On May 17, 2021 Palatin (NYSE American: PTN), a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin peptide receptor system, reported results for its third fiscal quarter ended March 31, 2021 (Press release, Palatin Technologies, MAY 17, 2021, View Source [SID1234580143]).

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"I am excited with Palatin’s evolution and development advancements utilizing our proprietary melanocortin agonists to treat patients with inflammatory and autoimmune conditions," stated Carl Spana, Ph.D., President and CEO of Palatin. "We are hosting a KOL webinar on May 21st to introduce our growing portfolio of melanocortin agonists to treat the harmful effects of inflammation in the eye. On the clinical front, we are targeting to commence a Phase 3 trial of PL9643 in patients with dry eye disease in the second half of calendar year 2021. The emerging profile of PL9643, with its rapid therapeutic onset and excellent tolerability profile, is a potentially distinct advantage over commercially available dry eye therapies. In addition, we are targeting to commence a Phase 2 study with an oral formulation of PL8177 in ulcerative colitis patients in the second half of calendar year 2021."

"I am also pleased with the progress we have made with the Vyleesi program," continued Spana. "Our quarter ended March 31, 2021 reflected significant increases in gross sales, net sales, prescriptions, and insurance coverage over the prior quarter."

Business Highlights and Updates

Anti-Inflammatory / Autoimmune Programs
PL9643 for the treatment of dry eye disease (DED):
Announced positive results from its Phase 2 clinical study reflecting statistically significant improvements in multiple signs and symptoms in the moderate to severe patient population after 2 weeks of dosing and at the 12-week visit. There were no safety signals identified and PL9643 had excellent ocular tolerability.
A Phase 3 clinical trial is currently planned for the second half of calendar year 2021, with data readout potentially in the first half of calendar year 2022.
Presented two presentations of the Company’s melanocortin platform, including Phase 2 clinical trial results for PL9643 in dry eye disease and preclinical data in retinal disease, at the Association for Research in Vision and Ophthalmology (ARVO) 2021 Annual Meeting, held virtually May 1-7, 2021.
PL8177 for the treatment of ulcerative colitis:
A Phase 2 proof-of-concept clinical study with an oral formulation of PL8177 in ulcerative colitis patients is targeted to start second half of calendar year 2021, with data readout potentially in mid-calendar year 2022.
Key Opinion Leader webinar planned for May 21, 2021 on melanocortin agonists for treating ocular indications, with a primary focus on PL9643 and data from the Company’s recently completed Phase 2 clinical trial for dry eye disease:
Introduces the Company’s growing portfolio of melanocortin agonists to treat the harmful effects of inflammation in the eye.
Vyleesi (bremelanotide injection) / Hypoactive Sexual Desire Disorder (HSDD)
Quarter ended March 31, 2021 gross product sales increased 89%, net revenue increased 154%, and prescriptions increased 24%, over the prior quarter ended December 31, 2020.
Geo-targeted marketing efforts expected to drive healthcare provider and consumer engagement. The current digital campaign applications reach thousands of healthcare providers and millions of premenopausal women monthly and has resulted in increased website and telemedicine traffic and conversions.
The Company continues to focus on expanding access and reimbursement coverage. The Company estimates that it has achieved approximately 75% of commercially insured lives and approximately 50% of commercial formulary coverage, including two of the three major pharmacy benefit managers and numerous regional plans.
Prescription increases and expanding access and reimbursement coverage have resulted in more favorable gross-to-net adjustments and positive quarterly net product revenue for the first time.
Palatin has filed an election to extend the patent term of U.S. patent 6,794,489 to June 26, 2025. This Vyleesi patent has claims to the bremelanotide composition of matter as well as methods for stimulating sexual response.
Third Quarter 2021 Results
Total net revenues, consisting of net product revenues of Vyleesi, were $88,741. There was no revenue reported for the third quarter of 2020.

Vyleesi gross sales amounted to $1,780,020, with net product revenue of $88,741, net of allowances and accruals, compared to gross sales for the prior quarter ended December 31, 2020 of $943,950, with net product revenue of $(163,971), net of allowances and accruals.
Total operating expenses were $6.6 million, compared to $5.7 million for the same period in 2020. The increase was mainly due to commercial expenses related to Vyleesi.

