1stOncology™: Cancer Intelligence Service – Page 12884 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Palatin Technologies, Inc. Reports First Quarter Fiscal Year 2020 Results and Provides Corporate Update

On November 13, 2019 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 first quarter ended September 30, 2019 (Press release, Palatin Technologies, NOV 13, 2019, View Source [SID1234551127]).

Quarter End and Recent Highlights

Hypoactive Sexual Desire Disorder / Vyleesi (bremelanotide injection)
Vyleesi is the first as needed treatment for premenopausal women with acquired, generalized HSDD.

AMAG Pharmaceuticals, Palatin’s North American licensee, launched Vyleesi nationally in September with its established women’s health sales force of approximately 125 sales representatives. In the four weeks since the national launch, more than 1,300 healthcare providers have prescribed Vyleesi, which has resulted in more than 3,000 prescriptions received by AMAG’s specialty pharmacy partners.

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). We announced positive results of a micro-dose study of radiolabeled PL8177, a selective melanocortin receptor 1 ("MC1r") peptide agonist, using an oral, delayed-release, polymer formulation. The study met all primary and secondary endpoints. PL8177 has potential application in treatment of ulcerative colitis and other inflammatory bowel diseases. The FDA has granted orphan drug designation for PL8177 for the treatment of non-infectious intermediate, posterior, pan and chronic anterior uveitis. Non-infectious uveitis (NIU) is a group of inflammatory diseases that produces swelling and destroys eye tissue and can result in vision loss. A Phase 2 proof-of-concept clinical study with a systemic formulation in NIU patients is anticipated to commence in the first quarter of calendar year 2020. A Phase 2 proof-of-concept clinical study with an oral formulation in ulcerative colitis patients is anticipated to commence in the second quarter of calendar year 2020.

An IND application for PL9643, a melanocortin peptide agonist, and commencement of a Phase 2 clinical study in dry eye disease, are currently anticipated in the first quarter of calendar year 2020.

Natriuretic Peptide Receptor ("NPR") System Program
The Company has designed and is developing potential drug candidates that are selective agonist 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"). Active collaborations with several institutions are ongoing for PL3994, an NPR-A agonist that 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, and PL5028, a dual NPR-A and NPR-C agonist in development for cardiovascular diseases, including reducing cardiac hypertrophy and fibrosis. A Phase 2A clinical trial evaluating PL3994 in heart failure patients with preserved left ventricular ejection fraction will begin enrollment in the latter half of calendar year 2019. This trial is supported by a grant from the American Heart Association.

Genetic Obesity Program
The Company’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 designation and potential development.

Corporate
Cash, cash equivalents and accounts receivable balances at September 30, 2019 total $96.8 million.

Debt and related liabilities were fully paid off in July 2019.

In September 2019, the Company’s Board of Directors approved a plan to offer to purchase and terminate certain outstanding common stock purchase warrants through privately negotiated transactions. The purchase and termination program has no time limit and may be suspended for periods or discontinued at any time.

To date, the Company entered into several warrant termination agreements to repurchase and cancel previously issued warrants. The Company repurchased and cancelled in the aggregate 6.5 million warrants at an aggregate buyback price of $2.5 million.

First Quarter Fiscal 2020 Financial Results
Palatin reported a net loss of $(4.5) million, or $(0.02) per basic and diluted share, for the quarter ended September 30, 2019, compared to a net loss of $(5.7) million, or $(0.03) per basic and diluted share, for the same period in 2018.

The difference in financial results between the three months ended September 30, 2019 and 2018 was due to reductions in operating and interest expenses combined with increases in reported license and contract revenue and investment income.

Revenue
For the quarter ended September 30, 2019, Palatin recognized as revenue $97,379 in reimbursement of shared Vyleesi costs compared to $34,505 for the quarter ended September 30, 2018.

Operating Expenses
Total operating expenses for the quarter ended September 30, 2019 were $5.0 million compared to $5.7 million for the comparable quarter of 2018. The decrease in operating expenses was mainly attributable to decreases in salaries and other employee related expenses.

Other Income/Expense
Total other income, net was $361,603 for the quarter ended September 30, 2019 compared to total other expense, net of $(53,288) for the quarter ended September 30, 2018. The difference is primarily related to an increase in investment income and secondarily to a decrease in interest expense.

Cash Position
Palatin’s cash, cash equivalents, and accounts receivable total $96.8 million as of September 30, 2019, compared to cash, cash equivalents and accounts receivable of $103.8 million at June 30, 2019. Current liabilities were $1.9 million as of September 30, 2019, compared to $4.2 million as of June 30, 2019.

