On August 7, 2019 Quanterix Corporation (Nasdaq: QTRX), a company digitizing biomarker analysis with the goal of advancing the science of precision health, reported that it has commenced an underwritten public offering of $75 million of shares of its common stock (Press release, Quanterix, AUG 7, 2019, View Source [SID1234538339]). In connection with the offering, Quanterix intends to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of common stock at the public offering price. All of the shares in the offering will be sold by Quanterix. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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J.P. Morgan Securities LLC and SVB Leerink LLC are acting as joint book-running managers for the offering. Canaccord Genuity LLC is acting as co-manager for the offering.

The public offering will be made pursuant to a shelf registration statement on Form S-3 that was previously filed with and declared effective by the Securities and Exchange Commission ("SEC"). A preliminary prospectus supplement and accompanying base prospectus relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website located at View Source The offering is being made only by means of a prospectus and related prospectus supplement, copies of which may be obtained, when available, from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, telephone: (866) 803-9204; or SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA, 02110, by telephone at (800) 808-7525, ext. 6132 or by e-mail at [email protected]. The final terms of the offering will be disclosed in a final prospectus supplement to be filed with the SEC.

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

On August 7, 2019 Stemline Therapeutics, Inc. (Nasdaq:STML), a commercial -stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing innovative oncology therapeutics, reported that it intends to offer and sell, subject to market conditions, 5,000,000 shares of its common stock in an underwritten public offering (Press release, Stemline Therapeutics, AUG 7, 2019, View Source [SID1234538368]). All of the shares to be sold in the offering will be offered by Stemline. In addition, Stemline intends to grant the underwriters a 30-day option to purchase up to an additional 750,000 shares of its common stock offered in the public offering.

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J.P. Morgan Securities LLC is acting as book-running manager for the offering.

Stemline intends to use the net proceeds from this offering for (i) commercial activities of ELZONRIS (tagraxofusp; SL-401), (ii) clinical trials for additional indications including CMML, MF, AML, and potentially other diseases such as certain lymphomas; (ii) clinical development of additional pipeline candidates (felezonexor (SL-801), SL-1001, SL-901 and SL-701); (iii) research and development and regulatory 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. 333-230341) with the U.S. Securities and Exchange Commission ("SEC") for the proposed public offering of its common stock. The offering will be made only by means of a prospectus and a prospectus supplement, which will be available on the SEC’s web site at www.sec.gov. Copies of the preliminary 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.

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 ELZONRIS
ELZONRIS (tagraxofusp-erzs), a CD123-directed cytotoxin, is approved by the U.S. Food and Drug Administration (FDA) and commercially available in the U.S. for the treatment of adult and pediatric patients, two years or older, with blastic plasmacytoid dendritic cell neoplasm (BPDCN). For full prescribing information in the U.S., visit www.ELZONRIS.com. In Europe, a marketing authorization application (MAA) is under review by the European Medicines Agency (EMA). ELZONRIS is also being evaluated in additional clinical trials in other indications including chronic myelomonocytic leukemia (CMML), myelofibrosis (MF), and acute myeloid leukemia (AML).

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

About CD123
CD123 is a cell surface target expressed on a wide range of myeloid tumors including blastic plasmacytoid dendritic cell neoplasm (BPDCN), certain myeloproliferative neoplasms (MPNs) including chronic myelomonocytic leukemia (CMML) and myelofibrosis (MF), acute myeloid leukemia (AML) (and potentially enriched in certain AML subsets), myelodysplastic syndrome (MDS), and chronic myeloid leukemia (CML). CD123 has also been reported on certain lymphoid malignancies including multiple myeloma (MM), acute lymphoid leukemia (ALL), hairy cell leukemia (HCL), Hodgkin’s lymphoma (HL), and certain Non-Hodgkin’s lymphomas (NHL). In addition, CD123 has been detected on some solid tumors as well as autoimmune disorders including cutaneous lupus and scleroderma.

On August 7th 2019 Inflection Biosciences Ltd, a company developing innovative therapeutics for the treatment of cancer, announced the publication of pre-clinical data showing the company’s PIM/PI3K/mTOR, AUM302 (formerly IBL-302), has promise as a treatment for neuroblastoma (Press release, Inflection Biosciences, AUG 7, 2019, View Source [SID1234538591]). This research has recently been published in the medical journal EMBO Molecular Medicine.

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This publication is the result of a collaboration between Inflection Biosciences and two research teams at the Lund University Cancer Centre, Sweden, led by Associate Professors Sofie Mohlin and Daniel Bexell. Inflection Biosciences recently announced that global development and commercialisation rights to AUM302 were granted to AUM Biosciences, Singapore.

