On December 4, 2020, Sorrento Therapeutics, Inc. (the "Company") reported that it entered into Amendment No. 1 (the "Amendment") to that certain Sales Agreement, dated April 27, 2020 (the "Sales Agreement"), by and between the Company and A.G.P./Alliance Global Partners (the "Agent") (Filing, 8-K, Sorrento Therapeutics, DEC 4, 2020, View Source [SID1234572173]).

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The Sales Agreement provides that the Company could offer and sell, from time to time, through or to the Agent, as sales agent and/or principal, up to $250,000,000 in shares of its common stock (the "Shares"), with the Shares to be issued pursuant to the Company’s Registration Statement on Form S-3 (File No. 333-237142) filed with the Securities and Exchange Commission (the "SEC") on March 13, 2020 and declared effective on March 20, 2020 (the "Form S-3"), the base prospectus dated March 20, 2020 included in the Form S-3 and the prospectus supplement, dated April 27, 2020. As of December 4, 2020, the Company has sold an aggregate of 29,543,092 Shares for gross proceeds of approximately $222.8 million, leaving an aggregate of approximately $27.2 million in Shares available for issuance under the Sales Agreement.

The Amendment amends the Sales Agreement to provide that the Company may offer and sell, from time to time, through or to the Agent, as sales agent and/or principal, up to an additional $450,000,000 in shares of the Company’s common stock (the "Additional Shares"), such that the Company may offer and sell up to an aggregate of $700,000,000 in shares of its common stock (the "Offering") pursuant to the Sales Agreement, as amended by the Amendment (the "Amended Sales Agreement"). Any Additional Shares offered and sold in the Offering will be issued pursuant to the Form S-3, the base prospectus dated March 20, 2020 included in the Form S-3 and the prospectus supplement, dated December 4, 2020, that will be filed with the SEC.

Subject to the terms and conditions of the Amended Sales Agreement, the Agent will use its commercially reasonable efforts to sell the shares of the Company’s common stock from time to time, based upon the Company’s instructions. Under the Amended Sales Agreement, the Agent may sell the shares of the Company’s common stock by any method permitted by law deemed to be an "at the market offering" as defined in Rule 415 promulgated under the Securities Act of 1933, as amended.

The Company has no obligation to sell any shares of its common stock pursuant to the Amended Sales Agreement, and may at any time suspend offers under the Amended Sales Agreement. The Offering will terminate upon (i) the election of the Agent upon the occurrence of certain adverse events, (ii) three business days’ advance notice from one party to the other, or (iii) the sale of all $700,000,000 of shares of the Company’s common stock pursuant thereto.

Under the terms of the Amended Sales Agreement, the Agent will be entitled to a commission at a fixed rate of 3.0% of the gross proceeds from each sale of shares of the Company’s common stock under the Amended Sales Agreement.

The Company currently intends to use any additional net proceeds from the Offering for working capital and general corporate purposes, which may include capital expenditures, research and development expenditures, regulatory affairs expenditures, clinical trial expenditures, acquisitions of new technologies and investments, business combinations and the repayment, refinancing, redemption or repurchase of indebtedness or capital stock. The Company may use a portion of the net proceeds to repurchase or redeem those certain senior secured notes due 2026 in an initial aggregate principal amount of $224,000,000 issued by Scilex Pharmaceuticals Inc., an indirect majority-owned subsidiary of the Company, in September 2018.

The foregoing description of the Sales Agreement and the Amendment does not purport to be complete and is qualified in its entirety by reference to: (i) the full text of the Sales Agreement, a copy of which was filed as Exhibit 1.1 to the Company’s Current Report on Form 8-K filed on April 27, 2020, and (ii) the full text of the Amendment, which is filed as Exhibit 1.1 hereto, each of which is incorporated herein by reference.

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

On December 4, 2020 Foghorn Therapeutics Inc. (Nasdaq: FHTX), a company pioneering the discovery and development of a new class of medicines targeting genetically determined dependencies within the chromatin regulatory system, reported financial results for the third quarter ended September 30, 2020 and provided a corporate update (Press release, Foghorn Therapeutics, DEC 4, 2020, View Source [SID1234572172]).

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"This is an eventful period for Foghorn as the company is on the cusp of transitioning our first two compounds into clinical studies," said Adrian Gottschalk, CEO of Foghorn. "We expect our first IND for FHD-286 to be submitted before the end of this year. In addition, our first degrader program, FHD-609, remains on track for an IND filing in the first half of next year. We have raised $240 million this year through a private financing round, subsequent IPO and our Merck collaboration, positioning the company to advance our broad pipeline targeting the chromatin regulatory system."

