Welcome!

Microsoft Cloud Authors: Pat Romanski, Srinivasan Sundara Rajan, Glenn Rossman, Janakiram MSV, Steven Mandel

News Feed Item

Cempra, Inc. Reports Third Quarter 2012 Financial and Operating Results

- Company to Host Conference Call and Webcast at 4:30 p.m. EST, Today, Nov. 8, 2012 -

CHAPEL HILL, N.C., Nov. 8, 2012 /PRNewswire/ -- Cempra, Inc. (Nasdaq: CEMP), a clinical-stage pharmaceutical company focused on developing antibiotics to meet critical medical needs in the treatment of bacterial infectious diseases, today reported financial results for the third quarter ended Sept. 30, 2012. The company will host a conference call and webcast at 4:30 p.m. EST, today.

"Most of our work during the third quarter was directed toward events and activities that have occurred or are expected to occur during the fourth quarter," said Prabhavathi Fernandes, Ph.D., chief executive officer of Cempra. "We continue to prepare for the solithromycin oral Phase 3 clinical trial in community-acquired bacterial pneumonia, which we expect to initiate before year end. Positive top-line results from the solithromycin gonococcus Phase 2 trial were announced in October, which not only adds to the solithromycin safety data base but demonstrates the broad activity of solithromycin.  We have designed the Taksta™ Phase 2 trial in prosthetic joint infections and identified clinical centers in the U.S. for this trial.  Finally, we raised $25 million in a private financing in late October that will be used for general corporate purposes including the funding of clinical trials and work to prepare for the initiation of the solithromycin IV-to-oral Phase 3 clinical trial.  The fourth quarter and 2013 are expected to be busy periods for Cempra and we look forward to reporting on the progress of our activities."

Financial Results

Quarter ended September 30, 2012 compared to quarter ended September 30, 2011

For the quarter ended September 30, 2012, Cempra reported a net loss of $5.0 million, or $0.24 per share, compared to a net loss of $8.9 million, or $16.59 per share, for the same period in  2011. 

Research and development expense in the quarter ended September 30, 2012, was $3.2 million, a decrease of 53% compared to the same quarter in 2011. The lower R&D expense was primarily due to a large purchase of solithromycin API in the third quarter of 2011 which did not recur in 2012.  General and administrative expense was $1.5 million, a 55% increase compared to the quarter ended September 30, 2011, driven by increased insurance and professional fees related to becoming a public company as well as increased stock-based compensation expense.

Nine months ended September 30, 2012 compared to nine months ended September 30, 2011

For the nine months ended September 30, 2012, Cempra reported a net loss of $18.0 million, or $0.97 per share, compared to a net loss of $21.2 million, or $40.49 per share, for the comparable period in 2011. 

Research and development expense was $12.5 million, a decrease of 19% compared to the same period in 2011. General and administrative expense was $4.2 million, a 60% increase compared to the nine months ended September 30, 2011.

At September 30, 2012, Cempra had cash and equivalents of $51.6 million.  The increase compared to December 31, 2011 was due to proceeds obtained from the IPO in February 2012 less operational expenses that were incurred during the first three quarters of 2012. Additionally, Cempra raised $25 million from the sale of 3.86 million shares in a private placement, which closed on October 24, 2012. 

Third Quarter and early fourth quarter 2012 Highlights

  • Presented both clinical and in vitro data at the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in San Francisco; this included a presentation on the solithromycin IV phase 1 study that will be used to select the IV dose for the IV-to-oral Phase 3 clinical trial
  • Released top-line results of the solithromycin Phase 2 trial in patients with uncomplicated urogenital gonococcal infections early in the fourth quarter of 2012; all 22 evaluable patients were cleared of their gonococcal infections at all infected body sites with a single dose of solithromycin
  • Announced results from the Phase 1 intravenous dosing clinical trial early in the fourth quarter of 2012 and indicated that 400 mg once-daily would be used in the IV-to-oral Phase 3 study
  • Raised $25 million in a private placement early in the fourth quarter of 2012; proceeds are to be used for general corporate and working capital purposes including the funding of clinical trials.

