On May 17, 2021 CohBar, Inc. (NASDAQ: CWBR), a clinical stage biotechnology company developing mitochondria based therapeutics to treat chronic diseases and extend healthy lifespan, reported its financial results for the first quarter ended March 31, 2021 (Press release, CohBar, MAY 17, 2021, View Source [SID1234580118]).

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"I am excited about the potential of CohBar’s mitochondria based therapeutic programs to make a significant difference in the lives of patients," stated Dr. Joseph Sarret, Chief Executive Officer. "We look forward to the Phase 1b data from our trial of CB4211 for the treatment of NASH and obesity in early July 2021. In parallel, we are continuing to advance our preclinical pipeline, most notably initiating IND-enabling studies with CB5138-3 for fibrotic diseases, including IPF, putting us on track for our goal of having at least 2 clinical-stage programs in 2022."

First Quarter 2021 and Recent Highlights

Completed last subject visit in the Phase 1b stage of the clinical study of CB4211 under development for nonalcoholic steatohepatitis (NASH) and obesity: The ongoing study evaluates CB4211 in subjects with non-alcoholic fatty liver disease (NAFLD) and obesity with at least 10% liver fat. The primary endpoints are safety and tolerability, with a secondary endpoint of pharmacokinetics, and exploratory endpoints of changes in liver fat, body weight, and biomarkers relevant to NASH, obesity, and metabolic disease. The company expects to release topline data in early July 2021.
Nominated CB5138-3 as lead clinical candidate for Idiopathic Pulmonary Fibrosis (IPF) and other fibrotic diseases and initiated IND-enabling activities: In March, the company announced the selection of CB5138-3 for advancement into IND-enabling activities, with the goal of starting clinical studies in 2022. In addition, the company is continuing to evaluate the efficacy of CB5138 Analogs in models of other fibrotic diseases.
Signed a Non-Clinical Evaluation Agreement (NCEA) with the National Institute of Allergy and Infectious Diseases (NIAID) to evaluate the potential of CB5064 Analogs for the treatment of COVID-19 Associated Acute Respiratory Distress Syndrome (ARDS): In January, the company announced it will be utilizing the non-clinical and pre-clinical services program offered by the NIAID, a division of the National Institutes of Health (NIH). NIAID will be responsible for any study conducted under the NCEA, including an evaluation using the golden Syrian hamster SARS-CoV-2 model, which has been used in the assessment of other COVID-19 therapeutics.
Appointed Joseph J. Sarret, M.D., J.D. as Chief Executive Officer and Director: In April, the company announced the appointment of Joseph J. Sarret, M.D., J.D. as Chief Executive Officer and Director, effective May 3, 2021. Dr. Sarret is a seasoned executive with a track record of success in biotechnology.
Gained additional bank research coverage: Recently, Wall Street banks Aegis Capital and Maxim Group initiated coverage on CohBar and issued research reports on the company.
Founders’ Update

During the first quarter and subsequent period, CohBar’s founders, Dr. Pinchas Cohen, Dean of the USC Leonard Davis School of Gerontology, and Dr. Nir Barzilai, Director of the Institute for Aging Research at Albert Einstein College of Medicine, continued to present and publish on the study of mitochondrial science, aging and age-related diseases.

Dr. Cohen and his colleagues published three landmark papers on the role of MOTS-c in human health. The first, "MOTS-c is an exercise-induced mitochondrial-encoded regulator of age-dependent physical decline and muscle homeostasis," published in Nature Communication, outlined the exercise mimetic actions of MOTS-c, and described the fitness- and health-enhancing effects of this hormone. The second paper, entitled "MOTS-c reduces myostatin and muscle atrophy signaling," published in the American Journal of Physiology, described a key mechanism for MOTS-c action, namely its effect on suppressing the myokine myostatin in animal models, which has implications for possible utility in diseases like frailty and sarcopenia. The third paper, entitled "A pro-diabetogenic mtDNA polymorphism in the mitochondrial-derived peptide, MOTS-c," published in the journal Aging, described the effects of a mutation in the MOTS-c gene, found in up to 8% of Japanese, Koreans and Northern Chinese. This mutation results in a "bio-inactive" variant of MOTS-c that is unable to induce the insulin-sensitizing and weight-loss effects the "wild-type" form elicits in male animals. Men who carry this mutation have elevated levels of (inactive) MOTS-c, increased abdominal fat and an elevated risk for type-2 diabetes; this risk is further increased in the subset of these men who are also sedentary, providing additional support for the relationship between MOTS-c and exercise.

