On October 18, 2021 bluebird bio, Inc. (NASDAQ: BLUE) reported that October 19, 2021 has been set as the record date for the dividend of shares of common stock of 2seventy to be distributed to bluebird stockholders in order to effect the separation of bluebird bio and 2seventy bio, Inc. into two independent, publicly traded companies (Press release, bluebird bio, OCT 18, 2021, View Source [SID1234591469]).

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Each bluebird bio stockholder of record as of the close of business on October 19, 2021 will receive, on the distribution date, one share of 2seventy common stock for every three shares of bluebird common stock held. The share dividend is expected to be distributed to bluebird stockholders on or about November 4, 2021. Following the separation, bluebird stockholders will also receive cash in lieu of any fractional shares of 2seventy common stock that those holders would have received after application of the 3:1 distribution ratio. No action is required by bluebird stockholders in order to receive the shares of 2seventy common stock in the dividend distribution.

Additionally, on October 18, 2021 the Securities and Exchange Commission declared 2seventy’s Registration Statement on Form 10 (the "Form 10") effective. This Form 10 contains further information regarding bluebird bio’s plans for a tax-free spin-off of its oncology programs and portfolio into 2seventy bio as a publicly traded company, including the conditions to completion of the separation.

"When-issued" trading for 2seventy common stock and "ex-distribution" trading for bluebird common stock is expected to commence on October 18, 2021 under the stock ticker symbols "TSVTV" and "BLUEV", respectively. A description of these expected trading markets is included in the Form 10. After the separation, 2seventy common stock is expected to trade on the Nasdaq Global Select Market under the stock ticker symbol "TSVT" and bluebird will continue to trade on Nasdaq Global Select Market under the stock ticker symbol "BLUE."

On October 18, 2021 Huahui Health reported completion of its Series A+ financing round back in March 2021, raising approximately CNY 500 million (Press release, Huahui Health, OCT 18, 2021, View Source [SID1234642183]). The A+ round was led by GL Ventures and joined by existing investors including Hankang Capital and Matrix Partners China. Raised fund will be used to support clinical development of its pipeline products, establishing pilot scale manufacturing for biologics, and building research platform for small molecules.

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"This financing round will fuel and further expedite the growth and expansion of Huahui, " said Dr. Wenhui Li, founder of Huahui. "We are pleased with the recognition and support from our partners. We will continue building and advancing our internal competence and capabilities in order to meet the needs of patients across the globe."

On October 18, 2021 Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, reported it has entered into an exclusive licensing agreement with Antares Pharma, Inc. to commercialize TLANDO in the United States (Press release, Lipocine, OCT 18, 2021, View Source [SID1234591454]). TLANDO is an oral testosterone product for testosterone replacement therapy ("TRT") in adult males indicated for conditions associated with a deficiency or absence of endogenous testosterone: primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired).

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As previously announced, the U.S. Food and Drug Administration ("FDA") granted tentative approval to TLANDO. Upon the expiration of the exclusivity period granted to Clarus Therapeutics, Inc., with respect to its drug, JATENZO, under the Hatch-Waxman Act, which expires on March 27, 2022, TLANDO will be eligible for final approval. The FDA has affirmed the NDA resubmission for final approval will be a Class 1 resubmission which includes a two-month FDA review goal period.

Under the terms of the agreement, Lipocine will receive an immediate upfront cash payment of $11.0 million and, subject to certain conditions, an additional $5.0 million licensing payment in January 2025 and another $5.0 million licensing payment in January 2026. Lipocine will also be entitled to receive sales-based commercial milestone payments totaling up to $160.0 million based on TLANDO net sales and, if Antares Pharma exercises its option, TLANDO XR sales, in addition to tiered royalty payments at rates ranging from the mid-teens to up to 20% on net sales of TLANDO. Lipocine retains all rights for ex-US territories, and non TRT indications for TLANDO. Under the agreement, Antares Pharma will undertake all commercialization, post-marketing obligations, and sourcing of TLANDO in the U.S.

In addition, Lipocine has granted Antares Pharma an option to license, on or before March 31, 2022, TLANDO XR, a next-generation, potential once-daily oral product candidate for TRT, in the U.S. TLANDO XR met primary and secondary regulatory end points for TRT in an earlier Phase 2 clinical study. Upon exercise of the TLANDO XR option, Lipocine is entitled to receive an additional $4.0 million in license fees, clinical and regulatory milestone payments of up to an aggregate of $35.0 million, and tiered royalties on net sales at rates ranging from the mid-teens to up to 20%. Antares Pharma will be responsible for development costs, regulatory filings, commercialization, and post-marketing commitments for TLANDO XR.

"We are very pleased to be partnering with Antares Pharma, a strong market leader with one of the largest sales forces in the TRT space," said Dr. Mahesh Patel, Chairman, President and Chief Executive Officer of Lipocine. Dr. Patel further stated, "Our agreement with Antares Pharma demonstrates our commitment to ensure efficient and effective patient access to TLANDO in the U.S. We are confident in Antares Pharma’s capabilities, given its established marketing experience and demonstrated success in the TRT space. Consistent with our current core competency, this agreement allows us to focus diligently on progressing our innovative pipeline candidates with the goal of serving patients with serious unmet needs."

On October 18, 2021 Phase Genomics, Inc., a biotech company leading advancements in next-generation sequencing (NGS) solutions for genome assembly and analysis, reported the launch of the beta version of its new platform for next generation cytogenomic applications in the reproductive genetics and oncology spaces (Press release, Phase Genomics, OCT 18, 2021, View Source [SID1234591470]).

