On January 11, 2019 Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical company, reported that it has entered into an exclusive License Agreement with Knight Therapeutics Inc. (TSX: GUD) that grants Knight the exclusive right to commercialize NERLYNX (neratinib) in Canada (Press release, Puma Biotechnology, JAN 11, 2019, https://investor.pumabiotechnology.com/press-release/puma-biotechnology-and-knight-therapeutics-enter-exclusive-license-agreement-commercia [SID1234532621]).

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Puma Biotechnology filed a new drug submission for NERLYNX with Health Canada in July 2018 for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer following adjuvant trastuzumab-based therapy. Under the terms of the License Agreement, Knight will be responsible for all commercial activities and future regulatory submissions for NERLYNX in Canada. Puma will receive upfront and milestone payments up to $7.2 million USD throughout the term of this agreement, as well as double digit royalties on net sales of NERLYNX in Canada.

"Our new agreement with Knight demonstrates our commitment to bringing NERLYNX to patients around the world while continuing to focus our commercial resources on the U.S. market," stated Alan H. Auerbach, Chief Executive Officer and President of Puma. "We are confident this new partnership will help patients in Canada access NERLYNX at the earliest opportunity."

"We are excited to partner with Puma to offer a new treatment option to Canadian breast cancer patients," said Jonathan Ross Goodman, Chief Executive Officer of Knight. "While adjuvant trastuzumab-based therapy has been shown to reduce the risk of recurrence in early stage HER2-positive breast cancer, up to 25% of patients treated with adjuvant trastuzumab will have a recurrence. NERLYNX has been shown to significantly reduce the risk of recurrence in those patients who were previously treated with trastuzumab."

Neratinib was approved by the U.S. Food and Drug Administration (FDA) in July 2017 for the extended adjuvant treatment of adult patients with early stage HER2-positive breast cancer following adjuvant trastuzumab-based therapy, and is marketed in the United States as NERLYNX (neratinib) tablets.

On January 11, 2019 Dr. Reddy’s Laboratories (BSE: 500124, NSE: DRREDDY, NYSE: RDY) reported that it will announce results for the quarter ended December 31, 2018 on Friday, February 1, 2019 after the Board Meeting (Press release, Dr Reddy’s, JAN 11, 2019, View Source [SID1234532623]).

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Summary of Events

Event

Date and Time

Medium

Release of financial results

February 1st, after the Board Meeting

Email, Media, Company website, Business wire

Press meet presentation

Will be available on the Company’s website

URL available on Company’s website, www.drreddys.com

Earnings Call

February 1st, 6:30 PM IST / 8:00 AM EST

Hosted by the Company

(Details below)

Playback of Earnings Call

After the earnings call till February 7th

Details below

Transcript of the Earnings call

Will be available on the Company’s website

URL available on Company’s website, www.drreddys.com

Earnings Call

Following the release, the management of the Company will host an earnings call to discuss the Company’s financial performance. (Dial In and other details given below)

Play Back

The play back will be available after the earnings call, through February 7th, 2019. For play back dial in phone No: 022 7194 5757 / 022 6663 5757, and Playback Code is 37176.

Conference Dial-In Numbers

Universal Access Number:

+91 22 6280 1219

+91 22 7115 8120

Local Access Number:

Available all over India

+91 70456 71221

International Toll Free Number:

USA: 1 866 746 2133

UK: 0 808 101 1573

Singapore: 800 101 2045

Hong Kong: 800 964 448

No password/pin number is necessary to dial in to any of the above numbers. The operator will provide instructions on asking questions before and during the call.

On January 11, 2019 Johnson & Johnson (NYSE: JNJ) reported that the conditions to its public tender offer for all of the outstanding shares of Ci:z Holdings Co., Ltd. (TYO: 4924) (the "Company") not already held by Johnson & Johnson or its affiliates that was previously announced on October 23, 2018, have been satisfied and the offering period for the tender offer has expired (Press release, Johnson & Johnson, JAN 11, 2019, View Source;johnson-announces-completion-of-offer-for-ciz-holdings-co-ltd-300776682.html [SID1234532626]).

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There were 20,004,934 shares of the Company tendered in the tender offer, representing 41% of the outstanding shares of the Company. Johnson & Johnson will acquire all tendered shares for ¥5,900 per share and will purchase additional shares of the Company through the acquisition of CIC Corporation ("CIC"), the ownership vehicle of the Company’s founder, Dr. Yoshinori Shirono. As of the expiration of the offering period, the shares tendered in the tender offer, together with shares already held by Johnson & Johnson or its affiliates and the shares to be acquired through the acquisition of CIC, will give Johnson & Johnson an aggregate ownership interest in the Company of 89%. The settlement of the tender offer and the acquisition of CIC will be completed by January 17, 2019. Following settlement of the tender offer and the acquisition of CIC, Johnson & Johnson plans to acquire the remaining shares of the Company that were not tendered in the tender offer through a share consolidation under Japanese law during the first half of 2019 and take appropriate actions to delist the Company from the Tokyo Stock Exchange.

Additional information on the tender offer and settlement procedures is available to the Company’s shareholders in the tender offer registration statement for the transaction filed on EDINET in Japan. Copies of an English translation of the tender offer explanatory statement, which includes all the information described in the tender offer registration statement, may be obtained by contacting Johnson & Johnson’s tender offer agent, SMBC Nikko (IBG_M&[email protected]).

On January 10, 2019 Advaxis, Inc. (NASDAQ: ADXS) (the Company), a late-stage biotechnology company focused on the discovery, development and commercialization of immunotherapy products, reported its financial results for the fiscal year ended October 31, 2018 and provides a business update (Press release, Advaxis, JAN 10, 2019, View Source [SID1234532616]).