Dr. Barzilai was featured at several conferences related to aging, including the "Annual Aging Research and Drug Discovery 2020: From aging mechanisms to interventions" symposium and publication. In addition, he was featured at the National University of Singapore Yong Loo Lin School of Medicine’s Healthy Longevity series in a webinar titled "Age Later: Lessons for This Pandemic and the Next". Dr. Barzilai was a keynote speaker at the Annual International (bio)Medical Students Meeting (AIMS) Meeting and the Geneva Science and Diplomacy Anticipator. He was also a panelist on the "Living Healthily to 120 and Beyond" session at the Fifth International Vatican Conference.

First Quarter 2021 Financial Highlights

Cash and Investments: CohBar had cash and investments of $17.8 million as of March 31, 2021, compared to $21.0 million as of December 31, 2020. The cash burn for the quarter ended March 31, 2021, was approximately $4.2 million.

R&D Expenses: Research and development expenses were $2.7 million for the three months ended March 31, 2021, compared to $1.5 million in the prior year quarter. The increase in research and development expenses was primarily due to the investment in the company’s research programs focused on the continued development of its peptides, and an increase in clinical trial costs due to the timing of those expenses, partially offset by a decrease in stock-based compensation costs.

G&A Expenses: General and administrative expenses were $1.4 million for the three months ended March 31, 2021, compared to $1.8 million in the prior year quarter. The decrease in general and administrative expenses was primarily due to lower stock-based compensation costs.

Net Loss: For the three months ended March 31, 2021, net loss, which included $0.4 million of non-cash expenses, was $4.0 million, or $0.07 per basic and diluted share. For the three months ended March 31, 2020, net loss, which included $1.8 million of non-cash expenses, was $4.2 million, or $0.10 per basic and diluted share.
First Quarter Investor Call:

Date: May 17, 2021
Time: 5:00 p.m. ET (2:00 p.m. PT)

Conference Audio Only

Dial-in U.S. and Canada: (877) 451-6152
Dial-in International: (201) 389-0879
Conference ID No.: 13718702
An audio replay of the call will be available beginning at 8:00 p.m. Eastern Time on May 17, 2021, through 11:59 p.m. Eastern Time on June 7, 2021. To access the recording please dial (844) 512-2921 in the U.S. and Canada, or (412) 317-6671 internationally, and reference Conference ID# 13718702. The audio recording will also be available at www.cohbar.com during the same period. For this call there will not be a slide presentation

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 SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, reported financial results for the first quarter ended on March 31, 2021 and provided an update on recent clinical and corporate developments (Press release, Scynexis, MAY 17, 2021, View Source [SID1234580158]).

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"Our team is executing on all cylinders as we approach our June 1, 2021 PDUFA for Brexafemme," said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. "So far this year, we have received a total of approximately $35 million in non-dilutive funding, which is adequate to support our Brexafemme U.S. launch in the second half of the year while further extending our cash runway into 2023. We are also advancing the development of ibrexafungerp in the hospital setting, including our new IV formulation currently in Phase 1. With ibrexafungerp poised to become the first new antifungal class approved in over 20 years, we believe that the approval of the VVC indication may represent just the first step in the larger build-out of our antifungal franchise."

Ibrexafungerp Update

Remain on track for anticipated June 1st approval of ibrexafungerp for the treatment of VVC and commercial launch in the second half of 2021. SCYNEXIS is currently in discussions with the FDA to finalize its recommended wording for different sections of the drug’s Prescribing Information to provide adequate information to prescribers.

Dosing is ongoing in Phase 1 testing of the liposomal IV formulation of ibrexafungerp. Based on promising pre-clinical data of our liposomal IV formulation of ibrexafungerp, SCYNEXIS is conducting a Phase 1, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of the IV liposomal formulation of ibrexafungerp in healthy subjects. The study is being conducted in South Africa and dosing began in March 2021.
Enrollment is complete in the Phase 3 CANDLE study, investigating the efficacy and safety of oral ibrexafungerp for the prevention of recurrent VVC, for which there is no approved therapy in the U.S. SCYNEXIS expects the last-patient / last-visit by the end of 2021 with top-line results and a supplemental NDA submission anticipated in the first half of 2022, resulting in a potential approval in late 2022.
Enrollment is ongoing in our refractory invasive fungal infections (rIFI) program, which comprises two open-label Phase 3 studies (FURI and CARES). On March 2, 2021 SCYNEXIS presented positive data from its third interim analysis of the FURI study and first interim analysis of the CARES study, showing oral ibrexafungerp’s ability to treat severe fungal infections in the hospital setting. Consistent with two prior interim analyses, the FURI results confirm positive clinical activity of oral ibrexafungerp in patients with difficult-to-treat, severe, mucocutaneous and invasive fungal infections, including those caused by resistant strains. In total, oral ibrexafungerp showed clinical benefits in 64 out of 74 patients (86.5%), with 46 patients achieving a complete or partial response. The first interim analysis of CARES study showed strong clinical activity of oral ibrexafungerp in patients with invasive candidiasis and candidemia due to Candida auris, a high-mortality infection classified by Centers for Disease Control and Prevention as an urgent threat to public health, with 8 out of 10 patients (80.0%) experiencing a complete response. The results support continued enrollment in both open-label Phase 3 studies, with potential future submissions under the LPAD regulatory pathway.
Ibrexafungerp Phase 3 data were presented at a key medical conference, reporting efficacy in non-albicans Candida (NAC) and severe patients with vulvovaginal candidiasis infections. On April 30, SCYNEXIS presented posters on two data sets from SCYNEXIS’s Phase 3 VANISH program demonstrating the therapeutic potential of ibrexafungerp at the 2021 American College of Obstetricians and Gynecologists (ACOG) Annual Meeting that took place virtually from April 30-May 2, 2021. The data highlighted ibrexafungerp efficacy in treating patients with NAC, which was comparable to that of the total patient population enrolled in the trial. Additionally, ibrexafungerp was shown to be efficacious in patients with severe VVC, and may provide a treatment alternative where currently available therapies may not be satisfactory.
Corporate Developments and Subsequent Events

