On September 11, 2019 Fate Therapeutics, Inc. (the "Company" or "Fate Therapeutics") (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, reported the pricing of an underwritten public offering of 8,600,000 shares of its common stock at a public offering price of $17.50 per share, before underwriting discounts, for an aggregate offering of approximately $150.5 million (Press release, Fate Therapeutics, SEP 11, 2019, View Source [SID1234539460]). Fate Therapeutics has granted the underwriters a 30-day option to purchase up to an additional 1,290,000 shares of its common stock. The proceeds to Fate Therapeutics from this offering are expected to be approximately $141.2 million after deducting underwriting discounts and commissions and other estimated offering expenses but excluding any exercise of the underwriters’ option. Fate Therapeutics intends to use the net proceeds from the offering to fund clinical trials and nonclinical studies, the manufacture of its clinical product candidates, the expansion of its cGMP compliant manufacturing operations, the conduct of preclinical research and development, and for general corporate purposes. All shares of common stock to be sold in the offering are being offered by Fate Therapeutics. The offering is expected to close on or about September 16, 2019, subject to customary closing conditions.

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Jefferies, Citigroup, SVB Leerink and Wells Fargo Securities are acting as joint book-running managers for the offering. Wedbush PacGrow and Cantor Fitzgerald & Co. are acting as co-managers for the offering.

The securities described above are being offered by Fate Therapeutics pursuant to an automatic shelf registration statement on Form S-3 (File No. 333-228513) that was previously filed by Fate Therapeutics with the Securities and Exchange Commission (the "SEC") and automatically became effective upon filing on November 21, 2018. The securities may be offered only by means of a prospectus.

A preliminary prospectus supplement related to the offering was filed with the SEC on September 11, 2019 and is available on the SEC’s website at View Source and a final prospectus supplement related to the offering will be filed with the SEC and will be available on the SEC’s website at View Source. Copies of the final prospectus supplement and the accompanying prospectus for the securities being offered may also be obtained, when available, by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by e-mail at [email protected] or by telephone at (877) 821-7388; Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (800) 831-9146; SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525 ext. 6132 or by email at [email protected]; or Wells Fargo Securities, LLC, Attention: Equity Syndicate Department, 375 Park Avenue, New York, New York 10152, by email at [email protected] or by telephone at (800) 326-5897.

This press release does 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.

On September 11, 2019 Fate Therapeutics, Inc. (the "Company" or "Fate Therapeutics") (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, reported that it has commenced an underwritten public offering of its common stock (Press release, Fate Therapeutics, SEP 11, 2019, View Source [SID1234539459]). Fate Therapeutics intends to use the net proceeds from the offering to fund clinical trials and nonclinical studies, the manufacture of its clinical product candidates, the expansion of its cGMP compliant manufacturing operations, the conduct of preclinical research and development, and for general corporate purposes. All shares of common stock to be sold in the offering will be offered by Fate Therapeutics. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or the actual size or terms of the offering.

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Jefferies and Citigroup are acting as joint book-running managers for the offering.

The securities described above are being offered by Fate Therapeutics pursuant to an automatic shelf registration statement on Form S-3 (File No. 333-228513) that was previously filed by Fate Therapeutics with the Securities and Exchange Commission (the "SEC") and automatically became effective upon filing on November 21, 2018.

A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website at View Source A copy of the preliminary prospectus supplement and accompanying prospectus can be obtained by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by e-mail at [email protected] or by telephone at (877) 821-7388; or Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (800) 831-9146.

This press release does 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 September 11, 2019 Apellis Pharmaceuticals, Inc. (Nasdaq:APLS), a clinical-stage biopharmaceutical company focused on the development of novel therapeutic compounds to treat disease through the inhibition of the complement system, reported that it intends to offer, subject to market and other conditions, $200 million aggregate principal amount of convertible senior notes due 2026 (the "notes") in a private offering to qualified institutional buyers in reliance on Rule 144A under the Securities Act of 1933, as amended (the "Securities Act") (Press release, Apellis Pharmaceuticals, SEP 11, 2019, View Source [SID1234539457]). Apellis also expects to grant to the initial purchasers of the notes a 13-day option to purchase up to an additional $30 million aggregate principal amount of the notes, solely to cover over-allotments, if any. The offering is subject to market and other conditions, and there can be no assurance as to whether, when or on what terms the offering may be completed.

