On July 19, 2021 CytoDyn Inc. (OTCQB: CYDY), ("CytoDyn" or the "Company"), a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, reported that Nader Pourhassan, Ph.D., President and Chief Executive Officer, Scott Kelly, M.D., Chairman, Chief Medical Officer and Head of Business Development, and Christopher Recknor, M.D., Chief Operating Officer and Head of Clinical Development, will host an investment community webcast on Thursday, July 22, 2021 (Press release, CytoDyn, JUL 19, 2021, View Source [SID1234585148]).

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Management will provide a full discussion of the results from the recently reported data from the mTNBC trials, along with updates on cancer, COVID-19, and NASH trials, and the status of the resubmission of the BLA for HIV.

Management will provide approximately 60 minutes to address questions submitted online by analysts and investors.

Prior to the webcast, questions can be submitted online to [email protected].
During the webcast, questions can be submitted through the webcast link below.
This is a "listen only" webcast, which can be accessed via CytoDyn’s corporate website at www.cytodyn.com under the Investors section/IR Calendar and will be archived for 30 days. Participants are encouraged to go to the website 15 minutes prior to the start of the webcast to register, download and install any necessary software. Please note the below website will not be operational until approximately 60 minutes prior to the start of the webcast, which can be accessed via the following link:

https://78449.themediaframe.com/dataconf/productusers/cydy/mediaframe/46064/indexl.html

The replay will be available approximately 60 minutes after the conclusion of the webcast and can be accessed via the above link until August 22, 2021.

On July 19, 2021 Brickell Biotech, Inc. (Nasdaq: BBI) ("Brickell" or the "Company"), a clinical-stage pharmaceutical company focused on developing innovative and differentiated prescription therapeutics for the treatment of debilitating skin diseases, reported that it has entered into an underwriting agreement with H.C. Wainwright & Co., LLC under which the underwriter has agreed to purchase on a firm commitment basis 8,064,517 shares of common stock of the Company at a price to the public of $0.62 per share, less underwriting discounts and commissions (Press release, Vical, JUL 19, 2021, View Source [SID1234585086]). The closing of the public offering is expected to occur on or about July 22, 2021, subject to satisfaction of customary closing conditions.

H.C. Wainwright & Co. is acting as the sole book-running manager for the offering.

The Company has granted to the underwriter a 30-day option to purchase up to an additional 1,209,677 shares of common stock at the public offering price, less underwriting discounts and commissions.

The gross proceeds of the offering are expected to be approximately $5.0 million, before deducting underwriting discounts and commissions and offering expenses payable by Brickell and assuming no exercise of the option to purchase additional shares. The Company intends to use the net proceeds of the offering for research and development, including clinical trials, working capital and general corporate purposes.

The shares of common stock described above are being offered by the Company pursuant to a "shelf" registration statement on Form S-3 (File No. 333-254037) filed with the Securities and Exchange Commission ("SEC") and declared effective on March 17, 2021. The offering of the shares of common stock is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A preliminary prospectus supplement and the accompanying prospectus relating to the offering have been filed with the SEC and are available on the SEC’s website at www.sec.gov. Electronic copies of the preliminary prospectus supplement and the accompanying prospectus, and the final prospectus supplement and accompanying prospectus, when available, may also be obtained by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by e-mail at [email protected] or by calling (212) 856-5711.

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This announcement is neither an offer to sell, nor a solicitation of an offer to buy, any of these securities and shall not constitute an offer, solicitation or sale in any state or jurisdiction in which such offer, solicitation, or sale is unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. Any offer, if at all, will be made only by means of the prospectus forming a part of the effective registration statement.

On July 19, 2021 PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a clinical-stage biotherapeutics company reported that its Founded Entity, Gelesis, Inc. ("Gelesis") and Capstar Special Purpose Acquisition Corp. (NYSE: CPSR) ("Capstar"), have entered into a definitive business combination agreement (Press release, PureTech Health, JUL 19, 2021, View Source [SID1234585018]). Upon completion of the transaction, the combined company’s securities are expected to be traded on the New York Stock Exchange (NYSE) under the symbol "GLS (Press release, PureTech Health, JUL 19, 2021, View Source [SID1234585018])."

