On July 2, 2021, Alpine Immune Sciences, Inc, a Delaware corporation, (the "Company"), reported that it entered into a sales agreement (the "Sales Agreement") with Cowen and Company, LLC ("Cowen") to sell shares of the Company’s common stock, par value $0.001 per share, having aggregate sales proceeds of up to $75 million, from time to time, through an "at the market" equity offering program under which Cowen will act as sales agent (Filing, 8-K, Alpine Immune Sciences, JUL 2, 2021, View Source [SID1234584569]).

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Under the Sales Agreement, the Company will set the parameters for the sale of shares, including the number of shares to be issued, the time period during which sales are requested to be made, limitation on the number of shares that may be sold in any one trading day and any minimum price below which sales may not be made. Subject to the terms and conditions of the Sales Agreement, Cowen may sell the shares by methods deemed to be an "at the market offering" as defined in Rule 415 promulgated under the Securities Act of 1933, as amended, including sales made directly on The Nasdaq Stock Market LLC or on any other existing trading market for the common stock or to or through a market maker. In addition, with the Company’s prior written approval, Cowen may also sell shares by any other method permitted by law, including in negotiated transactions. Cowen will use commercially reasonable efforts in conducting such sales activities consistent with its normal trading and sales practices, applicable state and federal laws, rules and regulations and the rules of The Nasdaq Stock Market LLC. The Sales Agreement may be terminated by the Company upon written notice to Cowen for any reason or by Cowen upon written notice to the Company for any reason or at any time under certain circumstances, including but not limited to the occurrence of a material adverse change in the Company.

The Sales Agreement provides that Cowen will be entitled to compensation for its services of up to 3.0% of the gross sales price per share of all shares sold through Cowen under the Sales Agreement. The Company has no obligation to sell any shares under the Sales Agreement, and may at any time suspend solicitation and offers under the Sales Agreement. The Sales Agreement contains customary representations, warranties and agreements by the Company, indemnification obligations of the Company and Cowen, other obligations of the parties and termination provisions. The representations, warranties and covenants contained in the Sales Agreement were made only for purposes of such agreement and as of specific dates, were solely for the benefit of the parties to such agreement, and may be subject to limitations agreed upon by the contracting parties.

The shares will be issued pursuant to the Company’s effective shelf registration statement on Form S-3 (File No. 333-256107), declared effective by the Securities and Exchange Commission (the "SEC") on May 20, 2021. The Company filed a prospectus supplement, dated July 2, 2021, with the SEC in connection with the offer and sale of the shares pursuant to the Sales Agreement.

The foregoing description of the Sales Agreement is not complete and is qualified in its entirety by reference to the full text of such agreement, a copy of which is filed herewith as Exhibit 1.1 to this Current Report on Form 8-K and is incorporated herein by reference.

The legal opinion of Wilson Sonsini Goodrich & Rosati, Professional Corporation, relating to the shares of common stock being offered is filed as Exhibit 5.1 to this Current Report on Form 8-K.
This Current Report shall not constitute an offer to sell or the solicitation of an offer to buy the securities discussed herein, nor shall there be any sale of such 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.

On July 2, 2021, G1 Therapeutics, Inc. ("the Company") reported that it entered into a Sales Agreement ("2021 Sales Agreement") with Cowen and Company, LLC ("Cowen") with respect to an at-the-market-offering program under which the Company may offer and sell, from time to time at its sole discretion, shares of its common stock, par value $0.0001 per share (the "Common Stock"), having an aggregate offering price of up to $150.0 million (the "Placement Shares") through Cowen as its sales agent (Filing, 8-K, G1 Therapeutics, JUL 2, 2021, View Source [SID1234584570]). The issuance and sale, if any, of the Placement Shares by the Company under the 2021 Sales Agreement is subject to the effectiveness of the Company’s registration statement on Form S-3ASR ("Form S-3"), which became effective when filed with the Securities and Exchange Commission on July 2, 2021. The Company makes no assurances as to the continued effectiveness of the registration statement.

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The Company is not obligated to make any sales of Common Stock under the 2021 Sales Agreement. The offering of Placement Shares pursuant to the 2021 Sales Agreement will terminate upon the earlier of (i) the sale of all Placement Shares subject to the 2021 Sales Agreement or (ii) termination of the 2021 Sales Agreement in accordance with its terms.

