On February 11, 2020 Astellas and Pfizer reported positive topline overall survival (OS) results from a Phase III trial evaluating Xtandi (enzalutamide) as a treatment in men with non-metastatic castration-resistant prostate cancer (nmCRPC) (Press release, Pfizer, FEB 11, 2020, View Source [SID1234554162]). The results demonstrated a statistically significant improvement in OS in patients with nmCRPC treated with the therapy, the companies announced.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Prostate cancer is the second most common cancer in men worldwide, with about 164,000 expected diagnoses in the United States this year. Castration-resistant prostate cancer (CRPC) refers to the subset of men whose prostate cancer progresses on androgen deprivation therapy despite castrate levels (less than 50 ng) of testosterone. Non-metastatic CRPC means there is no clinically detectable evidence of the cancer spreading to other parts of the body, and there is a rising prostate-specific antigen (PSA) level. Many men with non-metastatic CRPC and a rapidly rising PSA level go on to develop metastatic CRPC.

In the Phase III PROSPER trial, Pfizer and Astellas evaluated Xtandi in combination with androgen deprivation therapy (ADT) in men with nmCRPC against placebo and ADT. The companies said the results demonstrated a statistically significant improvement in OS, which was a key secondary endpoint of the trial. Full OS results from the PROSPER trial will be released at a later date, the companies said.

In 2017, Astellas and Pfizer announced initial top-line results from the Phase III trial that showed the combination of Xtandi and ADT met its primary endpoint of improved metastasis-free survival (MFS). MFS was measured as the time from patients entering the trial until their cancer was radiographically detected as having metastasized, or until death, within 112 days of treatment discontinuation. The Phase III trial showed that a combination of Xtandi plus ADT significantly reduced the risk of developing metastases or death by 71 percent. Additionally, the Phase III trial data showed the combination treatment had a 93 percent reduction in relative risk of prostate-specific antigen (PSA) progression, a biomarker tied to the worsening of a disease, compared to patients who received ADT alone. Those results eventually lead to the regulatory approval of Xtandi as a treatment for non-metastatic castration-resistant prostate cancer.

In December, Xtandi won approval from the U.S. Food and Drug Administration as a treatment for patients with metastatic castration-sensitive prostate cancer (mCSPC). It is estimated that more than 40,000 men in the United States are living with mCSPC, a form of prostate cancer that has spread to other parts of the body and still responds to a medical or surgical treatment that lowers testosterone.

In addition to the latest OS news for Xtandi, Astellas and Pfizer said they will share findings from two studies evaluating the same treatment for advanced prostate cancer at the 2020 Genitourinary Cancers Symposium later this week. The two evaluate the treatment in chemotherapy-naïve men with metastatic castration-resistant prostate cancer (mCRPC) in a real-world setting.

On February 11, 2020 Dana-Farber Cancer Institute and Kronos Incorporated reported that they have joined forces to provide dedicated oncology care navigation services via a new benefit for Kronos employees and their beneficiaries (Press release, Dana-Farber Cancer Institute, FEB 11, 2020, View Source [SID1234554180]). As part of the Dana-Farber Direct Connect program, each patient receives patient navigation assistance, highly specialized clinical care, and an expert team providing a multi-disciplinary approach to care that encompasses the full continuum of their oncology journey. Kronos, a global leader in workforce management and human capital management cloud solutions known worldwide for its award-winning WorkInspired culture, is the first employer to provide its employees with the Dana-Farber Direct Connect benefit.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Through this innovative program, Dana-Farber Direct Connect provides companies with dedicated support services for their employees and is proud to align with an organization like Kronos known for a culture steeped in caring for its employees, their families, and the communities where Kronos employees live and work. All Kronos employees and beneficiaries enrolled in the benefit will have access to a dedicated phone line and email that is staffed by experienced liaisons who are trained to support the unique needs of each patient and can help identify the right treatment options, facilitate appointments, and access support services based on the cancer type and the individual’s specific needs. Dana-Farber’s specialized treatment centers are comprised of teams of experts who work closely together to provide patients the latest therapies and strategies, including access to innovative clinical trials, integrative medicine services, stem-cell transplants, cell therapies, and immunotherapy.

