On June 14, 2019 Ampio Pharmaceuticals, Inc. (NYSE American: AMPE) ("Ampio"), reported that it intends to offer and sell shares of its common stock in an underwritten public offering (Press release, Ampio, JUN 14, 2019, View Source [SID1234537096]). Ampio expects to grant the underwriters a 45-day option to purchase additional shares of common stock offered in the public offering. The offering is subject to market 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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Ampio intends to use the net proceeds from the proposed offering for working capital and general corporate purposes, including funding for its clinical trial (AP-013).

ThinkEquity, a division of Fordham Financial Management, Inc., is acting as sole book-running manager for the offering.

A shelf registration statement on Form S-3 (File No. 333-217094) relating to the shares of common stock to be issued in the proposed offering was filed with the Securities and Exchange Commission (SEC) and is effective. 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.

A preliminary prospectus supplement and accompanying prospectus describing the terms of the proposed offering will be filed with the SEC. The securities may be offered only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the securities being offered may also be obtained from ThinkEquity, a division of Fordham Financial Management, Inc., 17 State Street, 22nd Floor, New York, New York 10004, by telephone at (877) 436-3673, by email at [email protected]. Electronic copies of the preliminary prospectus supplement and accompanying prospectus will also be available on the SEC’s website at View Source

Safe Harbor

This press release contains forward-looking statements regarding the proposed public offering and the intended use of proceeds from the offering. 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. Forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause actual results to differ materially, including those risks disclosed in under the caption "Risk Factors" in the preliminary prospectus supplement related to the offering and our Annual Report on Form 10-K filed with the SEC on March 18, 2019, our Quarterly Report on Form 10-Q filed with the SEC on May 10, 2019 and our other filings with the SEC. Ampio Pharmaceutcials, Inc. cautions readers not to place undue reliance on any forward-looking statements and it does not undertake, and specifically disclaims any obligation, to update

On June 14, 2019 Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a physician-led biopharmaceutical company focused on immuno-inflammatory and dermatological diseases, reported that management will present a company overview at the 2019 JMP Securities Life Sciences Conference on Thursday, June 20, 2019 at 11:30 AM ET at the St. Regis Hotel in New York, New York (Press release, Aclaris Therapeutics, JUN 14, 2019, View Source [SID1234537081]).

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A live audio webcast of the presentation may be accessed through the Company’s web site, www.aclaristx.com, on the ‘Events’ section. An archived version of the presentation will be available for 30 days.

On June 14, 2019 Tolero Pharmaceuticals, Inc., a clinical-stage company focused on developing novel therapeutics for hematological and oncological diseases, reported data for the first time from the ongoing Phase 1 Zella 101 study evaluating the safety and clinical activity of alvocidib, a potent CDK9 inhibitor, in combination with cytarabine and daunorubicin in patients with newly diagnosed acute myeloid leukemia (AML) (Press release, Tolero Pharmaceuticals, JUN 14, 2019, View Source [SID1234537097]). These results were presented in a poster presentation at the 24th Congress of the European Hematology Association (EHA) (Free EHA Whitepaper), being held June 13-16, 2019 in Amsterdam, The Netherlands.

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Preliminary data from the study indicated that alvocidib in combination with cytarabine and daunorubicin has shown clinical activity with acceptable safety in patients with newly diagnosed AML. Of the 18 evaluable patients, more than three-quarters (78%, n=14) achieved a complete remission (CR) or complete remission with incomplete hematologic recovery (CRi). Of these patients attaining a CR/CRi, 78% (n=11) reached the 30-day post-study evaluation, per the study protocol. A subset of these patients, 27% (n=3 of 11) proceeded to stem cell transplant. Additionally, among adverse cytogenic risk patients (n=9) who generally respond poorly to induction therapy, two-thirds (67%, n=6 of 9), achieved a CR/CRi.1

Of the patients that attained a CR/CRi (n=14), 10 (71%) are still in remission with a median follow-up of 76 days. In addition, 21 of 22 (95%) enrolled patients are still alive, with a median follow-up of 70 days.

Adverse events (AEs) in the study include diarrhea, tumor lysis syndrome, infections and elevated AST levels and were consistent with those noted in previous alvocidib studies.1

"These preliminary data from the Zella 101 study in patients with newly diagnosed AML are encouraging, as they add to the growing body of evidence from the alvocidib clinical program," said David J. Bearss, Ph.D., Chief Executive Officer of Tolero Pharmaceuticals. "We look forward to continuing this study to further our understanding of how the combination of alvocidib with cytarabine and daunorubicin may benefit this patient population."