Neuroblastoma is an extracranial childhood malignancy of the nervous system that accounts for 15% of all paediatric cancer fatalities. Despite advances in treatment, children with high‐risk disease have poor survival rates, with up to 40% 5‐year mortality. It has previously been shown that targeting the PI3K/mTOR pathway could be a viable treatment for aggressive neuroblastoma. Furthermore, in neuroblastoma cell lines and patient derived xenograft (PDX) derived cell cultures, high levels of PIM were also significantly associated with adverse neuroblastoma patient outcomes.

These published results show that from a panel of 707 cell lines across 47 tumour types, neuroblastoma was the most sensitive tumour type to AUM302 treatment, and out of 16 neuroblastoma cell lines, AUM302 was generally more effective than PI3K inhibitors alone. AUM302 improved the effect of three clinically used chemotherapeutic agents in vitro. AUM302 treatment alone reduced tumour growth in a neuroblastoma xenograft and inhibited neuroblastoma PDX growth in combination with low‐dose cisplatin.

Dr. Bexell, one of the lead authors on the publication, commented: "Adding AUM302 to current treatments to lower administered doses of highly toxic chemotherapy could decrease complications later in life and improve outcomes in these young neuroblastoma patients."

The publication titled ‘Anti‐tumor effects of PIM/PI3K/mTOR triple kinase inhibitor IBL‐302 in neuroblastoma’ can be accessed here.

The research was funded by the Swedish Cancer Society and the Swedish Childhood Cancer Foundation.

On August 7, 2019 Elicio Therapeutics, a next generation immuno-oncology company, reported that significant preclinical data from a novel lymph-node targeted vaccine targeting the seven KRAS mutations that drive 99% of all KRAS-driven cancers, estimated to be 25% of all human solid tumors (Press release, Elicio Therapeutics, AUG 7, 2019, View Source [SID1234538290]). Elicio’s "AMP KRAS vaccine" ELI-002 will enter initial patient studies in pancreatic cancer patients in Q1-2020.

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These studies, described in "Amphiphile-modifications target mKRAS-antigen and adjuvant to lymph nodes and enable polyfunctional mKRAS-specific immune responses with potent cytolytic activity," co-authored by Peter DeMuth, PhD., Elicio Vice President of Research, will be presented at the Immuno-Oncology Summit in Boston on August 8th, 2019.

"Previous vaccine approaches utilizing synthetic peptides have not effectively targeted the critical immune cells residing in the lymph nodes and have elicited only weak or undetectable immune responses in patients," said Dr. DeMuth. "The Amphiphile technology allows us to simultaneously generate immune response to the seven mutations commonly present in KRAS driven cancers by targeting peptides with a powerful adjuvant directly to the lymph nodes, significantly amplifying the resulting immune responses, and producing highly functional mKRAS-specific T cells capable of killing mKRAS-presenting cells in vivo."

Elicio has demonstrated in multiple tumor models that improving the targeting of immunogens and cell-therapy activators to lymph nodes, where resident immune cells potently orchestrate immunity, can substantially amplify their ability to induce effective tumor-killing immune responses. ELI-002 is an "AMP KRAS vaccine" containing seven Amphiphile mKRAS peptides and a proprietary Amphiphile adjuvant, administered subcutaneously.

The "AMP KRAS vaccine" administration and resulting immune response yields robust activation against all common mutations in the KRAS protein compared to low or undetectable responses generated by soluble or benchmark treatments which fail to effectively reach the lymph nodes. Further, this response is composed of CD4+ as well as CD8+ T-cells resulting in the production of high levels of Th1-associated cytokines upon re-stimulation with mKRAS-specific peptides in vitro. In vivo, robust cytolytic function towards mKRAS-presenting targets can be measured in the T-cells generated through the AMP vaccination regimen.

"To date, ‘drugging’ mKRAS directly has only been achieved in early clinical studies for the G12C allele, using covalent inhibitors. While validating mKRAS as a target in lung cancer, most human tumors have different mutations, or G12C is not a driver mutation. The concern is that chasing mutations is difficult and keeping up with the genomic instability of cancer may lead to resistance. The AMP vaccine approach covers 99% of all mKRAS tumors and G12X or G13X mutations need only be expressed, and not necessarily as driver mutations," said Julian Adams PhD, Elicio’s Chairman.

Elicio is developing ELI-002 to treat and prevent disease recurrence for hundreds of thousands of patients with mKRAS-driven cancers, including pancreatic, colorectal and lung cancer. KRAS mutations are present in 90% of pancreatic cancers, 40% of colorectal cancers, and 30% of non-small cell lung cancers. ELI-002has completed preclinical validation, IND-enabling GLP toxicology studies, GMP manufacturing, and a pre-IND meeting with the FDA and intends to enter initial patient studies in the first half of 2020. These trials will be multi-site, randomized, controlled studies.