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The notes will be unsecured, senior obligations of Apellis and will bear interest payable semi-annually in arrears on March 15 and September 15 of each year, beginning on March 15, 2020. The notes will mature on September 15, 2026, unless earlier repurchased, redeemed or converted in accordance with their terms. Subject to certain conditions, on or after September 20, 2023, Apellis may redeem for cash all or a portion of the notes. The notes will be convertible into cash, shares of Apellis common stock, or a combination of cash and shares of Apellis common stock, at Apellis’ election. Prior to March 15, 2026, the notes will be convertible only upon the occurrence of certain events and during certain periods, and thereafter, at any time until the second scheduled trading day immediately preceding the maturity date. The interest rate, conversion rate, conversion price and certain other terms of the notes will be determined at the time of pricing of the offering.

Apellis intends to use a portion of the net proceeds from the offering of the notes to pay the cost of the capped call transactions described below. If the initial purchasers exercise their option to purchase additional notes, Apellis intends to use a portion of the net proceeds from the sale of the additional notes to pay the cost of additional capped call transactions.

Apellis intends to use the remainder of the net proceeds from the sale of the notes to fund clinical development of APL-2, including preparation of a New Drug Application submission, to support the potential commercialization of APL-2, including the build-out of a commercial infrastructure and sales force, conduct research activities, repay in full the amount owed under a promissory note and for working capital and other general corporate purposes.

In connection with the pricing of the notes, Apellis expects to enter into capped call transactions with one or more of the initial purchasers of the notes and/or their respective affiliates and/or other financial institutions (the "option counterparties"). The capped call transactions are expected generally to reduce the potential dilutive effect on Apellis common stock upon any conversion of notes and/or offset any cash payments Apellis is required to make in excess of the principal amount of converted notes, as the case may be, with such reduction and/or offset subject to a cap. If the initial purchasers exercise their option to purchase additional notes, Apellis expects to enter into additional capped call transactions with the option counterparties.

In connection with establishing their initial hedge of the capped call transactions, the option counterparties have advised Apellis that they and/or their respective affiliates expect to purchase shares of Apellis common stock and/or enter into various derivative transactions with respect to Apellis common

stock concurrently with or shortly after the pricing of the notes, and, if applicable, the exercise by the initial purchasers of their option to purchase additional notes. This activity could increase (or reduce the size of any decrease in) the market price of Apellis common stock or the notes at that time.

In addition, the option counterparties have advised Apellis that they and/or their respective affiliates may modify their hedge positions by entering into or unwinding various derivatives with respect to Apellis common stock and/or purchasing or selling Apellis common stock or other securities of Apellis in secondary market transactions following the pricing of the notes and prior to the maturity of the notes (and are likely to do so during any observation period related to a conversion of notes or following any purchase of notes by Apellis upon any fundamental change purchase date or otherwise). This activity could also cause or avoid an increase or a decrease in the market price of Apellis common stock or the notes, which could affect noteholders’ ability to convert the notes and, to the extent the activity occurs during any observation period related to a conversion of notes, it could affect the amount and value of the consideration that noteholders will receive upon conversion of such notes.

The notes will be offered and sold to qualified institutional buyers pursuant to Rule 144A under the Securities Act. The offer and sale of the notes and the shares of common stock issuable upon conversion of the notes, if any, have not been and will not be registered under the Securities Act or the securities laws of any other jurisdiction, and the notes and any such shares may not be offered or sold in the United States absent registration or an applicable exemption from such registration requirements. Any offer of the notes will be made only by means of a private offering memorandum.

This press release shall not constitute an offer to sell, or a solicitation of an offer to buy the notes, nor shall there be any sale of, the notes in any state or jurisdiction in which such offer, solicitation or sale would be unlawful under the securities laws of any such state or jurisdiction.

