LIPOCINE CLOSES UNDERWRITTEN PUBLIC OFFERING OF COMMON STOCK

On January 28, 2021 Lipocine Inc. (NASDAQ:LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, reported the closing of an underwritten public offering of 16,428,571 shares of its common stock, offered at a price of $1.75 to the public, which included the exercise in full by the underwriters of their option to purchase 2,142,857 additional shares of common stock at the public offering price (Press release, Lipocine, JAN 28, 2021, View Source [SID1234574375]). Gross proceeds to Lipocine were approximately $28.7 million before deducting underwriting discounts and commissions and other offering expenses payable by the Company.

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Raymond James & Associates, Inc. acted as sole book-running manager and Ladenburg Thalmann & Co. Inc. acted as co-manager for the public offering.

The shares were offered pursuant to an effective shelf registration statement on Form S-3 (No. 333-250072) previously filed with the U.S. Securities and Exchange Commission (the "SEC") and declared effective by the SEC on November 23, 2020. A prospectus supplement and accompanying prospectus relating to the offering have been filed with the SEC and are available on the SEC’s web site at www.sec.gov. Copies of the prospectus supplement and accompanying prospectus may be obtained from Raymond James & Associates, Inc., Attention: Equity Syndicate, 880 Carillon Parkway, St. Petersburg, Florida 33716, by telephone at (800) 248-8863 or by e-mail at [email protected].

PerkinElmer Board Declares Quarterly Dividend

On January 28, 2021 The Board of Directors of PerkinElmer, Inc. (NYSE: PKI), reported a regular quarterly dividend of $0.07 per share of common stock January 28, 2021 (Press release, PerkinElmer, JAN 28, 2021, View Source [SID1234574374]). This dividend is payable on May 7, 2021 to all shareholders of record at the close of business on April 16, 2021.

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Evelo Biosciences Announces Proposed Public Offering of Common Stock

On January 28, 2021 Evelo Biosciences, Inc. (Nasdaq: EVLO) ("Evelo"), a clinical stage biotechnology company developing a new modality of orally delivered medicines, reported that it intends to offer and sell, subject to market and other conditions, $50 million of its common stock in an underwritten public offering (Press release, Evelo Biosciences, JAN 28, 2021, View Source [SID1234574373]). Evelo expects to grant the underwriters a 30-day option, solely to cover over-allotments, if any, to purchase up to an additional $7.5 million of its common stock. 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. All of the shares in the proposed offering are to be sold by Evelo.

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Morgan Stanley, Cowen and BMO Capital Markets are acting as joint book-running managers for the offering.

Evelo intends to use the net proceeds from the offering, in addition to its existing cash resources, for the following purposes: (i) continue the development of EDP1815 in a Phase 2 trial in psoriasis and initiate a Phase 2 trial of EDP1815 in atopic dermatitis; (ii) prepare to advance EDP1815 in multiple Phase 3 trials in psoriasis and atopic dermatitis, upon receipt of positive Phase 2 data; (iii) continue the Phase 2 and Phase 2/3 clinical trials of EDP1815 for the treatment of hyperinflammation caused by SARs-CoV-2; (iv) advance EDP1867 in a Phase 1b trial in atopic dermatitis; (v) progress its first bacterial extracellular vesicle product candidates into the clinic, including EDP2939 for inflammation and EDP1908 for oncology; (vi) other research and development activities for additional product candidates, including advancing additional oral product candidates through preclinical development across therapeutic areas; and (vii) the remainder, if any, for working capital and other general corporate purposes.

A registration statement relating to the securities being sold in the offering has been declared effective by the Securities and Exchange Commission. The securities will be offered only by means of a prospectus supplement and accompanying prospectus forming a part of the effective registration statement. A preliminary prospectus supplement related to the offering will be filed with the SEC and will be available on the SEC’s website located at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the securities being offered may also be obtained, when available, from: Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014; or Cowen and Company, LLC, c/o Broadridge Financial Services, 1155 Long Island Avenue, Edgewood, NY 11717, Attention: Prospectus Department, or by telephone at (833) 297-2926, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, 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.

CASI PHARMACEUTICALS PARTNER, BIOINVENT, PRESENTS PHASE I/IIA DATA THAT SUGGESTS BI-1206 RESTORES
ACTIVITY OF RITUXIMAB IN RELAPSED NON-HODGKIN’S LYMPHOMA PATIENTS

On January 28, 2021 CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, reported that its partner BioInvent International AB ("BioInvent") (OMXS: BINV), a biotech company focused on the discovery and development of novel and first-in-class immune-modulatory antibodies for cancer immunotherapy, positive interim results from the Phase I/IIa trial of the novel anti-FcγRIIB antibody BI-1206 in combination with rituximab (anti-CD20 monoclonal antibody) in patients with indolent relapsed or refractory B-cell non-Hodgkin’s lymphoma (NHL) (Press release, CASI Pharmaceuticals, JAN 28, 2021, View Source [SID1234574372]).

