On May 17, 2022 Palatin Technologies, Inc. (NYSE American: PTN), a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin and natriuretic peptide receptor systems, reported results for its fiscal third quarter ended March 31, 2022 (Press release, Palatin Technologies, MAY 17, 2022, View Source [SID1234614728]).

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"Patient enrollment is on track for our lead programs, a Phase 3 pivotal study of PL9643 in patients with dry eye disease with topline results currently expected in the second half of calendar year 2022, and a Phase 2 clinical study of PL8177 in patients with ulcerative colitis is expected to start next month with topline results currently expected first quarter calendar 2023," stated Carl Spana, Ph.D., President and CEO of Palatin. "Regarding Vyleesi, our March 31, 2022 quarter reflected increases across all value metrics compared to the prior quarter, including gross product sales, net product revenue, prescriptions dispensed, refill rates, and commercial insurance reimbursement."

Dr. Spana further commented, "Our $15 million preferred stock offering addresses several objectives. It puts us in an excellent position to effect a reverse split of our common stock at our annual meeting of stockholders, which will provide the Company with flexibility to fund future product development and retain and attract talented employees, price our common stock at a price per share reflective of the development stage of Palatin, increase our investor and financing options, and assuming the holders convert to either common stock or debt, coupled with our strong cash position of approximately $38 million at March 31, 2022, provide us with sufficient operating cash runway through at least calendar 2023."

Third Quarter Ended Fiscal Year 2022 Financial Highlights
Net loss for the quarter ended March 31, 2022, was $7.6 million, or $(0.03) per common share, compared to a net loss of $5.7 million, or $(0.02) per common share, for the same period in 2021.
As of March 31, 2022, the Company had cash and investments of $37.7 million, compared to $47.3 million as of December 31, 2021, and $60.1 million as of June 30, 2021, and no debt.
Vyleesi (bremelanotide injection) / Hypoactive Sexual Desire Disorder (HSDD): Gross product sales increased 67%, net product revenue increased 200% and prescriptions increased 20%, over the prior quarter.
Business Highlights and Updates
• Anti-Inflammatory / Autoimmune Programs

° PL9643 melanocortin agonist for the treatment of dry eye disease (DED):

– Pivotal Phase 3 clinical study in DED patients is ongoing. Topline data readout expected in the second half of calendar year 2022.

– NDA submission is targeted for the first half of calendar year 2024.

– Hosted Key Opinion Leader webinar on DED.

– Spotlight Presentation at the Eyecelerator@ASCRS 2022 conference in Washington D.C. covering the role of melanocortins in the treatment of ocular disease and Phase 2 study results with PL9643 for DED conducted.

– Presented posters at the Association for Research in Vision and Ophthalmology (ARVO) 2022 Annual Conference highlighting Palatin’s ocular research and PL9643 Phase 2 clinical data.

° PL8177 melanocortin agonist for the treatment of ulcerative colitis (UC):

– Presented the positive effects of PL8177 at the 2022 Crohn’s and Colitis Congress on treating UC in an animal disease model, including genomic data characterizing the anti-inflammatory effects of melanocortin agonists.

– A Phase 2 oral formulation study of PL8177 in UC is currently scheduled to start in the first half of calendar year 2022. Topline data readout currently expected in the first quarter of calendar year 2023.

• Vyleesi (bremelanotide injection) / Hypoactive Sexual Desire Disorder (HSDD): Goal of the Vyleesi program is to demonstrate product value in the marketplace with an objective of re-licensing the U.S. rights to a committed women’s healthcare company.

° For the quarter ended March 31, 2022:

– Gross product sales increased 67% over the prior quarter, decreased 27% over the comparable quarter in 2021.

– Net product revenue increased 200% over the prior quarter, increased 144% over the comparable quarter in 2021.

– Total prescriptions dispensed increased 20% over the prior quarter, flat compared to the comparable quarter in 2021.

– Refill rates, commercial insurance reimbursement, and net revenue per prescription dispensed increased over the prior quarter and comparable quarter in 2021.

° Patients and healthcare providers can learn more about HSDD and Vyleesi at www.vyleesi.com and www.vyleesipro.com

• Other: On May 11, 2022, Palatin entered into a securities purchase agreement with institutional investors, selling and issuing 8,100,000 shares of Series B Convertible Redeemable Preferred Stock ("Series B Preferred Stock") and 900,000 shares of Series C Convertible Redeemable Preferred Stock ("Series C Preferred Stock"). Each share of Series B Preferred Stock and Series C Preferred Stock had a purchase price of $1.67 and is convertible into Palatin common stock at an initial conversion price of $0.45 per share. The investors in the Series B Preferred Stock and Series C Preferred Stock also received warrants to purchase up to 1,666,667 shares of common stock at an exercise price of $0.50 per share, which expire 48 months following issuance. Total gross proceeds from the offering, before deducting offering expenses, is $15 million.