Clinical program update

The company is primarily focused on the development of its two lead clinical-stage antibiotic candidates, the fluoroketolide, solithromycin, and Taksta™, the oral antibiotic being developed for staphylococcal infections.  The company expects the following events to occur during the fourth quarter of 2012:

Solithromycin

  • Initiation of the oral Phase 3 clinical trial in CABP

Taksta

  • Initiation of the Phase 2 trial in prosthetic joint infection (PJI) patients

Financial Guidance

Cempra expects its research and development expense to increase due to the initiation of clinical trials during the fourth quarter of 2012.  If the $23.4 million in net proceeds from the private placement that occurred in October 2012 are included, the company's cash and equivalents are expected to be sufficient to fund current operations into 2015.  This projection does not include any proceeds from possible future partnerships or additional financing activities.

Conference Call and Webcast

The conference call may be accessed by dialing 877-377-7553 for domestic callers and 253-237-1151 for international callers. Please specify to the operator that you would like to join the "Cempra, Inc., Third Quarter 2012 Financial Results Call, conference ID#: 59073336." The conference call will be webcast live under the investor relations section of Cempra's website at www.cempra.com, and will be archived there for 30 days following the call. Please visit Cempra's website several minutes prior to the start of the broadcast to ensure adequate time for any software download that may be necessary.

About Cempra, Inc.

Founded in 2006, Cempra, Inc. is a clinical-stage pharmaceutical company focused on developing antibiotics to meet critical medical needs in the treatment of bacterial infectious diseases. Cempra's two lead product candidates have both completed oral Phase 2 clinical trials and seek to address the need for new treatments targeting drug-resistant bacterial infections in the hospital and in the community. The company also intends to utilize its series of proprietary lead compounds from its novel macrolide library for uses such as the treatment of chronic inflammatory diseases, endocrine diseases and gastric motility disorders. Additional information about Cempra can be found at www.cempra.com.

Please Note: This press release contains forward-looking statements regarding future events. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include, among others:  the costs, timing, regulatory review and results of our studies and clinical trials; our need to obtain additional funding and our ability to obtain future funding on acceptable terms; our ability to obtain FDA approval of our product candidates; our dependence on the success of solithromycin and Taksta; our anticipated capital expenditures and our estimates regarding our capital requirements; the possible impairment of, or inability to obtain, intellectual property rights and the costs of obtaining such rights from third parties; the unpredictability of the size of the markets for, and market acceptance of, any of our products, including solithromycin and Taksta; our ability to produce and sell any approved products and the price we are able realize for those products; our ability to retain and hire necessary employees and to staff our operations appropriately; our ability to compete in our industry; innovation by our competitors; and our ability to stay abreast of and comply with new or modified laws and regulations that currently apply or become applicable to our business.  The reader is referred to the documents that we file from time to time with the Securities and Exchange Commission.

CEMPRA, INC.

SELECTED FINANCIAL INFORMATION


Condensed Consolidated Balance Sheets



(in thousands)





September 30,

December 31,



2012

2011

ASSETS

     (unaudited)


Current assets




Cash and equivalents

$                51,643

$       15,602


Prepaid expenses

161

284


Deferred offering expenses

-

881

Total current assets

51,804

16,767

Furniture, fixtures and equipment, net

48

82

Deposits

321

10

Total assets

$               52,173

$       16,859





LIABILITIES



Current liabilities




Accounts payable

$                 1,327

$         2,981


Accrued expenses

236

545


Accrued payroll and benefits

502

421


Warrant liability

-

1,121


Current portion of long-term debt

1,465

-


          Total current liabilities

3,530

5,068

Convertible notes payable

-

4,458

Long-term debt

8,297

9,504

Total liabilities

$               11,827

$       19,030

Commitments and contingencies







Redeemable Convertible Preferred Shares



Redeemable convertible preferred shares

-

94,514





Shareholders' Equity (Deficit)



Common shares; 100,000,000 shares authorized, no par value;



533,839 shares issued and outstanding at December 31, 2011 and



none issued and outstanding at September 30, 2012

-

-

Common stock; $.001 par value; none issued and outstanding at



December 31, 2011 and 80,000,000 shares authorized; 21,039,313



shares and outstanding at September 30, 2012

21

-

Addition paid-in capital

154,983

-

Accumulated deficit during the development stage

(114,658)

(96,685)


Total shareholders' equity  (deficit)

40,346

(96,685)


Total liabilities, redeemable convertible preferred shares




and shareholders' equity (deficit)

$               52,173

$             16,859




Condensed Consolidated Statements of Operations

(unaudited; in thousands, except loss per share data)



