IPIX .. 7.29.19
i will admit that i found today's *trading* fascinating and not just because
most of today's trades were preceded by IP's Corporate Update .. IPIX
opened and closed today's trading with hidden trades .. -YOY% decreased
in alignment with PPS *increase* and targeted trades were done above the ask
(usually i'm used to seeing them done below bid)
Mon, Jul 29, 2019 9:34 am
Innovation Pharmaceuticals Provides Corporate Update Highlighting Clinical Pipeline Progress and Business Development Activities full update below
and while there was excellent info contained in Update .. the 2nd shot
across NRs' bow out of mgmt in the last 7 days .. *imo* was this:
Bertolino continued: “The Alfasigma licensing agreement, importantly, enables us to access non-dilutive capital immediately and potentially into the future, via structured milestone-based payments and royalties. Equally important, we can now dedicate further internal resources to moving our clinical portfolio ahead—developing novel oral medications for hard-to-treat diseases like IBD, Oral Mucositis and Cancer. Successfully completing additional strategic alliances and licensing deals remains a primary objective, towards which we are making notable progress, with multiple active advanced-stage negotiations ongoing. We are excited about the Company’s prospects heading into the second-half of 2019, and anticipate providing future updates as events unfold.”
DRS % .. 265052/612983 .. 43.23% .. (37.17% Friday)
Hidden trades .. 83679/612983 .. 13.65% .. (6.16% Friday) .. since 4.26.19
interesting change out
Liquidity .. .018c .. (HOD .188c/LOD 17c)
NR = Just A Few Probs
trades .. volume maintenance on the 90 day .. not the 10 day .. and again NRs'
wash trading (resets) beyond blatant and OTC Mkts had the *occasional* delay on IPIX's RT l2 ..
targeted trade .. done above or below B/A .. 30,900 went off above 184c ask
UC = undercut .. done by rote by NR on UPSIDE DOWN OTC targets on ASK
NC = No Change on the *size* shown by MM/ECN
Hidden = trade goes off between best Bid & best Ask *showing*
09:34:00 Innovation Pharmaceuticals Provides Corporate Update Highlighting Clinical Pipeline Progress and Business Development Activities
Detailed Quote:IPIX
INNOVATION PHARMACEUTICALS INC
0.1855Up 0.00882 (4.99 %)AS OF 3:59:55PM ET 07/29/2019
Last Trade 0.1855
Trade Time 3:59:55pm ET
Change 0.00882
% Change 4.99%
Bid 0.185
Bid Size 5000
Ask 0.187
Ask Size 5000
Open 0.1783
Day High 0.188 .. all that *effort* for .018c *liquidity*
Day Low 0.17
Previous Close
07/26/2019 0.17668
52-Week High
09/07/2018 0.5805
52-Week Low
12/31/2018 0.07
Price Performance (Last 52 Weeks)
07/26/2019 -67.58%
Volume 612,983
Volume (10 day Average) 748,261
Volume (90 day Average) 562,187
Market Capitalization $33.95M
Shares Outstanding 192,132,000
B/A .. volume 612983 .. may not align with Fido's above
Innovation Pharmaceuticals Provides Corporate Update Highlighting Clinical Pipeline Progress and Business Development Activities
Company building on momentum from recently executed licensing agreement with Alfasigma S.p.A.
Focus on transitioning to oral formulations of first-in-class drug candidates, and securing additional strategic alliances and licensing deals
BEVERLY, Mass., July 29, 2019 (GLOBE NEWSWIRE) -- Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, is pleased to provide a corporate update highlighting recent accomplishments, clinical pipeline progress, and ongoing business development activities across its first-in-class drug candidates, Brilacidin and Kevetrin.
“We are pleased with our accomplishments, thus far, in 2019, and are committed to advancing the clinical development of our pipeline,” commented Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Innovation Pharmaceuticals. “A significant milestone was recently achieved with our execution of a global licensing agreement with Alfasigma—an Italy-based multinational pharmaceutical company with robust R&D and manufacturing capabilities, employing 3,000 people and generating 2018 revenues in excess of €1 billion—granting them worldwide rights to develop locally-administered Brilacidin in Ulcerative Proctitis/ Ulcerative Proctosigmoiditis (UP/UPS). We look forward to leveraging this momentum. Brilacidin is a promising Inflammatory Bowel Disease (IBD) drug candidate that appears to address many root causes of chronic gut disorders. Brilacidin also has been shown in other mid-stage clinical trials to be safe and efficacious in Serious Skin Infections and Oral Mucositis, with both of these Brilacidin indications Phase 3-ready.”
