On August 31, 2020 Avid Bioservices, Inc. (NASDAQ:CDMO) (NASDAQ:CDMOP), a dedicated biologics contract development and manufacturing organization (CDMO) working to improve patient lives by providing high quality development and manufacturing services to biotechnology and pharmaceutical companies, reported that its Board of Directors has declared a quarterly cash dividend payment on the Company’s 10.50% Series E Convertible Preferred Stock (the "Series E Preferred Stock") (Press release, Avid Bioservices, AUG 31, 2020, View Source [SID1234564181]).

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The quarterly dividend on the Series E Preferred Stock is payable on October 1, 2020 to holders of record at the close of business on September 14, 2020.

The quarterly dividend payment on the Series E Preferred Stock will be $0.65625 per share, which is equivalent to an annualized 10.50% per share, based on the $25.00 per share stated liquidation preference, accruing from July 1, 2020 through September 30, 2020. The Series E Preferred Stock is listed on the NASDAQ Capital Market and trades under the ticker symbol "CDMOP".

On August 31, 2020 Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs, reported it received $24.6 million in cash from Juvenescence Ltd., representing principal and interest due under a convertible promissory note (Press release, Lineage Cell Therapeutics, AUG 31, 2020, View Source [SID1234564180]). The note was issued in August 2018 as partial payment for the sale by Lineage to Juvenescence of 14.4 million shares of common stock of AgeX Therapeutics, Inc.

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"Lineage has been tremendously successful at monetizing its extensive patent and technology portfolio, most notably through the creation and sale of businesses like AgeX and OncoCyte, and the license or sale of non-core assets. It is worth highlighting that we have not conducted a traditional equity financing in nearly three years, and with an additional $24 million just received from Juvenescence, we believe we have over two years of cash runway based on our current business plan. This cash runway extends well past the expected timing of several major clinical milestones. We are best known for our promising cell therapy programs that are advancing through clinical trials, but I believe our broad technology platform, our financial strategy, and our responsible spending approach are equally notable and likely under-appreciated, particularly in a capital-intensive industry," stated Brian M. Culley, Lineage CEO. "Our core technology continues to be highly productive, not least of all by providing the foundation for three unique cell therapy programs, each with emerging safety and efficacy data and significant commercial opportunities. Furthermore, the VAC program we recently reacquired from Cancer Research UK includes a platform capable of generating numerous new programs, which may unlock exciting opportunities for us or for partnerships with other companies. Our mission is to convert the power of our directed cell differentiation platform into novel products and provide our shareholders with long-term growth and sustainability."

Importantly, Lineage has the following plans and objectives for the remainder of 2020:

– Meet with BARDA as part of the BARDA CoronaWatch Meeting Program, to discuss the use of dendritic cells for vaccine development (revised to September).

– Report initial VAC2 clinical data from patients treated in the ongoing Phase 1 trial in NSCLC (non-small cell lung cancer) run by Cancer Research UK.

– Present new and accumulated OpRegen data from the ongoing Phase 1/2a clinical trial at the American Academy of Ophthalmology (AAO) Annual 2020 Meeting the second week of November.

– Complete patient enrollment in the U.S. with the Gyroscope Orbit SDS and new thaw-and-inject formulation in the ongoing Phase 1/2a clinical trial of OpRegen for the treatment of dry AMD.

– Update U.S. Food and Drug Administration (FDA) on our recent progress and discuss further development of the OPC1 program.

On August 31, 2020 Regulus Therapeutics Inc. (Nasdaq: RGLS), a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs, reported that pursuant to an amendment of its term loan agreement with Oxford LLC, the Company is eligible for up to an additional seven months of interest only payments in the event the Company pays down $10 million in loan principal before April 30, 2021 (the "Principal Paydown Event") utilizing proceeds from the sale of materials to, and potential milestones received from, Sanofi as described below (Press release, Regulus, AUG 31, 2020, View Source [SID1234564179]). In the event the Principal Paydown Event does not occur by April 30, 2021, the Company will make principal and accrued interest payments, in arrears, commencing May 1, 2021, in accordance with the previously amended terms. If the Principal Paydown Event occurs after April 30, 2021 but on or before July 31, 2021, then the Company will recommence an extended interest only payment period through December 31, 2021. In the event the Company receives the additional interest only period, principal and accrued interest payments will recommence on January 1, 2022.

