On July 2, 2021 Panbela Therapeutics, Inc. (Nasdaq: PBLA) (the "Company" or "Panbela"), a clinical stage biopharmaceutical company developing disruptive therapeutics for the treatment of patients with cancer, reported the closing of its previously announced public offering of 3,333,334 shares of common stock of the Company at a price to the public of $3.00 per share, less underwriting discounts and commissions (Press release, Panbela Therapeutics, JUL 2, 2021, View Source [SID1234584583]).

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H.C. Wainwright & Co. acted as the sole book-running manager for the offering.

The gross proceeds of the offering were approximately $10.0 million, before deducting underwriting discounts and commissions and offering expenses payable by Panbela. The Company intends to use the net proceeds of the offering for the continued clinical development of its initial product candidate SBP-101 and for working capital and other general corporate purposes.

The shares of common stock described above were offered by the Company pursuant to a "shelf" registration statement on Form S-3 (File No. 333-255751) filed with the Securities and Exchange Commission ("SEC") and declared effective on May 11, 2021. The offering of the shares of common stock was made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and the accompanying prospectus relating to the offering have been filed with the SEC and are available on the SEC’s website at www.sec.gov. Electronic copies of the final prospectus supplement and the accompanying prospectus may also be obtained by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by e-mail at [email protected] or by calling (212) 856-5711.

This announcement is neither an offer to sell, nor a solicitation of an offer to buy, any of these securities and shall not constitute an offer, solicitation or sale in any state or jurisdiction in which such offer, solicitation, or sale is unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. Any offer, if at all, will be made only by means of the prospectus forming a part of the effective registration statement.

On July 2, 2021 Alector, Inc. (Nasdaq: ALEC) and GlaxoSmithKline plc (LSE/NYSE: GSK), reported a strategic global collaboration for the development and commercialization of two clinical-stage, potential first-in-class monoclonal antibodies (AL001 and AL101) designed to elevate progranulin (PGRN) levels (Press release, Alector, JUL 2, 2021, View Source [SID1234584567]). PGRN is a key regulator of immune activity in the brain with genetic links to multiple neurodegenerative disorders, making it one of the most attractive genetically validated targets for the development of new immuno-neurology treatments.

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The collaboration brings together Alector’s leading immuno-neurology expertise with GSK’s R&D focus on the science of the immune system and human genetics, proven late-stage drug development capabilities and global footprint. Enrollment is currently underway for a pivotal Phase 3 trial for AL001 in people at risk for or with frontotemporal dementia due to a progranulin gene mutation (FTD-GRN). FTD-GRN is a rapidly progressing and severe form of dementia found most frequently in people less than 65 years old at the time of diagnosis and has no approved treatments. AL001 is also currently in a Phase 2 study in symptomatic FTD patients with a mutation in the C9orf72 gene and is planned to enter Phase 2 development for amyotrophic lateral sclerosis (ALS) in the second half of 2021. AL101 is in a Phase 1a clinical trial and is designed to treat patients suffering from more prevalent neurodegenerative diseases, including Parkinson’s disease and Alzheimer’s disease.

Dr Hal Barron, Chief Scientific Officer and President R&D, GSK, said: "Our focus on human genetics and the science of the immune system gives us unique insights into the potential of targets such as progranulin to help patients with a number of neurodegenerative diseases. Working with Alector’s world class scientists will allow us to investigate the potential of these immuno-neurology therapies to help patients with frontotemporal dementia, a devastating disease without any currently approved treatments, as well as explore the ability to help patients with other neurodegenerative diseases, such as ALS, Parkinson’s and Alzheimer’s."

Arnon Rosenthal, Ph.D., Chief Executive Officer, Alector, said: "This transformative collaboration brings together Alector’s leading immuno-neurology expertise with GSK’s commitment to immunology and human genetics, proven drug development capabilities and global footprint, to help expand and accelerate the development of our progranulin franchise into large indications, while bolstering the build out of our own late-stage development and commercial capabilities. Importantly, this collaboration is designed to fully support AL001 and AL101’s development and to enable Alector to continue building a fully integrated company as we strive to address the high unmet medical need in patients suffering from neurodegenerative diseases. We are confident that GSK’s extensive experience launching ground-breaking medicines at the intersection of immunology and human genetics, will ensure that AL001 and AL101 are developed to their full potential."

As part of the recent Investor Update day on 23 June 2021, GSK committed to an R&D approach focused on maximizing opportunities by leveraging an increased understanding of the science of the immune system and human genetics. The collaboration with Alector on AL001 and AL101, two antibodies designed to elevate PGRN levels and potentially slow the progression of FTD and other neurological disorders, provides GSK access to a promising clinical program in immuno-neurology.

