On July 12, 2021 Vernal Biosciences, Inc., a manufacturer of high purity mRNA for research and clinical use, reported the closing of a seed round of financing (Press release, Alloy Therapeutics, JUL 12, 2021, View Source [SID1234584786]). Alloy Therapeutics led the round and was joined by the Vermont Center for Emerging Technologies and individual angel investors. The proceeds of the financing will be used to scale Vernal’s technical development and commercial operations in the Burlington, VT region.

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Vernal is focused on achieving and maintaining high purity throughout the scaling of all mRNA manufacturing processes for clients in the research and ultimately clinical stages. The company was founded by CEO Christian Cobaugh, who previously held mRNA process and manufacturing leadership roles at Omega Therapeutics, Translate Bio, Arcturus Therapeutics, and Alexion Pharmaceuticals, where he was the first researcher in the Alexion-Moderna partnership. He brings a deep understanding of the mRNA manufacturing value-chain—including mRNA design and specifications, regulatory expectations, and quality product profiles—to improve Vernal clients’ odds of success through a highly adaptable and well-characterized manufacturing process.

"We are inspired to realize the potential of mRNA, a validated and revolutionary medicines modality, through democratizing access to unparalleled mRNA manufacturing technologies," said Christian Cobaugh, founder and CEO of Vernal. "The associated knowledge, technology, and talent has long been cloistered within select mRNA therapeutics companies. It is critical to remove barriers to mRNA manufacturing technologies for the benefit of patients and investors seeking novel use cases of mRNA. Equal access to high purity mRNA manufacturing will encourage growth in innovation, competition, and collaboration, accelerating the clinical impact of mRNA as a foundational therapeutic modality."

Through collaborative research and partnerships, Vernal is developing innovative process and analytical technologies to overcome the challenges of manufacturing high purity mRNA. The company’s universal platform, which emphasizes Quality-by-Design and documented process characterization, will accelerate client projects and simplify regulatory interactions. Vernal is fine-tuning this platform so that clients do not "hurry up and wait" for clinical manufacturing processes to start from scratch—enabling clients to focus on other high-value operations such as target biology, drug discovery, and clinical development. Vernal’s mRNA solutions will scale with client needs, regardless of discovery or clinical stage or use case.

Already engaging with clients on research and preclinical projects, Vernal’s seed financing will be used to scale its technology and business to add the GMP clinical manufacturing capability operations for ongoing and future client discovery projects. As part of the Series Seed financing, Errik Anderson, CEO and founder of Alloy Therapeutics, will join Vernal’s Board of Directors. Pat Sacco, longtime biotech technical operations and manufacturing executive (senior vice president of technical operations at both Translate Bio and Shire plc/TKT), will also be joining Vernal as a board advisor. While at Shire, Pat’s teams supported development, manufacturing, and commercialization of REPLAGAL, ELAPRASE, and VPRIV.

"Backing Vernal’s vision for mRNA manufacturing is fully aligned with Alloy’s ecosystem approach and our commitment to reinvest 100% of Alloy’s revenues back into innovation and access to innovation," said Anderson. "Collaboration and democratization of foundational drug discovery capabilities are critical in ensuring our industry delivers on its promise to get the best drugs to patients faster. Alloy is thrilled to support Christian and the Vernal team in their mission to bring high quality mRNA to innovative companies and projects of all sizes."

Vermont Seed Capital Fund Manager David Bradbury added, "We are thrilled to welcome mRNA veteran Christian Cobaugh and the Vernal team into Vermont and support the launch of this high potential new life sciences company."

On July 12, 2021 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery and development of drugs for the treatment of cancer, reported that it has entered into a development and commercialization collaboration with LegoChemBio, a clinical stage South Korea-based biotechnology company, for the development and commercialization of novel first-in-class phospholipid drug conjugates (PDCs) (Press release, Cellectar Biosciences, JUL 12, 2021, View Source [SID1234584785]).