           Three Months Ended September 30



2012

2011

Revenues

$                       -

$                       -

Operating expenses




Research and development

3,156

6,661


General and administrative

1,495

965


          Total operating expenses

4,651

7,626,

Loss from operations

(4,651)

(7,626)





Other income (expense), net

(330)

(290)





Net loss and comprehensive loss

(4,981)

(7,916)





Accretion of redeemable convertible preferred shares

-

(941)





Net loss attributable to common shareholders

$            (4,981)

$            (8,857)





Basic and diluted loss per share

$              (0.24)

$            (16.59)





Basis and diluted weighted average shares outstanding

21,038.0

533.8









Nine Months Ended September 30



2012

2011

Revenues

$                    -

$                      -

Costs and expenses




Research and development

12,456

15,414


General and administrative

4,244

2,651


          Total operating expenses

16,700

18,065

Loss from operations

(16,700)

(18,065)




Other income (expense), net

(958)

(289)

Net loss and comprehensive loss

(17,658)

(18,354)




Accretion of redeemable convertible preferred shares

(314)

(2,822)




Net loss attributable to common shareholders

$       (17,972)

$           (21,176)




Basic and diluted loss per share

$           (0.97)

$             (40.49)




Basis and diluted weighted average shares outstanding

18,450.6

522.9




Investor and Media Contacts:

Robert E. Flamm


[email protected]

Andreas Marathovouniotis
Russo Partners, LLC
(212) 845-4235
[email protected]

SOURCE Cempra, Inc.

