Athersys, Inc. | September 26, 2022
Athersys, Inc. a regenerative medicine company developing MultiStem® for critical care indications, announced that it has entered into amended agreements to extend the exercise period of the warrants that were issued as part of a registered direct offering that closed on August 17, 2022, among other changes, and to issue additional warrants to the same warrant holder, a healthcare-focused U.S. institutional investor.
The Purchase Agreement contains certain restrictions that, subject to certain exceptions, prohibit the Company from issuing its common stock in certain variable rate transactions for a period of 180 days following the Closing Date. The Purchase Agreement also gives the Purchasers the right to participate in certain future offerings of the Company in an amount of up to 30 percent in the aggregate of any offered securities during the 12 months following the Closing Date.
On September 22, 2022, the Company entered into an amendment to the Purchase Agreement with the Purchasers to, among other things, (i) extend the exercise period of the Initial Warrants from five years to seven years after the six-month anniversary of the Closing Date (the “Warrant Amendment”), (ii) reduce the Standstill Period from 180 days to 150 days following the Closing Date, (iii) reduce the term and amount of the Participation Right from twelve months to six months following the Closing Date and from 30 percent to 20 percent in the aggregate of any offered securities, respectively, and (iv) require the Purchasers, subject to certain conditions, to participate in the event the Company proposes to offer and sell shares of offered securities during the six months following the Closing Date to investors primarily for capital raising purposes.
In return, Athersys issued to the same warrant holder additional warrants that are exercisable for an aggregate of 2,000,000 shares of common stock and have an exercise price of $6.3850 for a seven-year period after the six-month anniversary of the date of issuance.
A more detailed discussion of the amendments is contained in a Current Report that Athersys filed on September 22, 2022 with the U.S. Securities and Exchange Commission on Form 8-K.
“We are pleased to have entered into this amendment with our new major investor which provides more financial flexibility going forward as well as a commitment for the investor that recently invested $12 million in Athersys to participate in future financings if requested. As Athersys continues to pursue licensing and other business development opportunities for our proprietary technology this amendment can help facilitate future transactions with financial and strategic investors. We are fortunate to have established a strong relationship with a prominent healthcare focused institutional investor that embraces the value of our MultiStem cell therapy and is responsive to our priorities,”
Dan Camardo, Chief Executive Officer of Athersys
“I am also pleased with progress we’ve made in our business transformation and I look forward to updating shareholders during a conference call to be held the week of October 3rd,” he added.
Athersys intends to issue a separate news release that will provide further information on the date and time of the call, as well as instructions regarding how to participate.
MultiStem® cell therapy is a patented regenerative medicine product in clinical development that has shown the ability to promote tissue repair and healing in a variety of ways, such as through the production of therapeutic factors in response to signals of inflammation and tissue damage. MultiStem therapy’s potential for multidimensional therapeutic impact distinguishes it from traditional biopharmaceutical therapies focused on a single mechanism of benefit. The therapy represents a unique “off-the-shelf” stem cell product that can be manufactured in a scalable manner, may be stored for years in frozen form, and is administered without tissue matching or the need for immune suppression. Based upon its efficacy profile, its novel mechanisms of action, and a favorable and consistent tolerability demonstrated in clinical studies, we believe that MultiStem therapy could provide a meaningful benefit to patients, including those suffering from serious diseases and conditions with unmet medical need.
Athersys is a biotechnology company engaged in the discovery and development of therapeutic product candidates designed to extend and enhance the quality of human life. The Company is developing its MultiStem® cell therapy product, a patented, adult-derived “off-the-shelf” stem cell product, initially for disease indications in the neurological, inflammatory and immune, and other critical care indications and has several ongoing clinical trials evaluating this potential regenerative medicine product. Athersys has forged strategic partnerships and a broad network of collaborations to further advance MultiStem cell therapy toward commercialization.
ElevateBio, LLC | November 07, 2022
ElevateBio, LLC (ElevateBio), a technology-driven company focused on powering transformative cell and gene therapies, announced the unveiling of ElevateBio BaseCamp’s proprietary LentiPeakTM lentiviral vector platform. LentiPeak is a serum-free, suspension-based, scalable production platform that has demonstrated high volumetric productivity of therapeutically relevant vector yields that meet regulatory guidelines. LentiPeak will enable efficient transition for cell and gene therapies from preclinical stage through clinical development and commercialization with accelerated timelines and reduced manufacturing costs.The LentiPeak platform leverages ElevateBio BaseCamp’s end-to-end process and analytical development expertise and scientific leadership and builds upon the company’s current Good Manufacturing Practice (cGMP) manufacturing capabilities for research, clinical and commercial cell and gene therapies, and regenerative medicines.
“As a 30-year veteran of the cell and gene therapy industry, I’ve witnessed the immense advancement of lentiviral vector technology from its infancy to the current landscape with six FDA-approved lentiviral vector-derived cell and gene therapies, The LentiPeak platform is made possible by ElevateBio’s strong scientific foundation, industry-leading expertise, and the investments we’ve made into viral vector production. Our pioneering work continues to be the basis for our continued innovation to drive many more therapies through development to commercialization for our partners.”
