Moderna, Inc. (NASDAQ:MRNA)

MRNA $MRNAD ($2.95) announced that Windlas Healthcare has agreed to invest $2 million in working capital to support MRNA’s manufacturing initiatives of its marketed product and its pipeline. In March of 2017, the Company signed a definitive manufacturing agreement with Windlas.

Quotes from management:

“We are very pleased that Windlas Healthcare has broadened our initial definitive manufacturing agreement with a $2 million working capital investment. It is a testament to their belief in our vision. The investment will reduce the amount of capital needed for the company to execute on its plans. Marina is at a critical inflection point and uniquely positioned to move forward quickly through commercialization and clinical testing for the often neglected disease intersection of pain and hypertension.”

MRNA ($0.33) - Marina announced this morning a 1-10 reverse split in anticipation of an uplist to the NASDAQ. The company’s press release stated:

The reverse split will be effective on the opening of trading on Thursday, August 3, 2017. The Company’s stock will trade on a post-split basis under the ticker symbol “MRNAD” for 20 business days and then revert back to “MRNA” thereafter.

Management commented:

“This is a critically important step in our corporate development and capital markets strategy. We are pleased with the endorsement of our stockholders and the Board to execute a reverse stock split. The reverse stock split will help us satisfy certain requirements, as part of our future plan to seek a listing on the NASDAQ Capital Market. In doing so, we believe that our shareholders will benefit from the improved liquidity and visibility of our stock with a broader range of institutional investors.”

MRNA ($0.37) announced a license agreement with Oncotelic, Inc for the Company’s SMARTICLES platform for the delivery of antisense DNA therapeutics.  Oncotelic is buying $250,000 worth of MRNA stock at a price of $0.51, with other options to buy more stock at premiums to current prices.

“This represents the first time that the Company’s SMARTICLES™ technologies have been licensed in connection with delivery of Marina’s proprietary Conformationally Restricted Nucleotides and other antisense nucleotides. Under terms of the agreement, Oncotelic will invest $250,000 in Marina at a share price of $0.51. In addition, Marina may receive in certain circumstances a commercial license fee consummated by the sale to Oncotelic of shares of the common stock of Marina for an aggregate purchase price of $500,000, with the purchase price for each share of Marina common stock being the greater of $0.51 or the volume weighted average price of the Marina common stock at the time of purchase, and as well sales milestones, which sales milestones shall not exceed in any event Ninety Million Dollars ($90,000,000).”

MRNA ($0.33) announced that it has acquired Prestalia®, a treatment of hypertension, from Symplmed Pharmaceuticals Inc.  

Prestalia will be marketed using Symplmed's patented telehealth technology platform, DyrctAxess™, which enables direct delivery of medications to a patient's home and helps to address the problem of poor compliance resulting from unfilled prescriptions.

Joseph Ramelli, CEO of Marina Biotech, stated, "This is a transformative event for Marina Biotech. In addition to bringing a commercial hypertension product into the Company, we believe there will be longer term benefits for our existing portfolio. For example, our two existing hypertension therapies, IT102 and IT103, if approved by the FDA, will benefit from the distribution capabilities we will have in place for Prestalia. This could provide us with a much faster and cost effective go-to-market strategy for these two therapies."

Dr. Vuong Trieu, Chairman of Marina Biotech, stated, "With the acquisition of Prestalia, Marina Biotech is poised to become an important player in the field of specialty pharma for hypertension. This acquisition is a testament to the strong and capable leadership of the management team and the board."

MRNA ($0.42) - In our April 6, 2017 email we stated that MRNA’s CEO had purchased 97,550 shares on the open market.  During the trading day last Friday, we issued a premium tweet stating that CEO Joe Ramelli filed his second form 4 of the week, buying another 35,500 shares, bringing his total shares purchased last week to 133k shares.  It should be noted that 22,500 of those shares occurred at $0.42.

MRNA ($0.29) provides business update:

“Since announcing Marina Biotech's merger with IthenaPharma just six months ago, we have moved quickly to assemble an operational team and implement a strategy to advance our pipeline of combination therapies and novel oligotherapeutics. We are driven by our commitment to improve the lives of patients by delivering novel therapies that we believe will improve outcomes while reducing the undesirable side effects of many current therapies.

In the past several weeks, we announced preclinical and clinical data at several healthcare conferences for our two arthritis pain/hypertension drug candidates, IT-102 and IT-103. This data further supports the development of IT-102 and IT-103, not only for combined hypertensive/pain, but also for the treatment of cancers such as FAP and colorectal cancer. We also announced the signing of a definitive agreement with Windlas Healthcare to manufacture the IT-102 CTM batch for our pivotal phase III trial to be initiated in the first quarter of 2018...

