On November 14, 2022 Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported financial results for the third quarter ended September 30, 2022 (Press release, Cogent Biosciences, NOV 14, 2022, View Source [SID1234623928]).

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"We are excited to announce the initiation of our Phase 3 PEAK trial in imatinib-resistant, second line GIST patients and look forward to presenting an update from our Phase 2 APEX trial in ASM patients in an oral presentation at ASH (Free ASH Whitepaper) 2022," said Andrew Robbins, President and CEO of Cogent Biosciences. "Our team has made tremendous progress this year, advancing our three bezuclastinib clinical trials, PEAK, APEX, and SUMMIT, recently presenting new data on our novel FGFR2 and ErbB2 selective programs, and delivering an optimized formulation of bezuclastinib which will significantly improve the patient experience."

Recent Business Highlights

Initiated the randomized portion of PEAK, a global Phase 3 clinical trial in GIST patients who have progressed following imatinib therapy. The trial is designed to explore the efficacy of bezuclastinib in combination with sunitinib compared to sunitinib alone.
The experimental arm of the PEAK trial includes a 600 mg daily dose of an optimized formulation of bezuclastinib, supplied as 75 mg tablets, which in the lead-in portion of the study demonstrated clinical exposures equivalent to the 1,000 mg daily dose of the original formulation used in the GIST Phase 1/2 clinical trial.

Presented preclinical data at the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) (ENA) annual meeting on a next-generation fibroblast growth factor receptor 2 (FGFR2) program, which retains potency across all primary, gatekeeper and molecular brake resistance mutations, including N549K and V564I, while sparing FGFR1 inhibition. This program remains on track for IND in 2023, with IND-enabling activities to commence early next year.

Presented preclinical data at ENA on a novel ErbB2 mutant selective program which demonstrates robust cellular inhibition of all key resistance and primary driver mutations, including L755S, V842I and S310F/Y, while sparing wild type EGFR target engagement.
Upcoming Milestones

Present updated clinical data from APEX, a global, multicenter Phase 2 clinical trial of bezuclastinib in patients with advanced systemic mastocytosis (AdvSM) in an oral presentation at the 64th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting on Sunday, December 11, 2022. The presentation will include measures of clinical activity, including initial patient response assessment, in addition to pharmacokinetic and safety data. Cogent will host an investor webcast on December 12, 2022 at 8:00 am ET to discuss these data.
Preliminary Safety and Efficacy from Apex, a Phase 2 Study of Bezuclastinib (CGT9486), a Novel, Highly Selective, Potent KIT D816V Tyrosine Kinase Inhibitor, in Adults with Advanced Systemic Mastocytosis (AdvSM)
Presenter: Daniel DeAngelo, M.D., Ph.D., Chief of the Division of Leukemia at the Dana-Farber Cancer Institute
Present initial safety and pharmacokinetic data from the PEAK lead-in study at the Connective Tissue Oncology Society (CTOS) annual meeting, November 16-19, 2022.
Peak Study: A Phase 3 Randomized, Open-label, Multicenter Clinical Study of Bezuclastinib (CGT9486) and Sunitinib Versus Sunitinib in Patients with Gastrointestinal Stromal Tumors
Presenter: Andrew J. Wagner, MD, Ph.D., Associate Chief Medical Officer at the Dana Farber Cancer Institute
Present initial clinical efficacy results from refractory GIST patients receiving bezuclastinib plus sunitinib in the PEAK lead-in study during first half of 2023.

