79 | 37 |
| Other assets | 242 | 743 |
| Total assets | $ 117,519 | $ 38,138 |
| Liabilities, Redeemable Convertible Preferred Stock and Stockholders' Equity (Deficit) | ||
| Current liabilities: | ||
| Accounts payable | $ 2,348 | $ 2,015 |
| Accrued expenses | 3,172 | 900 |
| Notes payable, current | 1,381 | -- |
| Total current liabilities | 6,901 | 2,915 |
| Notes payable, net of discount, long-term | 6,177 | -- |
| Total liabilities | 13,078 | 2,915 |
| Commitments and contingencies | ||
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Redeemable convertible preferred stock (Series A, B, C, D and E), |
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No shares and 99,292,610 shares authorized at |
-- | 103,797 |
| Stockholders' equity (deficit): | ||
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Preferred stock; |
-- | -- |
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Common stock, |
23 | 1 |
| Additional paid-in capital | 209,838 | 332 |
| Accumulated deficit | (105,385) | (68,907) |
| Accumulated other comprehensive loss | (35) | -- |
| Total stockholders' equity (deficit) | 104,441 | (68,574) |
| Total liabilities, redeemable convertible preferred stock and stockholders' equity (deficit) | $ 117,519 | $ 38,138 |
This selected financial information should be read in conjunction with the consolidated financial statements and notes thereto included in the final prospectus related to
CONTACT:Source:Zafgen, Inc. Patricia Allen Chief Financial Officer 617-648-9792 FTI ConsultingKimberly Ha Investor Relations (212) 850-5612 Kimberly.Ha@fticonsulting.comShauna Elkin Media Relations (212) 850-5613 Shauna.Elkin@fticonsulting.com
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