Palatin Drug Discovery and Development Programs
During the conference call and webcast, management will update and discuss next steps in Palatin’s portfolio of drug development programs. These include Palatin’s melanocortin receptor agonist peptides for treatment of inflammatory indications and natriuretic peptide receptor agonist compounds for treatment of cardiovascular and fibrotic diseases.

Conference Call / Webcast
Palatin will host a conference call and audio webcast on November 13, 2019 at 11:00 a.m. Eastern Time to discuss the quarter ended September 30, 2019 results of operations in greater detail and provide an update on corporate developments. Individuals interested in listening to the conference call live can dial 1-888-599-8686 (US/Canada) or 1-323-794-2575 (international), conference ID 1609183. 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 1609183. The webcast and telephone replay will be available through November 20, 2019.

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!

Cerus Corporation to Present at the Stifel 2019 Healthcare Conference

On November 13, 2019 Cerus Corporation (Nasdaq:CERS) reported that Kevin D. Green, Cerus’ chief financial officer, will present at the Stifel 2019 Healthcare Conference on Tuesday, November 19, 2019 at 2:25 p.m. ET in New York City (Press release, Cerus, NOV 13, 2019, View Source [SID1234551126]).

A live webcast of the presentation will be available on the Investor Relations page of the Cerus web site at View Source A replay of the webcast will be available for approximately two weeks following the completion of the event.

Avidity Biosciences Completes $100 Million Series C Financing

On November 13, 2019 Avidity Biosciences, a biotechnology company pioneering Antibody-Oligonucleotide Conjugates (AOCs) for the treatment of rare muscle disorders and other serious diseases, reported the completion of a $100 million Series C financing (Press release, Avidity Biosciences, NOV 13, 2019, View Source [SID1234551124]).

The financing was led by RTW Investments and included new investors Cormorant Asset Management, LP, CureDuchenne, Logos Capital, Perceptive Advisors LLC and ST Pharm. Existing investors also participated and include Alethea Capital, Alexandria Venture Investments, Boxer Capital of Tavistock Group, Brace Pharma Capital, EcoR1 Capital, Partner Fund Management and Takeda Ventures. Eli Lilly and Company contributed $15 million to the financing in connection with the research collaboration between Lilly and Avidity initiated in April 2019. Roderick T. Wong, M.D., managing partner of RTW Investments, will join Avidity Biosciences’ board of directors.

"Avidity pioneered AOC technology that combines two powerful technologies: monoclonal antibodies for effective delivery and oligonucleotide therapeutic for potent and selective activity," said Sarah Boyce, president and CEO of Avidity Biosciences. "Using our AOC platform, we can unlock new potential for RNA therapeutics by efficiently targeting muscle and immune cells. These funds will enable Avidity to advance our growing proprietary portfolio of multiple programs, including our AOC treatment of myotonic dystrophy type I, to treat serious muscle disorders."

"Our investment team is excited about Avidity’s first-in-class therapy for myotonic dystrophy, and the potential of its AOC platform to deliver RNA-based therapeutics to muscle and create transformative treatments for diseases with high unmet need," said Dr. Wong. "As a member of the board, I look forward to supporting the advancement of their pipeline into the clinic."

Dr. Wong is the founder of RTW Investments and is responsible for managing the firm’s investments focused on innovative drug development. Prior to forming RTW, he was a managing director and sole portfolio manager for the Davidson Kempner Healthcare Funds. Before this, he held various healthcare investment and research roles at Sigma Capital and Cowen & Company. Dr. Wong received his medical doctorate from the University of Pennsylvania Medical School and an MBA from Harvard Business School, as well as a bachelor’s degree in economics from Duke University.

SVB Leerink acted as lead financial advisor for Avidity Biosciences’ Series C financing.

Salarius Pharmaceuticals Reports Three and Nine Month 2019 Financial Results

On November 13, 2019 Salarius Pharmaceuticals, Inc. (Nasdaq: SLRX), a clinical-stage biotechnology company targeting the epigenetic causes of cancer, reported its corporate and financial results for the quarter ended September 30, 2019 (Press release, Flex Pharma, NOV 13, 2019, View Source [SID1234551123]).