Present initial clinical data from SUMMIT, a randomized, double-blind, placebo-controlled, global, multicenter, Phase 2 clinical trial of bezuclastinib in patients with nonadvanced systemic mastocytosis (NonAdvSM), now in the second half of 2023. Based on the exciting performance of bezuclastinib’s optimized formulation in the PEAK lead-in trial, as well as in a separate healthy volunteer study, the SUMMIT trial protocol will be amended to allow for the optimized formulation to be introduced during the dose exploration phase.
Begin IND enabling studies for a potentially best-in-class, FGFR1-sparing, pan-FGFR2 mutation tyrosine kinase inhibitor in early 2023. This program is Cogent’s first internally developed research program and has been designed to overcome the clinical challenges of emergent FGFR2 treatment resistance, including the gatekeeper and molecular brake mutations that are the most common drivers of resistance, as well as off-target FGFR1 related adverse events that may limit the use of currently available and development stage FGFR2 tyrosine kinase inhibitors.
Third Quarter 2022 Financial Results

Cash Position: As of September 30, 2022, cash, cash equivalents and marketable securities were $289.1 million, as compared to $325.6 million as of June 30, 2022. The company believes that its cash, cash equivalents and marketable securities will be sufficient to fund its operating expenses and capital expenditure requirements into 2025. During the third quarter of 2022 Cogent incurred one-time cash payments of $8.6 million mainly related to the build-out and equipment costs associated with its newly-constructed Research Lab in Boulder, CO.

R&D Expenses: Research and development expenses were $29.9 million for the third quarter of 2022 as compared to $14.8 million for the third quarter of 2021. R&D expenses include non-cash stock compensation expense of $2.1 million for the third quarter of 2022 compared to $1.4 million for the third quarter of 2021. Additional increases resulted from costs associated with the APEX, SUMMIT and PEAK clinical trials as well as costs related to expanding the Cogent Research Team, which was formed in the second quarter of 2021.

G&A Expenses: General and administrative expenses were $6.9 million for the third quarter of 2022 as compared to $5.0 million for the third quarter of 2021. G&A expenses include non-cash stock compensation expense of $2.6 million for the third quarter of 2022 compared to $2.0 million for the third quarter of 2021.

Net Loss: Net loss was $35.1 million for the third quarter of 2022 as compared to a net loss of $19.1 million for the same period of 2021.

On November 14, 2022 AstraZeneca and Daiichi Sankyo reported that it’s Enhertu (trastuzumab deruxtecan) has been recommended for approval in the European Union (EU) as monotherapy for the treatment of adult patients with advanced HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen (Press release, AstraZeneca, NOV 14, 2022, View Source [SID1234623927]).

Enhertu is a specifically engineered HER2-directed antibody drug conjugate (ADC) being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency based its positive opinion on results from the DESTINY-Gastric02 and the DESTINY-Gastric01 Phase II trials.

In DESTINY-Gastric02, conducted in patients from North America and Europe, updated results showed treatment with Enhertu resulted in a confirmed objective response rate (ORR) of 41.8% as assessed by independent central review (ICR). Median duration of response (DoR) was 8.1 months and median overall survival (OS) was 12.1 months. Primary results from the DESTINY-Gastric02 Phase II trial were presented at the 2021 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress, with the updated data presented at ESMO (Free ESMO Whitepaper) 2022.1

In DESTINY-Gastric01, conducted in patients from Japan and South Korea, updated results showed treatment with Enhertu resulted in an ORR of 51.3% versus 14.3% with chemotherapy (irinotecan or paclitaxel). Patients treated with Enhertu had a 40% reduction in the risk of death versus patients treated with chemotherapy (based on a hazard ratio of 0.60; 95% confidence interval: 0.42-0.86, p=0.01) with a median OS of 12.5 months versus 8.9 months. Additionally, confirmed ORR, a major efficacy outcome, was 42.0% with Enhertu versus 12.5% with chemotherapy as assessed by ICR. The primary analysis was published in The New England Journal of Medicine,2 with the updated data presented at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: "Gastric cancer is usually diagnosed in the advanced stage in many European countries and patients face high mortality rates. If approved, Enhertu would be the first HER2-directed medicine for patients with advanced gastric cancer in the European Union in more than a decade."