On February 11, 2021, SCYNEXIS entered into a licensing and strategic partnership agreement for ibrexafungerp with Hansoh Pharmaceutical that covers the Greater China region. So far SCYNEXIS received $11 million in upfront and milestone payments and is eligible to receive additional development and commercial milestone payments of up to $111 million, plus double-digit royalties on net sales.
On February 23, 2021, SCYNEXIS announced that it has partnered with Amplity Health, a leading global contract commercialization organization, to support the anticipated U.S. commercialization of Brexafemme (the conditionally FDA-approved brand name for ibrexafungerp for vaginal yeast infections) in the second half of 2021. SCYNEXIS will utilize Amplity’s commercial execution expertise and resources for sales force, remote engagement, training, market access and select operations services.
In May 2021, SCYNEXIS entered into an agreement with a third party to sell a portion of its unused 2020 New Jersey NOLs for approximately $4.2 million.
On May 10, 2021, SCYNEXIS granted stock options to three new employees to purchase an aggregate of 15,000 shares of SCYNEXIS common stock at a per share exercise price of $6.50, the closing trading price on May 10, 2021. Each option has a ten-year term, with one-fourth of the shares subject to the option vesting on the one-year anniversary of the employee’s first date of employment and the remainder vesting in equal monthly installments for thirty-six months thereafter, provided the employee continues to provide service to SCYNEXIS. The stock options were granted pursuant to SCYNEXIS’s 2015 Inducement Award Plan, as amended in April 2021, which was adopted by the SCYNEXIS’s board of directors in March 2015 under Rule 5635(c)(4) for equity grants to induce new employees to enter into employment with SCYNEXIS.
On May 11, 2021, SCYNEXIS announced the appointment of Christine Coyne as its Chief Commercial Officer to lead the anticipated U.S launch and commercialization of Brexafemme. She brings to the team deep anti-infective commercial expertise across hospital and community settings.
On May 13, 2021, SCYNEXIS entered into a loan agreement with Hercules Capital, Inc. and Silicon Valley Bank for an aggregate principal amount of $60.0 million. Under the terms of the loan agreement, SCYNEXIS received an initial tranche of $20.0 million from the lenders on the Closing Date and is eligible to receive an additional $10.0 million upon FDA approval of ibrexafungerp for the treatment of vaginal yeast infections. Subsequent cash injections will be available upon achieving certain milestones.
First Quarter 2021 Financial Results

Cash and cash equivalents totaled $92.0 million on March 31, 2021, compared to $93.0 million in cash and cash equivalents on December 31, 2020.

Research and development expense for the three months ended March 31, 2021 decreased to $6.9 million from $9.9 million for the three months ended March 31, 2020. The decrease of $2.9 million, or 30%, for the three months ended March 31, 2021, was primarily driven by a decrease of $2.1 million in clinical development expense, a decrease of $0.9 million in chemistry, manufacturing, and controls (CMC) expense, and a decrease of $0.5 million in preclinical expense, offset in part by an increase in salary related costs of $0.3 million and a net increase in other research and development expense of $0.3 million.

Selling, general & administrative expense for the three months ended March 31, 2021 increased to $6.7 million from $2.6 million for the three months ended March 31, 2020. The increase of $4.1 million, or 156%, for the three months ended March 31, 2021 was primarily driven by a $1.7 million increase in commercial related expense, an increase of $1.0 million in business development expense, an increase of $0.5 million in expense associated with increased information technology costs, and an increase of $0.3 million salary related costs.