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Fiscal Year 2018 and Recent Key Accomplishments

Received U.S. Food and Drug Administration allowance of the Investigational New Drug application for the Company’s first ADXS-HOT off-the-shelf neoantigen drug candidate, ADXS-503, for the treatment of all types of non-small cell lung cancer;
Dosed the first patients in the ADXS-NEO Phase 1 dose-escalation study in patients with several solid tumor types;
Raised gross proceeds totaling approximately $40 million from an underwritten public offering of common stock and an underwritten public offering of common stock and warrants;
Appointed a permanent chief executive officer, Kenneth A. Berlin, a new chief medical officer, Andres Gutierrez, M.D., and a new chief financial officer, Molly Henderson;
Licensed ADXS-HER2 to OS Therapies for evaluation in the treatment of pediatric osteosarcoma;
Significantly reduced annual net cash usage through a prioritization of programs and assets; and
Presented and published data from several preclinical and clinical trials with the Company’s drug candidates.
Management Commentary

"Fiscal 2018 was an eventful year for Advaxis as we worked to reorganize the company, prioritize our pipeline and define a strategic direction that supports our mission to improve the lives of people suffering from cancer and their loved ones," said Kenneth A. Berlin, president and chief executive officer of Advaxis. "Our diverse pipeline of drug candidates and constructs at various stages of development is based on our proprietary Lm platform, which has a significant safety database from first-generation constructs already tested in humans."

Mr. Berlin added, "We are dosing patients under our ADXS-NEO program and anticipate the first patient to be enrolled in our ADXS-503 study within the next several weeks. These are significant accomplishments for the Company and we’re excited to start to see early correlative and safety data from these neoantigen programs during the first half of 2019."

Mr. Berlin continued, "During the second half of fiscal year 2018 we took steps to significantly reduce our cash burn and align our spending in keeping with a company our size. We are committed to advancing our various clinical programs as rapidly and cost effectively as possible throughout fiscal year 2019. We also continue to evaluate opportunities for partnerships and collaborations across all of our programs, and anticipate several catalysts for the Company in 2019. We remain committed to demonstrating that the drug candidates emanating from our Lm platform have the potential to positively impact people with cancer," Mr. Berlin concluded.

Balance Sheet Highlights

As of October 31, 2018, Advaxis had cash and cash equivalents of $44.1 million. The Company used $62.1 million in cash to fund operations during fiscal 2018, mainly attributed to funding research and development and general and administrative activities. Throughout fiscal 2018, the Company completed an in-depth review of all programs and cash expenditures, and reduced its net annual cash usage to approximately $50 million.

Fiscal Year 2018 Financial Information

Research and development expenses for fiscal 2018 were $57.0 million, compared with $70.5 million for fiscal 2017. The $13.5 million decrease was primarily attributable to a decrease in laboratory costs, drug manufacturing process validation and drug stability studies.

General and administrative expenses for fiscal 2018 were $19.5 million, compared with $40.0 million for fiscal 2017. The $20.5 million decrease was primarily attributable to an $18.0 million decrease in stock-based compensation expense.

The net loss for the fiscal year ended October 31, 2018 was $66.5 million or $1.29 per share based on 51.5 million weighted average shares outstanding. This compares with a net loss for fiscal 2017 of $93.4 million or $2.31 per share based on 40.5 million weighted average shares outstanding.

Conference Call and Webcast Information

Advaxis’ senior management will host a conference call to review financial results, provide a business update and answer questions at 11:00 a.m. Eastern time on Tuesday, January 15, 2019.

To access the conference call please dial (844) 348-6133 for domestic callers or (631) 485-4564 for international callers. A live and archived audio webcast of the call will be available on the Company’s website at www.ir.advaxis.com/news-events.

A recording will be available beginning two hours after the call ends by dialing (855) 859-2056 for domestic callers or (404) 537-3406 for international callers and providing conference ID 4862946.

On January 9, 2019 Cancer Genetics, Inc. (Nasdaq: CGIX), a leader in enabling precision medicine for immuno-oncology and genomic medicine through molecular markers and diagnostics, reported that it intends to offer and sell, subject to market and other conditions, shares of its common stock in an underwritten public offering (Press release, BioServe Biotechnologies, JAN 9, 2019, View Source [SID1234532594]). Cancer Genetics also expects to grant the underwriter a 45-day option to purchase additional shares of its common stock to cover over-allotments, if any. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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H.C. Wainwright & Co. is acting as the sole book-running manager for the offering.

Cancer Genetics intends to use the net proceeds from this offering to pay lender fees and other costs incurred in connection with the potential forbearance agreements we are negotiating with our banks, to pay certain costs previously incurred by us in connection with our terminated transaction with NovellusDx Ltd., and if any proceeds remain available, to fund working capital and other general corporate purposes.

A shelf registration statement on Form S-3 relating to the public offering of the shares of common stock described above was filed with the Securities and Exchange Commission ("SEC") and was declared effective on June 5, 2017. A preliminary prospectus supplement describing the terms of the offering will be filed with the SEC and will form a part of the effective registration statement. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the offering may be obtained, when available, from H.C. Wainwright & Co., LLC, 430 Park Avenue 3rd Floor, New York, NY 10022, or by calling (646) 975-6996 or by emailing [email protected] or at the SEC’s website at View Source The final terms of the offering will be disclosed in a final prospectus supplement to be filed with the SEC.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. Any offer, if at all, will be made only by means of the prospectus supplement and accompanying prospectus forming a part of the effective registration statement