Third Quarter 2019 Financial Highlights:

Entered $10.9 million Stock Purchase Agreement with Aspire Capital
Initial $1.0 million stock sale completed
Three- and nine-month periods ended September 30, 2019 net loss per common share – basic and diluted – for continuing operations of $0.73 and $1.68, respectively
Total cash and cash equivalents of $4.0 million as of September 30, 2019
$9.1 million remains available to draw from the Cancer Prevention and Research Institute of Texas grant (CPRIT), upon meeting certain requirements
Recent Business Highlights:

Closed merger with Flex Pharma; initiated trading on Nasdaq Capital Market
Enrolled first patient in Phase 1 trial of Seclidemstat in advanced solid tumors (AST)
Achieved dose-escalation milestones in ongoing Phase 1/2 Ewing sarcoma and Phase 1 AST clinical trials
Added Memorial Sloan Kettering Cancer Center and Nationwide Children’s Hospital as clinical sites for Phase 1/2 trial of Seclidemstat in Ewing sarcoma
Entered a collaborative partnership with Ivy Brain Tumor Center to develop Seclidemstat for the treatment of glioblastoma
"The third quarter of 2019 was a transformative time for Salarius, highlighted by our merger with Flex Pharma and our subsequent listing on the Nasdaq Capital Market," stated David Arthur, President and Chief Executive of Salarius. "The importance of this accomplishment cannot be understated as it establishes a foundation for our future growth by providing increased exposure and access to institutional investors and a platform for Salarius to showcase the potential of our lead asset, Seclidemstat, as well as our broader clinical pipeline."

Mr. Arthur continued, "Key to Salarius’ value proposition is Seclidemstat, a potent reversible inhibitor of the LSD1 enzyme. Seclidemstat is currently being tested in a Phase 1/2 clinical trial in Ewing sarcoma, a rare and deadly pediatric bone cancer for which there is no approved targeted treatment, in addition to a Phase 1 trial in advanced solid tumors. During the quarter, we achieved important dose escalation and trial enrollment events for each program, putting us on target to report early patient data from both studies in 2020."

Mr. Arthur concluded, "As a publicly-traded company, Salarius has a foundation for future growth and a means to maximize the potential of Seclidemstat, which we believe to be one of the most advanced reversible LSD1 inhibitors now in the clinic. Subject to limitations in our stock purchase agreement with Aspire Capital, Salarius has access to a flexible source of capital over the next 30 months, as well as the support from Aspire Capital, an institutional investor that recognizes our tremendous upside potential. This capital, in addition to the non-dilutive financial support Salarius receives from the National Pediatric Cancer Foundation (NPCF) and the $9.1 million in non-dilutive funding still remaining from the $18.7 million grant Salarius received in 2016 from the Cancer Prevention and Research Institute of Texas puts Salarius in a good financial position as we continue our work developing targeted cancer therapies. Above all and underpinning our drive as a company is a dedication to the patients around the world who are unfortunately afflicted with the devastating cancers we aim to treat. Their bravery is our inspiration."

Third Quarter Financial Results:
For the quarter ended September 30, 2019, Salarius’ reported net loss was $2.6 million, or $0.73 per basic and diluted common share, compared to a net loss of $0.3 million, or $0.20 per basic and diluted share for the same period in 2018. The loss from operations before other income for the three-month span ended September 30, 2019 increased by $3.4 million compared to the loss from operations before other income for the same time span last year, which was primarily due to increases of $0.8 million in research and development expenses resulting from increased clinical expenses, and an increase of $3.1 million in general and administrative expenses, respectively. Increased general and administrative spending resulted primarily from costs related to the merger with Flex Pharma, Inc. ("Flex Pharma"), which was completed in July 2019. These merger-related costs include a one-time success fee of $1.35 million and $0.8 million in professional fees.

Nine Month Financial Results:
For the nine-month period ended September 30, 2019, Salarius’ reported net loss was $5.1 million, or $1.68 per basic and diluted share, compared to a net loss of $0.6 million, or $0.47 per basic and diluted share for the same period in 2018. The loss from operations before other income for the nine-month span ended September 30, 2019 increased by $5.6 million compared to the loss from operations for the same time span last year, which was primarily due to an increase of $1.9 million in research and development expenses resulting from increased clinical expenses and an increase of $4.9 million in general and administrative expenses, respectively. Increased general and administrative spending primarily resulted from professional fees of $1.4 million and one-time success fees totaling $1.35 million, both related to the merger with Flex Pharma.

As of September 30, 2019, total cash, cash equivalents and restricted cash was $4.0 million, compared to $6.1 million as of December 31, 2018.

Summary of Corporate and Operational Events:

Merger with Flex Pharma Completed:
On July 19, 2019, Salarius Pharmaceuticals, LLC completed its previously-announced merger with Flex Pharma. In accordance with the terms of the merger agreement, the newly combined company was renamed Salarius Pharmaceuticals, Inc., and would be led by Salarius’ then current management team under the leadership of David Arthur, President and Chief Executive Officer of Salarius Pharmaceuticals, LLC. Former Flex Pharma President and Chief Executive Officer William McVicar, Ph.D., joined Salarius’ Board of Directors upon completion of the merger.