Bertolino continued: “The Alfasigma licensing agreement, importantly, enables us to access non-dilutive capital immediately and potentially into the future, via structured milestone-based payments and royalties. Equally important, we can now dedicate further internal resources to moving our clinical portfolio ahead—developing novel oral medications for hard-to-treat diseases like IBD, Oral Mucositis and Cancer. Successfully completing additional strategic alliances and licensing deals remains a primary objective, towards which we are making notable progress, with multiple active advanced-stage negotiations ongoing. We are excited about the Company’s prospects heading into the second-half of 2019, and anticipate providing future updates as events unfold.”
2019 Announcements
Brilacidin
Inflammatory Bowel Disease
July 22, 2019: Announced the execution of a licensing agreement with Alfasigma, an Italy-based global pharmaceutical company, for worldwide rights to develop Brilacidin for localized treatment of Ulcerative Proctitis/Ulcerative Proctosigmoiditis (UP/UPS). As specified in the agreement, Alfasigma has assumed full responsibility for Brilacidin for UP/UPS, inclusive of all development, regulatory and commercialization activities and related expenses. In exchange for exclusive global rights, Alfasigma has committed to making an initial cash payment and other future cash payments to the Company upon certain milestones being met, totaling over $24 million. The Company also would receive a 6 percent royalty on net sales, resulting in additional annual recurring revenue. The initial payment will help cover substantially the costs of our upcoming clinical study of oral-dosed Brilacidin currently being developed for treating Ulcerative Colitis (UC). This first clinical trial, evaluating Brilacidin in oral tablet form, is targeted to commence later this year or early thereafter. In addition, the UP/UPS data generated by Alfasigma, to be shared with us, will help inform our internal development efforts in UC and as we explore other larger Gastrointestinal market opportunities.
June 6, 2019: Initiated, in partnership with BDD Pharma, oral development of Brilacidin in tablet form, utilizing BDD Pharma’s patented OralogiK™ tablet technology, which employs controlled erosion of a time-dependent barrier layer during small intestine transit to provide effective colon targeting. This will enable the testing of Brilacidin in more extensive forms of IBD, initially in UC and then in Crohn’s Disease—both chronic, hard-to-treat GI conditions for which oral therapies are highly sought after by patients and Big Pharma alike.
May 21, 2019: Attended the 2019 Digestive Disease Week (DDW) Conference, the world’s leading educational forum for professionals working in gastroenterology and related fields.
January 14, 2019: Completed early testing evaluating the stability of Brilacidin in simulated gastric fluid—a synthetic form of the fluid found in the stomach. Results showed very minimal degradation of Brilacidin across 4 hours, reinforcing the drug’s potential for oral development.
Oral Mucositis
May 1, 2019: Received End-of-Phase 2 Meeting Minutes from the Food and Drug Administration (FDA) to align our Phase 3 oral rinse Brilacidin program for the prevention of Severe Oral Mucositis (SOM) in Head and Neck Cancer (HNC) patients receiving chemoradiation. Currently, there are no approved drugs for this indication, with an annual global market opportunity estimated to approach $1 billion.
April 9, 2019: Achieved enhancements in manufacture of Brilacidin Phase 3 drug supply. This builds on the earlier contract signedwith Evonik to facilitate and refine bulk production of commercial-grade Brilacidin and on the drug product agreement signed with CoreRx to formulate Brilacidin into granular form in unit sachets, providing OM patients with a convenient, portable, quick-mixing “instant” Brilacidin oral rinse therapy.
March 28, 2019: Formed European subsidiary and granted a Scientific Advisory meeting with the European Medicines Agency (EMA) to discuss a briefing package submitted for Scientific Advice regarding the clinical development program of Brilacidin oral rinse to decrease the incidence of SOM in HNC patients receiving chemoradiation.
February 19, 2019: Obtained patent from the U.S. Patent & Trademark Office (USPTO) that covers methods for treating and/or preventing mucositis with one or more compounds, or pharmaceutically acceptable salts.
January 2, 2019: Obtained patent from USPTO for Brilacidin in the form of a composition containing water. The composition can also contain Tris-buffered saline. The patent also covers Brilacidin in combination with other medicaments.
