10-Q – Quarterly report [Sections 13 or 15(d)]

Champions Oncology has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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10-Q – Quarterly report [Sections 13 or 15(d)]

Champions Oncology has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Champions Oncology, 2017, DEC 15, 2017, View Source [SID1234522666]).

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Genoptix to Acquire Rosetta Genomics for $10 Million in Cash

On December 15, 2017 Genoptix, Inc., a leading oncology diagnostic laboratory, and Rosetta Genomics Ltd. (NASDAQ: ROSG), a genomic diagnostics company that improves treatment decisions by providing timely and accurate diagnostic information to physicians, reported that they have entered into a definitive merger agreement under which Genoptix will acquire all of the outstanding shares of Rosetta Genomics for a total gross purchase price of $10 million (Press release, Rosetta Genomics, DEC 21, 2017, View Source [SID1234522760]). After deducting expected payments for outstanding debt, convertible debentures, warrant termination payments, professional fees, expenses and other items, this purchase price equates to an amount that is preliminarily estimated to be $0.60, in cash, for each ordinary share of Rosetta Genomics outstanding at closing. Genoptix is a portfolio company of Ampersand Capital Partners and 1315 Capital.

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Genoptix is also providing a secured bridge loan facility of up to $1.8 million to fund the operations of Rosetta Genomics through the closing of this transaction.

This merger has been unanimously approved by the Board of Directors of both companies, and the closing is expected to occur during the first quarter of 2018, subject to approval by Rosetta Genomics’ shareholders and customary closing conditions. In connection with the proposed transaction, Rosetta Genomics intends to file a proxy statement with the Securities and Exchange Commission ("SEC"). Shareholders of Rosetta Genomics are urged to carefully review the proxy statement, when available, because it will contain important information about the proposed transaction and the estimated closing purchase price for each ordinary share.

Upon closing, trading in shares of Rosetta Genomics on the Nasdaq Capital Market will cease, and Rosetta Genomics will become a wholly owned subsidiary of Genoptix.

"After a comprehensive review of strategic alternatives that included financings, acquisitions, mergers, asset monetization and corporate partnerships, we determined that this proposed transaction with Genoptix is in the best interest of all Rosetta Genomics stakeholders, including our equity holders. Our current cash position is sufficient to fund operations only until the end of 2017, and given our current market capitalization, potential for pending delisting from the Nasdaq Capital Market and the difficult financing environment for microcap molecular diagnostics companies, we do not believe we could raise sufficient capital to continue as a going concern for an extended period of time," stated Kenneth A. Berlin, President and Chief Executive Officer of Rosetta Genomics.

"As a leader in cancer diagnostics with a more significant infrastructure, Genoptix is in a position to deploy the resources necessary to accelerate the growth of RosettaGX Revealä ("Reveal"), as well as add our solid tumor testing services to their existing product portfolio," added Mr. Berlin.

Joseph M. Limber, President and Chief Executive Officer of Genoptix, said, "The acquisition of Rosetta Genomics will broaden our product offering in oncology diagnostics, particularly in the solid tumor area. We believe that there is a significant opportunity in the diagnosis of thyroid cancer utilizing Reveal and we intend to leverage our world-class commercial capabilities to become a leader in this space. Furthermore, Rosetta’s cutting edge microRNA-based technology will be the foundation of many more diagnostic tests to be incorporated into Genoptix’ oncology portfolio."

Cantor Fitzgerald is serving as financial adviser to Rosetta Genomics on this transaction.

Advaxis to Host Business Update and Fiscal Year End 2017 Financial Results Conference Call on December 21, 2017

On December 14, 2017 Advaxis, Inc. (NASDAQ:ADXS), a late-stage biotechnology company focused on the discovery, development and commercialization of immunotherapy products, reported that the Company will release financial results for the fiscal year ended October 31, 2017 on Wednesday, December 20, 2017 (Press release, Advaxis, DEC 14, 2017, View Source [SID1234522644]).

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Advaxis’ senior management will host a conference call to review its financial results and provide a business update, which will include a discussion of the advantages of its Lm-based antigen delivery platform and clinical pipeline. The conference call and live audio webcast will begin at 10:00 a.m. Eastern time on Thursday, December 21, 2017.