Ken Takeshita, Global Head, Oncology R&D, Daiichi Sankyo, Inc, said: "Enhertu is the first HER2-directed medicine to demonstrate a significant improvement in overall survival compared to chemotherapy in patients with gastric cancer following initial treatment with a HER2-directed medicine in the advanced or metastatic setting. The CHMP opinion recognises the high unmet need in this patient population and brings us one step closer to bringing this medicine to patients with gastric cancer in Europe."

In both trials, the safety profiles observed in patients treated with Enhertu were consistent with those seen in other trials of Enhertu with no new safety signals identified.

Enhertu is approved in the US and several other countries for locally advanced or metastatic HER2-positive gastric cancer.

Notes

HER2-positive gastric cancer
Gastric (stomach) cancer is the fifth most common cancer worldwide and the fourth highest leading cause of cancer mortality, with a five-year global survival rate of 5% to 10% for advanced or metastatic disease.3-5 Approximately one million new patients were diagnosed with gastric cancer in 2020, with 768,000 deaths reported globally.6 In Europe, approximately 136,000 cases of gastric cancer are diagnosed annually, and Eastern Europe has the second highest incidence of gastric cancer worldwide after Eastern Asia.5-6 Gastric cancer is the sixth leading cause of cancer death in Europe and is typically diagnosed in the advanced stage. Even when diagnosed in earlier stages of the disease, the survival rate remains modest.5-7

Approximately one in five gastric cancers are HER2-positive.8,9 HER2 is a tyrosine kinase receptor growth promoting protein expressed on the surface of many types of tumours including breast, gastric, lung and colorectal cancers.8 HER2 overexpression may be associated with a specific HER2 gene alteration known as HER2 amplification.9

Recommended first-line treatment for HER2-positive advanced or metastatic gastric cancer is combination chemotherapy plus trastuzumab, an anti-HER2 medicine, which has been shown to improve survival outcomes when added to chemotherapy.10 For patients with metastatic gastric cancer that progresses following initial treatment with a trastuzumab-based regimen, treatment options are limited, and in many regions in the world there are no additional HER2 directed medicines available.2,11,12

DESTINY-Gastric02
DESTINY-Gastric02 is an open-label, single-arm Phase II trial in Western patients evaluating the efficacy and safety of Enhertu (6.4mg/kg) in patients with HER2-positive metastatic and/or unresectable gastric or GEJ adenocarcinoma with disease progression on or after a trastuzumab-containing regimen.

The primary endpoint of DESTINY-Gastric02 is confirmed ORR based on ICR. Secondary endpoints include progression-free survival (PFS), OS, DoR and safety.

DESTINY-Gastric02 enrolled 79 patients at multiple sites in North America and Europe. For more information about the trial, visit ClinicalTrials.gov.

DESTINY-Gastric01
DESTINY-Gastric01 is a randomised, open-label Phase II trial evaluating the efficacy and safety of Enhertu (6.4mg/kg) in patients from Japan and South Korea with primarily HER2-positive (defined as immunohistochemistry [IHC] 3+ or IHC 2+/in-situ hybridisation [ISH]+) advanced gastric cancer or GEJ adenocarcinoma whose tumours have progressed on two or more prior treatment regimens including fluoropyrimidine (5-FU), platinum chemotherapy and trastuzumab. Patients were randomised 2:1 to receive Enhertu or physician’s choice of chemotherapy (paclitaxel or irinotecan monotherapy).

The primary endpoint of DESTINY-Gastric01 is ORR. Secondary endpoints include OS, PFS, DoR, disease control rate and time to treatment failure, as well as pharmacokinetic and safety endpoints.

DESTINY-Gastric01 enrolled 187 patients at multiple sites in Japan and South Korea. For more information about the trial, visit ClinicalTrials.gov.

Enhertu
Enhertu is a HER2-directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC technology, Enhertu is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced programme in AstraZeneca’s ADC scientific platform. Enhertu consists of a HER2 monoclonal antibody attached to a topoisomerase I inhibitor payload, an exatecan derivative, via a stable tetrapeptide-based cleavable linker.