Palatin’s net loss was $(5.7) million, or $(0.02) per share, compared to a net loss of $(5.4) million, or $(0.02) per share, for the comparable quarter of 2020.

As of March 31, 2021, the Company had $68.6 million in cash and cash equivalents and $1.9 million in accounts receivable, compared to $82.9 million in cash and cash equivalents and no accounts receivable as of June 30, 2020, with no outstanding debt.

Conference Call / Webcast
Palatin will host a conference call and audio webcast on May 17, 2021 at 11:00 a.m. Eastern Time to discuss the quarter ended March 31, 2021 results of operations in greater detail and provide an update on corporate developments. Individuals interested in listening to the conference call live can dial 1-866-248-8441 (US/Canada) or 1-856-344-9206 (international), conference ID 6765353 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 6765353. The webcast and telephone replay will be available through May 24, 2021.

On May 17, 2021 ImmunityBio, Inc. (NASDAQ: IBRX), a clinical-stage immunotherapy company, reported it has received FDA authorization to conduct a Phase 1 study to evaluate the safety and preliminary efficacy of its m-ceNKÔ platform combined with its IL-15 superagonist Anktiva (N-803) in subjects with locally advanced or metastatic solid tumors (Press release, NantKwest, MAY 17, 2021, View Source [SID1234580142]). These NK cells retrieved from the patient and enriched with cytokines have the ability to recognize and kill cancer targets with increased production of interferon-g (IFN-γ), a cytokine demonstrating high activity.

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"Nearly two million Americans, including children, will be diagnosed with locally advanced or metastatic solid tumors this year alone and many of these tumor types are difficult to treat," said Patrick Soon-Shiong, M.D., Founder and Executive Chairman of ImmunityBio. "Our m-ceNK cells, which are isolated and enriched from the patient after a simple blood draw (apheresis), are characterized by their unique cell-surface marker profile, by their highly desirable feature of immune-memory, and marked by their pronounced anti-cancer activity for weeks to months in duration. These unique properties have made these memory NK cells a research focus for more than a decade and a promising candidate in immunotherapy for solid tumors," said Soon-Shiong.

"We are excited to launch this next evolution of our NK platform. Based on the novel techniques and cytokine expansion developed at ImmunityBio, a single apheresis will enable 10 to 20 doses of m-ceNK infusions of 0.5 billion NK cells per dose. These autologous and allogeneic cryopreserved memory NK cells could synergize with our engineered off-the- shelf NK-92 cells, as well as with our IL-15 Anktiva superagonist, which stimulates both NK and T cells. We believe the combination of these tools has the potential to place ImmunityBio in a leading position to activate the patient’s immune system in the fight against cancer across both solid and liquid tumors."

About Memory Cytokine-Enhanced NK Cells (m-ceNK):

In an initial, proof-of-concept clinical study, memory-like NK cells with freshly isolated cytokine-stimulated NK cells demonstrated encouraging results in patients with liquid tumors.1. ImmunityBio has successfully enriched and expanded donor natural killer cells obtained from peripheral blood of donors using a technique called apheresis, to generate a unique NK cell phenotype which exhibits both high cytotoxicity and interferon-g production together with a memory–like effect. These m-ceNK cells, or memory-cytokine enriched NK cells, have been designed for autologous cell therapy, but have also been generated as an allogeneic product from cord blood. m-ceNK provides a unique opportunity in clinics due to its ease of use and potential suitability for use in the ambulatory setting.

NK cells from aphaeretic blood from 20 subjects, 15 healthy and 5 cancer patient donors, were successfully used to generate m-ceNK cells in an Independent Review Board-approved volunteer study. Mononuclear cells obtained from the apheresis procedure were stimulated in the presence of ImmunityBio’s proprietary cytokine, N-803, for enrichment of primary natural killer cells. A 2 to 3 log-fold expansion of activated NK cells was achieved by the third week of the protocol. These NK Cells are then briefly exposed to a proprietary cytokine cocktail to impart the critical memory-like phenotype, characterized by higher effector responses after a resting period—a key feature of ImmunityBio’s m-ceNK cells. The m-ceNK product is characterized as CD56+ cells that are armed with NK cell activating surface receptors required for proliferation, homing and tumor recognition and binding. Both the healthy- and cancer patient-derived m-ceNK cells killed NK-resistant tumor cells with equal potency when tested against tumor cells of different origins, including breast, Merkel, ovarian, adenocarcinoma, and lymphoma.