On September 11, 2019 Gracell Biotechnologies Co., Ltd. ("Gracell"), a clinical-stage immune cell therapy company, reported a positive continued clinical readout of a multi-center pilot study designed to evaluate the safety and efficacy of Gracell’s first-in-class FasT CAR-19 (GC007F) investigational cell gene therapy (Press release, Gracell Biotechnologies, SEP 11, 2019, View Source [SID1234539452]). The results were announced during the CAR-TCR Summit held from 10-13 September in Boston.

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At present, anti-CD19 CAR-T bioprocessing takes on average two weeks to manufacture and seven days to pass quality testings. However, with Gracell’s FasT CAR solution, customized treatments which genetically modifies patient’s T-cells to express CD19-specific chimeric antigen receptor (CAR), preparation time can be cut to one day, with a manufacturing success rate of 26/26 (100%) without patient loss. FasT CAR technology can also be utilized on other immune cell programs, such as the treatment of multiple myeloma (MM) and Non-Hodgkin Lymphoma (NHL). With these advantages, FasT CAR-19 is highly cost-effective and has considerable potential to establish a new standard in CAR-T treatment for r/r B-ALL.

The multi-center investigational study enrolled 26 adolescent and adult patients aged from 14 to 70 years, with relapsed or refractory B-ALL, and had failed to respond to multiple prior lines of therapy. As of Sep. 4, all patients received a single infusion of FasT CAR-19 following lymphoid depleting chemotherapy. FasT CAR-19 was administered at three dose levels from low to high, equivalent to 1/30-1/10 of the conventional CAR-T therapy dose for B-ALL, respectively.

The treatment efficacy was assessed in 24 treated patients over 28 days of follow-up, of which:

23 (95.8%) achieved complete remission with or without complete blood count recovery (CR/CRi);
21 (87.5%) achieved undetectable minimal residual disease (uMRD) (< 10-4 detectable leukemic cells in bone marrow).
During the over three month-durable remission period, FasT CAR-19 demonstrated a good level of persistence. In terms of safety, all 26 patients well tolerated the single infusion of FasT CAR-19 at different dose levels. The most common safety concerns were cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) where mild to moderate side effects were observed.

In comparison to the high dose group, patients administered low to middle dose levels experienced mild adverse events. Across 20 patients in the low to mid doses group, only 2 (10%) Grade 3 CRS and 2 (10%) manageable Grade 3 ICANS were reported; while in the 6 patients of the high dose group, there were 5 (83.3%) Grade 3 CRS and 1 (16.7%) Grade 1-2 ICANS, indicating a dose-limiting toxicity.

Taking FasT CAR-T Further: GC012F and GC022F

CAR-T immunotherapy uses patients’ own immune cells to treat disease. In this form of therapy, immune cells are collected from a patient’s blood; engineered in a laboratory to create a chimeric antigen receptor cells (CAR) that target cancer cells and then reinfused back into the patient. However, such therapy is time-consuming, highly personalized. Furthermore, it can only target a single tumor antigen, which limits efficacy.

To combat this, treatments containing two separate CARs and dual transduction (GC012 targeting BCMA and antigen X, and GC022 targeting CD19 and CD22), which were expected to have a higher safety profile and ability to control and prevent relapse compared to single CAR-T cells were developed. As both programs (GC012F and GC022F) hold similar characteristics to GC007F, there is potential to enhance the therapies through the FasT CAR platform, enabling GC012F and GC022F to perform better than the conventionally manufactured dual CAR-T cells.

The results from in vitro studies have already shown that GC012F and GC022F provide a higher portion of centry memory T cells with less exhaustion, higher proliferation capacity, and killing ability similar to conventional CAR-T cells at the same cell basis. While in vivo studies, show lower dose poses higher potency, greater efficiency and better ability to eradicate tumor cells.

"We are very excited to see that the patients with refractory or relapsed B-ALL in this study gained substantial clinical benefit from FasT CAR-19" said CEO Dr. William CAO. "Dual CAR-T cells manufactured using the FasT CAR platform has the potential to offer more clinical benefits. The next stage will be to unlock these benefits with first-in-human trials."