On July 22, 2019, shares of Salarius’ common stock began trading on the Nasdaq Capital Market under the ticker symbol "SLRX". The shares reflected a 25:1 reverse stock split that was effective as of the close of business on July 19, 2019.

Stock Purchase Agreement with Aspire Capital:

On October 24, 2019, Salarius entered into a $10.9 million common stock purchase agreement with Aspire Capital Fund, LLC., a Chicago-based institutional investor. Under the agreement, Aspire Capital is committed to buy shares of Salarius common stock over a 30-month span extending into 2022 at our sole discretion, subject to certain terms and conditions. Immediately upon execution of the agreement, Aspire Capital made an initial purchase of 210,526 shares of Salarius stock for $1.0 million, at a per-share purchase price of $4.75, which was the closing price of Salarius shares on the date of the agreement.

Update on Seclidemstat Clinical and Pre-Clinical Programs:

Seclidemstat Clinical Trials in Ewing Sarcoma and Advanced Solid Tumors:

On September 24, 2019, Salarius announced that the Safety Review Committees overseeing the ongoing Phase 1/2 clinical study of Seclidemstat in patients with relapsed or refractory Ewing sarcoma and the Phase 1 study of Seclidemstat in patients with advanced solid tumors resistant to standard-of-care therapies have approved the advancement of both studies to the fourth level dosing cohort.

The two clinical trials are designed as open-label dose-finding studies to characterize the pharmacokinetics (PK), the maximum tolerated dose (MTD) and initial safety profile of Seclidemstat. Thus far, early PK data suggests Seclidemstat has a desirable half-life and plasma levels are dose proportional. Based on current projections, both studies are on track to reach maximum tolerated dose in early 2020 and report early patient data later in the same year.

The Phase 1/2 clinical trial of Seclidemstat in Ewing sarcoma opened patient enrollment in Q3 2018 and is currently enrolling patients of 12 years of age or older at leading cancer centers in the U.S. Meanwhile, the Phase 1 AST clinical trial began enrolling patients in June 2019 with a focus on prostate, breast, ovarian, melanoma, colorectal, non-Ewing’s sarcomas and other cancers where Seclidemstat demonstrated single-agent preclinical activity.

New Clinical Trial Sites Added to Ewing Sarcoma Study:

On October 8, 2019, Salarius announced the addition of Memorial Sloan Kettering Cancer Center (MSKCC) in New York City and Nationwide Children’s Hospital (Nationwide Children’s) in Columbus, OH as trial sites in the Phase 1/2 clinical trial of Seclidemstat in Ewing sarcoma patients. This brings the number of active sites to eight and helps facilitate enrollment as the trial advances.

Partnership with Ivy Brain Tumor Center:

On August 26, 2019, Salarius and the Ivy Brain Tumor Center at the Barrow Neurological Institute in Phoenix, AZ announced a collaborative partnership to test Seclidemstat for the treatment of glioblastoma, a rare brain cancer. Under the agreement, the organizations plan to launch what both believe to be the most comprehensive pre-clinical study to date evaluating the effect of targeting the LSD1 enzyme, which has increased expression in tumors of brain cancer patients.

Leadership Changes:

On September 13, 2019, Salarius appointed Mark Rosenblum as Interim Chief Financial Officer, as well as Executive Vice President Finance. Scott Jordan, Salarius’ previous Chief Financial Officer, transitioned to the new role of Chief Business Officer.

Magenta Therapeutics Reports Third Quarter 2019 Financial Results and Recent Business Highlights

On November 13, 2019 Magenta Therapeutics (NASDAQ: MGTA), a clinical-stage biotechnology company developing novel medicines to bring the curative power of stem cell transplant to more patients, reported financial results for the third quarter ended September 30, 2019 and recent business highlights (Press release, Magenta Therapeutics, NOV 13, 2019, View Source [SID1234551122]).

"Magenta has a big vision: to bring the curative power of immune reset through stem cell transplant to patients with autoimmune diseases, genetic diseases and blood cancers. At ASH (Free ASH Whitepaper) next month, we are looking forward to sharing important new data from across our portfolio. These will include clinical data from our MGTA-145 program, which we are developing as a new first-line standard of care for stem cell mobilization. We will also present the first gene therapy data on our CD117-ADC, which we are developing as a non-genotoxic preparation regimen for gene therapy and transplant," said Jason Gardner, D.Phil., Chief Executive Officer and President, Magenta Therapeutics. "In addition, earlier this week we presented our first data in autoimmune disease, showing that a single dose of our CD45-ADC led to successful immune reset in disease models of multiple sclerosis, systemic sclerosis and inflammatory arthritis. Immune reset through stem cell transplant has previously demonstrated durable remissions in thousands of patients with autoimmune diseases such as multiple sclerosis and systemic sclerosis, and it is recommended in multiple guidelines in US and Europe."

