PureTech Founded Entity Gelesis, the Maker of Plenity®, to Become a Publicly Traded Company via Merger with Capstar Special Purpose Acquisition Corp.

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])."

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"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.

Brickell Biotech Announces $5.0 Million Bought Deal Offering of Common Stock

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.

Immunic, Inc. Announces Closing of $45.0 Million Public Offering

On July 19, 2021 Immunic, Inc. (the "Company") (Nasdaq: IMUX), a clinical-stage biopharmaceutical company developing a pipeline of selective oral immunology therapies focused on treating chronic inflammatory and autoimmune diseases, reported the closing of an underwritten public offering of 4,500,000 shares of its common stock at a public offering price of $10.00 per share (Press release, Immunic, JUL 19, 2021, View Source [SID1234584952]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The Company received total proceeds from the offering, before deducting the underwriting discounts and other offering expenses, of $45.0 million.

Piper Sandler acted as sole book-runner for the offering. Ladenburg Thalmann & Co. Inc., Roth Capital Partners and Aegis Capital Corp. acted as co-managers for the offering.

The Company intends to use the net proceeds of the offering to fund the ongoing clinical development of its three lead product candidates, IMU-838, IMU-935 and IMU-856, and for other general corporate purposes.

The securities described above were offered by the Company pursuant to a shelf registration statement filed by the Company with the Securities and Exchange Commission ("SEC"), which was declared effective on November 24, 2020. A final prospectus supplement and accompanying prospectus related to the offering were filed with the SEC on July 16, 2021 and are available for free on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and accompanying prospectus related to the offering may be obtained from Piper Sandler & Co., 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, or by email at [email protected], or by telephone at (800) 747-3924.

This press release does not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, 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.

Subscription to raise £1,000,000

On July 19, 2021 Sareum Holdings plc (AIM: SAR), the specialist drug development company, reported that it has raised £1,000,000, before expenses, through a subscription by a high net worth individual (the "Subscriber") for 14,285,714 new ordinary shares of 0.025p each in the capital of the Company ("Ordinary Shares") (the "Subscription Shares") at a price of 7p per share (the "Subscription Price") (the "Subscription") (Press release, Sareum, JUL 19, 2021, View Source [SID1234586708]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Under the terms of the Subscription, the new Subscriber will also be issued one five-year warrant, exercisable at the Subscription Price, for every Subscription Share issued (the "Subscription Warrant"), which can only be exercised following the Company’s closing middle market share price being above 9p per Ordinary Share for five consecutive days. The Subscription Price represents a premium of approximately 4.5 per cent. to the closing middle market price for Sareum Shares on 16 July 2021.

The net proceeds from the Subscription will be used to progress the Company’s SDC-1801 and SDC-1802 TYK2/JAK1 inhibitor drug development programmes as well as for working capital purposes. As noted in the Company’s Trading Update of 25 May 2021, the Company is targeting the completion of preclinical studies for SDC-1801 in Q3 2021, subject to successful progress. Clinical trial plans, including priority autoimmune indications and potential Covid-19 application, will also be developed in parallel, subject to additional funding being raised.

Application will be made for the 14,285,714 Subscription Shares, which will rank pari passu with the Company’s existing Ordinary Shares, to be admitted to trading on the AIM market of the London Stock Exchange ("AIM") ("Admission"). It is anticipated that Admission will become effective at 8.00 am on 23 July 2021. The Subscription is subject to normal conditions including, inter alia, Admission.

Total Voting Rights

For the purpose of the Disclosure Guidance and Transparency Rules, following the above issue of equity, the issued share capital of the Company will comprise 3,353,579,936 Ordinary Shares. The above figure may be used by shareholders as the denominator for the calculations by which they will determine if they are required to notify their interest in, or a change to their interest in, the Company, under the Disclosure Guidance and Transparency Rules.

Dr Tim Mitchell, CEO of Sareum Holdings plc, said: "We are delighted that our proprietary TYK2/JAK1 development programmes are attracting such interest and new investment. With this new subscription, the total funds raised from recent subscriptions and warrant exercises is over £3.5 million. These new funds will allow us both to advance SDC-1801 into clinical development in autoimmune diseases, including the immune overreaction to Covid-19 and other viral infections, and to progress the preclinical development of our second TYK2/JAK1 inhibitor SDC-1802 against cancers."

Johnson & Johnson Announces Quarterly Dividend for Third Quarter 2021

On July 19, 2021 Johnson & Johnson (NYSE: JNJ) reported that its Board of Directors has declared a cash dividend for the third quarter of 2021 of $1.06 per share on the company’s common stock (Press release, Johnson & Johnson, JUL 19, 2021, View Source;johnson-announces-quarterly-dividend-for-third-quarter-2021-301336582.html [SID1234584953]). The dividend is payable on September 7, 2021 to shareholders of record at the close of business on August 24, 2021. The ex-dividend date is August 23, 2021.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!