On January 15, 2019 Five Prime Therapeutics, Inc. (NASDAQ: FPRX), a clinical-stage biotechnology company focused on discovering and developing innovative immuno-oncology protein therapeutics, reported a corporate restructuring to focus resources on its development pipeline, comprising five clinical-stage cancer programs in various solid tumor types and addressing multiple cell types in the tumor microenvironment (Press release, Five Prime Therapeutics, JAN 15, 2019, View Source [SID1234532678]).

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"While we are on track for multiple data read-outs and potential phase advances from our pipeline in 2019, the Executive Team and Board felt it was necessary to sharpen our focus on our current clinical programs and the advancement of our later-stage research initiatives," said Aron Knickerbocker, Chief Executive Officer of Five Prime Therapeutics. "This was a hard decision to make, but we believe that effective use of capital is crucial to supporting our strong pipeline of anti-cancer drug candidates. We remain committed to successfully executing our clinical trials and advancing our later-stage research programs with the same intensity and quality for which Five Prime is known."

The company is eliminating 41 current positions, representing approximately 20% of its current headcount, and will take a disciplined approach to replacing and adding headcount. The positions eliminated are primarily in areas relating to research, pathology and manufacturing. The company expects that the restructuring and other cost-saving efforts will result in a $10 million reduction in net cash used for operating activities during fiscal year 2019 as compared to 2018, with additional expected savings in 2020 and beyond due to lower ongoing personnel expense. Five Prime estimates that it will incur approximately $2 million of pre-tax charges for severance and other costs related to the restructuring, primarily during the first quarter of 2019.

The company’s financial guidance that it anticipates ending 2019 with $148 to $153 million in cash, cash equivalents and marketable securities reflects the expected reduction in the company’s operating expenses due to the elimination of positions. The company has no debt and ended 2018 with $270 million in cash, cash equivalents and marketable securities and believes this cash is sufficient to fund programs through multiple data readouts.

On January 15, 2019, Stemline Therapeutics, Inc. ("Stemline" or the "Company") reported that it has entered into an underwriting agreement (the "Underwriting Agreement") with J.P. Morgan Securities LLC, as representative of the several underwriters named therein (the "Underwriters") (Filing, 8-K, Stemline Therapeutics, JAN 15, 2019, View Source [SID1234532699]). Pursuant to the Underwriting Agreement, the Company agreed to sell to the Underwriters, in a firm commitment underwritten public offering, 8,888,889 shares (the "Firm Shares") of the Company’s common stock, $.0001 par value per share ("Common Stock"), at a price to the public of $9.00 per share, less underwriting discounts and commissions. Due to demand, this offering was upsized from the previously announced 6,600,000 shares. In addition, pursuant to the Underwriting Agreement, the Company has granted the Underwriters an option, exercisable for 30 days, to purchase up to an additional 1,333,333 shares of Common Stock (the "Additional Shares," together with the Firm Shares, the "Shares"). The transactions contemplated by the Underwriting Agreement are expected to close on January 18, 2019, subject to the satisfaction of customary closing conditions. A copy of the Underwriting Agreement is attached hereto as Exhibit 1.1 and is incorporated by reference herein.

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J.P. Morgan Securities LLC and Cowen and Company, LLC are acting as joint book-running managers for the offering.

The net proceeds to the Company are expected to be approximately $80,000,000, assuming no exercise of the option to purchase Additional Shares and after deducting underwriting discounts and commissions and estimated expenses payable by the Company associated with the offering.

The Underwriting Agreement contains customary representations, warranties and agreements by the Company, customary conditions to closing, indemnification obligations of the Company and the Underwriters, including for liabilities under the Securities Act of 1933, as amended, other obligations of the parties and termination provisions.

On January 15, 2019 Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical stage targeted oncology company, reported that it has dosed the first patient in a Phase 1/2 clinical trial of MRTX849, an investigational KRAS G12C inhibitor for patients with advanced solid tumors that harbor KRAS G12C mutations (Press release, Mirati, JAN 15, 2019, View Source [SID1234532661]).

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"Today we have achieved an important milestone in the battle against cancers driven by KRAS mutations, one of the most common and difficult to treat patient populations. MRTX849 has been designed to specifically target KRAS G12C mutations, which are thought to be responsible for at least 14% of non-small cell lung adenocarcinoma, 4% of colorectal cancer, and subsets of other types of cancers," said Charles Baum, M.D., Ph.D., President and Chief Executive Officer of Mirati. "In preclinical studies MRTX849 potently and specifically bound to KRAS G12C and produced durable tumor regressions in patient-derived cancer models implanted in mice. Our Phase 1/2 clinical trial is designed to rapidly advance MRTX849 towards registration and approval."