About FasT CAR-19

FasT CAR-19, or GC007F, is an investigational CD19-targeted CAR-T cell therapy for adolescent and adult patients with refractory or relapsed B-ALL, as well as aggressive non-Hodgkin lymphoma. Thanks to Gracell’s patented FasT CAR technology, the bioprocessing of GC007F has been significantly reduced to 24 hours with substantially lower cost. The younger and less exhausted T cell phenotype exhibited superior proliferation capabilities, potency, and extensive bone marrow migration making GC007F a potential best-in-class therapy for refractory or relapsed B-ALL.

About ALL

Acute lymphoblastic leukemia (ALL), although rare, is one of the most common forms of cancer in children between the ages of two and five and adults over the age of 50[1]. In 2015, ALL affected around 876,000 people globally and resulted in 110,000 deaths worldwide[2]. It is also the most common cause of cancer and death from cancer among children. ALL is typically treated initially with chemotherapy aimed at bringing about remission. This is then followed by further chemotherapy carried out over several years.

About MM

Multiple myeloma (MM) is a cancer that forms in a type of white blood cell known as a plasma cell. Plasma cells help fight infection by making antibodies. MM causes cancer cells to accumulate in the bone marrow, where they crowd out healthy blood cells. Rather than producing antibodies, the cancer cells produce abnormal proteins which cause complications (myeloma cells).

On September 11, 2019 Q BioMed, Inc. (OTCQB: QBIO) and Chemveda Life Sciences are very pleased to announce that after the recent successful chemical synthesis of a unique natural compound that has shown remarkable efficacy as a potential chemotherapy for the treatment of liver cancer, the two companies have formalized a collaboration to continue the work and to scale-up manufacturing of cGMP product for planned pre-clinical testing and clinical trials (Press release, Q BioMed, SEP 11, 2019, View Source [SID1234539451]).

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Since February 2017, Q BioMed and Chemveda have been engaged in a joint research program to synthesize uttroside B and several other derivatives. The goal of the program is to study their potential use in clinical trials for the treatment of hepatocellular carcinoma (liver cancer) as well as other cancers. The original compound was isolated and characterized from the leaves of Solanum nigrum Linn, a plant widely used in traditional medicines.

In a Scientific Reports study, researchers showed that in animal models, uttroside B was ten times more cytotoxic to the HepG2 liver cancer cell line than sorafenib, the only drug approved by the Food and Drug Administration for liver cancer at the time and the current first line treatment for hepatocellular carcinoma. Uttroside B drastically reduced tumors in mice bearing human liver cancer xenografts. In addition, in pre-clinical experiments, uttroside B induced cytotoxicity in all liver cancer cell lines and researchers were able to confirm its biological safety, both by in vitro and in vivo studies. Q BioMed is awaiting confirmatory cell line efficacy data from the synthesized drug product and its derivatives.

Denis Corin, Q BioMed CEO said, "Chemveda has been an excellent partner in this program, both in terms of execution and problem solving, and we look forward to the next phase as we advance this promising molecule and others towards the clinic."

Bheema Paraselli, Chemveda’s President & CEO said, "Since its inception in early 2017 we have been very interested in this research given to the novelty of its clinical end-point & nobility of this approach. What helped us cut through the initial uncertainty and risks surrounding the milestone approach was our stringent due-diligence, attention to detail, and tailored scientific approach. We are very thankful to Q BioMed for being of tremendous help."

Under the Agreement and depending upon reaching certain milestones, Q BioMed have agreed to pay Chemveda a combination of cash and stock and capped royalty on net sales of any and all drug product(s) resulting from the collaboration. Subject to the terms of the Agreement, Chemveda shall have the first right of refusal and, if exercised, the exclusive right to manufacture any products developed as a result of the program for pre-commercial and commercial production.

Chemotherapeutic options for liver cancer are limited, and the prognosis of patients remains challenging. According to the Centers for Disease Control and Prevention, it is the second most common cause of cancer deaths worldwide, claiming approximately 750,000 lives each year. In the US, the American Cancer Society estimates that 42,000 people will be diagnosed with liver cancer in 2019 and that 32,000 will die from the disease this year. Liver cancer incidence has more than tripled since 1980 and deaths in the US have increased 56% since 2003.

The uttroside B technology is covered by a provisional patent application. To see the full Scientific Reports study, go to:View Source

Please visit www.QBioMed.com for more information on our various pipeline products.