The Company expects to call a meeting of stockholders to seek approval of, including, but not limited to, an amendment to its certificate of incorporation authorizing a reverse stock split. Holders of the Series B Preferred Stock and Series C Preferred Stock are entitled to vote only on the reverse stock split and any adjournment of the meeting relating to the reverse stock split.

To the extent any shares of Series B Preferred Stock or Series C Preferred Stock are converted to common shares or redeemed for debt, the Company will use such net proceeds from this offering for working capital and general corporate purposes. Additional information regarding the securities described above and the terms of the offering are included in Palatin’s quarter ended March 31, 2022 10Q filing with the United States Securities and Exchange Commission.

Third Fiscal Quarter Ended March 31, 2022 Financial Results
Revenue
Total revenue consists of gross product sales of Vyleesi, net of allowances and accruals, and license and contract revenue.

Vyleesi gross product sales to pharmacy distributors for the quarter ended March 31, 2022, amounted to $1.3 million, with net product revenue of $216,097, compared to gross product sales of $1.8 million, with net product revenue of $88,741, for the comparable quarter in 2021. Gross product sales decreased 27% and net product revenue increased 144% over the comparable quarter in 2021.

Operating Expenses
Total operating expenses for the quarter ended March 31, 2022, were $8.0 million, compared to $6.6 million for the comparable quarter in 2021.

The increase in operating expenses was the result of increased research and development expenses primarily related to our ongoing pivotal Phase 3 clinical trial of PL9643 offset by decreased commercial expenses related to Vyleesi.

Other Income / (Expenses)
Total other income, net, consist mainly of unrealized foreign currency gains of $190,719 and $753,750, respectively, for the quarters ended March 31, 2022 and 2021.

Cash Flows
Palatin’s net cash used in operations for the quarter ended March 31, 2022, was $9.5 million, compared to net cash used in operations of $3.5 million for the same period in 2021. The increase in net cash used in operations is mainly due to a $4.3 payment received in March 2021 related to our Termination Agreement with AMAG Pharmaceuticals, offset by increased operating expenses.

Net Loss
Palatin’s net loss for the quarter ended March 31, 2022, was $7.6 million, or $(0.03) per basic and diluted common share compared to a net loss of $5.7 million, or $(0.02) per basic and diluted common share, for the same period in 2021.

The increase in net loss for the quarter ended March 31, 2022 over the quarter ended March 31, 2021, was mainly due to the increase in operating expenses.

Cash Position
As of March 31, 2022, Palatin’s cash and cash equivalents were $37.7 million with $0.8 million of accounts receivable, compared to cash and cash equivalents of $47.3 million with $0.6 million of accounts receivable as of December 31, 2021, and $60.1 million of cash and cash equivalents with $1.6 million of accounts receivable as of June 30, 2021.

Based on its current operating plan, Palatin believes that existing cash and cash equivalents along with the $15 million of proceeds raised from our recent private placement of Preferred Stock, assuming conversion to common stock or debt, will be sufficient to fund currently anticipated operating expenses through at least calendar year 2023.

Conference Call / Webcast
Palatin will host a conference call and audio webcast on May 17, 2022 at 11:00 a.m. Eastern Time to discuss the quarter ended March 31, 2022 results of operations in greater detail and provide an update on corporate developments. Individuals interested in listening to the conference call live can dial 1-800-304-0389 (US/Canada) or 1-313-209-5140 (International), conference ID 1376619. 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 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 1376619. The webcast and telephone replay will be available through May 24, 2022.

About Melanocortin Receptor Agonists and Inflammation
The melanocortin receptor ("MCr") system has effects on inflammation, immune system responses, metabolism, food intake, and sexual function. There are five melanocortin receptors, MC1r through MC5r. Modulation of these receptors, through use of receptor-specific agonists, which activate receptor function, or receptor-specific antagonists, which block receptor function, can have medically significant pharmacological effects.

Many tissues and immune cells located in the eye (and other places, for example the gut and kidney) express melanocortin receptors, empowering our opportunity to directly activate natural pathways to resolve disease inflammation.

