On January 26, 2022 Sierra Oncology, Inc. (NASDAQ: SRRA), a late-stage biopharmaceutical company dedicated to delivering targeted therapies for rare cancers, reported the pricing of an upsized underwritten public offering of 4,074,075 shares of its common stock and, in lieu of shares of common stock, to a certain investor, pre-funded warrants to purchase up to 925,925 shares of common stock pursuant to its existing shelf registration statement (Press release, Sierra Oncology, JAN 26, 2022, View Source [SID1234607414]). The shares of common stock are being offered at a public offering price of $27.00 per share and the pre-funded warrants are being offered at a public offering price of $26.999 per pre-funded warrant, which represents the per share public offering price for the common stock less the $0.001 per share exercise price for each pre-funded warrant. The expected gross proceeds to Sierra Oncology from the offering is approximately $135.0 million, before deducting underwriting discounts and commissions and other offering expenses. In addition, Sierra Oncology has granted to the underwriters a 30-day option to purchase up to 750,000 of additional shares of its common stock at the public offering price less underwriting discounts and commissions. Sierra Oncology intends to use the net proceeds of the offering to prepare for potential commercialization of momelotinib, clinical development of its other product candidates, research, clinical and process development and manufacturing of its product candidates, working capital, and capital expenditures and other general corporate purposes. All of the securities are being offered by Sierra Oncology. The offering is expected to close on or about January 31, 2022, subject to customary closing conditions.

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Jefferies and Cantor are acting as the joint book-running managers and representatives of the underwriters for the offering. LifeSci Capital, Oppenheimer & Co. and H.C. Wainwright & Co. are acting as lead managers for the offering.

A shelf registration statement on Form S-3 relating to the securities offered in the public offering described above was filed with the SEC on November 5, 2021 and declared effective by the SEC on November 12, 2021. A preliminary prospectus supplement and accompanying prospectus relating to the offering have been filed with the SEC and are available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to this offering may also be obtained, when available, by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 821-7388, or by email at [email protected]; or Cantor Fitzgerald & Co., Attention: Capital Markets, 499 Park Avenue, New York, New York 10022, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy the securities being offered, nor shall there be any sale of the securities being offered in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

On January 26, 2022 PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a clinical-stage biotherapeutics company reported that its Founded Entity, Akili Interactive ("Akili"), a leading digital medicine company developing cognitive treatments through game-changing technologies, has entered into a definitive agreement to become publicly traded via a merger with Social Capital Suvretta Holdings Corp. I ("SCS") (Nasdaq: DNAA), a special purpose acquisition company (Press release, PureTech Health, JAN 26, 2022, View Source [SID1234607433]). The transaction is expected to close in mid-2022, after which Akili will be listed on the Nasdaq stock market under the new ticker symbol "AKLI." As a public company with world-class backing and strong financial flexibility, Akili will be positioned to pioneer a new class of digital medicines for millions of people living with cognitive impairment.

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"Akili, as with all our Founded Entities, was co-invented and advanced through initial milestones by the PureTech team, and we are proud of Akili’s continued path of success, most notably with the FDA clearance of EndeavorRx and now with its potential listing on Nasdaq," said Bharatt Chowrira, Ph.D., J.D., President and Chief Business, Legal and Operating Officer of PureTech and Akili Board Member. "With Akili on its way to becoming yet another publicly-traded Founded Entity for PureTech, our unique model continues to demonstrate the multiple ways in which we are generating value at PureTech, including equity stakes in public and private Founded Entities, royalties and milestone payments due to us from certain invented products, pharma collaborations to advance non-core programs and – importantly – our rapidly progressing and advanced Wholly Owned Pipeline which we see as our major value driver going forward."

The full text of the announcement from Akili is as follows:

Akili Interactive, a Leader in Digital Medicine, to Become Publicly Traded Through Combination with Social Capital Suvretta Holdings Corp. I

●Akili’s leading digital therapeutic platform combines science and technology to address cognitive impairments in patients, reimagining how central nervous system medicines are designed, developed, and delivered

Transaction will support commercial launch of EndeavorRx, a first-of-its-kind, FDA-cleared and CE-marked prescription digital therapeutic for pediatric ADHD, as well as advance clinical development pipeline across multiple neuropsychiatric diseases, including expanded ADHD populations, multiple sclerosis, autism, and depression

