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Hot Stocks
Outlook Therapeutics announces $11.2M financings priced at-the-market » 08:09
06/23/20
06/23
08:09
06/23/20
08:09
OTLK

Outlook Therapeutics

$1.37 /

-0.01 (-0.72%)

Outlook Therapeutic…

Outlook Therapeutic announced that it has entered into definitive agreements with several healthcare-focused institutional investors for the purchase and sale, in a registered direct offering priced at-the-market under Nasdaq rules, of 8,407,411 shares of its common stock, at a purchase price of $1.215 per share, for aggregate gross proceeds of approximately $10.2M. H.C. Wainwright & Co. is acting as the exclusive placement agent. In addition, the Company has entered into a definitive agreement with Syntone Ventures for the purchase and sale, in a private placement priced at-the-market under Nasdaq rules, of 823,045 shares of its common stock at a purchase price of $1.215 per share, for aggregate gross proceeds of approximately $1M. The closing of the sale of the shares of common stock in the registered direct offering is expected to occur on or about June 24, 2020, subject to the satisfaction of customary closing conditions. The closing of the sale of the shares of common stock in the private placement to Syntone is expected to occur on or about July 21, 2020, subject to the satisfaction of customary closing conditions. Outlook Therapeutics intends to use the net proceeds from the financings for working capital and general corporate purposes, including in support of its ONS-5010 development program.

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OTLK Outlook Therapeutics
$1.37 /

-0.01 (-0.72%)

OTLK Outlook Therapeutics
$1.37 /

-0.01 (-0.72%)

05/05/20 Brookline
Outlook Therapeutics initiated with a Buy at Brookline
04/14/20 H.C. Wainwright
Outlook's NORSE-1 remaining on track 'comes as a relief,' says H.C. Wainwright
09/11/19 Ladenburg
Outlook Therapeutics initiated with a Buy at Ladenburg
07/18/19 H.C. Wainwright
Outlook Therapeutics initiated with a Buy at H.C. Wainwright
OTLK Outlook Therapeutics
$1.37 /

-0.01 (-0.72%)

Hot Stocks
Outlook Therapeutics expects topline results from NORSE 1 study in August » 08:07
06/17/20
06/17
08:07
06/17/20
08:07
OTLK

Outlook Therapeutics

$1.16 /

+0.05 (+4.50%)

Outlook Therapeutics…

Outlook Therapeutics provided a clinical update for ONS-5010 / LYTENAVA, the Company's investigational ophthalmic formulation of bevacizumab. Outlook Therapeutics is currently conducting two registration clinical trials for ONS-5010. At an End-of-Phase 2 meeting in April 2018, the U.S. Food and Drug Administration accepted the study design / size for the NORSE 1 and NORSE 2 trials and confirmed that each of them is acceptable and may support a new biologics license application under the 351(a) regulatory pathway toward approval for the treatment of wet age-related macular degeneration. The NORSE 1 clinical trial completed enrollment in August 2019 and is on pace to report topline data in August 2020. NORSE 1 enrolled a total of 61 treatment naive and previously treated patients at nine sites in Australia. NORSE 1 will provide initial safety and efficacy data for ONS-5010 in wet AMD patients for ONS-5010 dosed monthly compared to LUCENTIS dosed using the PIER alternative dosing regimen of three monthly doses followed by quarterly dosing. The NORSE 2 clinical trial commenced patient enrollment in July 2019 and is expected to enroll a total of approximately 220 treatment naive patients at more than 40 clinical trial sites in the United States. NORSE 2 has currently enrolled 204 of the 220 patients. Patients in the trial will be treated for 12 months. The primary outcome of the study at Month 11 is a statistically significant difference in the proportion of patients who gain at least 15 letters in the best corrected visual acuity for ONS-5010 over LUCENTIS, which is being dosed quarterly per the PIER regimen. The Company expects to report pivotal safety and efficacy data in the third calendar quarter of 2021. The NORSE 3 open-label safety study will be conducted to ensure the adequate number of safety exposures to ONS-5010 are available for the initial regulatory filings. In total, approximately 180 patients are expected to be enrolled in several different vascular and inflammatory retinal diseases where an anti-VEGF drug can be used as a therapeutic option. Patients in NORSE 3 will receive three doses of ONS-5010 over three months. In addition to NORSE 1 and NORSE 2 evaluating ONS-5010 for wet AMD, Outlook Therapeutics has received agreement from the FDA on three Special Protocol Assessments (SPAs), for three additional registration clinical trials. These SPAs cover the protocols for NORSE 4, a planned registration clinical trial evaluating ONS-5010 to treat branch retinal vein occlusion or BRVO, and NORSE 5 and NORSE 6, two planned registration clinical trials evaluating ONS-5010 for the treatment of diabetic macular edema, or DME. The Company intends to complete development of ONS-5010 for submission to the FDA as a new BLA under the 351(a) PHSA regulatory pathway for the treatment of wet AMD. The Company also has plans to submit for regulatory approvals in France, the United Kingdom, Italy, Germany, Spain and Japan, as well as other countries. If approved, ONS-5010 will be the first and only on-label ophthalmic formulation of bevacizumab for treating retinal diseases and has the potential to address a $9.1 billion anti-VEGF market.