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"Upon completion of the transaction, Gelesis will be PureTech’s third publicly-traded Founded Entity. Based on the expected valuation, Gelesis, along with Karuna and Vor, will have a combined value of over $5.4 billion," said Eric Elenko, Chief Innovation Officer at PureTech. "This is just another example of the unique and multi-pronged model PureTech has created to advance meaningful treatments for patients and drive future growth. We are very pleased with the progress that has been made towards the broad commercial launch of Plenity later this year and that Gelesis has the resources to meet the increasing demand."

Gelesis and Capstar will host a joint investor conference call to discuss the transaction today, July 19, 2021, at 8:30 a.m. Eastern Time. A telephone replay of the call will be available until July 29, 2021 via the same numbers, and a replay of the webcast will be archived on the investor relations website.

The conference call can be accessed via webcast on Gelesis’ investor relations website at gelesis.com/investors, or by dialing +1 844-512-2921 within the U.S. or +1 412-317-6671 for international callers and entering the passcode 1145464.

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

Gelesis, a Consumer-Focused Biotherapeutics Company and the Maker of Plenity, to Become a Publicly Traded Company via Merger with Capstar Special Purpose Acquisition Corp.

· Building on the successful beta launch of its first product Plenity, Gelesis aims to transform weight management. Gelesis developed a novel biomimetic therapeutic platform that has yielded Plenity and an advanced pipeline of therapeutic candidates for a range of other gut-related disorders

· Plenity makes it easier to eat less and feel fuller with smaller portions and offers a new weight management solution for over 150 million Americans, many of whom did not have a prescription alternative before. Plenity is FDA-cleared to aid in weight management in adults with excess weight or obesity, Body Mass Index (BMI) of 25 to 40 kg/m², when used in conjunction with diet and exercise

· Pro forma implied market value of approximately $1.3 billion and enterprise value of approximately $1.0 billion

· Transaction is expected to provide Gelesis with up to $376 million of gross proceeds to fund the full commercial launch of Plenity later this year and to expand manufacturing to meet demand, including $100 million from a common stock PIPE financing at $10.00 per share anchored by new and existing top tier investors and partners, including PIMCO private funds, Kennedy Lewis Investment Management, Pritzker Vlock Family Office, China Medical Systems Holdings Limited (CMS), and co-founder PureTech Health

BOSTON, MA & AUSTIN, TX, JULY 19, 2021 – Gelesis, Inc. ("Gelesis" or the "Company"), a biotherapeutics company advancing biomimetic superabsorbent hydrogels to treat excess weight and metabolic disorders, and Capstar Special Purpose Acquisition Corp. (NYSE: CPSR) ("Capstar"), a special purpose acquisition company sponsored by affiliates of Capstar Partners, LLC and certain private funds managed by PIMCO, announced today that they have entered into a definitive business combination agreement. Upon completion of the transaction, the combined company’s securities are expected to be traded on the New York Stock Exchange (NYSE) under the symbol "GLS."

A New Approach to Weight Management

Gelesis is a biotherapeutics company aiming to transform weight management using a proprietary biomimetic superabsorbent hydrogel technology. The Company’s first commercial product, Plenity, is a U.S. Food and Drug Administration (FDA) cleared aid in weight management in adults with excess weight or obesity, Body Mass Index (BMI) of 25 to 40 kg/m², when used in conjunction with diet and exercise. Plenity has the broadest BMI range of any prescription weight-management aid to date-over 150 million American adults could be eligible for treatment with Plenity, many of whom did not have a prescription alternative before. Plenity’s unique scientific approach and efficacy, safety and tolerability profile allow Gelesis to bring it to market in a completely new way.

Plenity capsules contain a non-systemic biomimetic hydrogel that is not absorbed but instead acts locally in the gastrointestinal (GI) tract. The capsules are taken with water before meals and are designed to help people feel satisfied with smaller meals. Plenity combines the simplicity and convenience of a consumer product with clinical and scientific validation as well as FDA regulatory clearance as a de novo Class II medical device. In clinical studies, ~6 out of 10 adults had clinically meaningful weight loss and those people lost on average, within six months, ten percent of their body weight (about 22 lbs). There was no difference in overall side effects compared to placebo. The most common side effects were diarrhea, distended abdomen, infrequent bowel movements and flatulence.

