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Sangamo Therapeutics (SGMO)

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As some know I have moved my interests into gene therapy and edit stocks.

I wrote couple of articles about Sangamo Therapeutics on SA

https://seekingalpha.com/article/4325158-despite-skepticism-sangamo-is-buy

 

and this one

https://seekingalpha.com/article/4328714-deal-biogen-boosts-recommendation-to-buy-sangamo-shares

Those who are interested to discuss Sangamo on the board here, are welcome to join.

This board is free and remains semi-monitored so no garbage gets in.

 

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Sangamo's GM to take place on May 18th. Asking to double the shares availability as they are short with 160M to cover options, 24M to Biogen etc.

 

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140M shares after the Biogen transaction, I think the company needs to be sensible how they hand out options. I will likely vote no to this proposal. They need to manage with reasonable expectations in those no so reasonable times. 

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Shorts cover 1m shares after Biogen deal. 16.5M shorts remain. 

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According to the proxy for the purpose of the general meeting, the issuance of the stock is addressed as follows:

"As of the close of business on March 20, 2020, of our 160,000,000 authorized shares of common stock, there were 116,211,355 shares of common stock issued and outstanding. In addition to the 116,211,355 shares of common stock outstanding on March 20, 2020, there were 24,420,157 shares reserved for issuance pursuant to that certain stock purchase agreement we entered into on February 26, 2020 with Biogen MA, Inc. and the remainder of our authorized shares of common stock as of the close of business on March 20, 2020 have all been reserved for issuance under our various equity compensation plans, including the 2018 Plan. Accordingly, at present, there are no available unissued and unreserved authorized shares of our common stock, including to give effect to the proposed Share Reserve Amendment with respect to the Amended 2018 Plan that is part of Proposal No. 3. In this regard, the effectiveness of the Share Reserve Amendment and the ISO Limit Amendment that are part of Proposal No. 3 are contingent upon approval of this Proposal No. 4 by our stockholders."

As it has been inaccurately stated elsewhere, the Biogen deal is not based on additional issuance of shares through this proposal. The change to the incentive plan from 2018 to 2020, is argued to have 9.9M shares addition, and that is the sole reason. Although a common practice, it is rather insensitive to require doubling of the shares. So having $600M, including the burn for the first quarter, literally is not enough to carry the company, even though $275M from Pfizer is being heralded as being on a cusp, and needing time. The $6.3B is not also considered as a potential income?

Why this meeting not one in 2021 or 2022?

Why not ask for 20M shares? The fiscal discipline has been mediocre, and it will continue having approved 160M shares.  The incentive plan simply asks for 50% more shares to be awarded yearly. Why?

I would not mind if they were buying those optioned shares. Macrae has 1M in options but owns zero. It is ATM, nothing else. I am going to vote no. This does not threaten the Biogen deal. And perhaps if it is because Biogen will not pay $9.21 per share and the management is ok to change the volume of shares to a larger amount than 24M.   

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Sangamo Announces Closing of Biogen Collaboration Agreement

- Sangamo has received $225 million in stock proceeds; will receive additional $125 million upfront license fee by May 8, 2020

BRISBANE, Calif.--(BUSINESS WIRE)--Apr. 9, 2020-- Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicine company, today announced the closing of its previously announced sale of stock to Biogen Inc. (Nasdaq: BIIB) and that the global licensing collaboration agreement with Biogen for the development and commercialization of gene regulation therapies for Alzheimer’s, Parkinson’s, neuromuscular and other neurological diseases is now effective. Under the terms of the collaboration, Sangamo has received $225 million from the purchase by Biogen of newly issued Sangamo stock and will receive an upfront license fee of $125 million from Biogen no later than May 8, 2020. Additionally, Sangamo is eligible to earn up to $2.37 billion in other development, regulatory and commercial milestone payments, including up to $925 million in pre-approval milestone payments and up to $1.445 billion in first commercial sale and other sales-based milestone payments. Sangamo is also eligible to earn tiered high single-digit to sub-teen double-digit royalties on potential net commercial sales of products arising from the collaboration.

“The Biogen transaction exemplifies our strategy to partner assets when we believe that a collaborator’s financial resources and clinical and therapeutic area expertise will enable more rapid development and availability of new treatments to patients,” said Sandy Macrae, Sangamo’s CEO. “Importantly, with the addition of the upfront consideration from this agreement, we believe we have the balance sheet strength to execute on our wholly owned and partnered development programs through multiple important milestones, including the potential filing of the BLA for SB-525 for hemophilia A.”