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

@ThingsExpo Stories
Information technology is an industry that has always experienced change, and the dramatic change sweeping across the industry today could not be truthfully described as the first time we've seen such widespread change impacting customer investments. However, the rate of the change, and the potential outcomes from today's digital transformation has the distinct potential to separate the industry into two camps: Organizations that see the change coming, embrace it, and successful leverage it; and...
SYS-CON Events announced today that Roundee / LinearHub will exhibit at the WebRTC Summit at @ThingsExpo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. LinearHub provides Roundee Service, a smart platform for enterprise video conferencing with enhanced features such as automatic recording and transcription service. Slack users can integrate Roundee to their team via Slack’s App Directory, and '/roundee' command lets your video conference ...
A strange thing is happening along the way to the Internet of Things, namely far too many devices to work with and manage. It has become clear that we'll need much higher efficiency user experiences that can allow us to more easily and scalably work with the thousands of devices that will soon be in each of our lives. Enter the conversational interface revolution, combining bots we can literally talk with, gesture to, and even direct with our thoughts, with embedded artificial intelligence, wh...
Digital transformation is too big and important for our future success to not understand the rules that apply to it. The first three rules for winning in this age of hyper-digital transformation are: Advantages in speed, analytics and operational tempos must be captured by implementing an optimized information logistics system (OILS) Real-time operational tempos (IT, people and business processes) must be achieved Businesses that can "analyze data and act and with speed" will dominate those t...
The Jevons Paradox suggests that when technological advances increase efficiency of a resource, it results in an overall increase in consumption. Writing on the increased use of coal as a result of technological improvements, 19th-century economist William Stanley Jevons found that these improvements led to the development of new ways to utilize coal. In his session at 19th Cloud Expo, Mark Thiele, Chief Strategy Officer for Apcera, will compare the Jevons Paradox to modern-day enterprise IT, e...
There are several IoTs: the Industrial Internet, Consumer Wearables, Wearables and Healthcare, Supply Chains, and the movement toward Smart Grids, Cities, Regions, and Nations. There are competing communications standards every step of the way, a bewildering array of sensors and devices, and an entire world of competing data analytics platforms. To some this appears to be chaos. In this power panel at @ThingsExpo, moderated by Conference Chair Roger Strukhoff, Bradley Holt, Developer Advocate a...
In his general session at 18th Cloud Expo, Lee Atchison, Principal Cloud Architect and Advocate at New Relic, discussed cloud as a ‘better data center’ and how it adds new capacity (faster) and improves application availability (redundancy). The cloud is a ‘Dynamic Tool for Dynamic Apps’ and resource allocation is an integral part of your application architecture, so use only the resources you need and allocate /de-allocate resources on the fly.
SYS-CON Events announced today that Bsquare has been named “Silver Sponsor” of SYS-CON's @ThingsExpo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. For more than two decades, Bsquare has helped its customers extract business value from a broad array of physical assets by making them intelligent, connecting them, and using the data they generate to optimize business processes.
There is growing need for data-driven applications and the need for digital platforms to build these apps. In his session at 19th Cloud Expo, Muddu Sudhakar, VP and GM of Security & IoT at Splunk, will cover different PaaS solutions and Big Data platforms that are available to build applications. In addition, AI and machine learning are creating new requirements that developers need in the building of next-gen apps. The next-generation digital platforms have some of the past platform needs a...
SYS-CON Events announced today that ReadyTalk, a leading provider of online conferencing and webinar services, has been named Vendor Presentation Sponsor at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. ReadyTalk delivers audio and web conferencing services that inspire collaboration and enable the Future of Work for today’s increasingly digital and mobile workforce. By combining intuitive, innovative tec...
Fact is, enterprises have significant legacy voice infrastructure that’s costly to replace with pure IP solutions. How can we bring this analog infrastructure into our shiny new cloud applications? There are proven methods to bind both legacy voice applications and traditional PSTN audio into cloud-based applications and services at a carrier scale. Some of the most successful implementations leverage WebRTC, WebSockets, SIP and other open source technologies. In his session at @ThingsExpo, Da...
Cognitive Computing is becoming the foundation for a new generation of solutions that have the potential to transform business. Unlike traditional approaches to building solutions, a cognitive computing approach allows the data to help determine the way applications are designed. This contrasts with conventional software development that begins with defining logic based on the current way a business operates. In her session at 18th Cloud Expo, Judith S. Hurwitz, President and CEO of Hurwitz & ...
Almost two-thirds of companies either have or soon will have IoT as the backbone of their business in 2016. However, IoT is far more complex than most firms expected. How can you not get trapped in the pitfalls? In his session at @ThingsExpo, Tony Shan, a renowned visionary and thought leader, will introduce a holistic method of IoTification, which is the process of IoTifying the existing technology and business models to adopt and leverage IoT. He will drill down to the components in this fra...
The Internet of Things can drive efficiency for airlines and airports. In their session at @ThingsExpo, Shyam Varan Nath, Principal Architect with GE, and Sudip Majumder, senior director of development at Oracle, will discuss the technical details of the connected airline baggage and related social media solutions. These IoT applications will enhance travelers' journey experience and drive efficiency for the airlines and the airports. The session will include a working demo and a technical d...
I'm a lonely sensor. I spend all day telling the world how I'm feeling, but none of the other sensors seem to care. I want to be connected. I want to build relationships with other sensors to be more useful for my human. I want my human to understand that when my friends next door are too hot for a while, I'll soon be flaming. And when all my friends go outside without me, I may be left behind. Don't just log my data; use the relationship graph. In his session at @ThingsExpo, Ryan Boyd, Engi...
SYS-CON Events announced today that Pulzze Systems will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Pulzze Systems, Inc. provides infrastructure products for the Internet of Things to enable any connected device and system to carry out matched operations without programming. For more information, visit http://www.pulzzesystems.com.
SYS-CON Events announced today that Numerex Corp, a leading provider of managed enterprise solutions enabling the Internet of Things (IoT), will exhibit at the 19th International Cloud Expo | @ThingsExpo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Numerex Corp. (NASDAQ:NMRX) is a leading provider of managed enterprise solutions enabling the Internet of Things (IoT). The Company's solutions produce new revenue streams or create operating...
If you’re responsible for an application that depends on the data or functionality of various IoT endpoints – either sensors or devices – your brand reputation depends on the security, reliability, and compliance of its many integrated parts. If your application fails to deliver the expected business results, your customers and partners won't care if that failure stems from the code you developed or from a component that you integrated. What can you do to ensure that the endpoints work as expect...
The Transparent Cloud-computing Consortium (abbreviation: T-Cloud Consortium) will conduct research activities into changes in the computing model as a result of collaboration between "device" and "cloud" and the creation of new value and markets through organic data processing High speed and high quality networks, and dramatic improvements in computer processing capabilities, have greatly changed the nature of applications and made the storing and processing of data on the network commonplace.
WebRTC adoption has generated a wave of creative uses of communications and collaboration through websites, sales apps, customer care and business applications. As WebRTC has become more mainstream it has evolved to use cases beyond the original peer-to-peer case, which has led to a repeating requirement for interoperability with existing infrastructures. In his session at @ThingsExpo, Graham Holt, Executive Vice President of Daitan Group, will cover implementation examples that have enabled ea...