Plenity is a prescription product with a direct-to-patient approach, giving the consumer the option of going through leading telehealth platform Ro, or through an in-person healthcare provider visit. This makes it easier for consumers to seek free physician evaluation on their own time and their own terms. If prescribed, the product is delivered to the consumer’s home within two days at a transparent cost of $98/month, or $1.75 per meal.

Plenity is now available in limited release, and over 48,000 members have begun their weight management journey. During Plenity’s beta launch in October 2020, with limited promotion and without brand awareness marketing, Plenity surpassed all branded prescription weight management products in new monthly members during the month of testing, with high satisfaction ratings. The Company anticipates the full commercial launch of Plenity later in 2021 and is currently constructing a larger manufacturing facility to meet anticipated demand.

Gelesis’ novel platform technology is inspired by the structural and mechanical properties of raw vegetables. When consumed, the hydrogel forms small solid gel pieces in the stomach consisting of water held by a 3D cellulose structures, similar to raw vegetables. The structures, which have no calories, are homogeneously mixed with the ingested foods, increasing the volume and firmness of that meal while reducing its caloric density. The hydrogel pieces are not absorbed and partially degrade in the large intestine, releasing the water before leaving the body naturally. In clinical trials, this therapeutic approach demonstrated a strong efficacy and safety profile.

Management Comments

"We are delighted to have found such a stellar group of partners and investors as we expand the launch of the first and only FDA-cleared and clinically validated prescription aid for weight management that is available for the broadest range of the population with excess weight, including even those who are overweight without co-morbidities," said Yishai Zohar, Founder and CEO of Gelesis. "Capstar’s leadership team has a track record of successfully building known brands and tackling fundamental consumer problems across a variety of industries. We look forward to building on the exciting momentum of our beta launch with this partnership and funding, and we are committed to making a meaningful difference in the lives of millions of Americans seeking scientifically proven and convenient options to manage their weight."

"Yishai and the Gelesis team have developed a tremendous solution that is poised to transform the weight management industry," said Steve Hicks, the Chairman and CEO of Capstar. "We raised our Capstar SPAC last year with the goal of finding a high-growth, disruptive business that is helping people live a better, healthier life. Gelesis fits that criteria perfectly and we are elated to partner with them as they start their exciting next leg of growth."

Transaction Overview

The transaction values the combined company at an implied enterprise value of approximately $1.0 billion and equity value of approximately $1.3 billion, based on a $10.00 per share price of Capstar common stock and assuming no redemptions by Capstar’s public shareholders. The transaction will provide up to $376 million in gross proceeds to the combined company from a combination of a $100 million common stock PIPE financing at $10.00 per share along with $276 million of cash held in Capstar’s trust account (assuming no redemptions by Capstar’s public shareholders). The PIPE financing is anchored by a mix of new and existing top tier investors and partners, including PIMCO private funds, Pritzker Vlock Family Office, China Medical Systems Holdings Limited (CMS), and co-founder PureTech Health. Kennedy Lewis Investment Management will invest $10 million in the PIPE conditioned upon the closing of their $100 million senior secured credit facility to the Company, which is subject to the completion of due diligence, final documentation, and customary closing conditions. Proceeds from the business combination, PIPE, and credit facility will be primarily used to support the full commercial launch of Plenity for weight management later this year and expanded manufacturing to meet consumer demand. Gelesis’ existing shareholders will convert 100% of their ownership stakes into the new company.

The transaction has been unanimously approved by the Boards of Directors of both Gelesis and Capstar. It is expected to close in the fourth quarter of 2021, subject to the satisfaction of certain closing conditions, including a registration statement being declared effective by the U.S. Securities and Exchange Commission (the "SEC") and the approval of Capstar shareholders.

Additional information about the transaction, including a copy of the business combination agreement and investor presentation, will be provided in a Current Report on Form 8-K to be filed by Capstar with the SEC and available at www.sec.gov.