"Finding out that you or someone you care about has cancer is a devastating and life-altering experience. There are so many questions to be answered – everything from, ‘Where can I find the best doctors?’ to ‘What does my insurance cover?’ Managing treatment, doctor visits, and billing can quickly become a full-time job when the patient’s focus and effort should be spent healing and fighting. By formalizing this new benefit with Dana-Farber Direct Connect, Kronites and their family members will have special access to top oncology doctors in Massachusetts along with all the support resources that the world-class Dana-Farber Cancer Institute has to offer," said David Almeda, Chief People Officer at Kronos.

In addition to helping all patients at a challenging time, Dana-Farber Direct Connect aims to:

reduce the variability in misdiagnosis
improve cancer outcomes, care, and experience for all patients across the country
assist employers in reducing health care costs by ensuring the right treatment, at the right time with coordinated care to improve outcomes
"We are pleased to work closely with Kronos to provide their employees and family members access to the exceptional patient care that Dana-Farber is known for and to work together on initiatives that will reduce health care costs," said James Terwilliger, Chief Operating Officer and Executive Vice President at Dana-Farber Cancer Institute. "Oncology care is complex, with advances in treatment and drug options being made at dramatic pace. The Dana-Farber Direct Connect program ensures that the best care and treatment options are offered to each patient so that they can focus on getting healthy."

On February 11, 2020, IntelGenx Technologies Corp. (the "Corporation") reported that it has entered into a warrant indenture (the "Warrant Indenture") with TSX Trust Company (the "Warrant Agent") (Filing, 8-K, IntelGenx, FEB 11, 2020, View Source [SID1234554196]). Pursuant to the Warrant Indenture, the Corporation issued an aggregate principal amount of CA$8,158,500 of units ("Units") at a price of CA$0.50 per Unit, each of which consists of one share of the Corporation’s common stock ("Common Stock") and one Common Stock purchase warrant ("Warrant"). Each Warrant is exercisable to purchase one share of the Corporation’s Common Stock ("Warrant Share") at an exercise price of CA$0.75 per Warrant Share, subject to adjustment. The Warrants are immediately exercisable and will expire at 5:00 p.m. (eastern time) on February 11, 2023.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The Warrant Indenture contains customary terms and conditions for the issuance, transfer and exercise of the Warrants and the terms governing actions taken by the Warrant holders and the obligations of the Corporation and the Warrant Agent in relation to the Warrants. The Warrant Indenture provides that in the event there is a subdivision, redivision, reduction, combination, consolidation or other change of the shares of Common Stock into a greater or lesser number of shares of Common Stock or securities of the Corporation, the exercise price of the Warrants and the number of the Warrant Shares issuable upon conversion of the Warrants will be adjusted accordingly.

On February 11, 2020 Palatin Technologies, Inc. (NYSE American: PTN), a specialized biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin and natriuretic peptide receptor systems, whose product candidates are targeted, receptor-specific therapeutics for the treatment of diseases with significant unmet medical need and commercial potential, reported results for its second quarter ended December 31, 2019 (Press release, Palatin Technologies, FEB 11, 2020, View Source [SID1234554147]).

"The June 2019 FDA approval of Vyleesi was meaningful on two fronts," said Carl Spana, Ph.D., President and Chief Executive Officer of Palatin. "For premenopausal women, it provides a safe and effective, as-needed treatment option for those with HSDD. For Palatin, we now have an enhanced cash position of $92 million at December 31, 2019, which puts us in an excellent position to advance our pipeline programs. We have two Phase 2 clinical studies starting in the first half of calendar year 2020: a dry eye disease study with data expected in the fourth quarter of calendar year 2020 and an ulcerative colitis trial with data expected in mid-calendar year 2021."