●Transaction values the combined company at an equity value post-money of up to approximately $1 billion and is expected to provide up to $412 million in gross cash proceeds

●Fully committed PIPE of $162 million led by $100 million from Social Capital with remaining $62 million from new and existing investors including: Suvretta Capital Management’s Averill strategy, Apeiron Investment Group, Temasek, co-founder PureTech Health, Polaris Partners, Evidity Health Capital, JAZZ Venture Partners and Omidyar Technology Ventures

●Chamath Palihapitiya expected to become Chair of Akili’s Board of Directors upon transaction close

BOSTON, Mass. and PALO ALTO, Calif. – January 26, 2022 – Akili Interactive ("Akili" or the "Company"), a leading digital medicine company developing cognitive treatments through game-changing technologies, has entered into a definitive agreement to become publicly traded via a merger with Social Capital Suvretta Holdings Corp. I ("SCS") (Nasdaq: DNAA), a special purpose acquisition company. The transaction is expected to close in mid-2022, after which Akili will be listed on the Nasdaq stock market under the new ticker symbol "AKLI." As a public company with world-class backing and strong financial flexibility, Akili will be positioned to pioneer a new class of digital medicines for millions of people living with cognitive impairment.

New Digital Approach to Cognitive Medicine

The Akili software platform was built on the belief that directly engaging brain function is the next frontier of science and medicine. Cognitive impairments – including poor concentration, memory loss, difficulties learning new skills, and difficulties with decision making – are in aggregate among the largest unmet medical needs, and are increasingly recognized as contributing to or associated with dozens of chronic diseases and acute illnesses, including attention-deficit/hyperactivity disorder (ADHD), major depressive disorder (MDD), multiple sclerosis (MS), and autism spectrum disorder (ASD), as well as postoperative cognitive dysfunction and COVID-19 "brain fog."

Despite the rapidly growing prevalence of these conditions, the acute exacerbation of these issues by the pandemic’s impact, and the chronic, escalating cognitive overload from the proliferation of on-demand attention-capturing technology, there has been limited innovation of novel treatment options. Specifically, current treatment options are designed to focus on symptoms and coping strategies instead of directly targeting cognitive functioning. These therapeutic shortfalls are especially concerning for younger populations who are potentially facing a lifetime of managing these conditions.

Akili’s First-of-Its-Kind, Clinically Validated Therapeutic

By harnessing advances in cognitive neuroscience and consumer technology, Akili is changing the neuropsychiatric treatment paradigm. Akili’s patented and clinically validated technology platform represents a new category of software-based medicine: advanced and proprietary digital therapeutics that are designed to directly target neural physiology to better serve the needs of patients and their families.

Akili’s core therapeutic engine, the Selective Stimulus Management Engine (SSMETM), is specifically designed to target and activate neural systems involved in attentional control. This core platform has the potential to be applied across a diverse set of indications within psychiatry and neurology. Backed by robust clinical research, Akili’s treatments are delivered to patients through engaging interactive mobile games, personalized to each individual and built to feel like high-end entertainment products.

The SSMETM technology has already demonstrated proof-of-concept in controlled trials targeting attention and cognitive dysfunction in ADHD, ASD, MS, and MDD. Built on the SSMETM technology, Akili developed EndeavorRx, the first-ever FDA-cleared prescription video game and the first-ever FDA-cleared commercial product indicated to improve attention function in children between the ages of 8 to 12 years with primarily inattentive or combined-type ADHD (see full indication below).

Key Investment Highlights:

●Patented and clinically validated technology platform. Developed with the collaboration of cognitive neuroscientists and mobile game developers, Akili’s proprietary technology is designed to target key neural systems underlying specific cognitive functions through adaptable, personalized closed-loop algorithms. The technology is clinically validated, using recognized endpoints, and delivered through smartphones or other mobile devices.

● First-and-only FDA-cleared video game-based digital therapeutic. Anticipated to launch in the second half of 2022, EndeavorRx is the first and only prescription video game treatment with FDA clearance and a CE mark (designating it has met European health, safety, performance, and environmental requirements) in pediatric ADHD. EndeavorRx has been validated through multiple clinical trials, including large randomized, controlled trials demonstrating improved patient outcomes.