Advisors

Citi is serving as exclusive financial advisor to Gelesis and Goodwin Procter LLP is serving as legal counsel to Gelesis. UBS Investment Bank is serving as exclusive financial and lead capital markets advisor to Capstar and Kramer Levin Naftalis & Frankel LLP is serving as its legal counsel. UBS Investment Bank and Citi are serving as private placement agents to Capstar with respect to the PIPE financing. Winston & Strawn LLP served as counsel to the placement agents. BTIG, LLC is also serving as a capital markets advisor to Capstar.

Conference Call Information

Gelesis and Capstar will host a joint investor conference call to discuss the transaction today, July 19, 2021, at 8:30 a.m. Eastern Time. A telephone replay of the call will be available until July 29, 2021 via the same numbers, and a replay of the webcast will be archived on the investor relations website.

The conference call can be accessed via webcast on Gelesis’ investor relations website at gelesis.com/investors, or by dialing +1 844-512-2921 within the U.S. or +1 412-317-6671 for international callers and entering the passcode 1145464.

Important Safety Information

· Patients who are pregnant or are allergic to cellulose, citric acid, sodium stearyl fumarate, gelatin, or titanium dioxide should not take Plenity.

· To avoid impact on the absorption of medications:

o For all medications that should be taken with food, take them after starting a meal.

o For all medications that should be taken without food (on an empty stomach), continue taking on an empty stomach or as recommended by your physician.

· The overall incidence of side effects with Plenity was no different than placebo. The most common side effects were diarrhea, distended abdomen, infrequent bowel movements, and flatulence.

· Contact a doctor right away if problems occur. If you have a severe allergic reaction, severe stomach pain, or severe diarrhea, stop using Plenity until you can speak to your doctor.

Rx Only. For the safe and proper use of Plenity or more information, talk to a healthcare professional, read the Patient Instructions for Use, or call 1-844-PLENITY.

On July 19, 2021 Frontier Medicines Corporation, a precision medicine company seeking to unlock the proteome to advance breakthroughs against otherwise undruggable disease-causing targets, reported the closing of an $88.5 million Series B financing round (Press release, Frontier Medicines, JUL 19, 2021, View Source [SID1234585006]). The financing was co-led by Woodline Partners LP and RA Capital Management, with equal participation by Deerfield Management Company. Additional new investors in the round included Deep Track Capital, ArrowMark Partners, Driehaus Capital Management, and Sphera Healthcare alongside existing investors DCVC, Droia Ventures, and MPM Capital.

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"We welcome the new group of investors who participated in this financing and appreciate the confidence they have shown in our highly differentiated scientific approach," said Chris Varma, Ph.D., chairman, CEO, and co-founder of Frontier Medicines. "Between the substantial protein degradation partnership with AbbVie announced at the end of last year and this financing round, we have significantly strengthened our resources to deliver on our vision of developing breakthrough medicines for patients."

The proceeds will be used to advance Frontier’s wholly-owned pipeline of precision medicines against the most important drivers of cancer. The company’s lead program is uniquely focused on the inhibition of both the activated and inactive forms of KRASG12C, which is implicated in a number of cancers such as non-small cell lung cancer, colorectal carcinoma, and pancreatic ductal adenocarcinoma.

"The ability to target both forms of KRASG12C, which includes the active and inactive states of the protein, with a small molecule therapy would be a long-awaited scientific breakthrough," said Frank McCormick, Ph.D., FRS, professor of the UCSF Helen Diller Family Comprehensive Cancer Center. "Importantly for patients, a drug with this dual inhibition may be more efficacious than a drug that targets just the inactive form of KRASG12C by addressing the large majority of patients who are non-responders to first generation single-form KRASG12C inhibitors, as well as those patients whose tumors become resistant to the first-generation molecules."

Derek DiRocco, partner at RA Capital Management and the newest member of the Frontier Board of Directors, added, "The foundational technologies that Frontier has built are impressive and are uniquely integrated to form a compelling discovery and development platform. In addition to the lead programs targeting notable cancer drivers, Frontier has identified over 150,000 hotspots on proteins of interest that can fuel further pipeline growth across therapeutic areas and protein degradation."