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OTLK Outlook Therapeutics
$1.16 /

+0.05 (+4.50%)

OTLK Outlook Therapeutics
$1.16 /

+0.05 (+4.50%)

05/05/20 Brookline
Outlook Therapeutics initiated with a Buy at Brookline
04/14/20 H.C. Wainwright
Outlook's NORSE-1 remaining on track 'comes as a relief,' says H.C. Wainwright
09/11/19 Ladenburg
Outlook Therapeutics initiated with a Buy at Ladenburg
07/18/19 H.C. Wainwright
Outlook Therapeutics initiated with a Buy at H.C. Wainwright
OTLK Outlook Therapeutics
$1.16 /

+0.05 (+4.50%)

Hot Stocks
Outlook Therapeutics regains compliance with Nasdaq minimum bid price rule » 08:31
06/11/20
06/11
08:31
06/11/20
08:31
OTLK

Outlook Therapeutics

$1.12 /

-0.015 (-1.33%)

Outlook Therapeutics…

Outlook Therapeutics announced that it has received notification from Nasdaq that it has regained compliance with the minimum bid price for continued listing on the Nasdaq Capital Market, as the closing bid price of the Company's common stock has been at $1.00 or greater for 10 consecutive trading days. Accordingly, this matter is now closed.

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OTLK Outlook Therapeutics
$1.12 /

-0.015 (-1.33%)

OTLK Outlook Therapeutics
$1.12 /

-0.015 (-1.33%)

05/05/20 Brookline
Outlook Therapeutics initiated with a Buy at Brookline
04/14/20 H.C. Wainwright
Outlook's NORSE-1 remaining on track 'comes as a relief,' says H.C. Wainwright
09/11/19 Ladenburg
Outlook Therapeutics initiated with a Buy at Ladenburg
07/18/19 H.C. Wainwright
Outlook Therapeutics initiated with a Buy at H.C. Wainwright
OTLK Outlook Therapeutics
$1.12 /

-0.015 (-1.33%)

Over a month ago
Syndicate
Outlook Therapeutics announces $16M private placement for ONS-5010 development » 08:23
05/26/20
05/26
08:23
05/26/20
08:23
OTLK

Outlook Therapeutics

$0.74 /

+0.009 (+1.24%)

Outlook Therapeutics…

Outlook Therapeutics announced it has entered into a Stock Purchase Agreement with Syntone Ventures LLC for a private placement of $16M of common stock at a price of $1.00 per share. In addition, Outlook Therapeutics entered into a joint venture agreement with Syntone Technologies Group Co. Ltd. to form a PRC joint venture to develop and commercialize ONS-5010 / LYTENAVA in China pursuant to a license agreement to be entered into between Outlook Therapeutics and the joint venture. Outlook Therapeutics will use $0.9 million of the private placement proceeds to fund its initial capital contribution to the PRC joint venture. The closing of the sale of the shares is expected to occur on or about June 1, 2020, subject to the satisfaction of customary closing conditions. Outlook Therapeutics intends to use the net proceeds from the financing for working capital and general corporate purposes, including in support of its ONS-5010 development program, with approximately $0.9M of the proceeds being used to fund its initial capital contribution to the planned PRC joint venture. An additional capital contribution from Outlook Therapeutics of approximately $2.1M will be required within the next 4 years. The planned PRC joint venture will be 80% owned by Syntone and 20% owned by Outlook Therapeutics and is intended to focus on the development and commercialization of ONS-5010 in the greater China market, which includes Hong Kong, Taiwan and Macau. Outlook Therapeutics has agreed to enter into a license agreement providing for the license to the PRC joint venture of rights to ONS-5010 in greater China.