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The platform enables rapid, efficient sample processing and does not require culturing of live, dividing cells nor high-molecular-weight DNA extraction. "This is a fast and inexpensive platform that is capable of providing tremendous benefit towards answering complex genomic questions that existing methods are unable to fully resolve,” said Shawn Sullivan, Co-founder and CTO of Phase Genomics. "The flexibility of this method allows us to use a low starting volume of cells from fresh and frozen material and, most notably, paraffin-embedded tissue. We can deliver an invaluable compendium of genetic information from a single sample without having to wait for results from multiple tests. With our robust chemistry and the machine learning underpinnings of our analytic technology, our platform offers the potential to complement or replace incumbent technologies like cytogenetics, FISH, and CMA in both solid and liquid cancers and in reproductive health."

While the platform can be broadly applied to constitutional genetics, Phase Genomics sees the immediate utility that it can bring to the prenatal market. According to Sullivan, the platform can help provide answers to the study of patient populations faced with infertility or unexplained repeated pregnancy loss. "For example, our platform can detect cryptic rearrangements potentially causing a couple’s fertility issues, it can uncover novel structural and copy-number changes essential to fetal development in non-viable or paraffin-embedded POC tissue samples and, most importantly, help fuel the translation of these discoveries into clinical tools that will remove emotional, financial and other burdens borne by patients working through these heartbreaking conditions."

Many of the same challenges exist in oncology. Unlocking and maximizing the use of the genetic information contained in unculturable and paraffin-embedded cancer samples is a unique property of the Phase Genomics platform. Phase Genomics’ Co-founder and CEO Dr. Ivan Liachko stated, "The Phase Genomics ultra-long-range sequencing method and machine learning-enabled analytical platform arm clinical researchers, and eventually, healthcare providers, with a cost-effective, high-throughput, sequencing-based method that delivers actionable information. This information provides insights that can be used in the development of new diagnostic and treatment options for cancer and genetic disease, ultimately leading to improved patient care and outcomes."

Today’s announcement opens RUO platform access to early beta participants. Phase Genomics is engaged in a number of active partnerships with research and commercial entities and is presenting early results in a poster at the American Society of Human Genetics Conference. The Phase Genomics platform is for research use only and is not for use in diagnostic procedures. More information on the platform is available here.

Join Phase Genomics for a webinar on Tuesday, November 30th to learn more about this technology and follow Phase Genomics on Twitter for the latest news and information.

On October 18, 2021 AstraZeneca PLC (AstraZeneca) (NASDAQ: AZN) reported that it has received notification of an unsolicited ‘mini-tender’ offer to holders of American Depositary Shares (ADSs) in AstraZeneca by TRC Capital Investment Corporation of Toronto, Canada (TRC Capital) (Press release, AstraZeneca, OCT 18, 2021, View Source [SID1234591497]). The offer documentation indicates that TRC Capital offers to purchase up to 2,000,000 ADSs, equivalent to approximately 0.06% of the outstanding Ordinary Shares in AstraZeneca, at a price of $57.88 per ADS in cash. TRC Capital’s offer price is 4.5% less than the closing price per share of an ADS on the Nasdaq Stock Market on October 8, 2021, the last trading day before the mini-tender offer commenced.

AstraZeneca does not in any way recommend or endorse the TRC Capital offer and recommends that shareholders reject the offer because the offer price is below the market price for ADSs immediately prior to this announcement.

Shareholders are advised that TRC Capital has reserved the right to delay payment for ADSs tendered, to withdraw its offer at any time and to amend its offer in any respect. TRC Capital may also decline to purchase ADSs tendered if any one of numerous conditions is not satisfied, including receipt by TRC Capital, on terms satisfactory to TRC Capital, of financing necessary to complete the offer or if there is any decrease in the market price of the AstraZeneca ADSs.

AstraZeneca shareholders who have already tendered their ADSs are advised that they may withdraw their shares by providing the written notice of withdrawal as described in the TRC Capital offer documentation prior to 12:01 a.m., New York City time, on November 9, 2021.

TRC Capital over the past several years has made numerous unsolicited ‘mini-tender’ offers for other companies’ shares. Neither AstraZeneca nor any of its directors or officers is affiliated with TRC Capital.

‘Mini-tender’ offers are offers to purchase less than five percent of a company’s outstanding shares, thereby avoiding many of the filing, disclosure and procedural requirements of the United States Securities and Exchange Commission (SEC). ‘Mini-tender’ offers do not therefore provide investors with the same level of protection as provided by larger tender offers under United States securities laws. The SEC has cautioned investors about mini-tender offers noting that "some bidders make mini-tender offers at below-market prices, hoping that they will catch investors off guard if the investors do not compare the offer price to the current market price." The SEC also published investor tips regarding these offers on its website at: View Source

AstraZeneca advises shareholders to obtain current market quotations for their ADSs, to consult with their investment advisors and to exercise caution with respect to this ‘mini-tender’ offer.

AstraZeneca encourages brokers and dealers, as well as other market participants, to review the SEC’s letter regarding broker-dealer mini-tender offer dissemination and disclosures on the SEC’s website at www.sec.gov/divisions/marketreg/minitenders/sia072401.htm.

AstraZeneca requests that a copy of this announcement be included with all distributions of materials relating to TRC’s mini-tender offer.

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