Upon delivery of a placement notice and subject to the terms and conditions of the 2021 Sales Agreement, Cowen may sell the Placement Shares by any method permitted by law deemed to be an "at the market" offering as defined in Rule 415 of the Securities Act of 1933, as amended, including, without limitation, sales made through The Nasdaq Global Select Market or on any other existing trading market for the Common Stock. Cowen will use commercially reasonable efforts to sell the Placement Shares from time to time, based upon instructions from the Company (including any price, time or size limits or other customary parameters or conditions the Company may impose). The Company will pay Cowen a commission equal to three percent (3%) of the gross sales proceeds of any Placement Shares sold through Cowen under the 2021 Sales Agreement, and also has provided Cowen with customary indemnification and contribution rights.

The foregoing description of the 2021 Sales Agreement is qualified in its entirety by reference to the full text of the 2021 Sales Agreement, which is attached as Exhibit 1.2 to the Company’s Form S-3 filed July 2, 2021.

Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C., counsel to the Company, has issued a legal opinion relating to the Placement Shares. A copy of such legal opinion, including the consent included therein, is attached as Exhibit 5.1 to the Company’s Form S-3 filed July 2, 2021.

This Current Report on Form 8-K shall not constitute an offer to sell or the solicitation of an offer to buy any shares under the 2021 Sales Agreement, nor shall there be any offer, solicitation, or sale of such shares in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state.

On July 2, 2021 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM: HCM; HKEX:13) reported that it will be announcing its interim results for the six months ended June 30, 2021 on Wednesday, July 28, 2021 at 12:00 noon British Summer Time (BST) (7:00 pm Hong Kong Time (HKT); 7:00 am Eastern Daylight Time (EDT)) (Press release, Hutchison China MediTech, JUL 2, 2021, View Source [SID1234586915]).

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Analysts and investors are invited to join a conference call and audio webcast presentation with Q&A, conducted by HUTCHMED management.

The conference call and audio webcast will take place at 1:00 pm BST / 8:00 pm HKT / 8:00 am EDT on Wednesday, July 28, 2021 and will be webcast live via the company website at www.hutch-med.com/investors/event-information/. The presentation will be available for downloading before the conference call begins. Details of the conference call dial-in will be provided in the financial results announcement and on the company website. A replay will also be available on the website shortly after the event.

On July 2, 2021 Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading clinical-stage genome editing company focused on developing curative therapeutics using CRISPR/Cas9 technology both in vivo and ex vivo, reported the closing of an underwritten public offering of 4,758,620 shares of its common stock, including the exercise in full by the underwriters of their option to purchase an additional 620,689 shares, at the public offering price of $145.00 per share (Press release, Intellia Therapeutics, JUL 2, 2021, View Source [SID1234584571]). The gross proceeds raised in the offering, before underwriting discounts and commissions and estimated expenses of the offering, were approximately $690 million.

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Goldman Sachs & Co. LLC, Jefferies, SVB Leerink, and Barclays acted as joint book-running managers for the offering. Truist Securities acted as co-manager for the offering.

The shares of common stock were offered by Intellia pursuant to an effective shelf registration statement that was previously filed with the U.S. Securities and Exchange Commission (SEC) and automatically became effective upon filing. A final prospectus supplement and accompanying prospectus relating to and describing the terms of the offering was filed with the SEC on July 1, 2021. The final prospectus supplement and accompanying prospectus relating to the offering may be obtained from: Goldman Sachs & Co. LLC, by mail at 200 West Street, New York, NY 10282, Attention: Prospectus Department, by telephone at (866) 471-2526, or by email at [email protected]; Jefferies LLC, by mail at 520 Madison Avenue, 2nd Floor, New York, NY 10022, Attention: Equity Syndicate Prospectus Department, by telephone at (877) 547-6340, or by email at [email protected]; SVB Leerink LLC, by mail at One Federal Street, 37th Floor, Boston, MA 02110, Attention: Syndicate Department, by telephone at (800) 808-7525, ext. 6105, or by email at [email protected]; Barclays Capital Inc., by mail at c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at (888) 603-5847, or by email at [email protected]; or by accessing the SEC’s website at www.sec.gov.

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.