ImmunityBio has also developed a novel method of production, which yields multiple clinical-dose forms from a single apheresis product using the company’s proprietary NANT 001 Bioreactor (GMP-in-a-Box), thereby alleviating pressures on supply of starting material. A tailored cryopreservation protocol for maximum shelf-life and potency upon recovery was also established, a necessary precedent for any off-the-shelf product. ImmunityBio is leveraging the unique properties of m-ceNK—including potent cytotoxicity, increased IFN-gamma production, proliferative capacity, activation surface markers and memory response—to establish a propriety autologous product.

QUILT 3.076 Study Details

Cryopreserved m-ceNK cells in combination with Anktiva (N-803) will be tested in this phase 1 study designed to evaluate safety in subjects with locally advanced or metastatic solid tumors. The study will compare the quantity and quality of the m-ceNK cells collected and manufactured from newly diagnosed patients who have not received prior treatment to the m-ceNK cells collected and manufactured from patients who have received at least two prior treatments for their cancer.

The study consists of two cohorts and there will be 10 participants in each cohort. Cohort 1 includes participants with newly diagnosed high-risk solid tumors who have not received prior treatment; and cohort 2 includes participants with relapsed/refractory (r/r) solid tumors who have progressive disease after receiving ≥ 2 prior therapies. Participants will be enrolled in the two cohorts simultaneously.

Participants in cohort 1 will participate in apheresis collection of lymphocytes (part A) and will not receive any investigational therapy in this study.
Participants in cohort 2 will undergo an apheresis collection of lymphocytes (part A) prior to receiving approximately four weeks of disease-specific therapy per their Oncologists’ recommendations.
Solid tumors represent approximately 90% of adult cancers and 40% of all cancers in children, according to data collected from the American Cancer Society. Tumors can develop in many parts of the human body including the breast, lung, prostate, colon, skin, bladder and kidney.

On May 17, 2021 Kinnate Biopharma Inc. (Nasdaq: KNTE) ("Kinnate"), a biopharmaceutical company focused on the discovery and development of small molecule kinase inhibitors for difficult-to-treat, genomically defined cancers, reported that the U.S Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for KIN-2787 and also announced financial results for the quarter ended March 31, 2021 (Press release, Kinnate Biopharma, MAY 17, 2021, View Source [SID1234580128]). Kinnate expects to initiate a first-in-human Phase 1 clinical trial of KIN-2787 in patients with mutant BRAF-driven solid tumors in mid-2021.

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"In the three years since our founding, Kinnate has consistently hit key milestones essential to our mission of delivering new therapies to patients with difficult-to-treat, genomically-defined cancers. The FDA’s clearance of our KIN-2787 IND marks another major achievement for the company and demonstrates the important progress we are making in our transition to becoming a clinical-stage company," said Nima Farzan, Chief Executive Officer of Kinnate. "As we prepare for our first-in-human trial of KIN-2787 later this year, we are also pleased with the rapid advance of our lead FGFR inhibitor candidate, KIN-3248, which we believe may offer a new option for certain patients with cancers like urothelial tumors or intrahepatic cholangiocarcinoma. We anticipate a first half of 2022 IND filing for KIN-3248."

The Phase 1 trial will evaluate the safety, tolerability, pharmacokinetics and anti-cancer activity of KIN-2787 in cancer patients with mutant BRAF-driven solid tumors. The dose escalation portion (Part A) of the trial will determine the recommended dose and schedule of KIN-2787 for further evaluation in patients with BRAF mutations. The dose expansion phase (Part B) of the trial will assess the safety and efficacy of KIN-2787 at the recommended dose and schedule in patients with cancers driven by BRAF Class II or III mutations, including lung cancer, melanoma and other selected adult solid tumors.