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Under the agreement, the two companies have the option to jointly develop three new small molecule PDCs utilizing Cellectar’s proprietary drug targeting platform, phospholipid ether (PLE) technology and LegoChemBio’s proprietary drug conjugate linker-toxin platform. The co-development option is exercisable at defined points with either party allowed to acquire full global commercialization rights. The parties have further agreed to focus development of the drug candidates on solid tumors with significant unmet medical need and potential for accelerated regulatory pathways . Details of the financial terms of the agreement have not been disclosed.

"This partnership reflects the shared commitment of LegoChemBio and Cellectar to rapidly provide novel targeted therapies to patients with difficult to treat cancers. LegoChemBio’s proprietary and validated ADC linker-toxin platform technology is well-suited to be combined with our validated PLE tumor targeting technology to generate new PDC’s" said James Caruso, president and CEO of Cellectar. "This collaboration has potential to further enrich our oncology pipeline and builds upon our strategy of developing our PDC platform across a multitude of targeted cancer treatment modalities, including radioisotopes small molecules as well as others."

Dr. Yong-Zu Kim, CEO of LegoChemBio said, "This collaboration is of great significance for the expansion of the application of LegoChemBio’s ADC linker-toxin platform using an innovative drug delivery platform technology with a novel mechanism beyond antibodies. Through this cooperation with Cellectar and its’ validated competitive platform technology in the field of targeted therapies, we will drive our research capabilities to create novel PDC clinical candidates with full speed."

On July 12, 2021 Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company developing onvansertib to treat cancers with the greatest medical needs for new treatment options, including KRAS-mutated colorectal cancer, pancreatic cancer, and castrate-resistant prostate cancer, reported the appointments of Katherine L. Ruffner, M.D., as chief medical officer (CMO) and James E. Levine as chief financial officer (CFO) (Press release, Cardiff Oncology, JUL 12, 2021, View Source [SID1234584783]).

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Dr. Ruffner has over 25 years of clinical care, oncology biotechnology, and pharmaceutical drug development experience. Mr. Levine has extensive corporate and investment banking experience in the biotechnology industry, including corporate finance, capital markets and business development. In their newly created roles at Cardiff Oncology, Dr. Ruffner will be responsible for overseeing the strategy and execution of clinical programs, as well as the identification and evaluation of pipeline expansion opportunities. In his role as CFO, Mr. Levine will guide Cardiff Oncology’s financial strategy and lead its business development efforts, which will focus on maintaining an optimal financial benefit-risk balance across each of the Company’s programs. Mr. Levine will also serve as the Company’s principal financial and accounting officer.

"With these appointments we have continued to execute on our goal of strengthening our executive team through the addition of highly talented individuals with complementary skill sets," said Mark Erlander, Ph.D., chief executive officer of Cardiff Oncology. "They come at a time of significant company opportunity and growth, as our lead program in KRAS-mutated metastatic colorectal cancer is poised for important clinical milestones and we have a meaningful and exciting platform of new clinical indications on the horizon. Katherine’s extensive experience in oncology clinical care and drug development, including advancing novel cancer treatments towards regulatory approval, makes her an ideal fit to lead onvansertib’s development as we work to advance our clinical programs. Her talents, along with Jamie’s track record of financing clinical-stage biotech companies, leading business development pre-clinical and clinical collaborations, and commercial partnerships, will be instrumental to our continued evolution as a company and our commitment to increasing shareholder value. We are thrilled to welcome Katherine and Jamie to our team."

"Onvansertib in combination with other anti-cancer therapeutics has the potential to address unmet patient needs in a number of critically important cancer indications that are currently underserved by available standard-of-care therapies," said Dr. Ruffner. "I am excited to be joining the Cardiff Oncology team to advance these important potential new treatment option in an environment that combines a rare blend of the nimbleness of a clinical-stage biotech company with the resources, expertise and rigor of a much more mature company."