"AMAG’s planned divestiture of Vyleesi is based on its change in strategy, and is not a result of the Vyleesi launch performance to date," continued Spana. "As the licensor, we maintain certain rights and will take appropriate steps to ensure that the value of Vyleesi remains intact and continues to grow. We will also continue to be opportunistic and flexible as the divestiture process advances, with the objective that the ultimate licensee of the North American rights to Vylessi is committed to the robust commercialization of the product."

Recent Business Highlights

Hypoactive Sexual Desire Disorder (HSDD) / Vyleesi (bremelanotide injection)
On January 9, 2020 AMAG Pharmaceuticals, Inc. ("AMAG") announced that, as a result of a strategic review, it will divest Vyleesi, which it exclusively licensed from Palatin for North America, and another female healthcare product, Intrarosa. AMAG stated that it has received preliminary expressions of interest in these assets.

Under the Vyleesi license agreement, AMAG has a contractual obligation to use commercially reasonable efforts to commercialize Vyleesi. If AMAG materially breaches this obligation and fails to cure such breach, Palatin could potentially have the right to terminate the license agreement and have Vyleesi returned to Palatin. In the event AMAG assigns its Vyleesi license, the assignee must expressly agree to be bound by the Vyleesi license agreement between AMAG and Palatin.

Palatin is advancing discussions on Vyleesi collaborations for territories outside the currently licensed territories of North America, China, and Korea, and anticipates executing multiple agreements during calendar year 2020. Vyleesi is licensed to Fosun Pharma in China and Kwangdong Pharmaceuticals in South Korea. Both companies are advancing Vyleesi through the regulatory process in their respective territories, which includes the conduct of certain clinical studies in those territories prior to filing for market approval.

Vyleesi is the first as-needed treatment approved for premenopausal women with acquired, generalized HSDD. AMAG Pharmaceuticals, Palatin’s North American licensee, launched Vyleesi nationally in September 2019 through select specialty pharmacies with its established women’s health sales force of approximately 125 sales representatives. While AMAG has not yet released prescription numbers for the quarter ended December 31, 2019, AMAG has stated publicly that the "Vyleesi launch is off to a strong start."

Anti-Inflammatory / Autoimmune Programs
Melanocortin agonist products are under development for the treatment of inflammatory and autoimmune diseases such as dry eye, uveitis, diabetic retinopathy and inflammatory bowel diseases (ulcerative colitis).

An investigational new drug application (IND) for PL9643 in dry eye disease was filed with the US Food and Drug Administration (FDA) in December 2019. A Phase 2 clinical study is expected to commence in the first quarter of calendar year 2020, with data readout anticipated in the fourth quarter of calendar year 2020.

A Phase 2 proof-of-concept clinical study with an oral formulation of PL8177 in ulcerative colitis patients is anticipated to start mid-calendar year 2020, with data readout mid-calendar year 2021.

Palatin continues its assessment and development work related to the treatment of patients with diabetic retinopathy and non-infectious uveitis (NIU), an indication which FDA granted orphan drug designation, with the objective of commencing clinical trials in calendar year 2021.

Natriuretic Peptide Receptor (NPR) System Program
Palatin has designed and is developing potential drug candidates that are selective agonists for one or more different natriuretic peptide receptors, including natriuretic peptide receptor-A (NPR-A), natriuretic peptide receptor B (NPR-B), and natriuretic peptide receptor C (NPR-C).

PL3994, an NPR-A agonist, will be evaluated in a Phase 2a clinical study in heart failure patients with preserved ejection fraction. The proposed study is a collaboration with two major academic medical centers and is supported by an American Heart Association grant. The study is anticipated to start patient enrollment in 2020.

PL3994 has potential utility in the treatment of a number of cardiovascular diseases, including genetic and orphan diseases resulting from a deficiency of endogenous active NPR-A. PL5028, a dual NPR-A and NPR-C agonist in development for cardiovascular diseases, has potential for reducing cardiac hypertrophy and fibrosis, among other indications.