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OTLK Outlook Therapeutics
$0.74 /

+0.009 (+1.24%)

OTLK Outlook Therapeutics
$0.74 /

+0.009 (+1.24%)

05/05/20 Brookline
Outlook Therapeutics initiated with a Buy at Brookline
04/14/20 H.C. Wainwright
Outlook's NORSE-1 remaining on track 'comes as a relief,' says H.C. Wainwright
09/11/19 Ladenburg
Outlook Therapeutics initiated with a Buy at Ladenburg
07/18/19 H.C. Wainwright
Outlook Therapeutics initiated with a Buy at H.C. Wainwright
OTLK Outlook Therapeutics
$0.74 /

+0.009 (+1.24%)

Hot Stocks
Outlook Therapeutics expects topline results from NORSE 1 study in 3Q20 » 08:26
05/15/20
05/15
08:26
05/15/20
08:26
OTLK

Outlook Therapeutics

$0.75 /

+0.0287 (+4.00%)

The company said,…

The company said, "The Company recently announced it received U.S. Food and Drug Administration (FDA) tentative approval of the trade name for ONS-5010 as LYTENAVA. The trade name is conditionally approved by FDA and will be subject to further review at the time of the Company's planned filing of a new biologics license application with the FDA under the 351 PHSA regulatory pathway for LYTENAVA in 2021. The NORSE 1 registration clinical trial completed enrollment in August 2019 and is on pace to report topline data in August 2020. NORSE 1 enrolled a total of 61 patients at nine sites in Australia. NORSE 1 will provide initial safety and efficacy data for ONS-5010 in wet AMD patients for ONS-5010 dosed monthly compared to LUCENTIS dosed using the PIER alternative dosing regimen of three monthly doses followed by quarterly dosing. The Company anticipates reporting data during the third calendar quarter of 2020. At this time, the COVID-19 pandemic is not expected to affect the completion of NORSE 1 and anticipated data readout date. The NORSE 2 registration clinical trial commenced patient enrollment in July 2019 and is expected to enroll a total of approximately 220 patients at more than 40 clinical trial sites in the United States. NORSE 2 continues to screen, enroll and treat patients, subject to additional COVID-19 safety protocols for both patients and staff at trial sites. Patients in the trial will be treated for 11 months. The primary outcome of the study is a statistically significant difference in the proportion of patients who gain at least 15 letters in the best corrected visual acuity for ONS-5010 over LUCENTIS. Outlook Therapeutics estimates that, subject to local conditions which have varying degrees of "shelter-in-place" and other similar government orders mandating various restrictions due to COVID-19, enrollment will be completed no later than August of 2020. The Company intends to complete development of ONS-5010 for submission to the FDA as a new BLA under the 351(a) PHSA regulatory pathway for the treatment of wet AMD. The Company also has plans to submit for regulatory approvals in France, United Kingdom, Italy, Germany, Spain and Japan, as well as other countries. If approved, ONS-5010 will be the first and only on-label ophthalmic formulation of bevacizumab for treating retinal diseases."

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OTLK Outlook Therapeutics
$0.75 /

+0.0287 (+4.00%)

OTLK Outlook Therapeutics
$0.75 /

+0.0287 (+4.00%)

05/05/20 Brookline
Outlook Therapeutics initiated with a Buy at Brookline
04/14/20 H.C. Wainwright
Outlook's NORSE-1 remaining on track 'comes as a relief,' says H.C. Wainwright
09/11/19 Ladenburg
Outlook Therapeutics initiated with a Buy at Ladenburg
07/18/19 H.C. Wainwright
Outlook Therapeutics initiated with a Buy at H.C. Wainwright
OTLK Outlook Therapeutics
$0.75 /

+0.0287 (+4.00%)

Earnings
Outlook Therapeutics reports Q2 adj. EPS (13c), two est. (15c) » 08:25
05/15/20
05/15
08:25
05/15/20
08:25
OTLK

Outlook Therapeutics

$0.75 /

+0.0287 (+4.00%)

"Over the course of…

"Over the course of the last quarter, we made notable progress amidst navigating the uncertainties of the evolving COVID-19 pandemic. Our team remains focused on advancing our ONS-5010 development program as efficiently and rapidly as possible while focusing on the safety, health and welfare of our employees, clinical trial site providers and the patients in our trials," said Lawrence A. Kenyon, President, CEO and CFO of the Company. "With the execution of the strategic approach that we took at the beginning of the fiscal year to streamline our capital structure and regain 100% ownership of any future net profits for ONS-5010, coupled with the regulatory approach towards potential approval of ONS-5010 that we continue to advance, I believe Outlook is well-positioned to build stockholder value in the near- and long-term."