In addition, the company revealed its Scientific Advisory Board (SAB), composed of renowned thought leaders and industry veterans who are an integral part of Frontier’s team:

Joan S. Brugge, Ph.D. is the director of the Harvard Ludwig Cancer Center and also a Louise Foote Pfeiffer Professor of Cell Biology at Harvard Medical School. She founded and was previously the scientific director of ARIAD Pharmaceuticals. She received the NIH Merit Award, an American Cancer Society Research Professorship and the ASCB Senior Career Recognition Award. She is an elected member of the American Academy of Arts and Sciences, the National Academy of Sciences and the National Academy of Medicine.

Giulio Draetta, M.D., Ph.D. is the chief scientific officer at the University of Texas MD Anderson Cancer Center. He is responsible for overall coordination of research efforts at MD Anderson, from discovery science to drug discovery and clinical translation, with the aim of better integrating academic and industrial science in the quest for cancer cures.

Steven Gygi, Ph.D. is a professor of Cell Biology at Harvard Medical School. His laboratory’s research centers around developing and applying new technologies in the field of mass spectrometry-based proteomics.

William C. Hahn, M.D., Ph.D. is the William Rosenberg Professor of Medicine and chief operating officer of Dana-Farber Cancer Institute, and is also an institute member of the Broad Institute. His laboratory focuses on understanding the cooperative interactions that conspire to transform human cells.

Kevin Koch, Ph.D. is the former chief scientific officer of Array BioPharma and a venture partner with OrbiMed. His expertise includes drug discovery, medicinal chemistry, and pre-clinical development.

Frank McCormick, Ph.D., FRS is a professor at the UCSF Helen Diller Family Comprehensive Cancer Center and a world-renowned expert in KRAS biology. His cancer-related work with biotechnology firms includes serving as director of molecular biology and vice president of research at Chiron Corporation. He founded and served as chief scientific officer at Onyx Pharmaceuticals, a company dedicated to developing new cancer therapies.

Daniel K. Nomura, Ph.D. is professor of Chemistry and professor of Molecular and Cell Biology, and Nutritional Sciences and Toxicology at UC Berkeley. He is a co-founder of Frontier Medicines and leading expert in chemoproteomics.

Roberto Zoncu, Ph.D. is an associate professor of Biochemistry, Biophysics and Structural Biology at UC Berkeley. He is a co-founder of Frontier Medicines and an expert in cancer biology, small GTPase signaling, and autophagy.

To further support its growth objectives, the company also announced the addition of a state-of-the-art facility in Boston, Massachusetts, where the company plans to build its employee expertise across research and development, including discovery, pre-clinical development, translational medicine, and early clinical development. The site will be integrated with Frontier’s South San Francisco, California headquarters, with department and project teams working across the two sites, including diverse talent that spans bench scientists to senior management.

On July 19, 2021 Cytokinetics, Incorporated (Nasdaq:CYTK) reported plans to offer, subject to market and other conditions, $200,000,000 of shares of its common stock in an underwritten public offering (Press release, Cytokinetics, JUL 19, 2021, View Source [SID1234584979]). There can be no assurance as to whether or when the offering may be completed, or the actual size or terms of the offering. Cytokinetics expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the number of shares of common stock sold in connection with the offering. All of the shares of common stock in the offering will be sold by Cytokinetics.

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J.P. Morgan and Morgan Stanley are acting as joint book-running managers for the offering. Mizuho Securities and JMP Securities are acting as passive book-runners.

The securities described above are being offered by Cytokinetics pursuant to a shelf registration statement (including a prospectus) filed on November 6, 2019 with the Securities and Exchange Commission (SEC), which has become automatically effective. A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available for free on the SEC’s website at View Source Copies of the preliminary prospectus supplement and accompanying prospectus relating to the offering, when available, may be obtained from: J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, by telephone: 1-866-803-9204, or by email at [email protected]; or Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, New York 10014, by telephone at 866-718-1649 or by email at [email protected].

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 these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.