Additional data from Tolero’s pipeline will also be presented in an oral presentation at the meeting, highlighting the impact of investigational agent TP-0903, an oral AXL receptor tyrosine kinase (RTK) inhibitor, on Axl-RTK inhibition in patients with several tumors, including chronic lymphocytic leukemia (CLL).

Below are the details for the presentations:

Abstract Title

Details

Zella 101: Phase 1 Study of Alvocidib
Followed by 7+3 Induction in Newly
Diagnosed AML Patients

Abstract # PF285

June 14, 5:30-7 p.m. CEST

Poster Presentation

AXL-RTK Inhibition Directs the
Functional Phenotype of Chimeric
Antigen Receptor T Cells

Abstract # S909

June 15, 4-4:15 p.m. CEST

Oral Presentation

About Alvocidib
Alvocidib is an investigational small molecule inhibitor of cyclin-dependent kinase 9 (CDK9) currently being evaluated in a Phase II study, Zella 201, in patients with relapsed or refractory MCL-1 dependent acute myeloid leukemia, AML, in combination with cytarabine and mitoxantrone (NCT02520011). Alvocidib is also being evaluated in Zella 101, a Phase I clinical study evaluating the maximum tolerated dose, safety and clinical activity of alvocidib in combination with (7+3) in newly diagnosed patients with AML (NCT03298984), and Zella 102, a Phase 1b/2 study in patients with myelodysplastic syndromes, MDS, in combination with decitabine (NCT03593915). In addition, alvocidib is being evaluated in a Phase 1 study in patients with relapsed or refractory AML in combination with venetoclax (NCT03441555).

About CDK9 Inhibition and MCL-1
MCL-1 is a member of the apoptosis-regulating BCL-2 family of proteins.2 In normal function, it is essential for early embryonic development and for the survival of multiple cell lineages, including lymphocytes and hematopoietic stem cells.3 In MCL-1–dependent AML, MCL-1 inhibits apoptosis and sustains the survival of leukemic blasts, which may lead to relapse or resistance to treatment.2,4 The expression of MCL-1 in leukemic blasts is regulated by cyclin-dependent kinase 9 (CDK9).5,6 Because of the short half-life of MCL-1 (2-4 hours), the effects of targeting upstream pathways are expected to reduce MCL-1 levels rapidly.5 Inhibition of CDK9 has been shown to block MCL-1 transcription, resulting in the rapid downregulation of MCL-1 protein, thus restoring the normal apoptotic regulation.2

On June 14, 2019 Aptose Biosciences Inc. ("Aptose" or the "Company") (NASDAQ: APTO, TSX: APS), a clinical-stage company developing highly differentiated therapeutics targeting the underlying mechanisms of cancer, reported that new preclinical data for CG-806, its oral, first-in-class pan-FLT3/pan-BTK inhibitor, is being presented in a poster presentation today at the 24th Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) in Amsterdam, the Netherlands (Press release, Aptose Biosciences, JUN 14, 2019, View Source [SID1234537082]).

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The poster, CG-806, preclinical in vivo efficacy and safety profile as a pan-FLT3 / pan-BTK inhibitor, highlights the in vivo anti-leukemic efficacy of CG-806 and its GLP toxicology and toxicokinetic profile. In a preclinical MV4-11 FLT3-ITD AML xenograft mouse model, CG-806 suppressed leukemia growth at all doses tested throughout the 28-day period of dosing. After dosing was halted, tumors treated with 10 mg/kg and 30 mg/kg resumed growth but responded again when CG-806 dosing was restarted. In the mice treated with 100 mg/kg, 5 of 11 (45%) were cured through day 120, and in the 300 mg/kg group, 10 of 11 (91%) of the mice were cured. Retreating the "uncured’ mice in these two dose groups for an additional 28 days beginning on day 88 led to rapid and robust antitumor response resulting in "cures" in all retreated mice through day 120. In the "re-treated" mice, no drug resistance and no toxicities were observed. GLP 28-day toxicology and TK studies mice and dogs showed no adverse CG-806-related effects on body weight, ophthalmic, respiratory or neurological examinations, clinical pathology (coagulation, clinical chemistry, or urinalysis), organ weight or macroscopic evaluations. No CG-806-related cardiovascular effects were noted in the 28-day GLP toxicology study or in a separate preclinical cardiovascular safety study.

The poster and abstract can be accessed here or at the publications and presentations section of Aptose’s website www.aptose.com.

"The wealth of preclinical data supporting CG-806 continues to grow and differentiate the molecule from other drugs on the market or in development," said William G. Rice, Ph.D., Chairman, President and Chief Executive Officer. "We are pleased to have reached the clinic with this compound and are hopeful that clinical testing will prove it to be an effective therapy for hematologic malignancy patients greatly in need of new treatment options."