Kevetrin
Oncology
June 2019: Abstract published—“Kevetrin Dampens MYC Expression and Cellular Metabolism in Acute Myeloid Leukemia”—in collaboration with independent cancer researchers; presented at the European Hematological Association (EHA) 2019 Annual Meeting. Results showed Kevetrin alters cellular metabolism and several key genes, including MYC, which when dysfunctional is implicated in many types of cancers. These results further support Kevetrin’s treatment potential in AML, especially among those patients carrying p53 mutations for whom few therapeutic options exist.
April 16, 2019: Notified by independent cancer researchers that a scientific article on Kevetrin is under review for publication by a leading oncology journal. The paper details Kevetrin’s treatment potential in AML by targeting p53, an important tumor suppressor protein, and several key leukemia-related genes. AML accounts for almost one-third of all leukemias worldwide and has a 5-year survival rate of only 25 percent. Pre-clinical research and academic literature also supports Kevetrin’s potential in combination with cancer immunotherapies.
Alerts
Sign-up for Innovation Pharmaceuticals email alerts is available at:
www.ipharminc.com/email-alerts/
About Innovation Pharmaceuticals
Innovation Pharmaceuticals Inc. (IPIX) is a clinical stage biopharmaceutical company developing a world-class portfolio of innovative therapies addressing multiple areas of unmet medical need, including inflammatory diseases, cancer, infectious disease, and dermatologic diseases. Brilacidin, a versatile compound with broad therapeutic potential, is in a new chemical class called defensin-mimetics. A Phase 2 trial of Brilacidin as an oral rinse for the prevention of Severe Oral Mucositis (SOM) in patients with Head and Neck Cancer, met its primary and secondary endpoints, including reducing the incidence of SOM. The Company plans to advance Brilacidin oral rinse into Phase 3 development, subject to available financial resources. Positive results were also observed in a Phase 2 Proof-of-Concept trial treating patients locally with Brilacidin for Ulcerative Proctitis/Ulcerative Proctosigmoiditis. Brilacidin for UP/UPS was licensed to Alfasigma S.p.A. in July 2019. A Phase 2b trial of Brilacidin showed a single intravenous dose of the drug delivered comparable outcomes to a seven-day dosing regimen of the FDA-approved blockbuster daptomycin in treating Acute Bacterial Skin and Skin Structure Infections. Kevetrin is a novel anti-cancer drug shown to modulate p53, often referred to as the “Guardian Angel Gene” due to its crucial role in controlling cell mutations and has successfully completed a Phase 2 trial in Ovarian Cancer. More information is available on the Company website at www.IPharmInc.com.
Forward-Looking Statements: This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 including statements concerning the future execution of a definitive agreement with a global pharmaceutical company and the anticipated terms thereof, our future drug development plans, other statements regarding future product developments, and markets, including with respect to specific indications, and any other statements which are other than statements of historical fact. These statements involve risks, uncertainties and assumptions that could cause the Company’s actual results and experience to differ materially from anticipated results and expectations expressed in these forward-looking statements. The Company has in some cases identified forward-looking statements by using words such as “anticipates,” “believes,” “hopes,” “estimates,” “looks,” “expects,” “plans,” “intends,” “goal,” “potential,” “may,” “suggest,” and similar expressions. Among other factors that could cause actual results to differ materially from those expressed in forward-looking statements are the Company’s need for, and the availability of, substantial capital in the future to fund its operations and research and development; including the amount and timing of the sale of shares of common stock under securities purchase agreements; the fact that the Company’s licensee(s) may not successfully complete pre-clinical or clinical testing and the Company will not receive milestone payments, or the fact that the Company’s compounds may not successfully complete pre-clinical or clinical testing, or be granted regulatory approval to be sold and marketed in the United States or elsewhere. A more complete description of these risk factors is included in the Company’s filings with the Securities and Exchange Commission. You should not place undue reliance on any forward-looking statements. The Company undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation.
