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 OncoCell MDx, Inc., a pan-disease immunogenomics platform company developing novel noninvasive blood-based tests to optimize patient care, reported it has raised $22.2 million in a Preferred Series B financing (Press release, OncoCell MDx, SEP 11, 2019, View Source [SID1234539441]). The financing was led by Savitr Capital, LLC (Savitr) with participation from existing investors.

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OncoCell MDx has raised more than $30 million to date in support of its vision to simultaneously detect and stage cancer and other diseases using a single blood sample. This funding bolsters the company’s balance sheet and supports ongoing development and commercialization of its pan-disease diagnostic testing platform. The company plans to launch a blood test for detection and grading of aggressive prostate cancer next year.

"OncoCell is harnessing the power of the immune system and leveraging their proprietary immunogenomics technology to diagnose and stage disease early when there is the greatest opportunity for cure," said Andrew Midler, Managing Member at Savitr.

"We are developing and commercializing novel noninvasive tests that provide accurate diagnostic information quickly to physicians and their patients to help optimize patient treatment and improve patient outcomes," said Mark McDonough, President and CEO of OncoCell MDx.

"In a relatively short time, we have built a database of over 2,000 patient subjects analyzed with RNA-Seq and identified unique immunogenomic signatures that can discriminate healthy patients from those with indolent versus aggressive disease, he said. In prostate cancer, we’ve developed a blood test to enable improved staging and determine if a patient can safely forego invasive surgery or radiation therapy. Then, by virtue of our noninvasive approach, the patient can be serially tested to rule out disease progression, reducing the cost of care and improving quality of life."

On September 11, 2019 Genprex, Inc. (NASDAQ: GNPX), a clinical-stage gene therapy company, reported that independent researchers reported in a recent study that TUSC2, a tumor suppressor gene and the active agent in Genprex’s Oncoprex immunogene therapy, prevented tumor growth in triple-negative breast cancer (TNBC), which is currently considered an incurable cancer with limited therapeutic options (Press release, Genprex, SEP 11, 2019, View Source [SID1234539442]). Genprex has no affiliation with these researchers.

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The study, published in Nature, first found MicroRNA-138 as a diagnostic biomarker for TNBC, which currently lacks targeted therapies due to its inability to express the estrogen and progesterone hormone receptors and the human epidermal growth factor receptor 2 (HER2), thus the name for triple-negative breast cancer. Depletion of miR-138 was found to lead to apoptotic cell death in vitro and prevented tumorigenesis in vivo. TUSC2 was found to be a direct target of miR-138, and TUSC2 mimics the effects of miR-138 knockdown, preventing tumor growth. The researchers deduced that TUSC2 is a downstream tumor suppressor that is directly repressed by miR-138.

The study reports that triple-negative breast cancer is an extremely aggressive subtype of breast cancer which is associated with poor prognosis and high mortality rates. The lack of targeted treatment for triple-negative breast cancer makes it an increasingly feared diagnosis.

Genprex is conducting clinical and pre-clinical research to evaluate the effectiveness of TUSC2 when combined with targeted therapies and immunotherapies for non-small cell lung cancer. Existing pre-clinical data also suggest that TUSC2 may be effective against glioblastoma, head and neck cancer, kidney cancer, and soft tissue sarcomas. Now, this new independent study raises the possibility that TUSC2 expression, through miR-138 targeting, may also be used to treat the most aggressive subset of breast cancer.

"The results of the study evaluating TUSC2 for the treatment of triple-negative breast cancer are encouraging," said Rodney Varner, Genprex’s Chairman and Chief Executive Officer. "We believe that the data reported in this Nature article by independent researchers supports our belief that TUSC2 may be effective to treat a variety of cancers, including some of the most deadly types of cancer."

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 FORMA Therapeutics, Inc. reported that abstracts for the company’s next generation IDH1m inhibitor, olutasidenib (FT-2102), have been accepted for two presentations at the 2019 Society for NeuroOncology Annual Meeting, taking place November 20-24, 2019 in Phoenix, Arizona (Press release, Forma Therapeutics, SEP 11, 2019, View Source [SID1234539443]). Olutasidenib was designed to have a differentiated efficacy, durability and safety profile, as well as blood brain barrier penetrance, and is intended to treat all cancers with IDH1 mutations, including acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), gliomas and other solid tumors.