-Mitchell Finer, Ph.D., Co-founder and President of R&D, ElevateBio
ElevateBio BaseCamp’s LentiPeak platform offers a robust and scalable platform process for development and cGMP manufacturing of lentiviral vectors. The LentiPeak platform utilizes a serum-free suspension process capable of producing clinically relevant lentiviral vectors with high titers ranging from 1x10^8 TU/ml to 1x10^9 TU/ml, suitable to meet various therapeutic program needs from preclinical scale to commercial scale supply. The LentiPeak platform can also be seamlessly integrated into cell therapy programs with ElevateBio’s ability to conduct both vector and cell production activities. By leveraging the aligned process unit operations, materials, analytics, and manufacturing expertise at ElevateBio BaseCamp, the LentiPeak platform will simplify the product development and commercialization lifecycle, reducing complexity and ensuring comparability between early-stage and pivotal trials.
“Our team of industry-leading experts have developed next-generation platform-based processes that are designed to address lentivirus manufacturing challenges head-on. With our partners’ needs in mind, our proprietary LentiPeak platform has demonstrated leading vector titers with high potency, and process scalability to help our partners de-risk vector production, right from the start, At ElevateBio BaseCamp, we are ever committed to simplifying the complex cell and gene therapy landscape to enable our partners to rapidly progress their therapeutic programs and make these therapies more accessible to patients in need.”
-Andrew Sandford, President, ElevateBio BaseCamp
ElevateBio is a technology-driven company built to power the development of transformative cell and gene therapies today and for many decades to come. The company has assembled industry-leading talent, built state-of-the-art facilities, and integrated diverse technology platforms, including gene editing, induced pluripotent stem cells (iPSCs), and protein, vector, and cellular engineering, necessary to drive innovation and commercialization of cellular and genetic medicines. In addition, ElevateBio BaseCamp in Waltham, MA, is a purpose-built facility offering process innovation, process sciences, and current Good Manufacturing Practice (cGMP) manufacturing capabilities. It was designed to support diverse cell and gene therapy products, including autologous, allogeneic, and regenerative medicine cell products and viral vector manufacturing capabilities.
Through BaseCamp and its enabling technologies, ElevateBio is focused on growing its collaborations with industry partners while also developing its own portfolio of cellular and genetic medicines. ElevateBio's team of scientists, drug developers, and company builders are redefining what it means to be a technology company in the world of drug development, blurring the line between technology and healthcare.
CELL AND GENE THERAPY
BioAge Labs, Inc. | October 14, 2022
BioAge Labs, Inc. a privately held clinical-stage biotechnology company developing therapeutics that target the molecular causes of aging to extend healthy human lifespan, announced that it will present updates on its NLRP3 inhibitor program at two upcoming conferences in the United States, Neurodegeneration Targets and the Inflammasome Therapeutics Summit, and at the BIO-Europe 2022 conference in Leipzig, Germany. BioAge is developing its novel, proprietary class of NLRP3 inhibitors, which have distinct structural and biological properties and include molecules that penetrate the blood–brain barrier, for neurodegenerative and neurosensory disorders associated with aging.
“Our family of potent, structurally differentiated NLRP3 inhibitors demonstrates BioAge’s capability to discover novel compounds for promising targets emerging from our discovery platform. I am excited about the potential of these drugs to treat diseases driven by brain aging, and our team is looking forward to the opportunity to share recent data from this program at multiple important scientific gatherings.”
BioAge CEO and co-founder Kristen Fortney, PhD
At the inaugural Neurodegeneration Targets meeting hosted by Cambridge Healthtech Institute [link], Rusty Montgomery, PhD, Vice President, Biology, will deliver a talk titled “Identification of a Novel Class of Highly Potent, CNS-Penetrant NLRP3-Specific Inhibitors with Excellent Drug-Like Physical Features” in Boston, MA on Oct. 20, 2022. Kevin Willhelmsen, PhD, Associate Director of Immunology, will present on the same topic at the Inflammasome Therapeutics Summit [link] in Boston on Nov. 29, 2022.
In addition, at BIO-Europe [link], Peng Leong, PhD, MBA, Chief Business Officer and Head of Brain Aging at BioAge, will speak on a panel titled “Immuno-inflammation: A Gateway to Therapeutic Areas and New Partners” on Oct. 24, 2022. He will be joined by panelists Vishal Sahni, Director, Corporate Business Development and Strategy at H. Lundbeck A/S; Duncan Emmerton, Executive Director, Pharma Intelligence; and Andrew Mackie, Chief Business Officer, Imcyse.
“The BioAge target discovery platform revealed that NLRP3 activity is correlated with mortality and cognitive decline,” Leong said, “Inhibition of NLRP3 and other mediators of chronic inflammation identified by our platform has the potential to prevent multiple age-related disorders driven by pathologic inflammation.”
Leong will be available at BIO-Europe for potential partnership discussions. Attendees can send meeting requests to BioAge via the contact information in this release.
About BioAge Labs, Inc.
BioAge is a clinical-stage biotechnology company developing a pipeline of treatments to extend healthy lifespan by targeting the molecular causes of aging. The company uses its discovery platform, which combines quantitative analysis of proprietary longitudinal human samples with detailed health records to map out the key molecular pathways that impact healthy human aging. By targeting the mechanisms of aging with a large and mechanistically diverse portfolio of drugs, BioAge is unlocking opportunities to treat or even prevent age-related disease in entirely new ways. BioAge currently has multiple clinical-stage programs in its growing portfolio targeting muscle, immune, and brain aging. To date, BioAge has raised $127M from Andreessen Horowitz, Kaiser Foundation Hospitals, and others.