...In addition to developing our pipeline of therapeutics, we are positioned to effectively tap into the significant partnership opportunities for our SMARTICLES and tkRNAi delivery platforms. In early-February, we announced a licensing agreement with LipoMedics through which Marina Biotech could receive up to $90 million in success-based milestone payments. We have obtained another line of credit with Autotelic Inc. to further extend the runway for the commercialization of IT-102 and IT-103. With the additional line of credit, definitive manufacturing agreement and strong clinical data findings, Marina is poised for execution going forward and prepared to support near term commercialization of its pipeline," concluded Mr. Ramelli.”

CITY OF INDUSTRY, CA--(Marketwired - Feb 10, 2017) - Marina Biotech, Inc. (OTCQB: MRNA), a biopharmaceutical company focused on the development and commercialization of innovative therapeutics for disease intersections of arthritis, hypertension and cancer, today announced that it has entered into two privately negotiated transactions pursuant to which it will issue an aggregate of approximately 6.15 million shares of its common stock for an effective price per share of $0.29. As a result of such transactions, the company will reduce the aggregate amount of its outstanding payables to its service providers by approximately $1.78 million.

"This is a very positive development for Marina Biotech," stated its CEO, Joseph W. Ramelli. "We completed this de facto financing at a 93% premium to yesterday's closing stock price of $0.15, and without any warrant coverage, even though the shares are restricted and thus cannot be sold for at least 6 months. I would like to thank these two service providers for believing in the strategic vision of the company and for wanting to take the ride along with us as shareholders."

MRNA ($0.10) announced merger with IthenaPharma,  a company focused on the development and commercialization of combination products for pain, arthritis, hypertension, and cancer.  The merger closed on November 15, 2016.

The merger with IthenaPharma will give Marina Biotech a clear path to revenue and profitability, with the potential for two commercial products by 2019. In addition, scientists at both companies see synergies between IthenaPharma's drugs and Marina's CEQ508 drug, unlocking its potential to treat not only familial adenomatous polyposis (FAP) but colorectal cancer in general. Both drugs target Beta-catenin and it is anticipated that within one year following the completion of the merger we would able enter clinical testing against colorectal cancer. The synergy of the combination is anticipated to de-risk and accelerate Marina Biotech's clinical development program...

...This merger is truly transformative for Marina Biotech, which has now become a clinical stage development and commercialization company. I am very excited about the prospects for the new Marina and am confident in our ability to create shareholder value," said Joseph Ramelli, CEO at Marina. "I have had the pleasure of getting to know Vuong quite well over the last four months and could not be more impressed with his vision and his history of innovation and value creation the biotech industry."

MRNA is issuing ~53 million shares of its common stock (roughly 64% of total outstanding shares) to the stockholders of IthenaPharma.  See the full transaction details and commentary from both parties here.

MRNA ($0.22) provided a Q1 2016business update.  Obviously the financials for an early stage biotech are relatively meaningless.  The key with MRNA will be the closing of the recent acquisition of Turing’s late-stage intranasal ketamine program. The company offered this commentary on the topic:

"The potential acquisition of Turing's late-stage intranasal ketamine program places us in a position where we can utilize our legacy expertise and experience to quickly move the compound to commercialization. We are excited to complete the transaction with Turing and begin moving the intranasal ketamine program forward. We believe this program offers a therapeutic alternative to a potentially broad patient base suffering from neuropsychiatric and pain disorders for which there are no effective therapeutic alternatives."

Upon the close of the transaction, the Company's main business will be the rapid advancement of the intranasal ketamine program for neuropsychiatric and pain indications with a focus on potential orphan disease opportunities. Over the coming weeks, Marina intends to assess the future needs of the Company, in order to put in place the best and most experienced Board of Directors and management team to take this valuable asset forward as quickly and as efficiently as possible.

The acquisition is expected to close by July 1, 2016.

BOTHELL, WA, and BAAR, SWITZERLAND--(Marketwired - May 3, 2016) - Marina Biotech, Inc. (OTCQB: MRNA), a leading nucleic acid-based drug discovery and development company focused on rare diseases and Turing Pharmaceuticals AG a privately-held biopharmaceutical company focused on developing and commercializing innovative treatments for serious diseases announced that the companies have executed a term sheet under which Marina intends to acquire Turing's intranasal ketamine program. Pending the negotiation of the definitive agreement, Marina is expected to acquire Turing's intranasal ketamine program for approximately 53 million Marina common shares.