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Sangamo Appoints D. Mark McClung as Executive Vice President and Chief Business Officer

April 17, 2020 at 8:30 AM EDT

BRISBANE, Calif.--(BUSINESS WIRE)--Apr. 17, 2020-- Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicine company, today announced the appointment of D. Mark McClung as Executive Vice President and Chief Business Officer. Mr. McClung will oversee commercial strategic planning, alliance management and corporate and business development.

Mr. McClung’s appointment is the latest in the evolution of Sangamo’s leadership implemented over the last three years as the Company’s technology and research programs have advanced into a diversified pipeline of therapeutic product candidates in various stages of clinical development. During this period, Sangamo has also appointed executive vice presidents overseeing R&D, manufacturing, legal and finance.

“I’m excited to welcome Mark to Sangamo. With our first product candidate entering Phase 3 and our broad pipeline of proprietary and partnered programs advancing in development, we are increasingly focused on late stage development and commercialization strategies for genomic medicines. Mark has extensive experience leading commercial organizations in therapeutic areas where innovative products have disrupted standards of care,” said Sandy Macrae, Sangamo’s CEO.

From 2015 through 2019, Mr. McClung was Vice President and General Manager of Global Oncology Commercial at Amgen, which he joined from Onyx Pharmaceuticals where he had served as Chief Commercial Officer. For two decades prior, Mr. McClung held roles of increasing responsibility at GlaxoSmithKline in marketing and sales, commercial operations, and general management in the United States and Europe, including as Vice President and Head of Global Commercial for GSK Oncology from 2009 – 2013.

“Over the next decade, genomic medicines have the potential to transform the practice of health care across therapeutic areas from rare monogenic diseases to immunology and oncology, and even to highly prevalent neurological disorders such as Alzheimer’s disease and Parkinson’s disease,” Mr. McClung commented. “With its deep scientific expertise, diverse technology platforms, broad pipeline and significant collaborations, Sangamo is well positioned for this new era, and I’m thrilled to join the Company at this time.”

Stephane Boissel, Executive Vice President of Corporate Strategy, will leave Sangamo at the end of July and eventually return to an entrepreneurial project. Mr. Boissel joined Sangamo in 2018 following the acquisition of TxCell (now Sangamo France), where he had served as CEO.

“Stephane’s impactful contributions to Sangamo will endure for many years. He has driven several remarkable deals to fruition, including most recently our transaction with Biogen, which is among the largest preclinical collaboration deals ever,” Macrae said. “It has been an enormous pleasure working with Stephane these last two years, and we wish him every success in the future.”

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The completion of the Biogen transaction should have helped Sangamo regain some lost ground from the perspective of COVID-19 impacts on the general market conditions. The transition of leadership is a bit old, new song. McClung replacing Boissel is likely not to have any added value. Boissel was named as the deliverer of the Biogen deal, and it is hard to define his specific contribution.

Macrae, in his characteristically overdoing format stated:

“He has driven several remarkable deals to fruition, including most recently our transaction with Biogen, which is among the largest preclinical collaboration deals ever.”

Boissel has sold Macrae TxCell for over $80M in cash. That was pretty remarkable for a company like Sangamo to buy another with cash. A company that could have been purchased for a much smaller amount to avoid bankruptcy.  I can credit Boissel with the two transactions,  but the “several” means more than two. Something not yet clearing the internal, confidential basket was also happening under his watch? Time will tell. Probably just Macrae's desire to make things up bigger than they really are is the reason for several. 

Pfizer, now the full owner of the SB-525, will report or not report on the start of phase 3, which most fear is not going to happen due to pandemic. April was suppose to be the math to start the trial, based on 6 months lead-in study. The update on phase 2, adding two more participants to match BioMarin’s phase 2 count, seem to be continuing, and it will likely extend the timeline as the trial shows recruiting in progress.

Still, it would be nice to see how five patients dosed have managed since the update in October. For some of them, the last six months is a longer period than the one reported in October. What will Pfizer do? A big reason why stock could do well, seem to be no longer in hands of the company. Pandemic took care of the rest, it could be, this entire year is again a loss of time. One can never be optimistic here, so I am not. 

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140M shares outstanding Sangamo is above $1B mark right now. 