Total other expense was $2.0 million for the three months ended March 31, 2021, compared to total other income of $5.5 million for the three months ended March 31, 2020. During the three months ended March 31, 2021 and 2020, SCYNEXIS recognized non-cash income of $1.3 million and $4.8 million, respectively, on the fair value adjustment of the warrant liabilities and during the three months ended March 31, 2021 and 2020, recognized non-cash expense of $0.1 million and non-cash gains of $0.7 million on the fair value adjustment of the derivative liabilities, respectively.

Net loss for the three months ended March 31, 2021 was $4.7 million, or ($0.18) per basic and ($0.23) per diluted share, compared to a net loss of $7.0 million, or ($0.72) per basic and diluted share for the three months ended March 31, 2020.

About Ibrexafungerp

Ibrexafungerp [pronounced eye-BREX-ah-FUN-jerp] is an investigational antifungal agent and the first representative of a novel class of structurally-distinct glucan synthase inhibitors, triterpenoids. This agent combines the well-established activity of glucan synthase inhibitors with the potential flexibility of having oral and intravenous (IV) formulations. Ibrexafungerp is currently under regulatory review for the treatment of vaginal yeast infection, also known as vulvovaginal candidiasis (VVC), and in late-stage development for multiple indications, including life-threatening fungal infections caused primarily by Candida (including C. auris) and Aspergillus species in hospitalized patients. It has demonstrated broad-spectrum antifungal activity, in vitro and in vivo, against multidrug-resistant pathogens, including azole- and echinocandin-resistant strains.

The FDA has accepted a New Drug Application for ibrexafungerp for the treatment of VVC and granted a Prescription Drug User Fee Act (PDUFA) action date of June 1, 2021. It also granted Qualified Infectious Disease Product (QIDP) and Fast Track designations for the IV and oral formulations of ibrexafungerp for the indications of invasive candidiasis (IC) (including candidemia) and invasive aspergillosis (IA), and has granted Orphan Drug Designation for the IC and IA indications. Ibrexafungerp is formerly known as SCY-078.

On May 17, 2021 Refuge Biotechnologies, Inc. ("Refuge"), a synthetic biology company developing intelligent cell therapeutics for cancer immunotherapy, and The University of Texas MD Anderson Cancer Center reported a strategic collaboration to advance new cell therapies for potential treatment of solid tumors (Press release, Refuge Biotechnologies, MAY 17, 2021, View Source [SID1234580119]). The agreement pairs Refuge’s innovative technologies with the experience and industrial capabilities of MD Anderson’s Biologics Development platform, within the Therapeutics Discovery division.

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Under the agreement, MD Anderson will possess exclusive rights to apply Refuge’s proprietary platform for next-generation cell engineering to its tumor infiltrating lymphocyte (TIL) programs. MD Anderson also will co-develop Refuge’s RB-340, a HER-2 targeted CAR T-cell therapy with context dependent inducible down-regulation of PD-1, including Investigational New Drug (IND) filing, Good Manufacturing Practice (GMP) production and Phase I/II clinical trials.

"MD Anderson has extensive expertise in developing and manufacturing innovative cell therapies, including groundbreaking work with TILs," said Bing Wang, Ph.D., chief executive officer and co-founder of Refuge Biotechnologies. "We look forward to working closely with MD Anderson researchers to apply our technology to this promising field of research, while also advancing development of our lead intelligent cell therapy program."

Using Refuge’s platform for programming cells to selectively react to tumor cells through direct modulation of gene expression utilizing CRISPR interference and activation, RB-340 is designed to conditionally and smartly down-regulate expression of PD-1 on approaching tumor cells, reducing T cell exhaustion and increasing T cell persistence and proliferation, thus creating better efficacy against solid tumors. Treatment with RB-340 in preclinical models has shown a clear survival benefit compared to conventional CAR T-cell therapy. IND filing is anticipated in the first half of 2022, with clinical development of RB-340 focused in solid tumors.

Through its Biologics Development platform, MD Anderson is advancing research into therapeutic applications for TILs – naturally occurring lymphocytes that can recognize cancer cells and penetrate a tumor. MD Anderson and Refuge will explore the use of Refuge’s platform to engineer TILs for enhanced anti-tumor activity.

"It is my belief that TILs are poised for a significant impact in the field of cancer therapy, and engineering improved TILs is a vital part of advancing this modality," said Jason Bock, Ph.D., vice president of Therapeutics Discovery and head of Biologics Development at MD Anderson. "We have been encouraged by the data coming from Refuge’s applications of its next generation, context dependent and inducible cell engineering platform, and we look forward to incorporating its potential into our TIL programs."

MD Anderson’s Biologics Development platform is built around an experienced team focused on pioneering impactful biologic therapeutics, including antibodies and cell therapies. With a state-of-the-art GMP cell therapy manufacturing facility, the platform unites MD Anderson research with industrial therapeutic development.

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.