4kids
i will admit that i found today's *trading* fascinating and not just because
most of today's trades were preceded by IP's Corporate Update .. IPIX
opened and closed today's trading with hidden trades .. -YOY% decreased
in alignment with PPS *increase* and targeted trades were done above the ask
(usually i'm used to seeing them done below bid)
Mon, Jul 29, 2019 9:34 am
Innovation Pharmaceuticals Provides Corporate Update Highlighting Clinical Pipeline Progress and Business Development Activities full update below
and while there was excellent info contained in Update .. the 2nd shot
across NRs' bow out of mgmt in the last 7 days .. *imo* was this:
Bertolino continued: “The Alfasigma licensing agreement, importantly, enables us to access non-dilutive capital immediately and potentially into the future, via structured milestone-based payments and royalties. Equally important, we can now dedicate further internal resources to moving our clinical portfolio ahead—developing novel oral medications for hard-to-treat diseases like IBD, Oral Mucositis and Cancer. Successfully completing additional strategic alliances and licensing deals remains a primary objective, towards which we are making notable progress, with multiple active advanced-stage negotiations ongoing. We are excited about the Company’s prospects heading into the second-half of 2019, and anticipate providing future updates as events unfold.”
DRS % .. 265052/612983 .. 43.23% .. (37.17% Friday)
Hidden trades .. 83679/612983 .. 13.65% .. (6.16% Friday) .. since 4.26.19
interesting change out
Liquidity .. .018c .. (HOD .188c/LOD 17c)
NR = Just A Few Probs
trades .. volume maintenance on the 90 day .. not the 10 day .. and again NRs'
wash trading (resets) beyond blatant and OTC Mkts had the *occasional* delay on IPIX's RT l2 ..
targeted trade .. done above or below B/A .. 30,900 went off above 184c ask
UC = undercut .. done by rote by NR on UPSIDE DOWN OTC targets on ASK
NC = No Change on the *size* shown by MM/ECN
Hidden = trade goes off between best Bid & best Ask *showing*
15:59:55 0.1855 975 OTO .. hidden
15:59:31 0.185 5000 OTO .. @ UC ask
15:59:15 0.1835 5000 OTO .. hidden .. mirrored (B/18 .. A/185)
15:56:21 0.18 100 OTO .. @ bid
15:50:25 0.1835 100 OTO .. hidden .. mirrored
15:50:25 0.184 800 OTO .. hidden (B/18c .. A/187)
15:48:22 0.187 4000 OTO .. @ ask
15:21:48 0.187 3500 OTO .. @ ask
15:21:46 0.187 12500 OTO .. @ relo/d ask
15:19:30 0.18 7500 OTO .. @ bid
15:19:22 0.18 7500 OTO .. @ jumped bid NC 17000
15:08:19 0.18 7310 OTO .. @ ask (7500 = 7310/190)
15:00:50 0.18 190 OTO .. @ ask
14:54:57 0.18 1000 OTO .. @ ask
14:53:00 0.18 5000 OTO .. hidden
14:52:56 0.18 10000 OTO .. @ ask
14:39:36 0.18 2500 OTO .. @ ask
14:39:26 0.18 4176 OTO .. @ UC ask
14:32:10 0.1756 200 OTO .. hidden
14:27:00 0.185 157 OTO .. @ ask
14:05:18 0.185 24343 OTO .. @ ask (25k split trade 24343/657)
14:05:11 0.1808 1000 OTO .. hidden .. (B/171 .. A/185)
13:54:57 0.175 5000 OTO .. @ jumped bid
13:49:22 0.185 657 OTO .. @ relo/d ask
13:49:21 0.185 20500 OTO .. trade done above ask (184c)
13:49:21 0.185 10400 OTO .. trade done above ask (184c)