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Concurrently with the Oxford amendment described above, the Company also entered into an amendment with Sanofi concerning the receipt of potential milestones from Sanofi for its development of miR-21 programs. The Company has also sold additional compound-related materials to Sanofi in exchange for $1 million. Under the terms of the amendment with Sanofi, and in lieu of the previous $10 million enrollment milestone, the Company is eligible to receive an additional $4 million upon the completion of transfer and verification of the materials sold to Sanofi and an additional $5 million milestone upon achievement of the enrollment milestone. In the event the enrollment milestone occurs first, the Company will receive the entire $9 million for both milestones. In addition, the Company is eligible to receive $25.0 million upon the achievement of an additional development milestone related to Sanofi’s development of miR-21 compounds.

"We are pleased to enter into these two amended agreements with our partner, Sanofi, and with our lender, Oxford," stated Jay Hagan, CEO of Regulus. "Their creative support in this restructuring provides Regulus the opportunity to pay down debt principal with Oxford from the proceeds received from Sanofi while potentially extending our interest-only period through the end of 2021."

On August 31, 2020 Mosaic ImmunoEngineering Inc., a private biotechnology company based in Novato, California, reported that it has signed a two-year option agreement with Case Western Reserve University and Dartmouth College, granting the company the exclusive right to license technology for a novel platform technology using virus-like nanoparticles ("VLP") to treat and prevent cancer and infectious diseases in humans and for veterinary use (Press release, Case Western Reserve University, AUG 31, 2020, View Source [SID1234564178]).

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The technology has broad potential to treat many different types of cancer and is supported by numerous scientific publications and grant funding. The technology also has direct application as part of a vaccine platform, which has generated promising data in both cancer and infectious diseases, including COVID-19, through research funded by the National Science Foundation (NSF).

An option agreement provides Mosaic two years to obtain a full license agreement. A license option typically is granted to a company interested in further evaluation of the technology before entering into a full license agreement that allows the company to commercially market it. The two-year option to license agreement, is managed through Case Western Reserve’s Technology Transfer Office.

"Along with providing world-class research in many areas, Case Western Reserve University and Dartmouth College are striving to translate these exciting discoveries into products that can make a difference in the lives of patients with life threatening illnesses," said Wayne Hawthorne, senior licensing manager in the university’s Technology Transfer Office. "We encourage our faculty to conduct basic research which can become the basis of discoveries that have direct application to clinical needs such as the technology that Mosaic is seeking to advance. Considerable research and progress was made on the technology through internal awards and grants that funded early product development and clinical proof from organizations such Coulter Foundation, Council to Advance Human Health and Ohio Third Frontier Technology Validation and Start-Up Fund."

The inventors of the technology include Nicole Steinmetz, professor in the Department of NanoEngineering and director of the Center for Nano-ImmunoEngineering at the University of California San Diego (UCSD), and Jonathan Pokorski, associate professor in the Department of NanoEngineering at UCSD. During their tenure at Case Western Reserve, they worked in conjunction with Steven Fiering, a professor of microbiology and immunology at Dartmouth Geisel School of Medicine.

The researchers have collectively demonstrated that plant-derived, engineered VLP-based nanotechnologies stimulate a potent anti-tumor immune response in mouse models of metastatic melanoma, ovarian cancer, colon cancer, brain cancer and breast cancer, including companion dogs with metastatic melanoma. This data supports the potential to translate preclinical studies into veterinary applications, such as the treatment of cancer in companion animals, which has high relevance to human melanoma.

"We are pleased to have completed this agreement with CWRU and Dartmouth, and look forward to working closely with the university and Drs. Steinmetz, Pokorski and Fiering to rapidly advance the highly promising technology platforms into the clinic," said Steven King, co-founder and chief executive officer of Mosaic. "This technology platform includes many opportunities in oncology and infectious diseases, including both human and veterinary applications. This is a very important milestone for Mosaic, and we are very happy to have the opportunity to work with prestigious universities and an impressive team of scientists."

