Altus Pharmaceuticals Reports Third Quarter 2007 Financial Results.CAMBRIDGE, Mass. -- Altus Pharmaceuticals Inc. (NASDAQ NASDAQ
in full National Association of Securities Dealers Automated Quotations
U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on : ALTU), a biopharmaceutical company focused on oral and injectable in·ject·a·ble
Capable of being injected. Used of a drug.
A drug or medicine that can be injected. protein therapeutics for gastrointestinal and metabolic disorders, today reported financial results for the quarter ended September 30, 2007.
For the third quarter of 2007, the Company reported a net loss attributable to common stockholders of $22.6 million, or $0.73 per share, compared to a net loss attributable to common stockholders of $16.0 million, or $0.71 per share, in the third quarter of 2006. Cash, cash equivalents and marketable securities Marketable Securities
Very liquid securities that can be converted into cash quickly at a reasonable price.
Marketable securities are very liquid as they tend to have maturities less than one year, and the rate at which these securities can be bought or sold has at September 30, 2007 totaled $152.2 million.
In the third quarter of 2007, the Company reported negative revenue of $0.6 million compared to negative revenue of $2.0 million in the third quarter of 2006. The Company's third quarter revenue in 2007 and 2006 was impacted by an increase in the total estimated development program costs related to Trizytek(TM) [porcine porcine /por·cine/ (por´sin) pertaining to swine.
pertaining to pig. See also hog (1), swine.
porcine circovirus 1
a nonpathogenic virus. free enzymes] (formerly ALTU-135). With respect to Trizytek, the Company recognizes revenue earned under collaboration agreements using the proportional performance method of revenue recognition. During the three months ended September 30, 2007, the Company reviewed the planned development program for Trizytek and increased the total estimated development costs from $137.5 million to $157.5 million. The impact of the increase in total estimated development costs, under the proportional performance method of revenue recognition, resulted in a cumulative negative revenue adjustment through September 30, 2007 of $2.0 million, which resulted in the Company reporting net negative revenue of $0.6 million in the third quarter of 2007.
Research and development expenses totaled $18.7 million in the third quarter of 2007 compared to $10.9 million in the third quarter of 2006. Third quarter 2007 R&D spending reflects continued clinical and manufacturing costs associated with Trizytek, investments in ALTU-238 clinical manufacturing capacity, outsourced third-party and internal costs related to the ALTU-237 Phase I clinical trial Noun 1. phase I clinical trial - a clinical trial on a few persons to determine the safety of a new drug or invasive medical device; for drugs, dosage or toxicity limits should be obtained
phase I and development spending on Altus' early stage pre-clinical projects. General, sales and administrative expenses were $4.4 million in the third quarter of 2007 compared to $4.2 million in the third quarter of 2006. The third quarter 2007 general, sales and administrative expenses primarily consisted of salaries and other related costs for personnel, including stock-based compensation expenses, legal, consulting and professional service fees to support the requirements of being a public company.
2007 Financial Guidance
Based on current operating plans and the expected timing of product development programs, Altus reiterates its previous guidance that net cash used in operating activities will be between $45 million and $55 million in 2007.
"The Altus team is focused on advancing the Company and its lead programs," stated Sheldon Berkle, President and Chief Executive Officer of Altus Pharmaceuticals. "By utilizing Altus' crystallization Crystallization
The formation of a solid from a solution, melt, vapor, or a different solid phase. Crystallization from solution is an important industrial operation because of the large number of materials marketed as crystalline particles. technology, we have created three clinical development programs that range from Phase I to Phase III Noun 1. phase III - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the FDA trials and we have two pre-clinical programs. In addition, our research team has crystallized crys·tal·lize also crys·tal·ize
v. crys·tal·lized also crys·tal·ized, crys·tal·liz·ing also crys·tal·iz·ing, crys·tal·liz·es also crys·tal·iz·es
1. more than 70 proteins, which could further strengthen our robust pipeline or provide new strategic opportunities for the Company."
During the second quarter of 2007, the Company announced the start of its Phase III clinical trials to evaluate the efficacy and safety of Trizytek, an oral enzyme replacement therapy Enzyme replacement therapy is a medical treatment replacing an enzyme in patients in whom that particular enzyme is deficient or absent. Usually this is done by giving the patient an intravenous (IV) infusion containing the enzyme. for cystic fibrosis cystic fibrosis (sĭs`tĭk fībrō`sĭs), inherited disorder of the exocrine glands (see gland), affecting children and young people; median survival is 25 years in females and 30 years in males. patients with pancreatic insufficiency pancreatic insufficiency A relative or absolute lack of pancreatic enzymes, a finding typical of cystic fibrosis. See Cystic fibrosis. . Altus' consistent and pure enzyme combination, Trizytek, is designed to improve fat, protein and carbohydrate absorption in pancreatic insufficient individuals. The DIGEST trials (Determining the efficacy and safety of an Innovative GastrointESTinal enzyme complex) consist of a Phase III Trizytek efficacy trial and a Phase III Trizytek safety trial.
