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8 8  
9 9  Moleculin Biotech has five other drug development projects:
10 10  
11 -- WP1066 has an approved physician-sponsored clinical trial open for enrollment for the treatment of brain tumors and is also being evaluated for potential treatment of AML and pancreatic cancer,
12 -- WP1220, an analog of WP1066 is being studied for the topical treatment of cutaneous T-cell lymphoma (CTCL) for which Moleculin Biotech has filed a CTA in Poland which, if approved, will give it a third drug in clinical trial,
13 -- WP1732, another analog of WP1066 that the company believe is particularly well suited for intravenous administration is being evaluated for potential treatment of AML, pancreatic and other cancers, and
14 -- WP1122 and WP1234 are being evaluated for their potential to treat brain tumors and pancreatic cancer via their ability to inhibit glycolysis.
11 +WP1066 has an approved physician-sponsored clinical trial open for enrollment for the treatment of brain tumors and is also being evaluated for potential treatment of AML and pancreatic cancer,WP1220, an analog of WP1066 is being studied for the topical treatment of cutaneous T-cell lymphoma (CTCL) for which Moleculin Biotech has filed a CTA in Poland which, if approved, will give it a third drug in clinical trial,WP1732, another analog of WP1066 that the company believe is particularly well suited for intravenous administration is being evaluated for potential treatment of AML, pancreatic and other cancers, andWP1122 and WP1234 are being evaluated for their potential to treat brain tumors and pancreatic cancer via their ability to inhibit glycolysis.
15 15  
16 16  Moleculin Biotech has been granted royalty-bearing, worldwide, exclusive licenses for the patent and technology rights related to all of its drug technologies, as these intellectual property rights are owned in part or entirely by MD Anderson. The Annamycin drug substance is no longer covered by any existing patent protection, however, the company intend to submit patent applications for formulation, synthetic process and reconstitution related to its Annamycin drug product candidate, although there is no assurance that the company will be successful in obtaining such patent protection. Independently from potential patent protection, Moleculin Biotech has received Orphan Drug designation from the FDA for Annamycin for the treatment of AML, which may provide tax and other benefits during product development, and if the product is approved for AML, may lead to a grant of a seven-year market exclusivity. Under that exclusivity, which runs from the date of approval of a New Drug Application (NDA) in the United States, the FDA general (there are important exceptions) could not approve another Annamycin product for AML. The company also intend to apply for similar status in the European Union (EU) where market exclusivity extends to 10 years from the date of Marketing Authorization Application (MAA) approval. Separately, the FDA may also grant market exclusivity of 5 years for newly approved new chemical entities (which the company believe Annamycin would be), but there can be no assurance that such exclusivity will be granted.
17 17  
18 18  With regard to additional potential clinical activity, the company received Polish National Office approval in June 2018 for a CTA in Poland, which enables it to begin a Phase I/II clinical trial there to study with Annamycin for the treatment of relapsed or refractory AML. This will be in addition to the previously announced allowance of its IND in the United States. The start of clinical trials in Poland is expected to begin in the second half of 2018. In the US, Moleculin Biotech has three sites recruiting patients and ready to provide treatments. Patient treatment began in the US in March 2018. In addition, the company continue to recruit and contract with clinics both in the United States and Poland. The company can provide no assurance of additional recruitment or that treatments will occur in the near term and on a timely basis, if at all.
19 19  
20 -The company continue to recruit additional clinics into this trial both in the United States and Poland. In the US, Moleculin Biotech has begun treating patients and have three sites open recruiting and ready to treat patients. Moleculin Biotech is actively pursuing additional treatment centers, both in the US and in Poland, to increase the access of this trial to potential patients. The company can provide no assurance additional sites, recruitment or treatments will occur in the near term and on a timely basis, if at all.
21 -
17 +The company continue to recruit additional clinics into this trial both in the United States and Poland. In the US, Moleculin Biotech has begun treating patients and have three sites open recruiting and ready to treat patients. Moleculin Biotech is actively pursuing additional treatment centers, both in the US and in Poland, to increase the access of this trial to potential patients. The company can provide no assurance additional sites, recruitment or treatments will occur in the near term and on a timely basis, if at all.
18 +
22 22  On May 1, 2018, the company engaged another CRO to evaluate additional countries for the expansion of its AML clinical trial, specifically Australia and several Western European countries to provide additional clinical sites to improve access for patients to its Phase I/II trial.
23 23  
24 24  In July 2018, the physician-sponsored WP1066 trial IND for the treatment of glioblastoma opened for recruitment in the US.
... ... @@ -25,8 +25,8 @@
25 25  
26 26  Furthermore, in September 2017 the company engaged a CRO to prepare for a proof-of-concept clinical trial in Poland to study its drug candidate WP1220, a part of the WP1066 portfolio, for the treatment of CTCL. The company filed a CTA in Poland for this use which, if approved, will give it a third drug in a clinical trial.
27 27  
28 -# Corporate Overview
29 -
25 +# Corporate Overview
26 +
30 30  Moleculin Biotech was founded in 2015 in order to combine and consolidate the development efforts involving several oncology technologies, based on license agreements with MD Anderson. This effort began with the acquisition of the Annamycin development project from AnnaMed, Inc., or AnnaMed, followed by the acquisition of the license rights to the WP1122 Portfolio from IntertechBio Corporation, or IntertechBio. Further, on behalf of Moleculin, LLC, the company entered into a co-development agreement with Houston Pharmaceuticals, Inc., or HPI, which culminated with the merger of Moleculin, LLC into MBI coincident with its initial public offering allowing it to gain control of the WP1066 Portfolio.