●Large and growing market opportunity. Tens of millions of people worldwide live with cognitive health issues, and many are actively searching for better solutions. With EndeavorRx, Akili is initially targeting the approximately $10 billion U.S. ADHD market. EndeavorRx will first launch for the FDA-cleared 8 to 12-year-old pediatric population. Akili is also seeking to expand into other U.S. ADHD populations, including younger children (3 to 7 years old), teens, and adults, while simultaneously working with a partner to gain approval as a treatment for pediatric ADHD in Japan.

● Strong clinical rigor. Akili has completed 20 clinical trials across 2,900 patients and nine disease populations. In addition, Akili’s clinical studies and data have been published in 16 leading peer-reviewed journals.

● Robust research and clinical pipeline. Akili has a strong development pipeline, initially focused on treatments for cognitive impairments across nine patient populations. In addition, Akili is progressing early discovery for two new platform technologies to address additional cognitive impairments and facilitate broader reach across disease spectrums. Akili is poised to begin pivotal studies in multiple indications where proof-of-concept has been achieved, including additional ADHD populations, ASD, MS, and MDD.

Management Comments

Eddie Martucci, Chief Executive Officer of Akili, said: "This transaction represents the next step in our journey to become the world’s leading digital medicine company directly targeting neurological function. Over the past 10 years, we have created a platform representing a new era of cognitive medicine, driven by our fundamental focus on patients, advanced science and proprietary technology, and the mission-driven hard work of our entire team. We believe medicine now can be both effective and engaging. Social Capital Suvretta shares our vision for the future, and we look forward to applying our combined experience as we drive the commercialization of our platform and advance our deep pipeline of prescription digital therapeutics to help people living with cognitive impairments across the globe."

Chamath Palihapitiya, Founder and CEO of Social Capital and Chairman and CEO of SCS, commented: "Akili is taking a new approach to cognitive science – using software to target our underlying cognitive function and creating an entirely new class of medicine as a byproduct. With its first-ever, clinically validated digital therapeutic (EndeavorRx), Akili has the unique opportunity to change how we treat pediatric ADHD. They have also laid the groundwork to treat a wide range of other cognitive issues affecting tens of millions of people around the world."

Kishen Mehta, Portfolio Manager of the Averill strategy at Suvretta Capital Management and President of SCS, said: "Akili has created a unique disease-agnostic technology platform with an advanced pipeline of product candidates across multiple indications where proof-of-concept has already been achieved. The Company is leading the advancement of digital cognitive therapies with an FDA-cleared product already on the market, and we believe Akili has only just scratched the surface of this new and exciting field of medicine. We look forward to working with Akili to accelerate the Company’s growth and allow it to continue developing treatment options for the hundreds of millions of people living with cognitive impairments."

Transaction Overview

The transaction implies a post-money equity value of the combined company of up to approximately $1 billion and is expected to deliver up to $412 million in gross cash proceeds to the Company, including the contribution of up to $250 million of cash held in SCS’s trust account and $162 million from PIPE investors at $10 per share. All references to available cash from the trust account and retained transaction proceeds are subject to any redemptions by the public shareholders of SCS and payment of transaction expenses. Akili plans to use the net proceeds to help fund the Company’s go-to-market strategy, to further advance its pipeline of prescription digital therapeutics targeting a range of chronic and acute cognitive disorders, and for other general corporate purposes.

Existing Akili shareholders will roll 100% of their equity into the combined company and will be eligible to receive additional SCS shares pursuant to an earnout based on the combined company’s future stock performance.

Chamath Palihapitiya is expected to join Akili’s board of directors as chair, upon the close of the transaction.

The proposed business combination, which has been unanimously approved by the boards of directors of both Akili and SCS, is expected to close in mid-2022, subject to approval by SCS’s and Akili’s shareholders, regulatory approvals, and other customary closing conditions.

Advisors

Morgan Stanley & Co. LLC ("Morgan Stanley") and Cowen and Company, LLC ("Cowen") are serving as financial advisors to Akili. Morgan Stanley, Credit Suisse, and Cowen are serving as co-placement agents to SCS with respect to the portion of the PIPE financing raised from non-insider qualified institutional buyers and institutional accredited investors. Morgan Stanley, Credit Suisse, and Cowen are not acting as agents or participating in any role with respect to, and will not earn any fees from, the portion of the PIPE financing raised from insiders and individual investors. Credit Suisse and Cowen are serving as capital markets advisors to Akili. BofA Securities, Inc. is acting as capital markets advisor to SCS.