Recent Business Highlights and Corporate Update:

In our RAF program, we filed an IND in April 2021 with the FDA to study KIN-2787 in patients with mutant BRAF-driven solid tumors. The FDA cleared the IND in May 2021 and we anticipate initiating a Phase 1 clinical trial for KIN-2787 in mid-2021. KIN-2787, our most advanced product candidate, is a RAF inhibitor we are developing for the treatment of patients with lung cancer, melanoma and other solid tumors. Unlike currently available treatments that target only Class I BRAF kinase mutations, we have designed KIN-2787 to target Class II and Class III BRAF mutations, where it would be a first-line targeted therapy, in addition to covering Class I BRAF mutations.
In May 2021 we closed a $35 million Series A financing of a joint venture in China. Established with OrbiMed Asia Partners, OrbiMed Private Investments and Foresite Capital, the joint venture will be headquartered in Shanghai and the financing will enable the potential development and commercialization by the joint venture of certain Kinnate targeted oncology product candidates across Greater China (mainland China, Hong Kong, Taiwan, and Macau). Kinnate Biopharma will be the majority shareholder in the joint venture. The company has also announced that veteran biopharmaceutical industry executive Wenn Sun, Ph.D., has been appointed as the joint venture’s Executive Chair.
Data from pre-clinical studies of KIN-2787 have been selected for poster presentation at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which will be held virtually June 4-8, 2021. The data to be presented at the ASCO (Free ASCO Whitepaper) annual meeting was derived from pre-clinical studies evaluating the efficacy and tolerability of KIN-2787 in vitro and in vivo in BRAF mutation-driven human cancer models.
In our FGFR program, we selected KIN-3248 as our lead FGFR inhibitor candidate for the treatment of intrahepatic cholangiocarcinoma and urothelial carcinoma and initiated GLP-toxicity studies of KIN-3248. Our FGFR candidates are designed to address clinically observed genomic alterations in FGFR2 and FGFR3 that drive resistance to current therapies. We anticipate filing an IND for KIN-3248 with the FDA in the first half of 2022 and, subject to our planned IND submission taking effect, initiating a Phase 1 clinical trial for KIN-3248 in the first half of 2022.
We continued to advance a number of other small molecule research programs, including a CDK12 inhibitor in our KIN004 program to target the treatment of ovarian carcinoma, triple-negative breast cancer and metastatic castration-resistant prostate cancer.
We expanded our organization to 41 full-time employees at March 31, 2021, of which 30 were engaged in research and development activities.
First Quarter 2021 Financial Results

First quarter net loss for 2021 was $17.5 million, compared to $3.9 million for the same period in 2020.
First quarter research and development expenses for 2021 were $12.7 million, compared to $3.2 million for the same period in 2020.
First quarter general and administrative expenses for 2021 were $4.8 million, compared to $1.0 million for the same period in 2020.
As of March 31, 2021, the total of cash and cash equivalents and investments was $383.1 million.

On May 17, 2021 Inhibikase Therapeutics, Inc. (Nasdaq: IKT) (Inhibikase), a clinical-stage pharmaceutical company developing therapeutics to modify the course of Parkinson’s disease and related disorders inside and outside of the brain, reported financial results for the first quarter ended March 31, 2021 and highlighted recent developments (Press release, Inhibikase Therapeutics, MAY 17, 2021, View Source [SID1234580126]).

