Cytocom, Inc. Second Quarter 2021 Financial Results Conference Call Replay Available Via Webcast

On August 16, 2021 Cytocom, Inc. (NASDAQ: CBLI), a leading biopharmaceutical company creating next-generation immune therapies that focus on immune restoration and homeostasis, reported that the audio archive of the second quarter 2021 corporate and financial results conference call may be accessed from the "Investors" section of the Cytocom website at https://www.cytocom.com/investors/ (Press release, Cytocom, AUG 16, 2021, https://www.cytocom.com/2021/08/16/cytocom-inc-second-quarter-2021-financial-results-conference-call-replay-available-via-webcast/?utm_source=rss&utm_medium=rss&utm_campaign=cytocom-inc-second-quarter-2021-financial-results-conference-call-replay-available-via-webcast [SID1234586626]). The replay of the webcast will be archived on the website for 90 days beginning at approximately 10:00 a.m. ET, on August 16, 2021.

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Novo Nordisk A/S – Share repurchase programme

On August 16, 2021 Novo Nordisk reported that it initiated a share repurchase programme in accordance with Article 5 of Regulation No 596/2014 of the European Parliament and Council of 16 April 2014 (MAR) and the Commission Delegated Regulation (EU) 2016/1052 of 8 March 2016 (the "Safe Harbour Rules") (Press release, Novo Nordisk, AUG 16, 2021, View Source [SID1234586625]). This programme is part of the overall share repurchase programme of up to DKK 18 billion to be executed during a 12-month period beginning 3 February 2021.

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Under the programme initiated 4 August 2021, Novo Nordisk will repurchase B shares for an amount up to DKK 3.3 billion in the period from 5 August 2021 to 1 November 2021.

Since the announcement of the programme, the following transactions have been made:

The details for each transaction made under the share repurchase programme are published on novonordisk.com.

Transactions related to Novo Nordisk’s incentive programmes have resulted in a net transfer from Novo Nordisk of 32,026 B shares in the period from 5 August 2021 to 13 August 2021. The shares in these transactions were not part of the Safe Harbour repurchase programme.

With the transactions stated above, Novo Nordisk owns a total of 18,096,886 B shares of DKK 0.20 as treasury shares, corresponding to 0.8% of the share capital. The total amount of A and B shares in the company is 2,310,000,000 including treasury shares.

Novo Nordisk expects to repurchase B shares for an amount up to DKK 18 billion during a 12- month period beginning 3 February 2021. As of 13 August 2021, Novo Nordisk has since 3 February 2021 repurchased a total of 19,290,414 B shares at an average share price of DKK 479.66 per B share equal to a transaction value of DKK 9,252,771,246.

Carrick Therapeutics Receives FDA Fast Track Designations for Two Samuraciclib Combinations for the Treatment of HR+, HER2- Advanced Breast Cancer and Locally Advanced or Metastatic Triple Negative Breast Cancer

On August 16, 2021 Carrick Therapeutics, an oncology-focused biopharmaceutical company discovering and developing highly differentiated therapies, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designations to samuraciclib in combination with fulvestrant for CDK4/6i resistant HR+, HER2- advanced breast cancer and samuraciclib in combination with chemotherapy for the treatment of locally advanced or metastatic triple negative breast cancer (TNBC) (Press release, Carrick Therapeutics, AUG 16, 2021, View Source [SID1234586624]).

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"The FDA’s decision to grant Fast Track designations for both samuraciclib combinations underscores the urgent need for innovative therapies that can significantly improve HR+, HER2- advanced breast cancer and locally advanced or metastatic TNBC patient outcomes," said Tim Pearson, Chief Executive Officer of Carrick Therapeutics. "This is a meaningful milestone for our development in samuraciclib as we work to advance innovative combination treatment approaches for patients who have few treatment options available today."

The FDA’s Fast Track program is designed to facilitate and expedite the development of investigational treatments that demonstrate a potential to address unmet medical needs in serious or life-threatening conditions. Programs with Fast Track designation can benefit from early and frequent communication with the FDA in addition to a rolling submission of the marketing application.

Samuraciclib in combination with fulvestrant is currently being evaluated in a Phase 2a study for CDK4/6i resistant HR+, HER2- metastatic breast cancer and the Company expects to present the new data from the ongoing study at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2021 in September. Meanwhile, samuraciclib in combination with chemotherapy for the treatment of treatment of TNBC is currently undergoing IND-enabling studies.

About Fast Track Designation
Fast Track is a process designed to facilitate the development, and expedite the review of, drugs to treat serious conditions that address an unmet medical need, by providing a therapy where none exists or providing a therapy which may be potentially better and shows some advantage over available therapy. Fast Track designation includes opportunities for more frequent meetings with the FDA to discuss trial design, development plans, data needed to support drug approval, submission of a New Drug Application (NDA) on a rolling basis, and eligibility for accelerated approval and priority review, if relevant criteria are met.

Visit the FDA’s website for more information on Fast Track Designation.