Goodwin Procter LLP is serving as legal counsel to Akili. Wachtell, Lipton, Rosen & Katz is serving as legal counsel to SCS. Skadden, Arps, Slate, Meagher & Flom LLP is serving as legal advisor to the PIPE placement agents.

Conference Call Information

A presentation made by the management teams each of Akili and SCS regarding the transaction will be available at View Source at 8:00 AM ET.

Additional information about the proposed transaction, including an investor presentation, will be provided in a Current Report on Form 8-K to be filed by SCS with the Securities and Exchange Commission and available at www.sec.gov.

On January 26, 2022 Sysmex Inostics, a global leader in the liquid biopsy revolution for oncology, reported the use of their HPV-SEQ test in the prospective University of Chicago clinical trial,1 "Pilot Study of Chemotherapy for HPV-Associated Oropharyngeal Cancer (Press release, Sysmex Inostics, JAN 26, 2022, View Source [SID1234607397])."

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"The ability to reliably detect HPV-DNA in plasma at such low frequency shows HPV-SEQ could be a promising non-invasive biomarker test for effectively assessing treatment response, appropriately de-intensifying treatment using real-time dynamic HPV quantification, and monitoring HPV-positive OPC patients’ post-treatment," said Dr. Nishant Agrawal, Professor of Surgery at the University of Chicago. "Therefore, the HPV-SEQ test has the potential to be an important tool for oncologists in treating patients with HPV-associated head and neck cancer," he concluded.

Current standard therapy used to treat OPC patients is associated with acute and long-term toxicities from chemotherapy, radiation, and surgery.2 In the trial, Dr. Agrawal and team will dynamically assess the level of cfHPV-DNA in patients’ blood and use this information to de-intensify treatment which would improve therapeutic outcome while minimizing treatment-associated toxicity.

Sysmex Inostics senior director of medical affairs, Fred Jones, noted, "The University of Chicago trial is a strong step forward in showing the clinical utility of HPV-SEQ test as a tool in treating patients with HPV-associated head and neck cancer. We look forward to the results of the trial."

HPV-associated OPC has increased dramatically over the last decade. In the United States HPV is thought to cause 70% of oropharyngeal cancers, back of the throat, including the base of the tongue and tonsils.3

Approximately 10 percent of men and 3.6 percent of women in the U.S. have HPV in their mouths and HPV infection is more commonly found with older age. While most people clear the infections on their own within a year or two, in some people HPV infection persists.4 Patients with HPV-driven disease respond better to treatment and demonstrate a more favorable prognosis, compared to patients with HPV negative head and neck cancer.

HPV-SEQ, Sysmex Inostics ultra-sensitive quantitative, CLIA-validated, blood test for the detection of cell-free HPV 16/18 DNA (cfHPV-DNA), will be used in the trial to monitor personalized treatment and de-escalation of HPV positive oropharyngeal cancer (OPC) patients. HPV-SEQ, which can detect as few as 5 HPV 16/18 molecules in a background of 20,000 wild-type molecules (0.025% allele frequency), empowers this ground-breaking trial. The protocol was published in the recent BMC Cancer paper,5 "Prospective study evaluating dynamic changes of cell-free HPV-DNA in locoregional viral-associated oropharyngeal cancer treated with induction chemotherapy and response-adaptive treatment."

The trial is a follow-on to the poster6 presented at the 2021 ASCO (Free ASCO Whitepaper) Annual Meeting in which Dr. Agrawal described how HPV-SEQ exhibits robust quantitative detection of cfHPV-DNA across a broad dynamic range, thus enabling high-resolution monitoring for patients with HPV positive OPC.

HPV-SEQ is available as a testing service provided by the Sysmex Inostics CLIA lab in Baltimore. MD.

January 26, 2022 Epizyme, Inc. (Nasdaq: EPZM), a fully integrated, commercial-stage biopharmaceutical company developing and delivering novel epigenetic therapies, reported that it intends to offer and sell shares of its common stock in an underwritten public offering (Press release, Epizyme, JAN 26, 2022, View Source [SID1234607415]). Epizyme also intends to grant the underwriters a 30-day option to purchase up to an additional fifteen percent (15%) of the shares of common stock offered in the offering. All of the shares in the proposed offering are to be sold by Epizyme.