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OTLK Outlook Therapeutics
$0.75 /

+0.0287 (+4.00%)

OTLK Outlook Therapeutics
$0.75 /

+0.0287 (+4.00%)

05/05/20 Brookline
Outlook Therapeutics initiated with a Buy at Brookline
04/14/20 H.C. Wainwright
Outlook's NORSE-1 remaining on track 'comes as a relief,' says H.C. Wainwright
09/11/19 Ladenburg
Outlook Therapeutics initiated with a Buy at Ladenburg
07/18/19 H.C. Wainwright
Outlook Therapeutics initiated with a Buy at H.C. Wainwright
OTLK Outlook Therapeutics
$0.75 /

+0.0287 (+4.00%)

Initiation
Outlook Therapeutics initiated with a Buy at Brookline » 10:23
05/05/20
05/05
10:23
05/05/20
10:23
OTLK

Outlook Therapeutics

$0.66 /

-0.0083 (-1.25%)

Brookline analyst…

Brookline analyst Kumaraguru Raja initiated coverage of Outlook Therapeutics with a Buy rating and $5 price target.

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OTLK Outlook Therapeutics
$0.66 /

-0.0083 (-1.25%)

04/14/20 H.C. Wainwright
Outlook's NORSE-1 remaining on track 'comes as a relief,' says H.C. Wainwright
09/11/19 Ladenburg
Outlook Therapeutics initiated with a Buy at Ladenburg
07/18/19 H.C. Wainwright
Outlook Therapeutics initiated with a Buy at H.C. Wainwright
05/16/19 Oppenheimer
Outlook Therapeutics initiated with an Outperform at Oppenheimer
Conference/Events
JTC Investor Relations + Integrated Communications to hold virtual summit » 04:55
04/23/20
04/23
04:55
04/23/20
04:55
AEZS

Aeterna Zentaris

$0.79 /

+0.009 (+1.15%)

, AREC

American Resources Corp.

$1.00 /

+0.0996 (+11.06%)

, COCP

Cocrystal Pharma

$0.93 /

-0.0646 (-6.53%)

, GHSI

Guardion Health Sciences

$0.42 /

-0.0453 (-9.68%)

, MTNB

Matinas BioPharma

$0.69 /

-0.009 (-1.29%)

, OTLK

Outlook Therapeutics

$0.68 /

+0.0265 (+4.06%)

, TFFP

TFF Pharmaceuticals

$4.70 /

+0.27 (+6.09%)

, XBIO

Xenetic

$0.92 /

+0.019 (+2.11%)

Virtual Investor Summit…

Virtual Investor Summit will be held at 10 am on April 22-23. Webcast Link

ShowHide Related Items >><<
AEZS Aeterna Zentaris
$0.79 /

+0.009 (+1.15%)

AREC American Resources Corp.
$1.00 /

+0.0996 (+11.06%)

09/10/19 Maxim
American Resources Corp. initiated with a Buy at Maxim
COCP Cocrystal Pharma
$0.93 /

-0.0646 (-6.53%)

GHSI Guardion Health Sciences
$0.42 /

-0.0453 (-9.68%)

MTNB Matinas BioPharma
$0.69 /

-0.009 (-1.29%)

03/31/20 Piper Sandler
Matinas BioPharma price target lowered to $1.50 from $3.00 at Piper Sandler
01/27/20
Fly Intel: Top five analyst initiations
01/26/20 Piper Sandler
Matinas BioPharma initiated with an Overweight at Piper Sandler
01/24/20
Fly Intel: Top five analyst initiations
OTLK Outlook Therapeutics
$0.68 /

+0.0265 (+4.06%)

04/14/20 H.C. Wainwright
Outlook's NORSE-1 remaining on track 'comes as a relief,' says H.C. Wainwright
09/11/19 Ladenburg
Outlook Therapeutics initiated with a Buy at Ladenburg
07/18/19 H.C. Wainwright
Outlook Therapeutics initiated with a Buy at H.C. Wainwright
05/16/19 Oppenheimer
Outlook Therapeutics initiated with an Outperform at Oppenheimer
TFFP TFF Pharmaceuticals
$4.70 /

+0.27 (+6.09%)

02/27/20 Roth Capital
TFF Pharmaceuticals initiated with a Buy at Roth Capital
XBIO Xenetic
$0.92 /

+0.019 (+2.11%)

01/08/20 Maxim
Xenetic initiated with a Buy at Maxim
Conference/Events
JTC Investor Relations + Integrated Communications to hold virtual summit » 08:06
04/22/20
04/22
08:06
04/22/20
08:06
AEZS

Aeterna Zentaris

$0.78 /

-0.055 (-6.59%)

, AREC

American Resources Corp.

