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Stellar Biotechnologies Reports Second Quarter 2014 Financial Results and Recent Corporate Developments

Companies mentioned in this article: Stellar Biotechnologies

PORT HUENEME, CA -- (Marketwired) -- 04/10/14 -- Stellar Biotechnologies, Inc. ("Stellar" or "the Company") (OTCQB: SBOTF) (TSX VENTURE: KLH), a leader in sustainable manufacture of Keyhole Limpet Hemocyanin (KLH), an important immune-stimulating protein used in wide-ranging therapeutic and diagnostic markets, has reported financial results for the second quarter and six months ended February 28, 2014, and provided operational highlights.

"We continue to make progress with our core KLH manufacturing and strengthen our relationships with key stakeholders and commercial partners," said Frank Oakes, president and chief executive officer of Stellar Biotechnologies. "On the new development front, we expect completion of the secondary preclinical study in our Active Immunotherapy program for Clostridium difficile ("C. diff") in 2014 and to publish results as soon as possible. Our financial position remains strong with approximately $15.8 million cash and equivalents which will support the enhancement of Stellar's immunotherapy program, KLH product research, aquaculture and KLH production expansion."

Second Quarter and Recent Business Highlights:

  • Collaborations and Supply Agreements: Stellar continues to gain high level strategic and collaborative interest from biopharma and research partners as those clinical programs advance to later stages of development. Stellar KLH technology serves as a platform for partnerships with long-term revenue, strategic, and clinical potential for the Company. In December 2013, Stellar executed a collaboration agreement with Amaran Biotechnology, Inc., to develop and evaluate methods for the manufacture of OBI-822 active immunotherapy using Stellar's GMP grade Keyhole Limpet Hemocyanin ("KLH"). The collaboration involves an important, multinational clinical project with long-term product development and commercial potential.

  • C. diff Active Immunotherapy Program Preclinical Study Update: In December 2013, Stellar began method development for manufacturing C. difficile bacteria fermentation and cell wall polysaccharide (PS) extraction with outside contract manufacturers. Upcoming milestones in this program, expected to implement throughout 2014, include engineering runs of the Stellar C. diff PS-KLH conjugate vaccine, validation of engineering prototypes in the preclinical C. diff model, and prototype scale-up.

  • Strong Financial Position: As of February 28, 2014 Company's current cash position is US$15.8 million. The strong financial position will continue to support the enhancement of Stellar's immunotherapy program, KLH product research, aquaculture operations, and KLH production expansion.

Key Financials:
Second Quarter and First Six Months 2014 Results

  • Cash Position: Cash and cash equivalents as of February 28, 2014 were $15.8 million, compared to $ 7.9 million at year-end August 31, 2013. The Company believes current cash will be sufficient to meet estimated working capital requirements and fund planned program development through 2015. During the six months ended February 28, 2014, the Company received $7 million gross proceeds under private placements (with $5 million of the September 2013 private placement subscribed and received prior to August 31, 2013) and $4.2 million gross proceeds from the exercise of warrants and options.

  • As of February 28, 2014, Stellar had shareholders equity of $9.1 million and approximately 78 million shares outstanding.

  • Revenues: Revenues were $91,103 in the second quarter and $150,267 for the six months ended February 28, 2014 compared to $61,481 and $177,208 in the comparable periods in 2013. Stellar completed the NSF Phase IIB grant during the first quarter of 2014 and generated additional contract and commercial sales revenue during the second quarter.

  • R&D Expenses: Research and development expenses were $536,621 in the second quarter of 2014 and $908,452 in the six months ended February 28, 2014, compared to $236,832 and $506,460 in the comparable periods in 2013. The increase in R&D expense was largely due to an increase in method development activities for vaccine manufacturing during the period related to the C. diff active immunotherapy research program.

  • Other Operating Expenses: Other operating expenses totaled $901,455 in the second quarter of 2014 and $2,118,044 in the six months ended February 28, 2014, compared to $572,303 and $1,159,365 in the comparable periods in 2013. The increase was primarily attributable to a higher level of activity, addition of key personnel, vesting and timing of stock options, and discontinuation of the temporary voluntary salary reduction that were initiated in the prior comparison period.