13:49:21 0.184 5000 OTO .. @ ask .. NC 5000 size
13:49:18 0.184 9000 OTO .. @ relo/d ask .. 14000 adjusts to 5000
13:49:12 0.18 10000 OTO .. @ ask 10000 size .. relo/s ask to 184c
13:39:52 0.172 1700 OTO .. hidden (B/171 .. A/18)
13:37:15 0.172 15500 OTO .. @ ask .. relo/s ask to 18c
13:34:29 0.172 5000 OTO .. @ ask 20500 adjusts to 15500
13:33:47 0.172 9000 OTO .. @ ask NC 20500
13:33:34 0.172 1000 OTO .. @ ask NC 20500
13:32:30 0.171 7000 OTO .. @ bid
13:30:56 0.171 426 OTO .. @ bid
13:30:56 0.171 16043 OTO .. @ relo/d bid
13:30:43 0.1711 5000 OTO .. @ bid .. relo/s bid
13:30:43 0.1711 3531 OTO .. @ bid
13:30:35 0.1711 40000 OTO .. @ jumped bid
13:24:43 0.172 500 OTO .. @ UC ask 21000 adjusts to 20500
13:24:41 0.172 1094 OTO .. @ UC ask NC 21000
13:24:41 0.172 400 OTO .. @ UC ask NC 21000
13:24:41 0.172 1300 OTO .. @ UC ask NC 21000 (10k/11k)
12:59:58 0.1845 1000 OTO .. @ ask NC 10000 size .. note timestamp
12:53:25 0.1845 300 OTO .. @ relo/d ask NC 10000 size
12:43:53 0.1775 5000 OTO .. @ bid .. relo/s bid
12:34:34 0.1775 4371 OTO .. @ bid NC 5000 (5k = 4371/629)
12:34:34 0.1788 629 OTO .. hidden
12:09:27 0.1827 2300 OTO .. hidden
12:08:30 0.18 500 OTO .. hidden (B/1775 .. A/184)
11:58:14 0.1775 100 OTO .. @ relo/d bid NC 5000 size
11:47:41 0.18 15000 OTO .. @ bid .. relo/s bid
11:46:55 0.18 10000 OTO .. @ bid NC 15000 size
11:46:55 0.18 5000 OTO .. @ relo/d bid NC 15000 size
11:46:50 0.182 5000 OTO .. @ bid .. relo/s bid to 18c
11:46:28 0.182 10000 OTO .. @ relo/d bid 10000 adjusts to 5000
11:44:59 0.183 15000 OTO .. @ bid .. relo/s bid to 182c
11:44:57 0.183 5000 OTO .. @ bid NC 5000
11:40:38 0.185 600 OTO .. @ ask 11000 adjusts to 10600
11:29:57 0.185 1700 OTO .. @ ask NC 11000
11:29:24 0.185 12700 OTO .. @ UC ask 23700 adjusts to 11000
11:27:55 0.1865 1300 OTO .. hidden (B/183 .. A/1895)
11:27:37 0.183 3000 OTO .. @ bid NC 5000
11:27:32 0.1856 1000 OTO .. hidden (B/183 .. A/1895)
11:26:47 0.188 7500 OTO .. @ relo/d ask .. HOD .. turn
11:17:37 0.1849 5000 OTO .. @ ask .. relo/s ask to 188c .. volume ~ 235,081
11:15:30 0.1849 4344 OTO .. @ ask NC 5000 size
11:15:30 0.1849 756 OTO .. @ ask NC 5000 size .. (6k = 756/5244)
11:14:45 0.1849 5244 OTO .. @ ask 11000 adjusts to 5000
11:14:42 0.1849 9000 OTO .. @ ask (10k = 9k/1k) .. NC 11000 size
11:14:37 0.1849 1000 OTO .. @ ask NC 11000 size
11:14:15 0.184 10000 OTO .. @ bid .. relo/s bid to 183c
11:13:38 0.184 10000 OTO .. @ bid NC 10000 size
11:05:12 0.1845 14000 OTO .. hidden
11:05:06 0.1843 1000 OTO .. hidden (B/184 .. A/1849 ask size 11k)
10:51:19 0.1849 25 OTO .. @ ask NC 5000 size .. imo signal (2x5=10)
10:41:06 0.183 5000 OTO .. @ bid 8000 adjusts to 5000 size
10:39:46 0.183 1550 OTO .. @ bid NC 8000 size
10:37:36 0.1849 9000 OTO .. @ ask NC 5000 size
10:37:29 0.1849 1000 OTO .. @ ask NC 5000 size
10:37:29 0.1843 1000 OTO .. hidden (B/183c .. A/1849c) .. mirrored
10:34:30 0.1849 8000 OTO .. @ ask NC 5000 size
10:34:00 0.1849 10000 OTO .. @ ask 15000 adjusts to 10000 size
10:27:17 0.1849 1000 OTO .. @ ask NC 15000 size
10:27:17 0.184 2000 OTO .. hidden