"There are no approved targeted treatment options for patients with KRAS-driven cancers," said Pasi A. Jänne, M.D., Ph.D., Mirati Scientific Advisory Board Member, and Director of the Lowe Center for Thoracic Oncology at the Dana Farber Cancer Institute. "The development of a direct inhibitor of KRAS G12C is an important advancement in the field and this clinical study is designed to rapidly and efficiently evaluate the tolerability and efficacy of MRTX849 to treat patients with tumors driven by this mutation."

Mirati’s Phase 1/2 clinical trial will evaluate MRTX849 as a single agent in patients with advanced solid tumors that harbor KRAS G12C mutations. The Phase 1 dose escalation phase of the trial will assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of MRTX849 in patients with molecularly-identified KRAS G12C-positive advanced solid tumors. A dose expansion phase is planned to follow the selection of a recommended Phase 2 dose. Additional information can be found at View Source

About MRTX849

MRTX849 is an investigational, orally-available small molecule that is designed to potently and selectively inhibit a form of KRAS which harbors a substitution mutation (G12C). KRAS G12C mutations are present in approximately 14% of NSCLC adenocarcinoma patients, 4% of colorectal cancer patients, and subsets of other types of cancer. Tumors characterized by KRAS G12C mutations are commonly associated with poor prognosis and resistance to therapy, and patients with these mutations have few treatment options. MRTX849 is being evaluated in a Phase 1/2 trial treating patients with molecularly-identified KRAS G12C-positive advanced solid tumors

On January 15, 2019 Stemline Therapeutics, Inc. (Nasdaq: STML), a commercial-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing innovative oncology therapeutics, reported the pricing of an underwritten public offering of 8,888,889 shares of its common stock at a price of $9.00 per share, with expected gross proceeds to Stemline of $80 million (Press release, Stemline Therapeutics, JAN 15, 2019, View Source [SID1234532662]). Due to demand, this offering was upsized from the previously announced 6,600,000 shares. Stemline has also granted the underwriters a 30-day option to purchase up to 1,333,333 additional shares of its common stock at the public offering price, less underwriting discounts and commissions. The offering is expected to close on January 18, 2019, subject to customary closing conditions.

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J.P. Morgan Securities LLC and Cowen and Company, LLC are acting as joint book-running managers for the offering. Cantor Fitzgerald & Co., Ladenburg Thalmann & Co. Inc. and H.C. Wainwright & Co., LLC are acting as co-lead managers and Roth Capital Partners, LLC, ThinkEquity, a division of Fordham Financial Management, Inc., A.G.P./Alliance Global Partners, National Securities Corporation, and Aegis Capital Corp. are acting as co-managers for the offering.

Stemline intends to use the net proceeds from this offering for (i) commercial activities of ELZONRIS (tagraxofusp; SL‑401) including clinical trials for additional indications including CMML, MF and other diseases; (ii) clinical development of SL‑801, SL‑701 and potentially SL-901; (iii) research and development activities; (iv) potential acquisitions and in-licensing; and (v) other general corporate purposes.

Stemline has filed a preliminary prospectus supplement to its shelf registration statement on Form S-3 (File No. 333-219794) with the U.S. Securities and Exchange Commission ("SEC") for the public offering of its common stock. The preliminary prospectus supplement is available on the SEC’s web site at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to these securities may also be obtained, when available, by contacting J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, Telephone: (866) 803-9204, or Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, Attn: Prospectus Department, or by email at [email protected].

The offering of these securities is being made under an effective shelf registration statement on file with the SEC. This press release shall 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.

About BPDCN
BPDCN is an aggressive hematologic malignancy with historically poor outcomes and an area of unmet medical need. The BPDCN cell of origin is the plasmacytoid dendritic cell (pDC) precursor. BPDCN typically presents in the bone marrow and/or skin and may also involve lymph nodes and viscera. The diagnosis of BPDCN is based on the immunophenotypic diagnostic triad of CD123, CD4, and CD56. For more information, please visit the BPDCN disease awareness website at www.bpdcninfo.com.

About ELZONRIS
ELZONRIS (tagraxofusp), a CD123-directed cytotoxin, was approved by the Food and Drug Administration (FDA) on December 21, 2018 for the treatment of adult and pediatric patients, two years and older, with blastic plasmacytoid dendritic cell neoplasm (BPDCN). In November 2018, the European Medicines Agency (EMA) granted ELZONRIS accelerated assessment to the marketing authorization application (MAA), which was submitted to the EMA in January 2019. ELZONRIS is also being evaluated in additional clinical trials in other indications including chronic myelomonocytic leukemia (CMML), myelofibrosis (MF) and other CD123 positive diseases.

On January 15, 2019 Moleculin Biotech, Inc presented the corporate presentation (Press release, Moleculin, JAN 15, 2019, View Source [SID1234532663]).

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