  • Net Loss: Net loss was $237,953 for the second quarter of 2014 and $5.6 million for the six months ended February 28, 2014, compared to net loss of $3.6 million and $4.4 million for the comparable periods in 2013. The decrease of $3.4 net loss for the second quarter of 2014, and cumulative increase of $1.2 million net loss for the six months ended February 28, 2014 were substantially affected by fluctuations in noncash change in fair value of warrant liability. As a result of having exercise prices denominated in Canadian dollars which is not the Company's functional currency of US dollars, some of the Company's warrants meet the definition of derivatives and are therefore classified as derivative liabilities. The noncash fair value gains and losses in these periods are a reflection of the Company's share price fluctuations with increases in share prices causing greater warrant liability and a loss on fair value of warrant liability, while decreases in share prices cause a gain on fair value of warrant liability. Changes in fair value of warrant liability have no impact on cash flow. If the warrants are exercised, the warrant liability is reclassified to share capital. If the warrants expire, the decrease in warrant liability offsets the changes in fair value.

To view the Company's second quarter and six months 2014 consolidated financial statements, related notes and Management Discussion & Analysis as well as all of Stellar Biotechnologies' past reports and filings please visit the Canadian Securities Administrators' website (www.sedar.com). To view the Company's filings under Form 20-F, please visit the U.S. SEC website (www.sec.gov/edgar).

Conference Call and Webcast Details:
Date: Thursday, April 10, 2014
Time: 1:30 p.m. Eastern Time / 10:30 a.m. Pacific Time
Conference Line (U.S.): 1-480-629-9712
International Dial-In: +1 480-629-9712
Conference ID: 4678236
Webcast: http://public.viavid.com/index.php?id=108588
Q&A submission: Questions for management may be submitted via the chat feature of the live online webcast.

Please log in at least 10 minutes before the start time to ensure timely participation and appropriate web interface platform.

A playback of the call will be available from 7:00 p.m. ET on April 10, 2014 to 7:00 p.m. ET on April 24, 2014. To listen, call 1-877-870-5176 within the United States or 1-858-384-5517 when calling internationally. Please use the replay pin number 4678236. For additional information please visit the investor section at www.stellarbiotech.com.

About Stellar Biotechnologies, Inc.

Stellar Biotechnologies, Inc. (OTCQB: SBOTF) (TSX VENTURE: KLH) is the world leader in sustainable manufacture of Keyhole Limpet Hemocyanin (KLH), an important immune-stimulating protein used in wide-ranging therapeutic and diagnostic markets. KLH is both an active pharmaceutical ingredient (API) in many new immunotherapies (targeting cancer, infectious diseases, and immune disorders) as well as a finished product for measuring immune status. Stellar Biotechnologies is unique in its proprietary methods, facilities, and KLH technology. We are committed to meeting the growing demand for commercial-scale supplies of GMP grade KLH, ensuring environmentally sound KLH production, and developing KLH-based active immunotherapies.

To learn more visit www.StellarBiotech.com and the KLH knowledge base www.KLHSite.org.

Safe Harbor Statement

There can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Readers should not place undue reliance on such statements. Except in accordance with applicable securities laws, the Company expressly disclaims any obligation to update any forward-looking statements or forward-looking statements that are incorporated by reference herein. This news release does not constitute an offer to sell, or a solicitation of an offer to buy any of the Company's securities set out herein in the United States, or to, or for the benefit or account of, a U.S. Person or person in the United States. Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of these releases.