Genetic Obesity Program
Palatin’s melanocortin receptor 4 (MC4r) peptide PL8905 and orally active small molecule PL9610 are currently under investigation for the treatment of rare genetic metabolic and obesity disorders. These programs are under internal evaluation for orphan designations, potential development, and licensing.

Second Quarter Fiscal Year 2020 Financial Results

Revenue
For the quarter ended December 31, 2019, Palatin recognized as revenue $20,610 in reimbursement of shared Vyleesi costs related to our license agreement with AMAG. There were no revenues recorded in the quarter ended December 31, 2018.

Operating Expenses
Total operating expenses for the quarter ended December 31, 2019 were $5.7 million compared to $5.1 million for the comparable quarter of 2018. The increase in operating expenses was mainly due to the final payment of $625,000 made in connection with the mutually agreed upon termination of our engagement agreement on Vyleesi with Greenhill & Co.

Other Income/Expense, net
Total other income was $397,480 for the quarter ended December 31, 2019 compared to total other income $7,871 for the quarter ended December 31, 2018. The difference is related primarily to the increase in investment income.

Net Loss
Palatin reported a net loss of $(5.2) million, or $(0.02) per basic and diluted share, for the quarter ended December 31, 2019, compared to a net loss of $(5.0) million, or $(0.02) per basic and diluted share, for the same period in 2018.

The difference in financial results between the three months ended December 31, 2019 and 2018 was attributable to the increase in operating expenses of $0.6 million offset by the increase of $0.4 million in other income.

Cash Position
Palatin’s cash, cash equivalents, and accounts receivable total $91.6 million as of December 31, 2019, compared to cash, cash equivalents, and accounts receivable of $103.8 million at June 30, 2019. Current liabilities were $1.4 million as of December 31, 2019, compared to $4.2 million as of June 30, 2019.

Conference Call / Webcast
Palatin will host a conference call and audio webcast on February 11, 2020 at 11:00 a.m. Eastern Time to discuss the results of operations for the quarter ended December 31, 2019 in greater detail and provide an update on corporate developments. Individuals interested in listening to the conference call live can dial 1-800-353-6461 (US/Canada) or 1-334-323-0501 (international), conference ID 7551093. The audio webcast and replay can be accessed by logging on to the "Investor/Webcasts" section of Palatin’s website at View Source A telephone and audio webcast replay will be available approximately one hour after the completion of the call. To access the telephone replay, dial 1-888-203-1112 (US/Canada) or 1-719-457-0820 (international), passcode 7551093. The webcast and telephone replay will be available through February 18, 2020.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

On February 11, 2020 DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biotechnology company, reported the pricing of an underwritten registered public offering of 2,125,000 of its common shares at a price to the public of $4.00 per share. All of the common shares are being offered by DiaMedica (Press release, DiaMedica, FEB 11, 2020, View Source [SID1234554163]). The offering is expected to close on or about February 13, 2020, subject to the satisfaction of customary closing conditions.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

DiaMedica expects the gross proceeds from the offering to be $8.5 million, before deducting the underwriting discount and other estimated offering expenses payable by DiaMedica. Net proceeds, after the underwriting discount, but before estimated expenses of the offering payable by DiaMedica, are expected to be approximately $7.9 million. DiaMedica intends to use the net proceeds from the offering to continue clinical and product development activities and for other working capital and general corporate purposes.

Craig-Hallum Capital Group LLC is acting as the sole managing underwriter for the offering.

The securities described above are being offered pursuant to a shelf registration statement on Form S-3 (File No. 333-235775) that was declared effective by the U.S. Securities and Exchange Commission, or the SEC, on January 9, 2020. A preliminary prospectus supplement and accompanying prospectus relating to and describing the terms of the offering were filed with the SEC on February 11, 2020. The final prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and, when available, may be obtained by visiting the SEC’s website at www.sec.gov or by contacting Craig-Hallum Capital Group LLC, 222 South Ninth Street, Suite 350, Minneapolis, MN 55402, by telephone at 612-334-6300 or by email at [email protected].

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 other 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 other jurisdiction.