"This immuno-oncology approach provides a personalized treatment approach by relieving the patient’s tumor-mediated immunosuppression and potentiating anti-tumor immunity against antigens expressed by their own tumor," said Steinmetz, a co-inventor of the technology and a co-founder and chief scientific officer of Mosaic. "The vaccine platform is a natural extension of the immune-stimulating properties of the VLP, combined with directing the response to pre-defined targets. Instead of being a personal vaccine, the modular approach of linking disease specific targets to the VLP allows the potential to rapidly develop countermeasures for pandemics such as COVID-19."

Mosaic, through its founding team, has identified a lead oncology candidate for advancement into clinical trials and the ongoing NSF funded research is supporting the application of the technology toward the development of a SARS-CoV-2 vaccine for the prevention of COVID-19. Over the past 10 years, the technology has been funded through numerous research grants totaling more than $20 million.

On August 31, 2020 Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) reported that its wholly-owned subsidiary, Pelican Acquisition Sub, Inc. (the "Purchaser"), is commencing a tender offer to purchase all outstanding shares of common stock of Pfenex, Inc. (NYSE American: PFNX) at an offer price of $12.00 per share in cash, plus one non-transferable contractual contingent value right per share representing the right to receive a contingent payment of $2.00 in cash, if a certain specified milestone is achieved (Press release, Ligand, AUG 31, 2020, View Source [SID1234564169]). The tender offer is being made pursuant to an Offer to Purchase, dated August 31, 2020 (the "Offer to Purchase"), and in connection with the Agreement and Plan of Merger, dated August 10, 2020, by and among Ligand, Purchaser and Pfenex (the "Merger Agreement"), which Ligand and Pfenex previously announced on August 10, 2020.

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The tender offer will expire at midnight (New York City time) at the end of the day on Tuesday, September 29, 2020, (such date and time, the "Expiration Date"), unless (i) the Purchaser extends the period during which the tender offer is open pursuant to and in accordance with the terms of the Merger Agreement, in which case the term "Expiration Date" means the latest date and time at which the offer period, as so extended by the Purchaser, will expire or (ii) the Merger Agreement has been earlier terminated. Pursuant to the Merger Agreement, the Purchaser will extend the offer period for any period or periods required by any applicable law or applicable rules, regulations, interpretations or positions of the Securities and Exchange Commission ("SEC") or its staff or the NYSE American, and the Purchaser may (and if requested by Pfenex shall) extend the Offer for successive periods of up to 10 business days each (or such longer period as may be approved by Pfenex), if on or prior to any then scheduled Expiration Date, any of the conditions to the offer (other than the Minimum Condition (as defined below)) has not been satisfied or waived (where permitted by applicable law or the Merger Agreement). The Purchaser will also extend the offer period for successive periods of 10 business days each (or such longer period as may be approved by Pfenex), if on or prior to any then scheduled Expiration Date, all conditions to the offer (other than the Minimum Condition) have been satisfied or waived (where permitted by applicable law or the Merger Agreement); provided, in no event will the Purchaser be required to extend the tender offer on more than two occasions (but may elect to do so in its sole and absolute discretion).

The tender offer is not subject to any financing condition. The tender offer is conditioned upon (i) there being validly tendered in the tender offer and not properly withdrawn prior to the Expiration Date, a number of shares of common stock which, together with the number of shares of common stock then owned by Ligand or any of its wholly-owned direct or indirect subsidiaries, including the Purchaser (if any), represents at least a majority of the then outstanding shares of common stock (determined in accordance with the Merger Agreement) (excluding from the number of tendered shares, shares tendered pursuant to guaranteed delivery procedures that have not yet been "received" as such term is defined in Section 251(h) of the General Corporation Law of the State of Delaware, by the depositary for the tender offer pursuant to such procedures) (the "Minimum Condition"); (ii) the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, having expired or been terminated; (iii) the absence of legal restraints that has the effect of prohibiting or otherwise preventing the consummation of the Offer or the Merger; and (iv) the satisfaction or waiver by the Purchaser of the other conditions and requirements of the tender offer. As soon as practicable following the consummation of the tender offer, the Purchaser will merge with and into Pfenex with Pfenex continuing as the surviving corporation and as a wholly-owned subsidiary of Ligand.

D.F. King & Co., Inc. is acting as information agent and American Stock Transfer & Trust Company, LLC is acting as depositary in the tender offer. Requests for documents and questions regarding the tender offer may be directed to the information agent by telephone at (800) 821-8781.