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"The responses observed in six out of nine patients are very encouraging and clearly suggest that BI-1206 may restore the response to rituximab in patients who have few treatment alternatives. The complete responses we have seen in two patients are particularly impressive and indicate that BI-1206 has the potential to significantly improve the lives of NHL patients who have progressed after several lines of treatment. Based on these results, we will now move to identify the recommended Phase II dose for the Phase IIa part of the trial and look forward to further evaluating the exciting potential of BI-1206 to bring much needed innovation to lymphoma patients," said Martin Welschof, Ph.D, CEO of BioInvent.

Of the 9 patients who completed the induction cycle, 6 patients have shown either complete or partial responses several of which are still ongoing. Two patients (30 mg and 70 mg dose) achieved a complete response, which continues to be sustained 12 and 24 months later. Another patient who had a blastoid form of MCL achieved a partial response, and a complete depletion of peripheral tumor cells. Readout from two patients is still pending.

A total of 15 patients have been recruited to date in the Phase I dose escalation part of the study, all of whom were late stage and have failed conventional treatments, including several lines of rituximab-containing therapies.

To address dose limiting toxicities seen at higher doses earlier in the trial, a new safety protocol was implemented, enabling higher doses to be administered. No dose-limiting toxicities have been observed in the five patients who have been treated under the current protocol, despite receiving higher doses of BI-1206.

Wei-Wu He, Ph.D., CASI’s Chairman and Chief Executive Officer, said, "We continue to be excited about this anti-FcγRIIB antibody’s potential in restoring rituximab’s activity in NHL patients, and these results provided further encouraging evidence of its potential as a durable and safe treatment alternative. We remain encouraged by its potential application across multiple tumor types in many first line treatments and in refractory settings and are excited to be taking an important step closer to making BI-1206 available to patients and healthcare providers across Greater China."

BioInvent will hold a key opinion leader (KOL) call today, Thursday, January 28 at 5:30 p.m. CET (11:30 a.m. ET) to discuss the results and next steps in clinical development of BI-1206. Renowned lymphoma expert Mats Jerkeman, MD, Lund University, will give a presentation on the current treatment landscape, and unmet medical need for patients with relapsed or refractory NHL. The BioInvent management team will be available for Q&A and CASI will provide an update on the development plan and potential for BI-1206 in China.

About the BioInvent Phase I/IIa study of BI-1206 in NHL The Phase I/IIa study consists of two parts: i) Phase l, with dose escalation cohorts using a 3+3 dose-escalation design and selection of the recommended Phase IIa dose (RP2D); and ii) Phase IIa, an expansion cohort at the RP2D, enriched with patients with mantle cell lymphoma (MCL). Subjects in each phase receive 1 cycle (4 doses) of induction therapy with BI-1206 in combination with rituximab. Subjects who show clinical benefit at week 6 continue onto maintenance therapy and receive BI-1206 and rituximab once every 8 weeks for up to 6 maintenance cycles, or up to 1 year from first dose of BI-1206.

CureVac Announces Pricing of $450 million Follow-on Public Offering of Common Shares

On January 28, 2021 CureVac N.V. (Nasdaq: CVAC) ("CureVac" or the "Company"), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid ("mRNA"), reported the pricing of its follow-on public offering of 5,000,000 common shares at a public offering price of $90.00 per common share, for total gross proceeds of approximately $450 million (Press release, CureVac, JAN 28, 2021, View Source [SID1234574364]). In addition, the Company has granted the underwriters a 30-day option to purchase up to an additional 750,000 common shares at the public offering price, less underwriting discounts and commissions. All of the common shares are being offered by CureVac. The offering is expected to close on February 1, 2021, subject to satisfaction of customary closing conditions.

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BofA Securities, Jefferies and Evercore ISI are acting as joint book-running managers for the offering. UBS Investment Bank, Guggenheim Securities, Berenberg and Kempen & Co are acting as passive book running managers for the offering.

A registration statement relating to these securities was declared effective by the Securities and Exchange Commission ("SEC") on January 27, 2021. The offering is being made only by means of a prospectus. Copies of the final prospectus relating to the offering may be obtained, when available, for free by visiting EDGAR on the SEC website at www.sec.gov. Alternatively, copies of the final prospectus, when available, may be obtained from BofA Securities, Attention: Prospectus Department, NC1-004-03-43, 200 North College Street, 3rd Floor, Charlotte, NC 28255-0001, by telephone at (800) 299-1322 or by email at [email protected]; 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]; and Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, New York 10055, or by telephone at (888) 474 0200, or by email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, 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.