Recent Corporate Highlights

Completed $135 Million Initial Public Offering: In October 2020, Foghorn sold 7,500,000 shares of common stock at a public offering price of $16 per share. In November 2020, the underwriters exercised their option to purchase an additional 951,837 shares of common stock at the public offering price. The gross proceeds of the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Foghorn, were $135.2 million.

Entered into collaboration agreement with Merck to discover and develop novel oncology therapeutics against a transcription factor target: Under the terms of the agreement, signed in July 2020, Foghorn received a $15 million upfront payment and is eligible to receive up to an additional $410 million in development, regulatory and commercial milestones as well as royalties on product sales if products are successfully developed and commercialized under the collaboration.

Strengthened management team: In November 2020, Foghorn appointed Michael LaCascia as Chief Legal Officer.
Key Upcoming Milestones

FHD-286 IND submission expected by year end 2020: FHD-286, a highly potent, selective, allosteric, orally available small molecule enzymatic inhibitor is initially being developed in acute myelogenous leukemia and uveal melanoma. The company remains on track to submit an Investigational New Drug (IND) to the FDA by year end.

FHD-609 IND submission expected in the first half of 2021: FHD-609, a highly potent, selective, intravenous, small molecule protein degrader of BRD9 is initially being developed for the treatment of synovial sarcoma with the intention to expand into indications beyond synovial sarcoma, including SMARCB1-deleted tumors. The company remains on track to file an IND with the FDA in the first half of 2021.
Third Quarter 2020 Financial Results

Cash Position and Financial Guidance: Cash and cash equivalents as of September 30, 2020 were $74.6 million, compared to $15.0 million as of December 31, 2019. The September 30, 2020 cash and equivalents excludes $122.2 million in net proceeds from our initial public offering, which was completed in October 2020.

Revenues: Collaboration revenues for the third quarter of 2020 were $0.2 million, compared to no revenue for the third quarter of 2019, which reflects revenue recognized under our research collaboration agreement with Merck which was entered into in July 2020.

Research and Development (R&D) Expenses: R&D expenses for the third quarter of 2020 were $16.1 million, compared to $11.3 million for the third quarter of 2019. The increase in R&D expenses was primarily attributable to higher preclinical costs related to our first two programs and increased personnel to support our research and development activities.

General and Administrative (G&A) Expenses: G&A expenses for the third quarter of 2020 were $2.6 million, compared to $1.8 million for the third quarter of 2019. The increase in G&A expenses was primarily attributable to an increase in headcount in our general and administrative functions to support our business.

Net Loss: Net loss attributable to common stockholders was $18.4 million, or $3.12 per share, for the quarter ended September 30, 2020, compared to $13.1 million, or $3.05 per share, for the quarter ended September 30, 2019.

On December 4, 2020, Thermo Fisher Scientific Inc. (the "Company") reported that replaced its existing $2.5 billion unsecured five-year revolving credit facility with a new $3.0 billion unsecured five-year revolving credit facility (the "Credit Facility") pursuant to a Credit Agreement (the "Credit Agreement"), among the Company, certain Subsidiaries of the Company from time to time party thereto as Designated Borrowers, Bank of America, N.A., as Administrative Agent and a syndicate of lenders from time to time party thereto (Filing, 8-K, Thermo Fisher Scientific, DEC 4, 2020, View Source [SID1234572171]). Capitalized terms used in this Form 8-K and not defined herein shall have the meanings ascribed to them in the Credit Agreement, which is attached to this Form 8-K as Exhibit 10.1.

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The Credit Facility expires December 4, 2025, subject to two one-year extensions at the request of the Company and with the consent of the lenders. The Credit Facility also contains an expansion option permitting the Company to request increases of up to an aggregate additional $1.0 billion from lenders that elect to make such increase available, upon the satisfaction of certain conditions. The proceeds of the Loans under the Credit Facility may be used for working capital purposes, capital expenditures, acquisitions, repurchases of stock, debentures and other securities, the refinancing of present and future debt and other general corporate purposes. If no Default or Event of Default has occurred, (i) each Eurocurrency Rate Loan and each Swing Line Loan denominated in Euros shall bear interest on the outstanding principal amount thereof for each Interest Period at a variable rate per annum equal to the Eurocurrency Rate for such Interest Period plus a margin of 1.025% to 1.600% based on the Company’s long-term debt credit ratings and (ii) each Base Rate Committed Loan and each Swing Line Loan denominated in Dollars shall bear interest on the outstanding principal amount thereof from the applicable borrowing date at a variable rate per annum equal to the Base Rate plus a margin of 0.025% to 0.600% based on the Company’s long-term debt credit rating. In addition, the Company has agreed to pay a facility fee equal to a variable rate between 0.100% and 0.275% per year based on the Company’s long-term debt credit rating times the actual daily amount of the Commitments, regardless of usage, quarterly in arrears on the last business day of each March, June, September and December, commencing with the first such date to occur after the Closing Date.