Enhertu (5.4mg/kg) is approved in more than 35 countries for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received a (or one or more) prior anti-HER2-based regimen either in the metastatic setting, or in the neoadjuvant or adjuvant setting and have developed disease recurrence during or within six months of completing therapy based on the results from the DESTINY-Breast03 trial.

Enhertu (5.4mg/kg) is approved in several countries for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens based on the results from the DESTINY-Breast01 trial.

Enhertu (5.4mg/kg) is approved in Brazil and the US for the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received a prior chemotherapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy based on the results from the DESTINY-Breast04 trial.

Enhertu (5.4mg/kg) is approved under accelerated approval in the US for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer whose tumours have activating HER2 (ERBB2) mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy, based on the results of the DESTINY-Lung02 trial. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Enhertu (6.4mg/kg) is approved in several countries for the treatment of adult patients with locally advanced or metastatic HER2-positive gastric or GEJ who have received a prior trastuzumab-based regimen based on the results from the DESTINY-Gastric01 trial.

Enhertu development programme
A comprehensive development programme is underway globally, evaluating the efficacy and safety of Enhertu monotherapy across multiple HER2-targetable cancers, including breast, gastric, lung and colorectal cancers. Trials in combination with other anticancer treatments, such as immunotherapy, are also underway.

Regulatory applications for Enhertu in breast and gastric cancer are currently under review in several other countries based on the DESTINY-Breast01, DESTINY-Breast03, DESTINY-Breast04, DESTINY-Gastric01 and DESTINY-Gastric02 trials, respectively.

Daiichi Sankyo collaboration
Daiichi Sankyo Company, Limited (TSE: 4568) [referred to as Daiichi Sankyo] and AstraZeneca entered into a global collaboration to jointly develop and commercialise Enhertu (a HER2-directed ADC) in March 2019, and datopotamab deruxtecan (DS-1062; a TROP2-directed ADC) in July 2020, except in Japan where Daiichi Sankyo maintains exclusive rights. Daiichi Sankyo is responsible for the manufacturing and supply of Enhertu and datopotamab deruxtecan.

AstraZeneca in gastrointestinal cancers
AstraZeneca has a broad development programme for the treatment of gastrointestinal (GI) cancers across several medicines and a variety of tumour types and stages of disease. In 2020, GI cancers collectively represented approximately 5.1 million new cancer cases leading to approximately 3.6 million deaths.13

Within this programme, the Company is committed to improving outcomes in gastric, liver, biliary tract, oesophageal, pancreatic and colorectal cancers.

Enhertu, a HER2-directed antibody drug conjugate, is approved in the US and several other countries for HER2-positive advanced gastric cancer and is being assessed in colorectal cancer. Enhertu is jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.

Imfinzi (durvalumab) is approved in the US and several other countries in combination with chemotherapy (gemcitabine plus cisplatin) for advanced biliary tract cancer and in the US in combination with Imjudo (tremelimumab) in unresectable hepatocellular carcinoma. Imfinzi is being assessed in combinations, including with Imjudo, in liver, oesophageal and gastric cancers in an extensive development programme spanning early to late-stage disease across settings.

Lynparza (olaparib), a first-in-class PARP inhibitor, is approved in the US and several other countries for the treatment of BRCA-mutated metastatic pancreatic cancer. Lynparza is developed and commercialised in collaboration with MSD (Merck & Co., Inc. inside the US and Canada).

AstraZeneca in oncology
AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients.

The Company’s focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience.

AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death.

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On November 14, 2022 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM: HCM, HKEX: 13) reported initial results from FRUTIGA, a Phase III study of fruquintinib combined with paclitaxel in 703 Chinese patients with advanced gastric or gastroesophageal junction ("GEJ") adenocarcinoma (Press release, HUTCHMED, NOV 14, 2022, View Source [SID1234623926]).