      Condensed Interim Consolidated Statements of Financial Position
                    (Unaudited - Prepared by Management)
                         (Expressed in US Dollars )

                                          ---------------- ----------------
                                            February 28,      August 31,
                                                2014             2013
                                          ---------------- ----------------

Assets:
  Cash and cash equivalents               $     15,840,974 $      7,859,889
  Other current assets                             149,479          274,633
  Noncurrent assets                                544,466          378,836

                                          ---------------- ----------------
    Total Assets                          $     16,534,919 $      8,513,358
                                          ================ ================

Liabilities and Shareholders' Equity
 (Deficiency):
  Accounts payable and accrued
   liabilities                            $        520,140 $        454,063
  Warrant liability, including current
   portion                                       6,884,098       11,200,807
  Shareholders' equity (deficiency)              9,130,681       (3,141,512)

                                          ---------------- ----------------
    Total Liabilities and Shareholders'
     Equity (Deficiency)                  $     16,534,919 $      8,513,358
                                          ================ ================


  Condensed Interim Consolidated Statements of Loss and Comprehensive Loss
                    (Unaudited - Prepared by Management)
                         (Expressed in US Dollars )

                 -------------  -------------  -------------  -------------
                      Three Months Ended             Six Months Ended
                  February 28,   February 28,   February 28,   February 28,
                      2014           2013           2014           2013
                 -------------  -------------  -------------  -------------
Revenues:
 Contract and
  collaboration
  income         $      72,000  $      15,000  $      87,000  $      30,000
 Commercial
  sales                 19,103          9,375         26,688         39,225
 Grant revenue               -         37,106         36,579        107,983

                 -------------  -------------  -------------  -------------
  Total Revenues        91,103         61,481        150,267        177,208

Costs of
 Production,
 Aquaculture and
 Grants                 96,868        100,949        218,568        264,423

                 -------------  -------------  -------------  -------------
Gross Margin
 (Loss)                 (5,765)       (39,468)       (68,301)       (87,215)
                 -------------  -------------  -------------  -------------

Operating
 Expenses:
 Research and
  development          536,621        236,832        908,452        506,460
 Other operating
  expenses             901,455        572,303      2,118,044      1,159,365

                 -------------  -------------  -------------  -------------
  Total
   Operating
   Expenses          1,438,076        809,135      3,026,496      1,665,825

Other Income
 (Loss):
 Foreign
  exchange loss       (266,941)       (29,003)      (337,010)       (29,954)
 Change in fair
  value of
  warrant
  liability          1,469,086     (2,767,283)    (2,200,472)    (2,628,621)
 Interest income        15,943          1,762         26,640          2,633

Income tax
 expense                12,200            800         12,200            800

                 -------------  -------------  -------------  -------------
Loss and
 Comprehensive
 Loss for the
 Period          $    (237,953) $  (3,643,927) $  (5,617,839) $  (4,409,782)
                 =============  =============  =============  =============

Loss per common
 share - basic
 and diluted     $       (0.00) $       (0.07) $       (0.08) $       (0.09)

Weighted average
 number of
 common shares
 outstanding        75,036,352     50,679,214     73,491,305     48,827,422



          Condensed Interim Consolidated Statements of Cash Flows
                    (Unaudited - Prepared by Management)
                         (Expressed in US Dollars )

                                         ----------------  ----------------
                                                  Six Months Ended
                                           February 28,      February 28,
                                               2014              2013
                                         ----------------  ----------------

Cash Flows Used In Operating Activities:
  Loss for the period                    $     (5,617,839) $     (4,409,782)
  Items not affecting cash:
    Amortization and depreciation                  79,057            61,902
    Share-based payments                          706,423           320,689
    Foreign exchange (gain) loss                   24,989            29,102
    Change in fair value of warrant
     liability                                  2,200,472         2,628,621
  Changes in non-cash working capital
   items                                          191,231          (141,392)

                                         ----------------  ----------------
Net cash used in operating activities          (2,415,667)       (1,510,860)

Net cash provided by financing
 activities                                    10,666,428         1,435,181

Net cash used in investing activities            (244,687)           (2,411)

Effect of exchange rate changes on cash
 and cash equivalents                             (24,989)              852

                                         ----------------  ----------------
Net change in cash and cash equivalents         7,981,085           (77,238)

Cash and cash equivalents - beginning of
 period                                         7,859,889           998,998

                                         ----------------  ----------------
Cash and cash equivalents - end of
 period                                  $     15,840,974  $        921,760
                                         ================  ================



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