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Key Business and Clinical Highlights

Accelerated timelines for Phase 1 Study of IkT-148009 for the treatment of PD and associated GI Disorders: In February, 2021 Inhibikase commenced patient dosing in its Phase 1 study evaluating the safety, tolerability and pharmacokinetics of IkT-148009, the Company’s novel brain penetrant Abelson tyrosine kinase (c-Abl) inhibitor with the potential to modify Parkinson’s disease and its gastrointestinal complications. In April, 2021, the Company announced that it had accelerated the timeline for completion of the study based on early data that provided the opportunity to seek regulatory approval to commence dosing of PD patients in the third quarter of 2021, much earlier than previously anticipated.
Advancing chronic toxicology studies of IkT-148009 to permit long-term dosing in patients: In January, 2021 Inhibikase initiated 3- and 6-month long-term toxicology studies of IkT-148009 in mice and 3- and 9-month long-term toxicology studies of IkT-148009 in primates as required to obtain regulatory approval for chronic administration of IkT-148009 in patients. The Company has completed 3-month toxicology studies and is presently completing its histopathology analysis in preparation for submission of the data for regulatory review early in the third quarter of 2021. The Company expects to complete 6- and 9-month toxicology studies in the fourth quarter of 2021.
Initiated clinical batch manufacturing and pill formulation of IkT-001Pro. In February, 2021, Inhibikase initiated clinical batch manufacturing and final product formulation of IkT-001Pro, the Company’s prodrug formulation of Imatinib, designed as a potentially safer, better tolerated treatment for Imatinib-sensitive cancers such as stable-phase Chronic Myeloid Leukemia (CML). Inhibikase expects to file an Investigational New Drug (IND) application in the third quarter of 2021, with initiation of clinical development as soon as practicable after the filing, subject to FDA acceptance of the IND.
"We are proud of the milestones we have achieved in the first quarter of 2021. The acceleration of our Phase 1 study for our lead candidate, IkT-148009 should allow us to move into evaluation of the safety, tolerability and pharmacokinetics in Parkinson’s patients early in the third quarter of 2021. Concurrently, we are advancing two long term toxicology studies in animals, which will allow for chronic administration of IKT-148009 in patients following FDA review and acceptance," commented Milton Werner, Ph.D., President and Chief Executive Officer of Inhibikase. "In the third quarter of 2021, we plan to file our IND application for IKT-001Pro, which holds the potential to be a safer and better tolerated treatment for cancers such as CML, and expect to initiate clinical development as soon as practicable following the submission of the IND application. We look forward to making 2021 a success as we work to advance our early stage programs forward."

First Quarter Financial Review

Net Loss: Net loss for the quarter ended March 31, 2021, was $2.6 million, or $0.26 per share, compared to a net loss of $0.5 million, or $0.07 per share for the first quarter in 2020.

R&D Expenses: Research and development expenses were $2.4 million for the quarter ended March 31, 2021 compared to $0.3 million for the first quarter in 2020. The increase was driven by an increase in grant related research expenditures and non-grant related research. The non-grant related research was expended primarily in connection with the Company’s Phase 1 clinical trials.

SG&A Expenses: Selling, general and administrative expenses for the quarter ended March 31, 2021 were $1.6 million compared to $0.5 million for the first quarter in 2020. The increase was primarily the result of increased non-cash stock compensation expense, increased directors and officer’s liability insurance related to the Company’s initial public offering in December 2020, increased legal fees, board fees, investor relations and consulting fees relating to operating as a public company registrant since December 2020, and an increase in other normal operating expenses.

Cash Position: Cash and cash equivalents were $9.6 million as of March 31, 2021.

On May 17, 2021 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM: HCM) reported that it will host a virtual investor update event on Wednesday, May 26, 2021 (Press release, Hutchison China MediTech, MAY 17, 2021, View Source [SID1234580125]). Members of the senior management team will provide updates on product launches in China, preparations for US commercialization, R&D, as well as a review of new data presented at the 2021 ASCO (Free ASCO Whitepaper) Annual Meeting.

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Analysts and investors are invited to join a conference call and audio webcast presentation. The event will take place at 8:00 a.m. Eastern Daylight Time / 1:00 p.m. British Summer Time (BST) / 8:00 p.m. Hong Kong Time (HKT) on Wednesday, May 26. A first Q&A session will immediately follow the prepared remarks. For Asian investors, a recording of the webcast will be available for viewing the following morning and a second Q&A session will start at 12:00 noon HKT on Thursday, May 27.

The event will be webcast live and can be accessed at www.hutch-med.com/event. Investors interested in listening to the live webcast should log on before the start time to download any software required. A replay of the event will be available shortly thereafter for approximately 90 days.