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Epizyme anticipates using the net proceeds from the offering, together with its existing cash, cash equivalents and marketable securities, to fund global development and commercialization costs of tazemetostat outside of Japan, including the costs of conducting the Company’s ongoing and planned clinical trials of tazemetostat, including the Company’s confirmatory Phase 1b/3 trials in epithelioid sarcoma and follicular lymphoma (FL), the Company’s clinical trials of tazemetostat in additional FL populations and the Company’s clinical trials of tazemetostat across multiple types of hematological malignancies and solid tumors; to fund the Company’s Phase 1/1b trial of its SETD2 inhibitor, EZM0414 and the discovery and identification of additional product candidates to expand the Company’s pipeline of novel epigenetic therapies; to fund initiatives to accelerate commercial adoption of TAZVERIK; and for working capital and other general corporate purposes, which may include the acquisition of companies or businesses or licensing of other products, businesses or technologies, and repayment and refinancing of debt.

Jefferies is acting as lead bookrunner for the proposed offering. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

The shares are being offered by Epizyme pursuant to a shelf registration statement that was previously filed with the U.S. Securities and Exchange Commission ("SEC") on May 6, 2021 and declared effective by the SEC on May 13, 2021. The offering will be made only by means of the written prospectus and prospectus supplement that form a part of the registration statement. The preliminary prospectus supplement relating to and describing the terms of the offering is expected to be filed with the SEC and, if and when filed, copies of the preliminary prospectus supplement relating to the offering may be obtained for free by visiting the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the securities being offered may also be obtained by contacting: Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by telephone at (877) 821-7388, or by email at [email protected]. The final terms of the offering will be disclosed in a final prospectus supplement to be filed with the SEC.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of, the securities being offered in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

On January 26, 2022 Servier, an independent international pharmaceutical company, reported that it has partnered with French start-up Epigene Labs to develop an artificial intelligence-based application that prioritizes new cancer drug targets to determine the best therapeutic pathway to treat cancer patients (Press release, Servier, JAN 26, 2022, View Source;utm_medium=rss&utm_campaign=oncology-servier-collaborates-to-create-innovative-application-for-researchers [SID1234607399]). The application will be deployed within Servier R&D in the first quarter of 2022.

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Founded in January 2019, French startup Epigene Labs has developed the mCUBE platform with augmented intelligence for aggregating and analyzing genomic data in oncology to derive biomarkers and prioritize new cancer drug targets.

Based on Epigene Labs’ mCUBE platform, the application is perfectly suited for oncology projects and Servier R&D users. The mCUBE platform allows users to cross-analyze clinical and molecular data (omics data) through a suite of dynamic dashboards, accelerating the decision-making process in the early phases of oncology projects.

Epigene Labs has developed this application based on specifications provided by Servier’s teams from several fields of expertise (Bioinformatics, IT/data, oncology, Digital Information and Data System – DIDS). The mCUBE platform is widely deployed among Servier R&D users. In order to ensure continuous improvement, users will regularly share their feedback with Epigene Labs teams.

According to Céline Lefebvre, Ph.D., who leads the computational medicine team at Servier R&D and who is in charge of this project: "Epigene Labs has delivered a solution that is perfectly adapted to Servier’s projects in the field of oncology and that is in line with Servier’s Data&IA R&D strategy. The mCUBE platform will accelerate our decision making. It is a great lever for improving our working methods for the benefit of cancer patients.

Akpéli Nordor, Pharm.D., Ph.D., co-founder and CEO of Epigene Labs, added, "Epigene Labs is pleased to work with Servier to demonstrate the utility of its tools. As oncologists, we have a unique understanding of the tools other oncologists need to accelerate data-driven drug discovery, biomarker identification and patient selection. We look forward to continuing our collaboration with Servier to rapidly deliver the best treatments to cancer patients."

The partnership with Epigene Labs illustrates Servier’s open and collaborative innovation dynamic, which aims to surround itself with a network of diversified partners to accelerate therapeutic innovation and offer patients innovative and personalized treatments.

Céline Triquel, Open Innovation Project Manager at Servier, concludes: "This project called for collaborative work methods, agility, courage and perseverance, with the objective of developing innovations for the patient. I would like to thank all the contributors to this project, which illustrates our willingness and ability to access and integrate cutting-edge technologies, driven by open innovation and supported by the startup@servier program. "*

* The startup@servier program aims to create value for the startup and Servier with the objective of accelerating therapeutic innovation for the benefit of patients. A first phase of joint work allows the startup to conduct a key study or pilot application of a technology, before entering into a classic collaboration.