The assets to be acquired will include all patents and intellectual property rights, clinical development plans, regulatory documents and existing product inventories. As per the term sheet, Marina will pay to Turing up to $95 million in success- and sales-based milestones plus a mid-single digit royalty on net sales. Further terms of the proposed transaction were not disclosed. 

"We are extremely pleased to have this opportunity to bring in a late-stage clinical program with the potential for approval in multiple indications including certain rare disorders," stated J. Michael French, President and CEO at Marina Biotech. "The program has been advanced worldwide with plans for U.S. and international clinical trial sites. The work thus far has predominately been directed at suicidality in post-traumatic stress disorder; a patient population with few, if any, therapeutic options. We believe the early clinical successes of this program combined with broadening acceptance of ketamine as a treatment for neurological and psychiatric diseases, presents a unique opportunity to rapidly move this compound into the U.S. market as early as 2019. In addition, there is some earlier work by academic centers suggesting that intranasal ketamine might be efficacious in patients suffering from certain rare diseases. We look forward to working with the Turing team to conclude this transaction and transfer the assets as quickly as possible in order to maintain the momentum of this program."

"We too are pleased to enter into this relationship with Marina and to have found a company capable of giving this program the priority it deserves," stated Eliseo Salinas, M.D., President of Research and Development at Turing Pharmaceuticals, "I have been impressed with the progress our research and development team has made over the past six months in advancing intranasal ketamine for the treatment of suicidality. I look forward to working with the Marina team to rapidly transition this program so that we can maintain our momentum and bring this compound to market as quickly as possible."

Marina's purchase of Turing's Phase 3 intranasal ketamine program is expected to close by July 1, 2016, pending the completion of customary due diligence considerations, the negotiation, execution and delivery of a definitive asset purchase agreement, and the satisfaction or waiver of the closing conditions set forth in the asset purchase agreement, including the completion by Marina of a financing transaction yielding proceeds sufficient to initiate and support the Phase 3 efforts. 

Mr. French added, "Regarding the sale of our nucleic acid therapeutics assets, which we previously announced in our press release dated March 15, 2016, we have terminated the on-going efforts to sell these assets to Microlin Bio, Inc. However, we continue to explore opportunities to advance our existing clinical and preclinical programs through either our own efforts or those of a collaboration partner and leverage our nucleic acid drug discovery engine through collaborative partnerships or sale. The Marina Board of Directors and I believe that the opportunity to bring the ketamine compound to market within the next four years combined with the ability to leverage our nucleic acid assets, creates the best opportunity to build value for our shareholders." 

BOTHELL, WA--(Marketwired - Mar 16, 2016) - Marina Biotech, Inc. (OTCQB: MRNA), a leading nucleic acid-based drug discovery and development company focused on rare diseases, announced today that they have entered into a license agreement covering the company's SMARTICLES and DiLA2 platforms for the delivery of an undisclosed genome editing technology. The agreement is notable in that it provides an exclusive access to Marina's SMARTICLES and DiLA2 platforms for a different gene editing field than was announced on February 17, 2016. This represents the first time that the company's combined delivery platforms, SMARTICLES and DiLA2 technologies, have been licensed in connection with gene editing. Under terms of the agreement, Marina could receive up to $40 MM in success based milestones. Further details of the agreement were not disclosed.

"With the execution of this gene editing delivery license agreement, the company extends its runway beyond the end of March," stated J. Michael French, president and CEO of Marina Biotech. "We are now beginning to see the rapid expansion of our delivery technologies in other therapeutic areas and hope to continue to capitalize on our ability to deliver nucleic-acid based compounds. We hope that the unique properties of our delivery technologies provide new therapeutic opportunities to the patient community."

MRNA ($0.17) is to pursue asset purchase and reverse merger opportunities.  MICB, a development stage biotechnology company focused on the development of microRNA based therapeutics for cancer, and Marina Biotech, Inc. (OTCQB: MRNA), a leading nucleic acid-based drug discovery and development company focused on rare diseases, announced that the companies have executed a term sheet under which Microlin intends to acquire Marina's nucleic acid therapeutics assets. Pending the negotiation of the definitive agreement and company shareholder approvals, Microlin is expected to acquire Marina's nucleic acid therapeutics assets for 6.7 million common shares and approximately $1 million in cash.

Quotes from MRNA management:

"The Marina Board of Directors and I believe the sale of our nucleic acid therapeutic assets to Microlin is the first step in creating the greatest value opportunity for our shareholders," stated J. Michael French, President and CEO at Marina Biotech. "We believe that our proprietary chemistries and delivery technologies are best suited for development of therapeutic compounds that modulate non-coding RNA. Therefore, we feel strongly that these technologies are synergistic and complementary to Microlin's novel microRNA assets and that Microlin is in a strong position to move these assets forward. We believe the second step to creating value for our shareholders is the acquisition of other assets or perhaps a reverse merger. The combination of two transactions permits Marina shareholders the potential to recognize value through two diverse clinical efforts -- nucleic acid therapeutics with Microlin and another asset we're currently in the process of identifying and negotiating. We look forward to working with the Microlin team to build value through the integration of Marina's technologies."