Terms of the Collaboration
Under the terms of the collaboration agreement, Alector will receive $700 million in upfront payments. In addition, Alector will be eligible to receive up to an additional $1.5 billion in clinical development, regulatory and commercial launch-related milestone payments.

Alector will lead the global clinical development of AL001 and AL101 through Phase 2 proof-of-concept. Thereafter, Alector and GSK will share development responsibilities for all late-stage clinical studies for AL001 and AL101 and all costs for global development will be divided between the two companies.

The companies will be jointly responsible for commercialization in the U.S. and will share profits and losses. Alector will lead commercial efforts associated with AL001 in orphan indications and GSK will lead the commercialization of AL101 in Alzheimer’s and Parkinson’s disease. Outside the U.S., GSK will be responsible for commercialization of AL001 and AL101 and Alector will be eligible for tiered royalties.

The collaboration agreement is conditional upon customary conditions including review by the appropriate regulatory agencies under the Hart-Scott-Rodino Act.

About the Progranulin-Elevating Monoclonal Antibodies – AL001 and AL101
Decreased levels of PGRN, a key regulator of immune response, lysosomal function, and neuronal survival in the brain, are genetically linked to many neurodegenerative disorders. AL001 and AL101 are novel human monoclonal antibodies that elevate levels of progranulin by blocking the sortilin receptor responsible for progranulin degradation. AL001 is currently in a pivotal Phase 3 clinical study in people at risk for or with frontotemporal dementia due to a progranulin gene mutation (FTD-GRN). AL001 is also currently in a Phase 2 study in symptomatic FTD patients with a C9orf72 mutation, with another Phase 2 study in patients with ALS planned to begin in the second half of 2021. AL101, is designed to treat people suffering from more prevalent neurodegenerative diseases and is currently in a Phase 1a study in healthy volunteers. AL101 is intended to be developed for treatment of Parkinson’s disease and Alzheimer’s disease.

About Frontotemporal Dementia (FTD)
Frontotemporal dementia is a rapidly progressing and severe form of dementia. It affects 50,000 to 60,000 people in the United States and roughly 110,000 in the European Union, with potentially higher prevalence in Asia and Latin America. There are currently no FDA-approved treatment options for FTD.

There are multiple heritable forms of FTD. In one form, FTD-GRN, people have a mutation in the progranulin gene. This population represents 5% to 10% of all people with FTD. Mutations in a single copy of a progranulin gene leads to a 50% or greater decrease in the level of progranulin protein and invariably leads to development of FTD. In another form, people with mutations in the chromosome 9 open reading frame 72 (C9orf72) gene can develop FTD. FTD-C9orf72 is associated with abnormal accumulation of the protein TDP-43, which is also a hallmark in FTD-GRN. To date researchers have identified more than 120 inherited loss of function mutations in the progranulin gene that lead to FTD.

Alector Conference Call Information
Alector management will host a conference call to discuss the collaboration today at 8:30 a.m. ET. Analysts and investors are invited to participate in the conference call by dialling (888) 705-0365 from the U.S. and Canada or (415) 817-9241 internationally and using the conference ID 9476664. The live webcast can be accessed on the investor page of Alector’s website at investors.alector.com. A replay of the webcast will be available on Alector’s website approximately two hours after the completion of the event and will be archived for up to 30 days.

On July 2, 2021 Experts at UCL and spinout company Odin Vision working with clinicians at UCLH reported that have used artificial intelligence (AI) to help detect early signs of oesophageal cancer (Press release, UCLB, JUL 2, 2021, View Source [SID1234584584]).

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The first procedure in the world using the AI technology was performed at University College Hospital by UCLH consultant gastroenterologist Dr Rehan Haidry. The system, called CADU, uses AI to support doctors in identifying cancerous tissue.

CADU achieved regulatory approval at the start of 2021 making it the first medical device using AI for oesophageal cancer to be CE and UKCA approved for use on patients.

It has been developed in collaboration with UCL scientists, including Dr Haidry, who is also Associate Professor at UCL, and Odin Vision, a spinout formed out of the research and innovation work at the UCL Wellcome / EPSRC Centre for Interventional and Surgical Sciences.

Peter Mountney, Odin Vision CEO and Honorary Associate Professor, UCL Computer Science, said: "AI has great potential to transform healthcare. We are very excited to achieve this landmark procedure and use our AI technology to support doctors in the fight against one of the most aggressive forms of cancer."

Odin Vision has previously received support from the UCL Technology Fund and was also one of the first spinouts to arise from Portico Ventures, a UCLB commercialisation model designed to help UCL researchers set up technology-based businesses that can thrive in a fast-moving ecosystem.