About CG-806
CG-806 is an oral, first-in-class pan-FLT3/pan-BTK multi-cluster kinase inhibitor in Phase 1 clinical development for hematologic malignancies. This small molecule, in-licensed from CrystalGenomics Inc. in Seoul, South Korea, demonstrates potent inhibition of wild type and all mutant forms of FLT3 (including internal tandem duplication, or ITD, and mutations of the receptor tyrosine kinase domain and gatekeeper region), cures animals of acute myeloid leukemia (AML) tumors in the absence of toxicity in murine xenograft models, and represents a potential best-in-class therapeutic for patients with AML. Likewise, CG-806 demonstrates potent, non-covalent inhibition of the wild type and Cys481Ser (C481S) mutant forms of the BTK enzyme, as well as other oncogenic pathways operative in B cell malignancies, suggesting CG-806 may be developed for various B cell malignancy patients (including CLL/SLL, FL, MCL, DLBCL and others) that are resistant/refractory/intolerant to covalent BTK inhibitors. Because CG-806 targets key kinases/pathways operative in malignancies derived from the bone marrow, it is in development for B-cell cancers and AML.

On June 14, 2019 Aura Biosciences, a leader in the development of novel targeted therapies in ocular oncology, reported that interim clinical data from its ongoing Phase 1b/2 clinical trial evaluating the safety and efficacy of light-activated AU-011, the Company’s lead product candidate for the treatment of primary choroidal melanoma, will be highlighted in an oral presentation at the European Society of Ophthalmology 2019 Congress being held June 13-16, 2019, in Nice, France (Press release, Aura Biosciences, JUN 14, 2019, View Source [SID1234537083]).

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"The data with additional follow up time continues to demonstrate a good tolerability and safety profile of light-activated AU-011 at single and multiple administrations. There is also consistent evidence of tumor control and visual acuity preservation, which are key benefits of this novel treatment," said Ivana K. Kim, M.D., Co-Director, Ocular Melanoma Center, Massachusetts Eye and Ear, Associate Professor of Ophthalmology, Harvard Medical School. "Interest in AU-011 as a potential first line treatment for early stage disease is very high as current treatments for primary choroidal melanoma typically result in severe vision loss and ocular morbidity."

Oral presentation details are as follows:

Title: Interim Results of a Phase 1b/2 Open-Label Clinical Trial of AU-011 for the Treatment of Small to Medium Choroidal Melanoma

Presenter: Ivana K. Kim, M.D., Co-Director, Ocular Melanoma Center, Massachusetts Eye and Ear and Associate Professor of Ophthalmology, Harvard Medical School

Session: Innovation in Retina

Date and time: Friday, June 14, 2019; 3:00-3:12pm CEST

Location: Gallieni 5, Acropolis Convention Centre

About Choroidal Melanoma

Choroidal melanoma is a rare and aggressive type of eye cancer. Choroidal melanoma is the most common primary intraocular tumor in adults and develops in the uveal tract of the eye. No targeted therapies are available at present, and current radiotherapy treatments can be associated with severe visual loss and other long-term sequelae such as dry eye, glaucoma, cataracts and radiation retinopathy. The most common current treatment is plaque radiotherapy, which involves surgical placement of a radiation device on the exterior of the eye over the tumor. The alternative is enucleation, or total surgical removal of the eye. Choroidal melanoma metastasizes in approximately 50 percent of cases with liver involvement in 80-90% of cases and, unfortunately, metastatic disease is universally fatal (source: OMF). There is a very high unmet need for a new vision sparing targeted therapy that could enable early treatment intervention for this life-threatening rare disease given the lack of approved therapies, and the comorbidities of radioactive treatment options.

About Light-Activated AU-011

AU-011 is a first-in-class targeted therapy in development for the treatment of primary choroidal melanoma. The therapy consists of proprietary viral-like particle bioconjugates (VPB) that are activated with an ophthalmic laser. The VPBs bind selectively to unique receptors on cancer cells in the eye and are derived from technology originally pioneered by Dr. John Schiller of the Center for Cancer Research at the National Cancer Institute (NCI), recipient of the 2017 Lasker-DeBakey Award. Upon activation with an ophthalmic laser, the drug rapidly and specifically disrupts the cell membrane of tumor cells while sparing key eye structures, which may allow for the potential of preserving patients’ vision and reducing other long-term complications of radiation treatment. AU-011 can be delivered using equipment commonly found in an ophthalmologist’s office and does not require a surgical procedure, pointing to a potentially less invasive, more convenient therapy for patients and physicians. AU-011 for the treatment of choroidal melanoma has been granted orphan drug and fast track designations by the U.S. Food and Drug Administration and is currently in clinical development.