On October 18, 2021 Orphagen Pharmaceuticals, a privately-held pharmaceutical company, reported that the National Cancer Institute (NCI) has indicated its intention to award the company $2.0 million under the Small Business Innovation Research (SBIR) program to support preclinical development of OR-449, a small molecule drug candidate designed and synthesized by Orphagen, as a first-in-class therapy for adrenocortical carcinoma (ACC), a rare cancer of the adrenal gland with very limited treatment options and a poor prognosis (Press release, Orphagen, OCT 18, 2021, View Source [SID1234591500]).

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OR-449 is a potent and selective inhibitor of steroidogenic factor-1 (SF-1 or NR5A1), an orphan nuclear receptor and transcription factor that is essential for the growth and development of the adrenal gland. Multiple findings indicate that SF-1 has a crucial role in the pathogenesis of ACC.

"Orphagen has a strong platform for nuclear receptor discovery and our technology has allowed us to identify promising antagonists to a previously unexplored nuclear receptor, known as steroidogenic factor-1, or SF-1," said Scott Thacher, CEO of Orphagen and Principal Investigator of this grant. "The discovery and characterization of OR-449, which led to this prestigious award, was the product of an immensely talented team, with expertise in compound screening, medicinal chemistry, the implementation of novel tumor models, and small molecule drug development. The creation of this new drug candidate for ACC patients would not have been possible without the dedicated efforts of Orphagen’s multidisciplinary team."

Notice of first-year funding for this proposal can be found on the NIH web site at: RePORT ⟩ RePORTER (nih.gov).

On October 18, 2021 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, reported that it will host a webcast and conference call on Saturday, November 13, at 5:30 p.m. ET to discuss SITC (Free SITC Whitepaper) clinical data updates for Iovance tumor-infiltrating lymphocyte (TIL) cell therapy in relapsed, refractory lung cancer as well as Iovance TIL in combination with pembrolizumab in patients with advanced cancers (Press release, Iovance Biotherapeutics, OCT 18, 2021, https://ir.iovance.com/news-releases/news-release-details/iovance-biotherapeutics-host-conference-call-and-webcast [SID1234591498]).

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Iovance senior leadership will be joined by key opinion leaders and principal investigators in Iovance clinical studies.

The conference call dial-in numbers are 1-844-646-4465 (domestic) or 1-615-247-0257 (international) and the access code is 3263399. The live webcast can be accessed in the Investors section of the company’s website at www.iovance.com. The archived webcast will be available for one year following the event.

Posters and Presentations at SITC (Free SITC Whitepaper) Annual Meeting (November 12-14, 2021)

Title: Phase 2 efficacy and safety of autologous tumor-infiltrating lymphocyte (TIL) cell therapy in combination with pembrolizumab in immune checkpoint inhibitor-naïve patients with advanced cancers
Authors: D O’Malley, et al.
Presentation Type: Oral Presentation
Date and Time: Saturday, November 13, 2021 at 4:20 p.m. ET
Abstract ID: 492

Title: First phase 2 results of autologous tumor-infiltrating lymphocyte (TIL; LN-145) monotherapy in patients with advanced, immune checkpoint inhibitor-treated, non-small cell lung cancer (NSCLC)
Authors: A Schoenfeld, et al.
Presentation Type: Poster (available beginning on Friday, November 12, 2021 at 7 a.m. ET)
Abstract ID: 458

Title: Successful generation of tumor-infiltrating lymphocyte (TIL) product from renal cell carcinoma (RCC) tumors for adoptive cell therapy
Authors: B Halbert, et al.
Presentation Type: Poster (available beginning on Friday, November 12, 2021 at 7 a.m. ET)
Abstract ID: 176

Title: Expansion of tumor-infiltrating lymphocytes (TIL) using static bag for the clinical manufacturing rapid expansion protocol (REP) process
Authors: K Onimus, et al.
Presentation Type: Poster (available beginning on Friday, November 12, 2021 at 7 a.m. ET)
Abstract ID: 101

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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On October 18, 2021 Flex (NASDAQ: FLEX) reported it has entered into a definitive agreement to acquire Anord Mardix, a global leader in critical power solutions, from private equity firm Bertram Capital (Press release, Flex Pharma, OCT 18, 2021, View Source [SID1234591493]). The acquisition adds to Flex’s portfolio of Power products and expands its offering in the data center market. The $540 million all-cash transaction has been unanimously approved by Flex’s Board of Directors and is expected to close in the fourth quarter of calendar 2021, subject to customary closing conditions, including regulatory approval.

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Anord Mardix was established in 2018 as a result of a business combination between Anord Control Systems and Mardix, each with over 50 years of engineering experience. Anord Mardix offers an extensive product portfolio of critical power solutions including switchgear, busway, power distribution and modular power systems, along with monitoring solutions and services. This portfolio combined with Flex’s embedded power, server and storage products, racks and enclosures and full systems assembly capability will accelerate the company’s growth in the data center market. Anord Mardix will also leverage Flex’s global footprint and supply chain to establish itself as a trusted provider of quality products at scale across all major regions.

"This acquisition builds on Flex’s previously articulated strategy to move toward higher margin opportunities in faster growing verticals in our Reliability business," said Revathi Advaithi, Chief Executive Officer of Flex. "With Anord Mardix, Flex’s business will be better positioned to capture rising global demand for data center power solutions."

"Anord Mardix primarily markets critical power directly to data center operators. By joining Flex, we will be able to build out Anord Mardix’s comprehensive range of end-to-end power systems for critical data facilities, leveraging Flex’s expertise and efficiencies in advanced manufacturing and global supply chain. We look forward to being a part of Flex and expanding our abilities to provide quality data center solutions to our customers," said James Peacock, who will be Managing Director, of Anord Mardix.

As a widely trusted partner serving a diverse, global customer base, Flex’s global scale and key relationships with industry leaders will benefit Anord Mardix as they work to expand into the U.S. and Asian markets, with key hyperscale and colocation partners. Together, the combined offerings provide a broad opportunity for strategic growth and for Flex to further penetrate a $10 billion addressable market, that is expected to grow at an approximately 9% CAGR through 2026.

Anord Mardix is on track to generate approximately $360 million in revenue in calendar 2021 and is well positioned for continued growth in the coming years. Flex expects the Anord Mardix transaction to be accretive to adjusted EPS and to deliver mid-teens EBITDA margins in fiscal year 2023, which begins April 1, 2022. For reporting purposes, Anord Mardix will be included in the Industrial business unit inside Flex’s Reliability Solutions segment.

Flex management will further discuss the acquisition on its upcoming earnings call on Wednesday, October 27th, 2021 at 1:30 p.m. Pacific Time (4:30 p.m. Eastern Time).

On October 18, 2021 Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, reported it will report its third quarter 2021 financial results and operational highlights on Thursday, November 4, 2021, following the close of U.S. financial markets (Press release, Novavax, OCT 18, 2021, https://www.prnewswire.com/news-releases/novavax-to-host-conference-call-to-discuss-third-quarter-financial-results-and-operational-highlights-on-november-4-2021-301402234.html [SID1234591492]). Details of the event and replay are as follows:

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Participants will be prompted to request to join the Novavax, Inc. call.
To ensure a timely connection, it is recommended that participants join at least 10 minutes prior to the scheduled webcast.