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The trial was positive, having met one of the primary endpoints of statistically significant improvement in progression-free survival ("PFS"), which is clinically meaningful. The other primary endpoint of overall survival ("OS") was not statistically significant per the pre-specified statistical plan, although there was an improvement in median OS. Fruquintinib also demonstrated a statistically significant improvement in secondary endpoints including objective response rate (ORR), disease control rate (DCR), and improved duration of response (DoR). The safety profile of fruquintinib in FRUTIGA was consistent with previously reported studies.

Full detailed results are subject to ongoing analysis and are expected to be disclosed at an upcoming scientific meeting. These results as well as further analyses will be shared with the China National Medical Products Administration ("NMPA").

"The combination of fruquintinib and paclitaxel demonstrated significant clinical benefits for these patients in controlling this disease. Our team will continue to analyze the data and discuss these findings with the NMPA for possible NDA filing," said Dr Weiguo Su, Chief Executive Officer and Chief Scientific Officer of HUTCHMED.

Professor Rui-Hua Xu, MD, President of the Sun Yat-Sen University Cancer Center, who served as the FRUTIGA lead principal investigator and Steering Committee Chairman, said: "By meeting the primary endpoint of PFS, fruquintinib demonstrated consistent efficacy and safety in gastric cancer indication in addition to its approved colorectal cancer indication. I am extremely excited that fruquintinib may provide a potential new oral treatment option for second line gastric cancer patients based on the FRUTIGA trial."

HUTCHMED retains all commercial rights to fruquintinib outside of China. In China, where fruquintinib is marketed under the brand name ELUNATE, HUTCHMED is partnered with Eli Lilly and Company. HUTCHMED is responsible for development and execution of all on-the-ground medical detailing, promotion and local and regional marketing. Fruquintinib is not approved for use outside of China.

About FRUTIGA and Gastric Cancer

The safety and efficacy of fruquintinib for the following investigational uses have not been established and there is no guarantee that it will receive health authority approval or become commercially available in any country for the uses being investigated:

The FRUTIGA study is a randomized, double-blind, Phase III study in China to evaluate fruquintinib combined with paclitaxel compared with paclitaxel monotherapy, for second-line treatment of advanced gastric cancer or GEJ adenocarcinoma. The trial enrolled patients who did not respond to first-line standard chemotherapy. Patients were randomized at a 1:1 ratio and stratified according to factors such as stomach vs. GEJ tumor type and performance status. Additional details about this study can be found at clinicaltrials.gov, using identifier NCT03223376.

Gastric cancer is the fourth leading cause of cancer death worldwide. Over one million new cases of gastric cancer and approximately 769,000 deaths were estimated in 2020 worldwide, with the highest incidence rates in several Eastern Asian countries. In 2020, there were 478,500 new gastric cancer cases and 331,600 deaths estimated in China.1 Due to late-onset symptoms, gastric cancer is often diagnosed at an advanced stage with poor prognosis and limited treatment options.

About Fruquintinib

Fruquintinib is a highly selective and potent oral inhibitor of VEGFR-1, -2 and -3. VEGFR inhibitors play a pivotal role in blocking tumor angiogenesis. Fruquintinib was designed to improve kinase selectivity to minimize off-target toxicities, improve tolerability and provide more consistent target coverage. The generally good tolerability in patients to date, along with fruquintinib’s low potential for drug-drug interaction based on preclinical assessment, suggests that it may also be highly suitable for combinations with other anti-cancer therapies.

About Fruquintinib Approval in China

Metastatic colorectal cancer ("CRC") in China: Fruquintinib was approved for marketing by the NMPA in September 2018 and commercially launched in China in November 2018 under the brand name ELUNATE. It has been included in the China National Reimbursement Drug List (NRDL) since January 2020. ELUNATE is indicated for the treatment of patients with metastatic CRC who have been previously treated with fluoropyrimidine, oxaliplatin and irinotecan, including those who have previously received anti-VEGF therapy and/or anti-EGFR therapy (RAS wild type). Results of the FRESCO study2, a Phase III pivotal registration trial of fruquintinib in 416 patients with metastatic CRC in China, were published in The Journal of the American Medical Association, JAMA, in June 2018 (NCT02314819).