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"I am proud of the progress FORMA has made in the first eight months of 2019 and am truly excited for this next phase of growth for our company centered on our wholly-owned therapeutic pipeline focused on rare hematologic diseases and cancers," said Frank Lee, CEO of FORMA Therapeutics. "Gliomas are the most common, aggressive and difficult-to-treat primary brain tumors, with current treatment options limited to surgery, chemotherapy and radiation. Furthermore, gliomas typically affect relatively young patients. We look forward to presenting data regarding the brain penetrant activity of olutasidenib as well as initial results from our ongoing Phase 1b/2 study in patients with relapsed/refractory IDH1 mutant gliomas this November at SNO."

Olutasidenib Status in Gliomas/Solid Tumors:

An ongoing Phase 1b/2 study of olutasidenib is enrolling patients with gliomas or other advanced solid tumors with an IDH1 mutation.
Data from olutasidenib clinical trials have been submitted for presentation at medical meetings in the fourth quarter of 2019. Abstracts accepted for presentation at SNO include:
Oral Presentation: FT-2102 – A Potent and Selective Brain Penetrant Inhibitor of Mutant Isocitrate Dehydrogenase
Date and Time: Wednesday, November 20, 2019, 9:45-9:55 AM, MST
Oral Abstract Session: BBB Physiology at the SNO-SCIDOT Joint Conference on Therapeutic Delivery to the CNS
Presenter: Maria Ribadeneira, PhD, FORMA Therapeutics
E-Talk Presentation: Phase 1 study of FT-2102, an inhibitor of mutant IDH1, in patients with relapsed/refractory IDH1 mutant gliomas: preliminary safety and clinical activity
Date and Time: Saturday, November 23, 2019, 5:20 PM – 5:24 PM, MST
E-Talks Session: Group 1: Adult Therapeutics/Immunology Rare Tumors
Presenter: Macarena de la Fuente, MD, Sylvester Cancer Center, University of Miami
About Olutasidenib (FT-2102)

FORMA’s most advanced clinical asset, olutasidenib was designed as a potent and selective next generation inhibitor of mutated isocitrate dehydrogenase 1 (IDH1m) intended to treat patients with relapsed/refractory acute myeloid leukemia (RR/AML) or myelodysplastic syndrome (MDS), and patients with glioma and other solid tumors with an IDH1 mutation. IDH1 is a natural enzyme that is part of the normal metabolism of all cells, but when mutated its activity can promote blood malignancies and solid tumors. IDH1 mutations are present in up to 16% of patients with AML and over 80% of patients with low-grade gliomas. In AML, hypermethylation driven by IDH mutations inhibits normal differentiation of progenitor cells leading to accumulation of immature blasts. Quality of life declines with each successive line of treatment for AML and well-tolerated treatments in relapsed disease remain an unmet need. In gliomas, IDH1 mutations occur early in the tumor pathogenesis and persist throughout progression from a neural stem or progenitor cell. Gliomas are the most common, aggressive and difficult-to-treat primary brain tumors and high-grade gliomas are associated with poor long-term prognosis, with a median survival ranging from 5 to 7 years. Treatment options for relapsed glioma are limited. The rationale for targeting IDH1m is to reverse the oncogenic hypermethylated state to reduce tumor burden through induction of differentiation of immature blasts in AML and by slowing or stopping cancer cell growth in glioma.

In addition to the ongoing Phase 1b/2 study in patients with gliomas and other advanced solid tumors with an IDH1 mutation, a multi-cohort study with olutasidenib as a single agent and in combination with azacitidine is currently enrolling patients with AML and MDS, including a pivotal arm with olutasidenib as a single agent in R/R AML. Patients with treatment-naïve AML and R/R MDS with IDH1m are also being evaluated. Top-line data in patients with R/R AML are expected in the first half of 2020. If there is a positive outcome in R/R AML patients, a new drug application (NDA) is expected to be filed in the second half of 2020.