On May 17, 2022 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI), a clinical-stage biotechnology company developing eganelisib, a first-in-class, oral, immuno-oncology macrophage reprogramming therapeutic, reported that management will be presenting a corporate overview and participating in 1-on-1 meetings at the upcoming H.C. Wainwright Global Investment Conference May 23-25, 2022 (Press release, Infinity Pharmaceuticals, MAY 17, 2022, View Source [SID1234614727]).

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H.C. Wainwright Global Investment Conference Presentation (hybrid)
Date: Tuesday, May 24th, 2022
Time: 7:00 am Eastern Standard Time
Speaker: Adelene Perkins, Chief Executive Officer
Format: Company presentation and virtual 1-on-1 meetings
Webcast Registration Link.
*a replay will be available following the presentation for 90 days

On May 17, 2022 IMV Inc. (NASDAQ: IMV; TSX: IMV), a clinical-stage company developing a portfolio of immune-educating therapies based on its novel DPX platform to treat solid and hematologic cancers, reported that members of IMV’s executive management team will be participating in person at the H.C. Wainwright Global Investment Conference, which will be held in person and virtually May 23-26, 2022 in Miami, FL (Press release, IMV, MAY 17, 2022, View Source [SID1234614726]).

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H.C. Wainwright Global Investment Conference
Format: Presentation and one-on-one investor meetings
Date: Wednesday May 25, 2022
Time: 9:30 a.m. ET

A link to this presentation is available under the ‘Events, Webcasts & Presentations’ section of IMV’s website and a replay of the presentation will be available in for 90 days.

On May 17, 2022 Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE) and Abeona Therapeutics Inc. (Nasdaq: ABEO) reported an exclusive license agreement for AAV gene therapy ABO-102 (now UX111) for the treatment of Sanfilippo syndrome type A (MPS IIIA) (Press release, Abeona Therapeutics, MAY 17, 2022, View Source [SID1234614725]). Under the terms of the agreement, Ultragenyx will assume responsibility for the ABO-102 program and in return Abeona is eligible to receive tiered royalties of up to 10% on net sales and commercial milestone payments following regulatory approval.

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"Based on promising data from Abeona’s clinical program, regulatory feedback to date, and our experience developing treatments for other MPS diseases, we believe ABO-102 has the potential to be a transformative therapy for patients with MPS IIIA," said Emil D. Kakkis, M.D., Ph.D., Chief Executive Officer and President of Ultragenyx. "Our team’s expertise in MPS and gene therapy clinical development makes this program a seamless integration and it has the potential to be our first gene therapy to market. The Sanfilippo community has been waiting too long for a first treatment and we believe we can help accelerate this program."

"Data from the ongoing Transpher A trial demonstrate ABO-102 holds significant potential to improve outcomes for patients with MPS IIIA who experience relentlessly progressing neurodevelopmental and physical decline that is life-threatening at a very young age," said Vish Seshadri, Ph.D., Chief Executive Officer of Abeona. "We believe that Ultragenyx, with deep expertise in rare, genetic, metabolic lysosomal storage disorders and a demonstrated commitment towards MPS diseases, is the ideal partner to eventually bring ABO-102 to patients."

Abeona has completed a successful Type B meeting with the U.S. Food and Drug Administration (FDA) regarding the pivotal Transpher A trial to support filing and approval for ABO-102 for the treatment of patients with MPS IIIA. Interim results from the Transpher A trial presented in an encore presentation at the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) today demonstrate that neurocognitive development was preserved in children treated before 2 years old or development quotient (DQ) > 60 (n=10) within normal range of a non-afflicted child after treatment with ABO-102 (3×1013 vg/kg). The interim results also showed continued or stabilized cognitive function and behavioral progress using standard developmental assessments. Some of these patients have reached 24-months post treatment and stabilization or increase in cortical gray matter, total cerebral, and amygdala volumes have been observed. Statistically significant reduction in liver volume was seen with ABO-102 treatment. Dose-dependent and statistically significant reductions in cerebrospinal fluid and plasma heparan sulfate, demonstrating replacement of enzyme activity consistent with levels required for disease correction in the central nervous system, have been sustained in treated patients for two years after treatment. ABO-102 has been well-tolerated with no treatment-related serious adverse events and no clinically meaningful adverse events reported.

"MPS IIIA is characterized by severe neurodegeneration with debilitating symptoms for which there is currently no treatment," said Kevin Flanigan, M.D., director of the Center for Gene Therapy at Nationwide Children’s Hospital in Columbus, Ohio, and Transpher A study principal investigator. "The promising results to date suggest a single intravenous dose of ABO-102 AAV-based gene therapy has the potential to help children with MPS IIIA sustain neurocognitive development when they are treated during early stages of their disease."