Conference Call & Webcast Information

WHEN: Thursday, December 21, 2017 at 10:00 a.m. Eastern time.
DOMESTIC DIAL-IN: (844) 348-6133
INTERNATIONAL DIAL-IN: (631) 485-4564
CONFERENCE ID: 4682169
WEBCAST: www.ir.advaxis.com/news-events

For those unable to participate in the live conference call or webcast, a digital recording will be available beginning December 21, 2017 two hours after the close of the conference call. To access the recording, dial (855) 859-2056 or (404) 537-3406 and provide the operator with the conference ID: 4682169. In addition, the audio webcast will be archived on the Company’s website for a period of time at www.ir.advaxis.com/news-events.

AmpliPhi Biosciences Provides Corporate and Strategic Update

On December 14, 2017 AmpliPhi Biosciences Corporation (NYSE American: APHB), a clinical-stage biotechnology company focused on the development of therapies for antibiotic-resistant infections using bacteriophage technology, reported its progress in 2017 and near-term strategic goals and initiatives (Press release, AmpliPhi Biosciences, DEC 14, 2017, View Source [SID1234522649]).

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2017 Corporate Highlights

In April, AmpliPhi received positive feedback from a U.S. Food and Drug Administration (FDA) Type B meeting in which the FDA "acknowledged that phage therapy is an exciting approach to treatment of multi-drug resistant organisms and expressed a commitment to addressing the unique regulatory challenges that might arise during product development." The FDA also stated that "the clinical safety and effectiveness data collected during development, including from emergency case studies, could inform future discussions for clinical development and ultimately, the regulatory pathway to approval."
In August, AmpliPhi announced the first-in-human administration of its therapeutic candidate AB-PA01 targeting Pseudomonas aeruginosa (P. aeruginosa) under an Emergency IND allowed by the FDA. AmpliPhi provided AB-PA01 for a patient suffering from a life-threatening multidrug-resistant P. aeruginosa lung infection. Multiple doses of AB-PA01 were administered intravenously and by inhalation through a nebulizer and were well tolerated.
In September, AmpliPhi announced the first-in-human intravenous administration of its therapeutic candidate AB-SA01 targeting Staphylococcus aureus (S. aureus) under the Special Access Scheme of the Australian Therapeutic Goods Administration. AmpliPhi provided AB-SA01 for a patient suffering from a life-threatening S. aureus endocarditis. AB-SA01 was administered intravenously over a two week duration and was well tolerated.
A total of seven patients, suffering from serious and life-threatening infections who were not responding to antibiotic therapy, have been treated with AB-SA01 or AB-PA01 in 2017.
Raised $9.4 million in net proceeds from an equity securities offering in May, and received a $2.0 million Research and Development Tax Incentive cash rebate in September from the Australian Tax Office based on the Company’s R&D spending in Australia during 2016.
Continued to raise awareness of the Company’s bacteriophage development programs through presentations and participation in various scientific and medical meetings, including: 2017 Australian Society of Otolaryngology Head and Neck Surgery Meeting in March, Solutions for Drug-Resistant Infections Meeting in Brisbane in April, and "Bacteriophage Therapy: Scientific and Regulatory Issues" workshop sponsored by the FDA and the National Institutes of Health in July.
In December, the Company engaged Ladenburg Thalmann & Co. Inc. to assist the Company in exploring strategic alternatives in an effort to maximize shareholder value. The Company has not set a timetable for completion of this exploratory process and cannot provide any assurances that the process will result in the consummation of a strategic transaction of any kind, or that the Company will not abandon the process. The Company does not intend to discuss or disclose further developments during this process unless and until its board of directors has approved a specific action or the Company otherwise determines that further disclosure is appropriate.
Potential Milestones and Initiatives for the First Half of 2018

In early 2018, the Company plans to present topline results from the treatment of seven patients with serious and life-threatening infections, not responding to antibiotics, completed under the Company’s single-patient expanded access program in 2017.

The Company intends to continue its expanded access clinical strategy in the first half of 2018, present data from approximately 25 expanded access clinical cases to the FDA in mid-2018 and initiate a Phase 2 or registrational clinical trial as early as the second half of 2018.

The Company will present an overview and update of its current business activities at the 9th Annual Biotech Showcase Conference on January 8, 2018 at 9:30 a.m. PT being held in San Francisco.

"AmpliPhi has made tremendous progress throughout 2017," said Paul C. Grint, M.D., CEO of AmpliPhi Biosciences. "To date, under the expanded access program, we have dosed seven patients in dire need, who were suffering from serious and life-threatening infections and were not responding to antibiotic therapies. We look forward to presenting topline results in early 2018. We have set a goal of dosing approximately 20 additional patients during the first half of 2018. We continue the dialogue with the FDA and key thought leaders in the infectious disease community regarding design of Phase 2 and registrational clinical studies of our bacteriophage therapies."