Dr Anne Lane, CEO of UCL Business, said: "This milestone for Odin Vision’s oesophageal cancer detection system demonstrates the huge potential of UCL research to change lives through its successful commercialisation. We are proud to have supported Odin Vision from its early stages through the UCL Technology Fund and are excited to see what the future holds."

On July 2, 2021 Almac Group, the global contract pharmaceutical development and manufacturing organisation, reported that Ciara Cassidy, Principal Applications Developer, was awarded ‘Developer of the Year’ at this year’s Digital DNA Awards, live-streamed from Belfast (Press release, Almac, JUL 2, 2021, View Source [SID1234584568]).

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Now in their 6th year, the Digital DNA Awards are widely regarded as the number one awards programme for companies and individuals working within the fast growing and highly competitive tech industry in Northern Ireland.

Ciara Cassidy was named ‘Developer of the Year’ for her role as Lead Developer in Almac’s first foray into serverless application development, through a partnership with Amazon Web Services. Ciara’s team worked to architect and ramp up AWS to meet the needs of a business critical project, and after only 3 months of development, the solution went into production and is now actively used by a large Almac team.

Commented Brendan Woods, Group Head of Systems Delivery, "Almac’s Information Services team is a global and disparate central unit that supports mission critical life sciences applications 24/7. We are delighted to have a ‘Developer of the Year’ within our IS organisation, and congratulate Ciara on her well-deserved success."

Commented Mark McColgan, Group Head of Software Engineering, "Since joining Almac in 2018, Ciara has become an integral part of our IS organisation. She expertly bridges the gap between pharma regulations, business applications, and the latest technologies to drive modernisation in our organisation, all while effectively mentoring other team members. She is very deserving of the ‘Developer of the Year’ award and I am thrilled to congratulate her success."

On July 2, 2021, Alpine Immune Sciences, Inc, a Delaware corporation, (the "Company"), reported that it entered into a sales agreement (the "Sales Agreement") with Cowen and Company, LLC ("Cowen") to sell shares of the Company’s common stock, par value $0.001 per share, having aggregate sales proceeds of up to $75 million, from time to time, through an "at the market" equity offering program under which Cowen will act as sales agent (Filing, 8-K, Alpine Immune Sciences, JUL 2, 2021, View Source [SID1234584569]).

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Under the Sales Agreement, the Company will set the parameters for the sale of shares, including the number of shares to be issued, the time period during which sales are requested to be made, limitation on the number of shares that may be sold in any one trading day and any minimum price below which sales may not be made. Subject to the terms and conditions of the Sales Agreement, Cowen may sell the shares by methods deemed to be an "at the market offering" as defined in Rule 415 promulgated under the Securities Act of 1933, as amended, including sales made directly on The Nasdaq Stock Market LLC or on any other existing trading market for the common stock or to or through a market maker. In addition, with the Company’s prior written approval, Cowen may also sell shares by any other method permitted by law, including in negotiated transactions. Cowen will use commercially reasonable efforts in conducting such sales activities consistent with its normal trading and sales practices, applicable state and federal laws, rules and regulations and the rules of The Nasdaq Stock Market LLC. The Sales Agreement may be terminated by the Company upon written notice to Cowen for any reason or by Cowen upon written notice to the Company for any reason or at any time under certain circumstances, including but not limited to the occurrence of a material adverse change in the Company.

The Sales Agreement provides that Cowen will be entitled to compensation for its services of up to 3.0% of the gross sales price per share of all shares sold through Cowen under the Sales Agreement. The Company has no obligation to sell any shares under the Sales Agreement, and may at any time suspend solicitation and offers under the Sales Agreement. The Sales Agreement contains customary representations, warranties and agreements by the Company, indemnification obligations of the Company and Cowen, other obligations of the parties and termination provisions. The representations, warranties and covenants contained in the Sales Agreement were made only for purposes of such agreement and as of specific dates, were solely for the benefit of the parties to such agreement, and may be subject to limitations agreed upon by the contracting parties.

The shares will be issued pursuant to the Company’s effective shelf registration statement on Form S-3 (File No. 333-256107), declared effective by the Securities and Exchange Commission (the "SEC") on May 20, 2021. The Company filed a prospectus supplement, dated July 2, 2021, with the SEC in connection with the offer and sale of the shares pursuant to the Sales Agreement.

The foregoing description of the Sales Agreement is not complete and is qualified in its entirety by reference to the full text of such agreement, a copy of which is filed herewith as Exhibit 1.1 to this Current Report on Form 8-K and is incorporated herein by reference.

The legal opinion of Wilson Sonsini Goodrich & Rosati, Professional Corporation, relating to the shares of common stock being offered is filed as Exhibit 5.1 to this Current Report on Form 8-K.
This Current Report shall not constitute an offer to sell or the solicitation of an offer to buy the securities discussed herein, nor shall there be any sale of such securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.