$0.90 /

-0.0696 (-7.18%)

, COCP

Cocrystal Pharma

$0.99 /

+0.0998 (+11.21%)

, GHSI

Guardion Health Sciences

$0.47 /

+0.015 (+3.31%)

, MTNB

Matinas BioPharma

$0.70 /

-0.0509 (-6.79%)

, OTLK

Outlook Therapeutics

$0.65 /

-0.0615 (-8.60%)

, TFFP

TFF Pharmaceuticals

$4.43 /

-0.21 (-4.53%)

, XBIO

Xenetic

$0.90 /

+0.0061 (+0.68%)

Virtual Investor Summit…

Virtual Investor Summit will be held at 10 am on April 22-23. Webcast Link

ShowHide Related Items >><<
AEZS Aeterna Zentaris
$0.78 /

-0.055 (-6.59%)

AREC American Resources Corp.
$0.90 /

-0.0696 (-7.18%)

09/10/19 Maxim
American Resources Corp. initiated with a Buy at Maxim
COCP Cocrystal Pharma
$0.99 /

+0.0998 (+11.21%)

GHSI Guardion Health Sciences
$0.47 /

+0.015 (+3.31%)

MTNB Matinas BioPharma
$0.70 /

-0.0509 (-6.79%)

03/31/20 Piper Sandler
Matinas BioPharma price target lowered to $1.50 from $3.00 at Piper Sandler
01/27/20
Fly Intel: Top five analyst initiations
01/26/20 Piper Sandler
Matinas BioPharma initiated with an Overweight at Piper Sandler
01/24/20
Fly Intel: Top five analyst initiations
OTLK Outlook Therapeutics
$0.65 /

-0.0615 (-8.60%)

04/14/20 H.C. Wainwright
Outlook's NORSE-1 remaining on track 'comes as a relief,' says H.C. Wainwright
09/11/19 Ladenburg
Outlook Therapeutics initiated with a Buy at Ladenburg
07/18/19 H.C. Wainwright
Outlook Therapeutics initiated with a Buy at H.C. Wainwright
05/16/19 Oppenheimer
Outlook Therapeutics initiated with an Outperform at Oppenheimer
TFFP TFF Pharmaceuticals
$4.43 /

-0.21 (-4.53%)

02/27/20 Roth Capital
TFF Pharmaceuticals initiated with a Buy at Roth Capital
XBIO Xenetic
$0.90 /

+0.0061 (+0.68%)

01/08/20 Maxim
Xenetic initiated with a Buy at Maxim
Hot Stocks
Outlook Therapeutics appoints Gerd Auffarth, Julian Gangolli to board » 08:53
04/21/20
04/21
08:53
04/21/20
08:53
OTLK

Outlook Therapeutics

$0.72 /

-0.0256 (-3.46%)

, GWPH

GW Pharmaceuticals

$106.45 /

+4.2 (+4.11%)

Outlook Therapeutics,…

Outlook Therapeutics, Inc. (OTLK) announced it has bolstered its Board of Directors with the appointments of Prof. Dr. Gerd Auffarth and Mr. Julian Gangolli. Dr. Auffarth is an internationally recognized ophthalmologist in the area of research and development as well as clinical care for patients. He currently serves as the Medical Director of Heidelberg University Eye Clinic. Gangolli most recently served as President, North America of Greenwich Biosciences, a GW Pharmaceuticals PLC (GWPH).

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OTLK Outlook Therapeutics
$0.72 /

-0.0256 (-3.46%)

04/14/20 H.C. Wainwright
Outlook's NORSE-1 remaining on track 'comes as a relief,' says H.C. Wainwright
09/11/19 Ladenburg
Outlook Therapeutics initiated with a Buy at Ladenburg
07/18/19 H.C. Wainwright
Outlook Therapeutics initiated with a Buy at H.C. Wainwright
05/16/19 Oppenheimer
Outlook Therapeutics initiated with an Outperform at Oppenheimer
GWPH GW Pharmaceuticals
$106.45 /

+4.2 (+4.11%)

04/08/20 Northland
GW Pharmaceuticals initiated with an Outperform at Northland
03/06/20 Citi
Citi starts GW Pharmaceuticals at Buy, says recent pullback overdone
03/05/20 Citi
GW Pharmaceuticals initiated with a Buy at Citi
02/26/20 Oppenheimer
GW Pharmaceuticals price target lowered to $173 from $203 at Oppenheimer

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