Mr. Levine added, "This is a pivotal time to be joining Cardiff Oncology. With a strong financial foundation, a base of healthcare-focused institutional investors and promising clinical data, the Company is well positioned for upcoming clinical and pre-clinical catalysts. I look forward to working with my new colleagues as we strive to generate shareholder value and, most importantly, address the medical needs of patients with cancer through onvansertib’s continued clinical development."

Appointee Bios
Dr. Ruffner is a US-trained hematologist/oncologist and brings extensive experience in oncology clinical development and clinical care, from early clinical phase through post-commercialization, both at major pharma companies and focused biotech companies.
Most recently, Dr. Ruffner served as vice president, clinical development for ALX Oncology, where she led strategy and execution of their initial clinical asset across a number of different malignancies, both solid tumor and hematologic, and achieved rapid clinical growth from a single trial open in two countries to a program with six global trials across five different cancer indications. Prior to joining ALX, she was a consulting global clinical lead for Lumoxiti at Acerta/Astra Zeneca, and from April 2008 to February 2019, held multiple clinical development positions within the oncology field, most recently as vice president, clinical development for CTI Biopharma, where she oversaw design of Phase 3 confirmatory protocol for pacritinib in myelofibrosis. Previously, Dr. Ruffner served as senior director, clinical development/medical affairs for Seattle Genetics, and before that, as clinical lead for the immuno-oncology agent pidilizumab in hematologic malignancies at Medivation. Earlier in her career, Dr. Ruffner worked in oncology clinical development at Pfizer, Biogen, and Amgen in addition to providing clinical care of patients undergoing treatment for hematologic malignancies.
Dr. Ruffner earned a BS in Biology from Duke University and an MD from the University of Tennessee. She went on to complete her internal medicine residency at the University of Michigan and her oncology fellowship at the University of Washington/Fred Hutchinson Cancer Research Center. Prior to joining industry, she was an Assistant Professor at Vanderbilt University from 2002-2007 on the Hematopoietic Stem Cell faculty.
Mr. Levine joins Cardiff Oncology with extensive corporate and investment banking experience with both private and public biotechnology and pharmaceutical companies. Prior to joining Cardiff Oncology, Mr. Levine served as CFO of Cidara Therapeutics, where he led the financial aspects of important pre-clinical and clinical collaborations with Janssen Pharmaceuticals (part of Johnson & Johnson) and Mundipharma with a combined value of over $1.3 billion. Previously, Mr. Levine was the president and chief executive officer of Sapphire Energy Inc., a private industrial biotechnology company that was sold to two private investor groups. He also previously served in the same roles at Verenium Corp., where he negotiated six product commercialization partnerships and asset sales, before selling the company to BASF. He also previously was a managing director in the investment banking division of Goldman Sachs & Co., serving in its healthcare and energy groups.
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Mr. Levine earned an MBA in finance from the Wharton School of the University of Pennsylvania and a BA in economics from Brandeis University.
Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
In connection with Dr. Ruffner and Mr. Levine joining Cardiff Oncology, the Company’s Board of Directors approved the grant of non-qualified stock option awards to purchase 200,000 and 390,000, shares of Cardiff Oncology common stock, respectively, outside of the Cardiff Oncology 2021 Omnibus Equity Incentive Plan. The stock options were granted as inducements material to Dr. Ruffner and Mr. Levine becoming employees of Cardiff Oncology in accordance with Nasdaq Listing Rule 5635(c)(4). The options were granted to Dr. Ruffner and Mr. Levine as of July 12, 2021, and have an exercise price of $6.55 per share, which is equal to the closing price of Cardiff Oncology’s common stock on the day immediately preceding the grant date. The options vest over four years, with 25% vesting after 12 months and the remaining shares vesting monthly over the following 36 months, subject to Dr. Ruffner’s and Mr. Levine ‘s continued employment with Cardiff Oncology on such vesting dates.