The Company has unconditionally and irrevocably guaranteed the obligations of each of its subsidiaries in the event a subsidiary is named a borrower under the Credit Facility. The Credit Agreement contains customary conditions precedent, representations and warranties, affirmative and negative covenants, events of default and indemnities. The negative covenants include restrictions on liens and fundamental changes. These covenants are subject to a number of important exceptions and qualifications. The Credit Agreement also requires a minimum consolidated net interest coverage ratio of 3.5 to 1.0 as at the last day of any fiscal quarter. Certain changes of control with respect to the Company would constitute an event of default under the Credit Facility. Upon the occurrence and during the continuance of an event of default, the lenders may declare the outstanding advances and all other obligations under the Credit Facility immediately due and payable. Borrowings under the Credit Facility are prepayable at the Company’s option in whole or in part without premium or penalty.

The foregoing description of the Credit Agreement does not purport to be a complete statement of the parties’ rights under such agreement and is qualified in its entirety by reference to the full text of the Credit Agreement (including exhibits), which is filed as Exhibit 10.1 and incorporated by reference herein.

In the ordinary course of business, certain of the lenders under the Credit Agreement and their affiliates have provided, and may in the future provide, investment banking, commercial banking, cash management, foreign exchange or other financial services to the Company for which they have received compensation and may receive compensation in the future.

On December 4, 2020 Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, reported positive interim data from the Company’s dose escalation Phase 1 study of FT516 in combination with rituximab for patients with relapsed / refractory B-cell lymphoma (Press release, Fate Therapeutics, DEC 4, 2020, View Source [SID1234572170]). FT516 is the Company’s universal, off-the-shelf natural killer (NK) cell product candidate derived from a clonal master induced pluripotent stem cell (iPSC) line engineered with a novel high-affinity, non-cleavable CD16 (hnCD16) Fc receptor, which is designed to maximize antibody-dependent cellular cytotoxicity (ADCC), a potent anti-tumor mechanism by which NK cells recognize, bind and kill antibody-coated cancer cells.

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"We are highly encouraged by these Phase 1 data, which clearly demonstrate that off-the-shelf, iPSC-derived NK cells can drive complete responses for cancer patients and that our proprietary hnCD16 Fc receptor can effectively synergize with and enhance the mechanism of action of tumor-targeted antibodies," said Scott Wolchko, President and Chief Executive Officer of Fate Therapeutics. "Importantly, the safety profile of FT516 continues to suggest multiple doses of iPSC-derived NK cells can be administered in the outpatient setting, and supports potential use across multiple lines of therapy, including as part of early-line CD20-targeted monoclonal antibody regimens, for the treatment of B-cell lymphoma."

As of a November 16, 2020 data cutoff, three patients in the second dose cohort of 90 million cells per dose and one patient in the third dose cohort of 300 million cells per dose were available for assessment of safety and efficacy. All four patients were heavily pre-treated, having received at least two prior rituximab-containing regimens. Each patient received two 30-day treatment cycles, with each cycle consisting of fludarabine and cyclophosphamide lympho-conditioning followed by three once-weekly doses of FT516, IL-2 cytokine support, and rituximab.

Safety Data
All four relapsed / refractory patients were administered FT516 in an outpatient setting with no requirement for inpatient monitoring. No dose-limiting toxicities, and no cases of any grade of cytokine release syndrome, immune effector cell-associated neurotoxicity syndrome, or graft-versus-host disease, were observed. The multi-dose, two-cycle treatment regimen was well-tolerated with no FT516-related grade 3 or greater adverse events reported by investigators. In addition, no evidence of anti-product T- or B-cell mediated host-versus-product alloreactivity was detected, supporting the potential to safely administer up to six doses of FT516 in the outpatient setting without patient matching. All grade 3 or greater treatment emergent adverse events were not related to FT516 and were consistent with lympho-conditioning chemotherapy and underlying disease.

Activity Data
Three of four relapsed / refractory patients achieved an objective response, including two complete responses (CR), following the second FT516 treatment cycle as assessed by PET-CT scan per Lugano 2014 criteria. A CR was achieved in one patient with diffuse large B-cell lymphoma (DLBCL) who was most recently refractory to a rituximab-containing treatment regimen, and a CR was achieved in one patient with follicular lymphoma (FL) who had previously been treated with four rituximab-containing treatment regimens. Notably, in one patient for which an interim tumor assessment showed a partial response following the first FT516 treatment cycle, the response deepened to a CR following administration of the second FT516 treatment cycle, suggesting that additional FT516 treatment cycles can confer clinical benefit.