We are looking into the details of the transaction.

On November 25, 2014 we wrote this article, suggesting that Marina was a “forgotten and grossly undervalued game changer.”  Shares briefly traded up 17% to $1.10 after we published our article, but have since retraced sharply since then. We continue to believe that the company could be a potential takeover or partnership target.

After hours yesterday, MRNAfiled a registration withdrawal request as well as an updated investor presentation that was presented at the 2015 BIO International Convention on June 16, 2015.

“The Registration Statement, which has not been declared effective by the Commission, is being withdrawn due to recent changes in the Company’s financing plans. Specifically, the Company has determined that a significant capital raising transaction is not in the best interests of shareholders at this time. Instead, the Company intends to pursue other methods to advance its corporate strategy with a focus on near-term, non-dilutive fund raising through licensing and collaborative transactions.”

BOTHELL, WA and ANN ARBOR, MI--(Marketwire - Mar 14, 2012) - Marina Biotech, Inc. (OTCQX: MRNA), a leading nucleic acid-based drug discovery and development company, and ProNAi Therapeutics, Inc. (ProNAi), a privately-held biotechnology company pioneering DNA interference (DNAi) therapies for cancer, announced today that the Companies have entered into an Exclusive License Agreement regarding the development and commercialization of DNAi-based therapeutics utilizing Marina Biotech's novel SMARTICLES® liposomal delivery technology. ProNAi will have full responsibility for the development and commercialization of any products arising under the Agreement. Under terms of the Agreement, Marina Biotech could receive up to $14 million for each gene target in total upfront, clinical and commercialization milestone payments, as well as royalties on sales, with ProNAi having the option to select any number of additional gene targets. For example, if ProNAi licenses five products over time under this Agreement, Marina Biotech could receive up to $70 million in total milestones, plus royalties. Further terms of the Agreement were not disclosed.

"We are pleased that twenty-two patients have been dosed with PNT2258 in our Phase I clinical trial in advanced solid tumor patients to evaluate safety and tolerability, maximum tolerated dose, pharmacokinetics and pharmacodynamics. PNT2258 is our first DNAi oligonucleotide targeted against the anti-apoptotic bcl-2 oncogene and encapsulated in Marina's SMARTICLES® technology. This novel delivery technology offers protection for the DNAi oligonucleotide during systemic administration with good circulation times and extrahepatic tumor exposure. DNAi are short single-strand unmodified oligonucleotides designed to silence genes by interfering with DNA. The DNAi silencing approach is differentiated from that of RNAi, antisense or miRNA in that it targets genomic sequences within the noncoding region of DNA disrupting transcription. The progress and delivery validation in the clinic this past year on the novel DNAi-SMARTICLES® formulation gives us confidence to bring forward more first-in-class drug candidates alone or with partners. ProNAi is now positioned to advance additional cancer therapies from its pre-clinical leads targeting other oncogenes such as c-myc and k-ras while also exploring other disease targets in areas such as inflammation and genetics diseases," said Charles L. Bisgaier, Ph.D., President and CEO of ProNAi Therapeutics.

"We are extremely pleased to have entered into a relationship with a company like ProNAi that is developing a first-in-class nucleic acid therapeutic," stated J. Michael French, President and CEO of Marina Biotech. "In addition, we are excited to see the continued advancement of oligonucleotide-based therapeutics using our SMARTICLES^® technology. Besides advancements within our own internal research programs, we have now been able to establish two license agreements broadening the application of the SMARTICLES^® technology to the systemic administration of both single- and double-stranded oligonucleotide therapeutics. We look forward to the rapid advancement of ProNAi Therapeutics' clinical pipeline and the opportunity to bring novel therapeutics to patients in need."

ProNAi is conducting an open-label, single arm, Phase I dose-escalation study of PNT2258 in patients with advanced solid tumors for which no standard therapy exists at START in San Antonio, Texas. PNT2258 is ProNAi's first drug candidate from the DNAi drug platform. Patients receive PNT2258 as an intravenous infusion once daily for 5 consecutive days (Days 1-5) of every 21-day cycle (3 weeks). ProNAi plans to report the results of this Phase I study at oncology conferences later this year and initiate the next Phase I/II safety and efficacy studies in select cancer patients based upon the safety and dose findings from this Phase I study.