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Mogrify and Sangamo announce collaboration and exclusive license agreement for Mogrify’s iPSC- and ESC-derived regulatory T cells

April 21, 2020 at 7:00 AM EDT
Download PDF
CAMBRIDGE, England & BRISBANE, Calif.--(BUSINESS WIRE)--Apr. 21, 2020-- Mogrify Ltd (Mogrify®), a UK company aiming to transform the development of cell therapies by the systematic discovery of novel cell conversions, and Sangamo Therapeutics (Sangamo) (Nasdaq: SGMO), a genomic medicine company, today announced that they have executed a collaboration and exclusive license agreement for Sangamo to develop allogeneic cell therapies from Mogrify’s proprietary induced pluripotent stem cells (iPSCs) and embryonic stem cells (ESCs) and Sangamo’s zinc finger protein (ZFP) gene-engineered chimeric antigen receptor regulatory T cell (CAR-Treg) technology.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200421005170/en/

“Mogrify is delighted to announce its second commercial deal with a US biopharma and the first in the exciting field of T cell immunotherapy,” said Dr. Darrin M. Disley OBE, CEO, Mogrify. “The combination of Mogrify’s proprietary systematic cell conversion technology and Sangamo’s regulatory T cell platform and proprietary ZFP platform is a natural fit. Sangamo is at the forefront of the development of a world-class engineered ZFP genome editing platform and we are very happy to be partnering with such an innovative company.”

“This license agreement provides Sangamo with access to Mogrify’s cell conversion technology, which will diversify our options as we develop off-the-shelf allogeneic CAR-Treg cell therapies,” said Jason Fontenot, SVP, Head of Cell Therapy at Sangamo. “We expect this collaboration to accelerate our development of scalable and accessible CAR-Treg cell therapies, so that we can potentially deliver treatments to patients with inflammatory and autoimmune diseases more rapidly.”

Mogrify’s technology enables the transformation of any human cell type into any other human cell type. This transformation is achieved using transcription factors or small molecules identified using proprietary big data technologies. iPSCs and ESCs provide an evergreen starting material for the generation of Tregs, and facilitate more complex engineering and greater manufacturing scalability, potentially enabling the resulting therapies to be more cost-effective and thus more accessible to larger patient populations.

Under the terms of the agreement, Mogrify will be responsible for the discovery and optimization of the cell conversion technology from iPSCs or ESCs to regulatory T cells, and Sangamo will be granted exclusive rights to use Mogrify’s technology to create Tregs from iPSCs or ESCs. Sangamo expects to then use its ZFP gene-engineering technology and therapeutic development capabilities to transform these Tregs into novel “off-the-shelf” allogeneic CAR-Treg cell therapy candidates and hopes to take them through clinical development through to registration for the treatment of inflammatory and autoimmune diseases.

Under the terms of the agreement, Sangamo will pay Mogrify an upfront payment. Mogrify is also eligible to receive potential additional payments related to development and regulatory milestones, and product sales.

About Mogrify Direct Cell Conversion Technology

The Mogrify platform (Rackham et al., Nature Genetics, 2016)* takes a systematic big-data approach that leverages data from next-generation sequencing and the construction of gene-regulatory networks (DNA-protein & protein-protein), to identify, the transcription factors (in vitro) or small molecules (in vivo) needed to convert any source human cell type into any target human cell type. The Mogrify platform offers the potential to optimize cell conversions in order to deliver cells that exhibit improved safety, efficacy and scalable manufacturing profiles suitable for development as cell therapies.

*Rackham OJL et al, A predictive computational framework for direct reprogramming between human cell types. Nature Genetics 48(3), 331–335 (2016).

About Sangamo’s Regulatory T cells (Tregs) and CAR-Tregs Technology

Tregs are a subset of T lymphocytes and act as the key regulators of the immune system. They ensure that the immune system does not mistakenly harm healthy organs while still protecting the body from pathogenic microorganisms.

CAR-Tregs are regulatory T cells (or Tregs) which are genetically engineered with a Chimeric Antigen Receptor (CAR) to precisely target sites of autoimmune and inflammatory pathology. Sangamo’s CAR-Treg platform aims to use CAR and zinc finger protein (ZFP) technologies to genetically engineer Tregs ex vivo to treat autoimmune and inflammatory diseases.

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Tuesday, April 28th, Pfizer reports Q1.
Some expectations toward progress on SB-525 can be held. The last update from phase 2 trial had a cutoff data from October. 6 months offer a potent update on stability/durability of the treatment. The 18 months' threshold is still some time away. The 18 months marks the fading of Bio Marin's treatment. For Sangamo, this time frame arrives in June and August.
Perhaps the announcement of phase 3 start could be expected as well. It is hard to have expectations of significant recruitment into a trial.

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Rumor Sanofi is going to buy QURE. A comparable company to SGMO. I wrote an article comparing the two. 

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I have been enjoying a bit of returns on Sangamo. I managed to average in mid 8s, so about 31%, The data release for hemophilia A is still ahead of us. Pfizer is starting the phase 3 in July delayed by the pandemic. Bigen deal worth billions, is going to make the company a multi-billion entity based on targeting Alzheimer's and Parkinson's. It will take time longer than shorter, but when it happens, it could be North of $50 per share. 

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