Altus plans to recruit approximately 300 patients from more than 50 sites worldwide for the two trials, making this Phase III program the largest ever conducted to evaluate the efficacy and safety of pancreatic enzyme replacement therapy in cystic fibrosis patients. The DIGEST efficacy trial, which is testing a one capsule per meal dosing regimen, is studying the fat absorption in cystic fibrosis patients with exocrine pancreatic insufficiency Exocrine pancreatic insufficiency (EPI) is the inability to properly digest food due to a lack of digestive enzymes made by the pancreas. This disease is found frequently in dogs. EPI is also found in humans afflicted with cystic fibrosis. through the measurement of the coefficient of fat absorption (CFA (Computer Fraud and Abuse Act of 1986) Signed into law in 1986, the CFA was a significant step forward in criminalizing unauthorized access to computer systems and networks. The Act applies to "federal interest computers" that include any system used by the U.S. ). In parallel, Altus is conducting a long-term safety study that will evaluate Trizytek over one year of open-label treatment.
Regarding the Trizytek DIGEST trials, Berkle said, "The DIGEST trials continue to enroll clinical sites and patients. To date, we have 24 sites in the efficacy trial and 36 sites in the safety trial that are initiated in this worldwide Phase III program. Our goal is to report top-line efficacy data from the trial in the second quarter of 2008 and we expect to file a new drug application with the FDA FDA
Food and Drug Administration
n.pr See Food and Drug Administration.
n.pr the abbreviation for the Food and Drug Administration. for Trizytek in the first half of 2009."
During the third quarter of this year, Altus started a Phase I clinical trial for ALTU-237, an orally-delivered crystalline formulation of an oxalate-degrading enzyme that is being developed for the treatment of hyperoxalurias and the possible prevention of recurrent kidney stones Kidney Stones Definition
Kidney stones are solid accumulations of material that form in the tubal system of the kidney. Kidney stones cause problems when they block the flow of urine through or out of the kidney. in individuals with a high risk or history of kidney stones. ALTU-237 has the potential to address these conditions, for which there are limited effective pharmacological treatments.
The ALTU-237 Phase I clinical trial is a single-center, double-blind, placebo-controlled, dose escalating study evaluating the safety and tolerability of ALTU-237 in normal, healthy adults. A secondary objective of the trial is to determine the clinical activity of escalating dose levels of ALTU-237, as measured by changes in urinary oxalate oxalate /ox·a·late/ (ok´sah-lat) any salt of oxalic acid.
A salt or ester of oxalic acid. levels in normal healthy adults on a controlled, high oxalate diet and to identify a dose of ALTU-237 for future studies.
Berkle concluded, "The ALTU-237 Phase I trial continues to move forward. This Phase I trial is comprised of 64 subjects randomized ran·dom·ize
tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es
To make random in arrangement, especially in order to control the variables in an experiment. into four cohorts. I am pleased to report that the first cohort is completed; we expect the second cohort to be completed this month; and we anticipate enrolling subjects in the third and fourth cohorts in the first quarter of next year."
Conference Call Access Information
The Company will host a conference call to discuss the third quarter results at 11:00 a.m. ET on November 7. The call may be joined via telephone by dialing (800) 776-0087 or (913) 312-1521 (for international participants) at least 5 minutes prior to the start of the call. The conference confirmation code is: 3384864. For 72 hours following the call, an audio replay can be accessed by dialing (719) 457-0820 or (888) 203-1112 and using the conference confirmation code 3384864. A live audio webcast of the call will also be available on the "Investor Relations Investor relations
The process by which the corporation communicates with its investors. " section of the company's website, www.altus.com. An archived audio webcast will be available on the Altus website approximately two hours after the event and will be archived for 30 days.
About Altus Pharmaceuticals Inc.
Altus Pharmaceuticals (NASDAQ: ALTU) is a biopharmaceutical company focused on the development and commercialization of oral and injectable protein therapeutics for patients with gastrointestinal and metabolic disorders. The Company's website is http://www.altus.com.
Safe Harbor Safe Harbor
1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated.
2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. Statement
Certain statements in this news release concerning Altus' business are considered "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995. These statements include, but are not limited to, those relating to relating to relate prep → concernant
relating to relate prep → bezüglich +gen, mit Bezug auf +acc the anticipated net cash requirements to be used to fund on-going development programs and operations, the expected enrollment of our Trizytek and ALTU-237 clinical trials, the expected time for completion and reporting of results in our Trizytek and ALTU-237 clinical trials, the ultimate scientific robustness of our clinical development programs and the potential strengthening of our product pipeline and possibilities for new strategic opportunities. Any or all of the forward-looking statements in this press release may turn out to be wrong. They can be affected by inaccurate assumptions Altus might make or by known or unknown risks and uncertainties, including, but not limited to uncertainties as to the future cost, timing, enrollment and success of ongoing and planned clinical trials; the continuing risks associated with the development and manufacture of products to supply the clinical trials and the unproven safety and efficacy of products under development. Consequently, no forward-looking statement can be guaranteed, and actual results may vary materially. Additional information concerning factors that could cause actual results to materially differ from those in the forward-looking statements is contained in Altus' reports to the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q Form 10-Q
See 10-Q. for the quarter ended September 30, 2007. However, Altus undertakes no obligation to publicly update forward-looking statements, whether because of new information, future events or otherwise.
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