31 31  
32 32  Moleculin, LLC was formed in 2006 and was working to develop the WP1066 Portfolio it licensed from MD Anderson. On May 2, 2016, Moleculin, LLC was merged with and into MBI. As a result of the merger, the company issued the holders of Moleculin, LLC equity interests and convertible notes an aggregate of approximately 999,931 shares of its common stock. Since Moleculin, LLC commenced operations in 2006, substantially all of its efforts had been focused on research, development and the advancement of the WP1066 Portfolio. Moleculin, LLC did not generate any revenue from product sales and, as a result, incurred significant losses.
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33 33  
34 34  In June 2018, the company formed Moleculin Australia Pty. Ltd., a wholly-owned subsidiary to oversee pre-clinical development in Australia. The Australian government provides an aggressive incentive for research and development carried out in their country. The company believe having an Australian subsidiary could provide a great opportunity to speed up pre-clinical development and reduce the overall cost of its continued drug development efforts.
35 35  
36 -The company do not have manufacturing facilities and all manufacturing activities are contracted out to third parties. Additionally, the company do not have a sales organization.
37 -
33 +The company do not have manufacturing facilities and all manufacturing activities are contracted out to third parties. Additionally, the company do not have a sales organization.
34 +
38 38  # Portfolio Status
39 39  
40 40  Below are important developments for each drug/portfolio of MBI.
... ... @@ -107,8 +107,8 @@
107 107  
108 108  In June 2018, the company announced that the company had entered into an agreement with the Jagiellonian University in Krakow, Poland, for the development of its STAT3 inhibitor, WP1732, for the treatment of ocular tumors. The company believe that there are very limited options for the treatment of ocular tumors. The company believe that the water soluble nature of WP1732 could make it an ideal candidate for targeting these unique and highly metastatic tumors.
109 109  
110 -Also in June 2018, the company announced that the company entered into an agreement with The University of Iowa Pharmaceuticals for the development of a formulation for WP1732. WP1732, which the company believe, based on pre-clinical testing, may be a breakthrough discovery, is now advancing to the stage of formulation development. The company believe that this agreement marks the beginning of its creating a pre-clinical package to submit to the FDA in order to request Investigational New Drug status.
111 -
107 +Also in June 2018, the company announced that the company entered into an agreement with The University of Iowa Pharmaceuticals for the development of a formulation for WP1732. WP1732, which the company believe, based on pre-clinical testing, may be a breakthrough discovery, is now advancing to the stage of formulation development. The company believe that this agreement marks the beginning of its creating a pre-clinical package to submit to the FDA in order to request Investigational New Drug status.
108 +
112 112  **$2.3 million Registered Direct Offering**
113 113  
114 114  On June 22, 2018, the company entered into an agreement with institutional investors for a registered direct offering of securities with gross proceeds of approximately $2.3 million. Concurrently, with the sale of common shares, pursuant to the agreement, the company also sold warrants to purchase 710,212 shares of common stock. Subject to certain beneficial ownership limitations, the warrants will be initially exercisable on the six-month anniversary of the issuance date at an exercise price equal to $2.02 per share of common stock, subject to adjustments as provided under the terms of the warrants. The warrants are exercisable for five years from the initial exercise date. The closing of the sales of these securities under the agreement closed on June 22, 2018.
... ... @@ -115,8 +115,8 @@
115 115  
116 116  **$9 million Registered Direct Offering**
117 117  
118 -On February 16, 2018, the company entered into a Securities Purchase Agreement (the "Purchase Agreement") with certain institutional investors for the sale by it of 4,290,000 shares of its common stock, at a purchase price of $2.10 per share. Concurrently with the sale of the common shares, pursuant to the Purchase Agreement, the company also sold warrants to purchase 2,145,000 shares of common stock. The company sold the common shares and warrants for aggregate gross proceeds of approximately $9.0 million with net proceed approximating $8.2 million. Subject to certain beneficial ownership limitations, the warrants will be initially exercisable on the six-month anniversary of the issuance date at an exercise price equal to $2.80 per share of common stock, subject to adjustments as provided under the terms of the warrants. The warrants are exercisable for five years from the initial exercise date. The closing of the sales of these securities under the Purchase Agreement closed on February 21, 2018.
119 -
115 +On February 16, 2018, the company entered into a Securities Purchase Agreement (the "Purchase Agreement") with certain institutional investors for the sale by it of 4,290,000 shares of its common stock, at a purchase price of $2.10 per share. Concurrently with the sale of the common shares, pursuant to the Purchase Agreement, the company also sold warrants to purchase 2,145,000 shares of common stock. The company sold the common shares and warrants for aggregate gross proceeds of approximately $9.0 million with net proceed approximating $8.2 million. Subject to certain beneficial ownership limitations, the warrants will be initially exercisable on the six-month anniversary of the issuance date at an exercise price equal to $2.80 per share of common stock, subject to adjustments as provided under the terms of the warrants. The warrants are exercisable for five years from the initial exercise date. The closing of the sales of these securities under the Purchase Agreement closed on February 21, 2018.
116 +
120 120  **Lease Agreement**
121 121  
122 122  On March 22, 2018, the company entered into a Lease Agreement (the "Lease") with IPX Memorial Drive Investors, LLC (the "Landlord") for the lease of 2,333 rentable square feet "RSF", which Moleculin Biotech is using for corporate office space and headquarters. The term of the Lease began in August 2018 and will continue for an initial term of 66 months, which may be renewed for an additional 5 years. Moleculin Biotech is required to remit base monthly rent of approximately $4,300 which will increase at an average approximate rate of 3% each year. Moleculin Biotech is also required to pay additional rent in the form of its pro-rata share of certain specified operating expenses of the Landlord. The newly leased space is located in Houston, Texas.
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