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 Heat Biologics, Inc. (NASDAQ: HTBX), a biopharmaceutical company developing therapies designed to activate a patient’s immune system against cancer, reported a business update regarding the company’s progress and plans for 2019 (Press release, Heat Biologics, JAN 10, 2019, View Source [SID1234532613]).

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Key highlights:

Phase 2 trial expanded to evaluate the benefit of HS-110 in combination with a different anti-PD-1 checkpoint inhibitor to treat patients earlier in the course of their metastatic disease
Selected to deliver podium presentation of interim Phase 2 lung cancer data at ASCO (Free ASCO Whitepaper)-SITC Clinical Immuno-Oncology Symposium on February 28, 2019
Remains on track to complete enrollment of Phase 2 lung cancer trial in Q2, 2019
Strong balance sheet entering 2019
Jeff Wolf, Heat’s CEO, commented, "We have postponed reporting our most recent interim data to enable us to present this data at a leading oncology conference. We are honored that our lead investigator, Daniel Morgensztern, MD, Associate Professor of Medicine and Director of Thoracic Oncology, Washington University School of Medicine, has been selected to deliver an oral presentation of this data at the 2019 ASCO (Free ASCO Whitepaper)-SITC Clinical Immuno-Oncology Symposium on February 28."

Mr. Wolf continued, "We continue to make rapid progress on our Phase 2 trial and remain on track to complete enrollment in this trial in Q2, 2019. The resources provided by our recent funding have enabled us to explore a variety of options to expand the current trial to evaluate the benefit of HS-110 in combination with a different anti-PD-1 checkpoint inhibitor to treat patients earlier in the course of their metastatic disease. The details of this expansion will be announced shortly."

"Our balance sheet is strong as we head into the new year. We recently completed a capital raise of $13.8 million in addition to our cash balance of $21.0 million at the end of the third quarter of 2018. We also expect to receive an additional $6.9 million in CPRIT grant funds later this year. The strength of our balance sheet provides us much greater flexibility to expand our lead Phase 2 trial, accelerate our internal programs and explore complementary opportunities within the lung cancer market and beyond."

On January 10, 2019 Generex Biotechnology Corporation (www.generex.com) (OTCQB:GNBT) reported that it will hold an investor conference call on Wednesday, January 16th, at 4:00 p.m. to update investors on the previously announced and pending acquisitions that offer significant value to the Generex parent company (Press release, Generex, JAN 10, 2019, View Source [SID1234532615]). Joseph Moscato, Generex President & Chief Executive Officer, will discuss the company’s financing plans related to the acquisitions, as well as the strategic focus of Generex for 2019 and beyond. Additionally, Mr. Moscato will provide guidance on the recent merger of Antigen Express into the newly-formed NuGenerex Immuno-oncology, and the proposed spin-out of the company as an independent, public company with a new direction and strategic focus to advance the Ii-Key technology for the immunotherapy of cancer, which includes plans for a rights offering and stock dividend for Generex shareholders in NuGenerex Immuno-Oncology. Further, Mr. Moscato will discuss plans to up-list Generex to a major stock exchange.

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Mr. Moscato stated, "We have worked diligently over the last several years to transform Generex into an integrated healthcare holding company. In the last two years, we have completed a complex reorganization plan, and we continue to execute on the strategic acquisition of several exciting companies with revenues, products, and new technologies.

"We are in the early stages of our plan that has begun with acquisitions of an MSO network of physicians and surgeons, pharmacies, a laboratory, a surgical supply business, a manufacturer of surgical implants, and two regenerative medicine companies, Regentys and Olaregen. These and future acquisitions will enable Generex to grow through generating significant product and service revenues, while creating exponential value for our shareholders through development of our deep pipeline of clinical-stage assets. I look forward to addressing my fellow Generex shareholders to provide details about recent and pending acquisitions, our growth strategies for NuGenerex Distribution Solutions, and the launch of Generex’s first commercial product Excellagen. I will also discuss the strategy to spin out NuGenerex Immuno-Oncology as an independent public company, with an update on the plan for up-listing Generex."

Dial-in instructions for the investor conference call will be announced on Monday, January 14, 2019.