AKELA Pharma Files Restated MD&A for the Fiscal Year 2008 |
Austin, Texas; March 12, 2010 – Akela Pharma, Inc., (TSX: AKL) a leader in the development of therapeutics for the treatment of pain, and the company’s wholly owned subsidiary, PharmaForm, today that it has today filed a restated Management Discussion and Analysis (“MD&A) for the fiscal year ended 2008. The filing of the restated MD&A was undertaken at the request of the Autorité des marchés financiers as part of its Continuous Disclosure Review of the Company’s filings.
The restated MD&A did not involve the restatement of any unaudited interim or audited consolidated financial statements published previously by the Corporation or any financial results included in the MD&A.
The amendments to this MD&A as originally filed include modifications to the discussion on the Company’s obligation to revise or update forward-looking statements and information to reflect subsequent events or circumstances; expanded discussion of the expected effect of the business combination of Akela and Nventa Biopharmaceuticals Corporation on the financial condition, results of operation and cash flows of the Company; expanded discussion and commentary on the Company’s business operations, overall performance and operating results including the Company’s wholly owned subsidiary PharmaForm; and expenses related to specific product development programs associated with the development of Akela’s lead candidate product Fentanyl Taifun®.
The amendments to this MD&A also included expanded discussion to enhance the disclosure of the Company’s financial liquidity, the Basis of Presentation of the Company related to operating on a going concern basis, and critical accounting estimates related to the Company’s treatment of goodwill and intangibles.
The restated MD&A has been posted on SEDAR and may be viewed at www.sedar.com.
About Akela Pharma Inc.:
Akela Pharma is a drug development company with its lead product, Fentanyl TAIFUN®, being developed for the treatment of breakthrough cancer pain. Fentanyl TAIFUN is a fast-acting fentanyl formulation delivered using the company’s TAIFUN multi-dose dry powder inhaler platform. Akela’s pipeline also includes a growth hormone releasing hormone (GHRH), which is being developed for frailty and wasting in chronic renal disease.
About PharmaForm:
PharmaForm, Akela’s wholly owned subsidiary, is a leading specialty contract service provider in the area of pharmaceutical dosage form development and manufacturing, specializing in controlled release and bioavailability enhancement technologies, such as hot melt extrusion, liquid filled capsules, and spray drying. Through its diverse offerings, PharmaForm solutions help pharmaceutical and biotechnology clients reach their development targets, reduce development costs and accelerate time-to-market.
Akela’s common shares trade on The Toronto Stock Exchange (“TSX”) under the symbol “AKL” with 30.9 million shares outstanding.
This press release contains statements which may constitute forward-looking information under applicable Canadian securities legislation or forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1955. Such forward-looking statements or information may include financial and other projections as well as statements regarding the company’s future plans, objectives, performance, revenues, growth, profits, operating expenses or the company’s underlying assumptions. The words “may”, “would”, “could”, “will”, “likely”, “expect”, anticipate”, “intend”, “plan”, “forecast”, “project”, “estimate” and “believe” or other similar words and phrases may identify forward-looking statements or information. Persons reading this press release are cautioned that such statements or information are only expectations, and that the company’s actual future results or performance may be materially different.
Forward-looking statements or information in this press release include, but are not limited to, statements or information concerning our ongoing drug development programs and collaborations as well as the possible receipt of future payments upon achievement of milestones.
Such forward-looking statements or information involve known and unknown risks, uncertainties and other factors that may cause our actual results, events or developments to be materially different from results, events or developments expressed or implied by such forward-looking statements or information. Such factors include, among others, the possibility that risks associated with requirements for approvals by government agencies such as the FDA before products can be tested in clinical trials; the possibility that such government agency approvals will not be obtained in a timely manner or at all or will be conditioned in a manner that would impair our ability to advance development; risks associated with the requirement that a drug candidate be found safe and effective after extensive clinical trials; our dependence on suppliers, collaborative partners and other third parties and the prospects and timing for negotiating supply agreements, corporate collaborations or licensing arrangements; our ability to attract and retain key personnel; and other factors as described in detail in our filings with the Canadian securities regulatory authorities at http:www.sedar.com.
Assumptions underlying our expectations regarding forward-looking statements or information contained in this press release include, among others, that future clinical trail results will be favorable; that our drug candidate will treat target diseases as intended; that we will raise enough capital, on reasonable terms and in a timely manner; that we will retain our key personnel; that we will obtain the necessary regulatory approvals.
In the event that any of these assumptions prove to be incorrect, or in the event that we are impacted by any of the risks identified above, we may not be able to continue in our business as planned.
For a complete discussion of the assumptions, risks and uncertainties related to our business, you are encouraged to review our filings with Canadian securities regulatory authorities, filed on SEDAR at http://www.sedar.com.
All forward-looking statements and information made herein are based on our current expectations as of the date hereof and we disclaim any intention or obligation to revise or update such forward-looking statements and information to reflect subsequent events or circumstances, except as required by law.
For further information please contact:
Akela Pharma
Gregory M. McKee
President and Chief Executive Officer
Tel: 512-834-0449
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