About ABO-102 / UX111

ABO-102 (now UX111), is a novel gene therapy in Phase 1/2 development for Sanfilippo syndrome type A (MPS IIIA), a rare lysosomal storage disease with no approved treatment that primarily affects the central nervous system (CNS). ABO-102 is dosed in a one-time intravenous infusion using a self-complementary AAV9 vector to deliver a functional copy of the SGSH gene to cells of the CNS and peripheral organs. The therapy is designed to address the underlying SGSH enzyme deficiency responsible for abnormal accumulation of glycosaminoglycans in the brain and throughout the body that results in progressive cell damage and neurodevelopmental and physical decline. The ABO-102 program has received Regenerative Medicine Advanced Therapy, Fast Track, Rare Pediatric Disease, and Orphan Drug designations in the U.S., and PRIME and Orphan medicinal product designations in the EU.

About the Transpher A Study

The Transpher A Study (ABT-001) is an ongoing, two-year, open-label, dose-escalation, Phase 1/2 global clinical trial assessing ABO-102 for the treatment of patients with Sanfilippo syndrome type A (MPS IIIA). The study is intended for patients from birth to 2 years of age, or patients older than 2 years with a cognitive developmental quotient of 60% or above. ABO-102 gene therapy is delivered using AAV9 technology via a single-dose intravenous infusion. The study primary endpoints are neurodevelopment and safety, with secondary endpoints including behavior evaluations, quality of life, enzyme activity in cerebrospinal fluid (CSF) and plasma, heparan sulfate levels in CSF, plasma and urine, and brain and liver volume.

Further details can be referenced here: View Source

About Sanfilippo syndrome type A (MPS IIIA)

Sanfilippo syndrome type A (MPS IIIA) is a rare, fatal lysosomal storage disease with no approved treatment that primarily affects the CNS and is characterized by rapid neurodevelopmental and physical decline, often by age three. MPS IIIA has a global incidence of one in 100,000 with a median life expectancy of 15 years.

Children with MPS IIIA present with progressive language and cognitive decline and behavioral abnormalities. Other symptoms include sleep problems and frequent ear infections. Additionally, distinctive facial features with thick eyebrows or a unibrow, full lips and excessive body hair for one’s age, and liver/spleen enlargement are also present in early childhood. MPS IIIA is caused by genetic mutations that lead to a deficiency in the SGSH enzyme responsible for breaking down glycosaminoglycans, which accumulate in cells throughout the body resulting in rapid health decline associated with the disorder.

On May 17, 2022 EVERSANA, the pioneer of next-generation commercial services to the global life sciences industry, reported four senior leaders have been named to the prestigious PM360 ELITE List for 2022 (Press release, EVERSANA, MAY 17, 2022, View Source [SID1234614724]). Now in its eighth year, the PM360 ELITE (Exceptional, Leaders, Innovators, Transformers, Entrepreneurs) represents the most influential people in the healthcare industry today.

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Jim Lang, CEO, and Faruk Capan, Chief Innovation Officer and CEO of Intouch Group, an EVERSANA Company, were recognized together in the Transformational Leader category. Lang and Capan have closely worked together over the past six months as Intouch Group continues its integration with EVERSANA. Their combined vision to join forces to create a next-generation marketing agency for the pharmaceutical industry was announced in late 2021. This is the second consecutive year Lang has been named in this category.

Amy Peek, Executive Director, Talent Acquisition, Field Deployment Solutions, has been named in the Talent Acquisition Leader category. Amy leads the recruitment arm for EVERSANA’s field deployment team, which recruits and hires hundreds of pharmaceutical sales representatives, medical science liaisons and other deployment professionals each year for clients.

Nicholas Capanear, Senior Vice President and Executive Craft Director at Intouch Group, an EVERSANA Company, has been named in PM360’s Creative Director category. Capanear has helped the Intouch creative team reach new heights since joining the team in early 2021.

"It’s an honor to see colleagues across EVERSANA be recognized by their peers and industry publications like PM360 as industry leaders," said Jim Lang, CEO, EVERSANA. "Being named to this list speaks to each winner’s accomplishments while reinforcing the type of top talent we aspire to find and retain across our organization. Congrats to everyone on this year’s ELITE 100 list for your many contributions to the pharma industry."

The annual award recognizes individuals and teams who have made a significant impact on the life sciences and healthcare industries throughout their careers. Winners are profiled in PM360’s May 2022 issue, which can be found here.