On July 2, 2021 Philogen S.p.A. (BIT:PHIL), a clinical-stage biotechnology company focused on the development of innovative medicines based on tumor targeting antibodies and small molecule ligands, reported to provide an update on three R&D programs: Fibromun, OncoFAP and ABBV-022 (Press release, Philogen, JUL 2, 2021, View Source [SID1234584934]). A full pipeline update will be made to the market on 28 September, 2021, in the Company’s Half Year results announcement.

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Prof. Dr. Dario Neri, Co-Founder, Chief Executive Officer and Chief Scientific Officer of Philogen S.p.A., said: "We are extremely pleased to see that our technology has been delivering exciting product candidates of diverse nature, both by our partners such as AbbVie and under our ownership, across a variety of clinical trials. The early signs of activity support our ambition to bring innovative treatment options to patients with serious unmet medical need."

Fibromun

Fibromun (L19TNF), wholly-owned by Philogen, is a fully-human immunomodulatory product consisting of the L19 antibody and TNF (a strong pro-inflammatory cytokine). Recombinant TNF has so far been approved only for certain loco-regional clinical applications.

Promising interim survival benefits have been demonstrated in the European Phase I/II trial, investigating Fibromun as a monotherapy for the treatment of IDH wildtype WHO Grade III-IV High-Grade Glioma at first recurrence/relapse. Data on progression free survival at six months are being finalized, while the overall survival data will be consolidated by the end of 2021, with expected publication in a peer-reviewed scientific journal in 2022.
In the European Phase I/II trial, in which Fibromun is combined with lomustine for the treatment of Glioblastoma at first recurrence/relapse, a partial response has been observed already in the first patient treated in the study. The historical overall response rate for this patient population is 4.3% (Wick et al., J Clin Oncol 2010, 28,1168)
A Parallel Scientific Advice (PSA) with the European Medicines Agency and the US Food and Drug Administration has been completed in June 2021. The development plan for the treatment of glioblastoma and the proposed strategy for marketing authorization have been discussed and agreed with competent authorities. Philogen will follow the recommendations that were provided during the PSA.
In the European Phase II trial, in which Fibromun is combined with dacarbazine for the treatment of pretreated advanced/metastatic Soft Tissue Sarcoma (3rd line), the second patient treated in the study enjoyed a partial response. The historical overall response rate for this patient population is 4.0% (Garcia-del-Muro et al., J Clin Oncol 2011, 29,2528). After the run-in part of the trial, the trial progresses to a randomized part.
Fibromun is investigated in six clinical trials, of which five have a pivotal potential. In Soft Tissue Sarcoma, the European Phase III trial in 1st line and the Phase II trial in 3rd line are expected to read out by the end of 2023.

OncoFAP

OncoFAP is a small molecule radiotracer, wholly-owned by Philogen, with ultra-high affinity for Fibroblast Activation Protein (FAP). The product is suitable for the non-invasive detection of a variety of metastatic solid tumors, as FAP is overexpressed in more than 90% of epithelial cancers (e.g., malignant breast, colorectal, ovarian, lung, skin, prostate, and pancreatic cancers, as well as in some soft tissue and bone sarcomas)

Clinicians from the Department of Nuclear Medicine at the University Hospital of Münster have employed a OncoFAP-based radionuclide conjugate (OncoFAP-68Ga) in clinical scanning of patients with various FAP-positive cancer types and have shown excellent tumor uptake in both primary and metastatic lesions with low uptake in healthy organs (including kidneys) after intravenous injection.
These clinical results also support the investigation of OncoFAP-177Lu for Radionuclide Ligand Therapy (RLT).
Philogen is currently planning international, exploratory, clinical trials to investigate OncoFAP in a variety of cancer indications. The results from these studies will provide the basis for a pivotal clinical program in selected cancer types.

ABBV-022

ABBV-022, a product out-licensed by Philogen to AbbVie, consists of an IL-22 payload fused to a targeting antibody. The cytokine, selectively delivered to the epithelial surface of damaged gut mucosa, promotes survival of intestinal stem cells, improves goblet cell function and epithelial barrier, thereby reducing inflammation.

ABBV-022 has started a Phase I clinical trial for the treatment of Ulcerative Colitis. The original collaboration between Philogen and AbbVie began in 2014.