About the Amphiphile Platform

The Elicio Amphiphile platform enables precise targeting and delivery of immunogens and cell-therapy activators directly to the lymphatic system, the "brain center" of the immune response, to significantly amplify and enhance the body’s own system of defenses, defeat solid and hematologic cancers, and prevent their recurrence. Once in the lymph nodes, Amphiphile immunotherapies are taken up by antigen presenting cells (APC’s) to orchestrate signaling to natural or engineered immune cells in order to maximize therapeutic immune responses to disease. This strategy has been used to improve the activity of immunostimulatory agents, antigens, adjuvants, and cell-therapies that generate little to no response when used in the conventional forms. By precisely targeting these immunotherapies to the lymph nodes, Amphiphiles can unlock their full potential to generate and amplify anti-tumor immune responses. This substantially enhanced anti-tumor functionality and long-term protective memory may someday unlock the full potential of the immune response to eliminate cancer.

On August 7, 2019 Rexahn Pharmaceuticals, Inc. (NasdaqCM: REXN), a clinical stage biopharmaceutical company developing innovative therapies to improve patient outcomes in cancers that are difficult to treat, reported financial results for the three and six months ended June 30, 2019 and provided an update on RX-3117 development (Press release, Rexahn, AUG 7, 2019, View Source [SID1234538306]).

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Recent Highlights and RX-3117 Development Updates:

Announced a collaboration and license agreement with BioSense Global LLC, a New Jersey- and Suzhou, China-based biopharmaceutical company, to advance the development and commercialization of RX-3117 for pancreatic and other cancers in Greater China. Under the agreement, Rexahn will receive an upfront payment, a portion of which has been paid, and will be eligible to receive up to $126 million in development and regulatory milestones and up to $100 million in commercial milestones for each product containing RX-3117, contingent on achieving commercial goals.

As of July 24, 2019, an overall response rate of 23% has been observed in 40 patients that have had at least one scan on treatment in the Phase 2a study of RX-3117 in combination with ABRAXANE (paclitaxel protein-bound particles for injectable suspension) in patients newly diagnosed with metastatic pancreatic cancer. The Company previously reported in January 2019 an overall response rate of 38% in the first 24 patients who had at least one scan on treatment. Preliminary and unaudited data indicates that the median progression free survival for patients in the study is approximately 5.4 months. Patients currently active in the study will continue to be treated and final data from the trial is expected to be available in 2020.

Transferred its stock exchange listing to the Nasdaq Capital Market from its previous listing on NYSE American.

Effected a 1-for-12 reverse stock split of outstanding shares on April 12, 2019.

As of August 7, 2019, had approximately $15.3 million in cash, cash equivalents, and marketable securities (unaudited). Rexahn expects that its cash, cash equivalents and marketable securities will be sufficient to fund the company’s currently expected cash flow requirements for its activities for at least the next 12 months.

"We are surprised and disappointed with the most recent preliminary data from the ongoing Phase 2a trial of RX-3117 in combination with ABRAXANE in first line metastatic pancreatic cancer patients," said Douglas J. Swirsky president and chief executive officer of Rexahn. "RX-3117 appears to be well tolerated and we are evaluating development options for RX-3117 in other indications, including through our collaboration with BioSense. In the near term, we are focused on supporting our collaborations with BioSense and Zhejiang Haichang Biotechnology Co., Ltd. as we evaluate the best path forward for our programs."

See the discussion below under Important Cautionary Statements regarding our cash balance and the other forward-looking statements in this release.

Q2 2019 Financial Results:

R&D Expenses: Research and development expenses were $1.6 million for the three months ended June 30, 2019, compared to $3.4 million for the three months ended June 30, 2018. Research and development expenses were $3.9 million for the six months ended June 30, 2019, compared to $7.5 million for the six months ended June 30, 2018. The decrease in research and development expenses is primarily attributable to decreases in drug manufacturing and clinical trial costs and a reduction in preclinical programs and headcount.

G&A Expenses: General and administrative expenses were $1.3 million for the three months ended June 30, 2019 compared to $1.6 million for the three months ended June 30, 2018. General and administrative expenses were $3.0 million for the six months ended June 30, 2019 compared to $3.4 million for the six months ended June 30, 2018. The decrease is primarily attributable to a decrease in personnel expenses, offset by increases in professional fees.

Net Loss: Rexahn’s loss from operations was $3.0 million and $5.0 million for the three months ended June 30, 2019 and 2018, respectively. Rexahn’s net loss was $2.5 million, or $0.61 per share, for the three months ended June 30, 2019, compared to a net loss of $3.8 million, or $1.45 per share, for the three months ended June 30, 2018. For the six-month period ended June 30, 2019, Rexahn’s net loss was $4.8 million, or $1.23 per share, compared to a net loss of $5.9 million, or $2.24 per share for the six months ended June 30, 2018. The net loss for the six months ended June 30, 2019 and 2018 includes unrealized gains on the fair value of warrants of $1.9 million and $4.5 million, respectively. The fair value adjustments are non-cash charges and are primarily a result of changes in stock price between reporting periods.