Recent Business Highlights:

First clinical data for MGTA-145 stem cell mobilization program and groundbreaking CD117-ADC gene therapy data to be presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting: On November 6th, 2019, Magenta announced that the Company will share results from six abstracts at ASH (Free ASH Whitepaper) in December 2019, covering Magenta’s patient preparation, mobilization and cell therapy programs. The Company will present clinical data for the MGTA-145 stem cell mobilization program, building on the positive early data in the ASH (Free ASH Whitepaper) abstract. Magenta is developing MGTA-145 to be the new standard of care for first-line stem cell mobilization, with mobilization and collection taking place in a single day without the use of G-CSF, the current standard of care. The Company will also highlight important proof-of-concept data from the CD117-ADC patient preparation program. In a rhesus model of gene therapy, a single dose of CD117-ADC enabled engraftment of stem cells modified with the β-globin gene, the gene that causes sickle cell disease and β-thalassemia when mutated. These results showed for the first time that a single dose of CD117-ADC can enable successful gene therapy transplant in non-human primates without the need for chemotherapy or radiation.

First Magenta preclinical immune reset data presented at the American College of Rheumatology (ACR) annual meeting: On November 10th, 2019, Magenta presented the first data on the use of targeted antibody-drug conjugates (ADCs) to reset the immune system and halt progression of autoimmune disease. Results showed that a single dose of C45-ADC removed disease-causing cells, enabled successful reset and rebuild of the immune system and was well tolerated in models of multiple sclerosis, systemic sclerosis and inflammatory arthritis. Further, a single dose of CD45-ADC significantly delayed disease onset in a model of multiple sclerosis that has successfully provided preclinical proof of concept for many clinically validated standard of care therapies.

Exercised option with Heidelberg Pharma for ADCs using an amanitin payload and targeting CD45: On November 11th, 2019, Magenta announced that it had exercised its option with Heidelberg Pharma for exclusive worldwide development and marketing rights for ADCs using an amanitin payload and targeting CD45.

Received Regenerative Medicine Advanced Therapies (RMAT) Designation for MGTA-456 in inherited metabolic disorders: In September 2019, Magenta announced that the FDA granted RMAT designation for MGTA-456, a one-time cell therapy for the treatment of multiple inherited metabolic disorders, based on encouraging clinical data generated to date in the Company’s ongoing Phase II trial. RMAT designation is a dedicated program designed to expedite the development and approval processes for promising pipeline products, including cell therapies. Potential advantages of the RMAT designation include all of the benefits of the fast track and breakthrough therapy designation programs, including early interactions with the FDA that may be used to discuss potential surrogate or intermediate endpoints to support accelerated approval.

Appointed Senior Vice President, Head of Translational Sciences; Chief Scientific Officer to transition out of Company: In October 2019, Magenta announced that it had hired Jan Pinkas, Ph.D., as Senior Vice President, Head of Translational Sciences. Dr. Pinkas is a seasoned scientist with deep expertise in leading drug development programs, including ADCs. Prior to joining Magenta, he was Head of Translational Research & Development at ImmunoGen, Inc., where he led nonclinical and translational research and development-related activities for all programs in discovery through late-stage clinical development. The Company also announced that Mike Cooke, Ph.D., Chief Scientific Officer, will leave Magenta to pursue other opportunities.

Financial Results:

Cash Position: Cash, cash equivalents and marketable securities as of September 30, 2019, were $160.6 million compared to $142.6 million on December 31, 2018. Magenta anticipates that its cash, cash equivalents and marketable securities will be sufficient to fund operations and capital expenditures into the second half of 2021.

Research and Development Expenses: Research and development expenses were $16.5 million in the third quarter of 2019, compared to $11.4 million in the third quarter of 2018. The increase was driven primarily by investments in clinical activities for MGTA-145, as well as manufacturing related to our patient preparation programs.

General and Administrative Expenses: General and administrative expenses were $6.1 million for the third quarter of 2019, compared to $5.3 million for the third quarter of 2018. The increase was primarily due to an increase in professional fees and facility costs associated with the growth of the Company.

Net Loss: Net loss was $ 21.0 million for the third quarter of 2019, compared to net loss of $16.0 million for the third quarter of 2018.