About Samuraciclib (CT7001)
Samuraciclib is the most advanced oral CDK7 inhibitor in clinical development. Inhibiting CDK7 is a promising therapeutic strategy in cancer as CDK7 regulates the transcription of cancer-causing genes, promotes uncontrolled cell cycle progression and resistance to anti-hormone therapy. Samuraciclib has demonstrated a favorable safety profile and encouraging efficacy in early clinical studies. Samuraciclib has been granted Fast Track designations from the U.S. Food and Drug Administration (FDA) for use in combination with fulvestrant for the treatment of CDK4/6i resistant HR+, HER2- advanced breast cancer and samuraciclib in combination with chemotherapy for the treatment of locally advanced or metastatic triple negative breast cancer (TNBC).

BioReference Laboratories Acquires U.S. Ariosa Centralized Laboratory Prenatal Testing Business

On August 16, 2021 BioReference Laboratories, Inc., an OPKO Health company (NASDAQ:OPK), reported the acquisition of the U.S. Ariosa centralized laboratory prenatal testing business from Roche (Press release, Opko Health, AUG 16, 2021, View Source [SID1234586623]).

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BioReference announced the acquisition of the U.S. Ariosa centralized laboratory prenatal testing business from Roche.
Ariosa’s non invasive prenatal screening (NIPS) test, the Harmony Prenatal Test, is one of the most widely studied tests utilized in prenatal screening. The test has been performed in over 1.5 million patients. GenPath, BioReference’s specialty health division, currently offers, ClariTest Core, which utilizes the same core technology as the Harmony Prenatal Test. The acquisition of Ariosa will complement this current NIPS offering.

"Throughout BioReference’s 40 year legacy of diagnostic testing, women’s health has been at the forefront of our focus," said Jon R. Cohen, M.D., Executive Chairman of BioReference Laboratories. "Last year, there were about six million pregnancies in the U.S., and prenatal screening for Down syndrome has become common practice. Acquiring the U.S. Ariosa centralized laboratory prenatal testing business allows us to expand our NIPS offerings and further underscores our commitment to prenatal screening, allowing BioReference and GenPath to advance high quality and accessible testing that positively impacts the medical care and outcomes of patients and their families."

Exelixis and Invenra Expand Collaboration to Discover and Develop Novel Biologics in Oncology

On August 16, 2021 Exelixis, Inc. (Nasdaq: EXEL) and Invenra, Inc. reported that they have expanded their discovery and licensing collaboration to include an additional 20 oncology targets (Press release, Exelixis, AUG 16, 2021, View Source [SID1234586622]). The augmented partnership builds on the two companies’ ongoing collaboration and license agreement to discover and develop mono-specific and multi-specific antibodies for incorporation into novel biologics to treat cancer, which was originally announced in May 2018 and expanded in October 2019.

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"We believe the continued success of our collaboration with the Exelixis team speaks to the quality of our unique and versatile antibody discovery platform, and we are proud to continue to support the Exelixis oncology pipeline"

"We’re very pleased with the successful relationship we’ve had with Invenra to-date and look forward to expanding our existing collaboration to include additional oncology targets," said Peter Lamb, Ph.D., Executive Vice President, Scientific Strategy and Chief Scientific Officer of Exelixis. "As Exelixis seeks to build a differentiated next-generation pipeline in oncology, we’re leveraging Invenra’s expertise in antibody and bispecific discovery to provide key building blocks for potential future Exelixis biologics, including antibody-drug conjugates. Our expanded collaboration with Invenra accelerates and deepens our work together and furthers Exelixis’ mission to pursue cancer therapies that help patients live longer and recover stronger."

Under the terms of this newly expanded collaboration, Exelixis has agreed to pay Invenra an upfront fee of $15.0 million, as well as additional fees and funding for the option to nominate up to 20 additional targets in oncology. Invenra will be eligible for development, regulatory, and commercial milestones, as well as tiered royalties on net sales of any approved products. Exelixis will own all antibody sequences discovered from the collaboration for all therapeutic uses in oncology and any other disease areas. The expanded collaboration also provides Exelixis with an option to obtain development and commercialization rights to certain of Invenra’s future internal pipeline programs, in exchange for an opt-in fee.

"We believe the continued success of our collaboration with the Exelixis team speaks to the quality of our unique and versatile antibody discovery platform, and we are proud to continue to support the Exelixis oncology pipeline," said Roland Green, Ph.D., Co-Founder and Chief Executive Officer of Invenra. "Additionally, we expect that the financial support provided to us by Exelixis will allow Invenra to further expand our research capabilities and advance our pipeline, including our best-in-class tumor selective Treg depleter, as we aim to harness the human immune response and optimize therapies to address a broader range of cancers."

Under the terms of the original agreement, announced by the parties on May 2, 2018, Exelixis and Invenra are currently collaborating to discover and develop mono-specific and multi-specific antibodies using Invenra’s antibody and B-Body platforms. Invenra is responsible for antibody lead discovery and generation. Exelixis leads investigational new drug (IND)-enabling studies, manufacturing, and clinical development in single-agent and combination therapy regimens, as well as future regulatory and commercialization activities. Invenra is eligible to receive payments based on the achievement of specific pre-clinical, clinical development, and regulatory milestones. Upon successful commercialization of a product, Invenra is eligible to receive milestone payments and royalties. Prior to today’s announcement, the companies expanded their collaboration on October 31, 2019 to generate additional programs.