10:17:57 0.1835 15000 OTO .. @ relo/d bid .. relo/s bid to 18c
10:16:57 0.18 16000 OTO .. @ relo/d bid .. relo/s bid to 1835c
10:15:51 0.1834 1375 OTO .. hidden
10:15:31 0.1849 8159 OTO .. @ ask NC 15000 size
10:15:07 0.1839 1800 OTO .. hidden
10:14:05 0.184 1000 OTO .. hidden
10:02:27 0.181 8625 OTO .. @ bid (10k split trade) relo/s bid to 18c
10:02:26 0.181 1375 OTO .. @ jumped bid NC 10000 size
09:57:00 0.18 5000 OTO .. @ ask .. relo/s ask to 1849c
09:46:32 0.18 12500 OTO .. @ UC ask .. 15000 adjusts to 5000
09:45:23 0.1775 15000 OTO .. hidden
09:44:24 0.184 4636 OTO .. @ relo/d ask
09:43:50 0.1825 7000 OTO .. @ ask .. 7000 adjusts .. relo/s ask
09:43:16 0.1825 8000 OTO .. @ relo/d ask .. 15000 adjusts
09:37:48 0.1799 5000 OTO .. hidden
09:37:15 0.1799 800 OTO .. @ ask (size 5000) .. relo/s ask to 1825c
09:37:15 0.1783 200 OTO .. hidden
09:34:00 Innovation Pharmaceuticals Provides Corporate Update Highlighting Clinical Pipeline Progress and Business Development Activities
09:32:58 0.1778 500 OTO .. hidden
09:32:26 0.17 3737 OTO .. @ bid .. LOD
09:32:26 0.17 155 OTO .. @ bid NC .. LOD
09:32:26 0.175 20000 OTO .. hidden (B/17 .. A/1799)
09:30:06 0.1783 300 OTO .. hidden (B/175 .. A/1799)
Detailed Quote:IPIX
INNOVATION PHARMACEUTICALS INC
0.1855Up 0.00882 (4.99 %)AS OF 3:59:55PM ET 07/29/2019
Last Trade 0.1855
Trade Time 3:59:55pm ET
Change 0.00882
% Change 4.99%
Bid 0.185
Bid Size 5000
Ask 0.187
Ask Size 5000
Open 0.1783
Day High 0.188 .. all that *effort* for .018c *liquidity*
Day Low 0.17
Previous Close
07/26/2019 0.17668
52-Week High
09/07/2018 0.5805
52-Week Low
12/31/2018 0.07
Price Performance (Last 52 Weeks)
07/26/2019 -67.58%
Volume 612,983
Volume (10 day Average) 748,261
Volume (90 day Average) 562,187
Market Capitalization $33.95M
Shares Outstanding 192,132,000
B/A .. volume 612983 .. may not align with Fido's above
NITE 0.185 15,000 15:59
CDEL 0.18 7,094 15:59
ETRF 0.171 5,000 15:33
CSTI 0.16 25,000 09:30
CFGN 0.132 5,000 07/24
GTSM 0.13 10,000 09:30
LAFC 0.13 5,000 07/24
VNDM 0.11 5,000 07/26
STXG 0.06 10,000 02/19
VERT 0.05 10,000 05/21
PUMA 0.05 10,000 08:10
MAXM 0.0001 10,000 07:35
OTCX U 0 14:39
CDEL 0.186 12,500 15:59
ETRF 0.187 26,500 15:38
CSTI 0.187 5,000 14:53
NITE 0.1899 5,000 15:20
CFGN 0.199 5,000 10:00
GTSM 0.2173 2,500 07/23
PUMA 0.40 2,500 08:10
VERT 0.45 2,500 05/17
VNDM 0.45 2,500 07/26
LAFC 0.45 2,500 11:17
OTCX 1.00 100 09:30
STXG 2.00 100 02/19
MAXM 8.00 100 07:35
Innovation Pharmaceuticals Provides Corporate Update Highlighting Clinical Pipeline Progress and Business Development Activities
Company building on momentum from recently executed licensing agreement with Alfasigma S.p.A.
Focus on transitioning to oral formulations of first-in-class drug candidates, and securing additional strategic alliances and licensing deals
BEVERLY, Mass., July 29, 2019 (GLOBE NEWSWIRE) -- Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, is pleased to provide a corporate update highlighting recent accomplishments, clinical pipeline progress, and ongoing business development activities across its first-in-class drug candidates, Brilacidin and Kevetrin.