On July 12, 2021 HUTCHMED (China) Limited ("HUTCHMED" or the "Company") (Nasdaq/AIM: HCM, HKEX:13) reported the full exercise of the over-allotment option of the Global Offering (Press release, Hutchison China MediTech, JUL 12, 2021, View Source [SID1234584782]). The Joint Global Coordinators, on behalf of the International Underwriters, on July 12, 2021, fully exercised the Over-allotment Option, in respect of an aggregate of 15,600,000 offer shares (the "Over-allotment Shares"), representing approximately 15% of the total number of offer shares initially available under the Global Offering before any exercise of the Over-allotment Option to (among other things) facilitate the return to Hutchison Healthcare Holdings Limited (an indirect wholly owned subsidiary of CK Hutchison Holdings Limited) the borrowed shares under the Stock Borrowing Agreement which were used to cover over-allocations in the International Offering. The Company has been notified that following the return of such shares, the shareholding of CK Hutchison Holdings Limited in the Company will be 332,502,740 shares, representing 38.48% of the total number of voting rights of the Company as enlarged by the issuance of the Over-allotment Shares.

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The Over-allotment Shares will be allotted and issued by the Company at HK$40.10 per offer share (exclusive of brokerage of 1%, Securities and Futures Commission transaction levy of 0.0027% and Hong Kong Stock Exchange trading fee of 0.005%), being the offer price per offer share under the Global Offering.

Approval of Listing

Approval for the listing of and permission to deal in the Over-allotment Shares has already been granted by the Listing Committee of the Hong Kong Stock Exchange. Listing of and dealings in the Over-allotment Shares are expected to commence on the Main Board of the Hong Kong Stock Exchange at 9:00 a.m. on Thursday, July 15, 2021.

Total Number of Issued Shares upon the Full Exercise of the Over-Allotment Option

The Company’s total number of issued shares as of the date of this announcement and immediately after the completion of the full exercise of the Over-allotment Option (assuming there are no other changes to the total number of issued shares since the date of this announcement) is 848,515,660 shares and 864,115,660 shares, respectively.

AIM Admission

Application will be made to the London Stock Exchange for the 15,600,000 Over-allotment Shares to be admitted to the AIM market operated by the London Stock Exchange ("Admission"). It is expected that Admission will become effective at 8:00 a.m. UK time on July 16, 2021.

Following the above, the issued share capital of HUTCHMED will consist of 864,115,660 ordinary shares of US$0.10 each, with each share carrying one right to vote and with no shares held in treasury. This figure may be used by shareholders as the denominator for the calculations by which they could determine if they are required to notify their interest in, or a change to their interest in, HUTCHMED under the Financial Conduct Authority’s Disclosure Guidance and Transparency Rules. For illustrative purposes only, 864,115,660 shares would be equivalent to 864,115,660 depositary interests (each equating to one ordinary share) which are traded on AIM or, if the depositary interests were converted in their entirety, equivalent to 172,823,132 ADSs (each equating to five ordinary shares) which are traded on Nasdaq.

Use of Proceeds

The gross proceeds to the Company from the Over-allotment Option, before deducting underwriting fees and the offering expenses, are expected to be approximately HK$625 million. The Company intends to apply the additional net proceeds towards the same purposes as set out in the section headed "Use of Proceeds" in the prospectus.

The Company will make a further announcement after the end of the stabilization period in connection with the Global Offering pursuant to Section 9(2) of the Securities and Futures (Price Stabilizing) Rules (Chapter 571W of the Laws of Hong Kong).

On July 12, 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, JUL 12, 2021, View Source [SID1234584781]). 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 7 May 2021, Novo Nordisk will repurchase B shares for an amount up to DKK 3.3 billion in the period from 10 May 2021 to 3 August 2021.

Since the announcement as of 5 July 2021, the following transactions have been made:

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

With the transactions stated above, Novo Nordisk owns a total of 15,794,444 B shares of DKK 0.20 as treasury shares, corresponding to 0.7% 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 9 July 2021, Novo Nordisk has since 3 February 2021 repurchased a total of 16,955,946 B shares at an average share price of DKK 465.96 per B share equal to a transaction value of DKK 7,900,742,314.