FT516 Dose
Cohort
Subject
#
Lymphoma
Type
Prior Systemic Therapy Protocol-defined
Response1
Rituximab-containing
Therapies Relapsed /
Refractory
90M cells
2005 DLBCL 2 Refractory CR
2006 DLBCL 2 Relapsed PR
2007 DLBCL 3 Relapsed PD
300M cells 2008 FL 4 Relapsed CR
M = million; CR = Complete Response; PR = Partial Response; PD = Progressive Disease
As of November 16, 2020 database entry. Data subject to cleaning and source document verification.
1 Day 29 of the second FT516 treatment cycle as assessed per Lugano 2014 criteria

Dose escalation is continuing in the current dose cohort of 300 million cells per dose in combination with rituximab, and a fourth dose cohort of 900 million cells per dose in combination with rituximab is planned. The Company previously reported that two patients treated in the first dose cohort of 30 million cells per dose in combination with rituximab showed a protocol-defined response assessment of progressive disease. No events of cytokine release syndrome, immune effector cell-associated neurotoxicity syndrome, or graft-versus-host disease were observed in either patient.

About Fate Therapeutics’ iPSC Product Platform
The Company’s proprietary induced pluripotent stem cell (iPSC) product platform enables mass production of off-the-shelf, engineered, homogeneous cell products that can be administered with multiple doses to deliver more effective pharmacologic activity, including in combination with other cancer treatments. Human iPSCs possess the unique dual properties of unlimited self-renewal and differentiation potential into all cell types of the body. The Company’s first-of-kind approach involves engineering human iPSCs in a one-time genetic modification event and selecting a single engineered iPSC for maintenance as a clonal master iPSC line. Analogous to master cell lines used to manufacture biopharmaceutical drug products such as monoclonal antibodies, clonal master iPSC lines are a renewable source for manufacturing cell therapy products which are well-defined and uniform in composition, can be mass produced at significant scale in a cost-effective manner, and can be delivered off-the-shelf for patient treatment. As a result, the Company’s platform is uniquely capable of overcoming numerous limitations associated with the production of cell therapies using patient- or donor-sourced cells, which is logistically complex and expensive and is subject to batch-to-batch and cell-to-cell variability that can affect clinical safety and efficacy. Fate Therapeutics’ iPSC product platform is supported by an intellectual property portfolio of over 300 issued patents and 150 pending patent applications.

About FT516
FT516 is an investigational, universal, off-the-shelf natural killer (NK) cell cancer immunotherapy derived from a clonal master induced pluripotent stem cell (iPSC) line engineered to express a novel high-affinity 158V, non-cleavable CD16 (hnCD16) Fc receptor, which has been modified to prevent its down-regulation and to enhance its binding to tumor-targeting antibodies. CD16 mediates antibody-dependent cellular cytotoxicity (ADCC), a potent anti-tumor mechanism by which NK cells recognize, bind and kill antibody-coated cancer cells. ADCC is dependent on NK cells maintaining stable and effective expression of CD16, which has been shown to undergo considerable down-regulation in cancer patients. In addition, CD16 occurs in two variants, 158V or 158F, that elicit high or low binding affinity, respectively, to the Fc domain of IgG1 antibodies. Scientists from the Company have shown in a peer-reviewed publication (Blood. 2020;135(6):399-410) that hnCD16 iPSC-derived NK cells, compared to peripheral blood NK cells, elicit a more durable anti-tumor response and extend survival in combination with anti-CD20 monoclonal antibodies in an in vivo xenograft mouse model of human lymphoma. Numerous clinical studies with FDA-approved tumor-targeting antibodies, including rituximab, trastuzumab and cetuximab, have demonstrated that patients homozygous for the 158V variant, which is present in only about 15% of patients, have improved clinical outcomes. FT516 is being investigated in an open-label, multi-dose Phase 1 clinical trial as a monotherapy for the treatment of acute myeloid leukemia and in combination with CD20-targeted monoclonal antibodies for the treatment of advanced B-cell lymphoma (NCT04023071). Additionally, FT516 is being investigated in an open-label, multi-dose Phase 1 clinical trial in combination with avelumab for the treatment of advanced solid tumor resistant to anti-PDL1 checkpoint inhibitor therapy (NCT04551885).

On December 4, 2020 Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading 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 5,513,699 shares of its common stock, including the exercise in full by the underwriters of their option to purchase an additional 719,178 shares, at the public offering price of $36.50 per share (Press release, Intellia Therapeutics, DEC 4, 2020, View Source [SID1234572169]). The gross proceeds raised in the offering, before underwriting discounts and commissions and expenses of the offering, were approximately $201 million.

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

The shares of common stock were offered by Intellia pursuant to a 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 December 2, 2020. 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]; or 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]; or SVB Leerink LLC, by mail at One Federal Street, 37th Floor, Boston, MA 02110, Attention: Syndicate Department, by telephone at (800) 808-7525, ext. 6132, 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.