“We are pleased with our accomplishments, thus far, in 2019, and are committed to advancing the clinical development of our pipeline,” commented Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Innovation Pharmaceuticals. “A significant milestone was recently achieved with our execution of a global licensing agreement with Alfasigma—an Italy-based multinational pharmaceutical company with robust R&D and manufacturing capabilities, employing 3,000 people and generating 2018 revenues in excess of €1 billion—granting them worldwide rights to develop locally-administered Brilacidin in Ulcerative Proctitis/ Ulcerative Proctosigmoiditis (UP/UPS). We look forward to leveraging this momentum. Brilacidin is a promising Inflammatory Bowel Disease (IBD) drug candidate that appears to address many root causes of chronic gut disorders. Brilacidin also has been shown in other mid-stage clinical trials to be safe and efficacious in Serious Skin Infections and Oral Mucositis, with both of these Brilacidin indications Phase 3-ready.”
Bertolino continued: “The Alfasigma licensing agreement, importantly, enables us to access non-dilutive capital immediately and potentially into the future, via structured milestone-based payments and royalties. Equally important, we can now dedicate further internal resources to moving our clinical portfolio ahead—developing novel oral medications for hard-to-treat diseases like IBD, Oral Mucositis and Cancer. Successfully completing additional strategic alliances and licensing deals remains a primary objective, towards which we are making notable progress, with multiple active advanced-stage negotiations ongoing. We are excited about the Company’s prospects heading into the second-half of 2019, and anticipate providing future updates as events unfold.”
2019 Announcements
Brilacidin
Inflammatory Bowel Disease
July 22, 2019: Announced the execution of a licensing agreement with Alfasigma, an Italy-based global pharmaceutical company, for worldwide rights to develop Brilacidin for localized treatment of Ulcerative Proctitis/Ulcerative Proctosigmoiditis (UP/UPS). As specified in the agreement, Alfasigma has assumed full responsibility for Brilacidin for UP/UPS, inclusive of all development, regulatory and commercialization activities and related expenses. In exchange for exclusive global rights, Alfasigma has committed to making an initial cash payment and other future cash payments to the Company upon certain milestones being met, totaling over $24 million. The Company also would receive a 6 percent royalty on net sales, resulting in additional annual recurring revenue. The initial payment will help cover substantially the costs of our upcoming clinical study of oral-dosed Brilacidin currently being developed for treating Ulcerative Colitis (UC). This first clinical trial, evaluating Brilacidin in oral tablet form, is targeted to commence later this year or early thereafter. In addition, the UP/UPS data generated by Alfasigma, to be shared with us, will help inform our internal development efforts in UC and as we explore other larger Gastrointestinal market opportunities.
June 6, 2019: Initiated, in partnership with BDD Pharma, oral development of Brilacidin in tablet form, utilizing BDD Pharma’s patented OralogiK™ tablet technology, which employs controlled erosion of a time-dependent barrier layer during small intestine transit to provide effective colon targeting. This will enable the testing of Brilacidin in more extensive forms of IBD, initially in UC and then in Crohn’s Disease—both chronic, hard-to-treat GI conditions for which oral therapies are highly sought after by patients and Big Pharma alike.
May 21, 2019: Attended the 2019 Digestive Disease Week (DDW) Conference, the world’s leading educational forum for professionals working in gastroenterology and related fields.
January 14, 2019: Completed early testing evaluating the stability of Brilacidin in simulated gastric fluid—a synthetic form of the fluid found in the stomach. Results showed very minimal degradation of Brilacidin across 4 hours, reinforcing the drug’s potential for oral development.
Oral Mucositis
May 1, 2019: Received End-of-Phase 2 Meeting Minutes from the Food and Drug Administration (FDA) to align our Phase 3 oral rinse Brilacidin program for the prevention of Severe Oral Mucositis (SOM) in Head and Neck Cancer (HNC) patients receiving chemoradiation. Currently, there are no approved drugs for this indication, with an annual global market opportunity estimated to approach $1 billion.
April 9, 2019: Achieved enhancements in manufacture of Brilacidin Phase 3 drug supply. This builds on the earlier contract signedwith Evonik to facilitate and refine bulk production of commercial-grade Brilacidin and on the drug product agreement signed with CoreRx to formulate Brilacidin into granular form in unit sachets, providing OM patients with a convenient, portable, quick-mixing “instant” Brilacidin oral rinse therapy.
March 28, 2019: Formed European subsidiary and granted a Scientific Advisory meeting with the European Medicines Agency (EMA) to discuss a briefing package submitted for Scientific Advice regarding the clinical development program of Brilacidin oral rinse to decrease the incidence of SOM in HNC patients receiving chemoradiation.
February 19, 2019: Obtained patent from the U.S. Patent & Trademark Office (USPTO) that covers methods for treating and/or preventing mucositis with one or more compounds, or pharmaceutically acceptable salts.
January 2, 2019: Obtained patent from USPTO for Brilacidin in the form of a composition containing water. The composition can also contain Tris-buffered saline. The patent also covers Brilacidin in combination with other medicaments.
Kevetrin
Oncology
June 2019: Abstract published—“Kevetrin Dampens MYC Expression and Cellular Metabolism in Acute Myeloid Leukemia”—in collaboration with independent cancer researchers; presented at the European Hematological Association (EHA) 2019 Annual Meeting. Results showed Kevetrin alters cellular metabolism and several key genes, including MYC, which when dysfunctional is implicated in many types of cancers. These results further support Kevetrin’s treatment potential in AML, especially among those patients carrying p53 mutations for whom few therapeutic options exist.
April 16, 2019: Notified by independent cancer researchers that a scientific article on Kevetrin is under review for publication by a leading oncology journal. The paper details Kevetrin’s treatment potential in AML by targeting p53, an important tumor suppressor protein, and several key leukemia-related genes. AML accounts for almost one-third of all leukemias worldwide and has a 5-year survival rate of only 25 percent. Pre-clinical research and academic literature also supports Kevetrin’s potential in combination with cancer immunotherapies.
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About Innovation Pharmaceuticals
Innovation Pharmaceuticals Inc. (IPIX) is a clinical stage biopharmaceutical company developing a world-class portfolio of innovative therapies addressing multiple areas of unmet medical need, including inflammatory diseases, cancer, infectious disease, and dermatologic diseases. Brilacidin, a versatile compound with broad therapeutic potential, is in a new chemical class called defensin-mimetics. A Phase 2 trial of Brilacidin as an oral rinse for the prevention of Severe Oral Mucositis (SOM) in patients with Head and Neck Cancer, met its primary and secondary endpoints, including reducing the incidence of SOM. The Company plans to advance Brilacidin oral rinse into Phase 3 development, subject to available financial resources. Positive results were also observed in a Phase 2 Proof-of-Concept trial treating patients locally with Brilacidin for Ulcerative Proctitis/Ulcerative Proctosigmoiditis. Brilacidin for UP/UPS was licensed to Alfasigma S.p.A. in July 2019. A Phase 2b trial of Brilacidin showed a single intravenous dose of the drug delivered comparable outcomes to a seven-day dosing regimen of the FDA-approved blockbuster daptomycin in treating Acute Bacterial Skin and Skin Structure Infections. Kevetrin is a novel anti-cancer drug shown to modulate p53, often referred to as the “Guardian Angel Gene” due to its crucial role in controlling cell mutations and has successfully completed a Phase 2 trial in Ovarian Cancer. More information is available on the Company website at www.IPharmInc.com.
Forward-Looking Statements: This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 including statements concerning the future execution of a definitive agreement with a global pharmaceutical company and the anticipated terms thereof, our future drug development plans, other statements regarding future product developments, and markets, including with respect to specific indications, and any other statements which are other than statements of historical fact. These statements involve risks, uncertainties and assumptions that could cause the Company’s actual results and experience to differ materially from anticipated results and expectations expressed in these forward-looking statements. The Company has in some cases identified forward-looking statements by using words such as “anticipates,” “believes,” “hopes,” “estimates,” “looks,” “expects,” “plans,” “intends,” “goal,” “potential,” “may,” “suggest,” and similar expressions. Among other factors that could cause actual results to differ materially from those expressed in forward-looking statements are the Company’s need for, and the availability of, substantial capital in the future to fund its operations and research and development; including the amount and timing of the sale of shares of common stock under securities purchase agreements; the fact that the Company’s licensee(s) may not successfully complete pre-clinical or clinical testing and the Company will not receive milestone payments, or the fact that the Company’s compounds may not successfully complete pre-clinical or clinical testing, or be granted regulatory approval to be sold and marketed in the United States or elsewhere. A more complete description of these risk factors is included in the Company’s filings with the Securities and Exchange Commission. You should not place undue reliance on any forward-looking statements. The Company undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation.
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