About Other Fruquintinib Development

Metastatic CRC in the U.S., Europe, Japan and Australia: The FRESCO-2 study is a multi-regional clinical trial ("MRCT") conducted in the U.S., Europe, Japan and Australia that investigated fruquintinib plus best supportive care ("BSC") vs placebo plus BSC in patients with advanced, refractory metastatic CRC. The results were recently presented at the European Society for Medical Oncology Congress 2022. The MRCT FRESCO-2 study demonstrated that treatment with fruquintinib resulted in a statistically significant and clinically meaningful increase in the primary OS endpoint and key secondary PFS endpoint compared to treatment with placebo. The safety profile of fruquintinib in FRESCO-2 was consistent with previously reported fruquintinib studies. We plan to complete new drug application filings in the U.S., Europe and Japan in 2023 (NCT04322539). The U.S. FDA granted Fast Track Designation for the development of fruquintinib for the treatment of patients with metastatic CRC in June 2020.

Immunotherapy combinations: HUTCHMED has entered into collaboration agreements to evaluate the safety, tolerability and efficacy of fruquintinib in combination with PD-1 monoclonal antibodies, including with tislelizumab (developed by BeiGene, Ltd) and sintilimab (developed by Innovent Biologics, Inc.).

●Metastatic breast, endometrial, and colorectal cancers in the U.S.: HUTCHMED initiated this open-label, multi-center, non-randomized, Phase Ib/II study in the U.S. to investigate if the addition of fruquintinib can potentially induce activity to immune checkpoint inhibitor therapy in advanced, refractory triple negative breast cancer ("TNBC"), endometrial cancer, and CRC (NCT04577963). Safety and preliminary efficacy of fruquintinib as a single agent were demonstrated in advanced solid tumors, including TNBC, in a Phase I study conducted in China (NCT01645215) and a Phase I/Ib study is ongoing in the U.S. (NCT03251378).

●Gastric, colorectal and non-small cell lung cancers ("NSCLC") in China & Korea: BeiGene, Ltd. initiated this open-label, multi-center, Phase II study to assess the safety and efficacy of fruquintinib in combination with tislelizumab in patients with advanced or metastatic, unresectable gastric cancer, CRC or NSCLC (NCT04716634).

●Endometrial cancer and other solid tumors in China: HUTCHMED initiated this open-label, multi-center, non-randomized, Phase II study to assess the safety and efficacy of fruquintinib in combination with sintilimab in patients with advanced cervical cancer, endometrial cancer, gastric cancer, hepatocellular carcinoma (HCC), NSCLC or renal cell carcinoma (RCC). Preliminary results of certain cohorts were presented at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (ASCO) (Free ASCO Whitepaper) and the Chinese Society of Clinical Oncology Annual Meeting (CSCO). Following encouraging data in the advanced endometrial cancer cohort, it has been expanded into a single-arm registrational Phase II study of over 130 patients (NCT03903705).

On November 14, 2022 Vivoryon Therapeutics N.V. (Euronext Amsterdam: VVY; NL00150002Q7) (Vivoryon), a clinical stage company focused on the discovery and development of small molecule medicines to modulate the activity and stability of pathologically altered proteins, reported that it will publish its third quarter financial results for the period ended September 30, 2022, and provide a corporate update on Tuesday, November 22, 2022 (Press release, Vivoryon Therapeutics, NOV 14, 2022, View Source [SID1234623924]). The Company will host a conference call and webcast open to the public. The report will be available for download on the Company’s website (View Source).

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On November 14, 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 receptor system, reported financial results for its fiscal first quarter ended September 30, 2022 (Press release, Palatin Technologies, NOV 14, 2022, View Source [SID1234623923]).

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"Topline results from our Phase 3 pivotal study of PL9643 is currently expected in the second quarter calendar of 2023, and the interim analysis from the Phase 2 study of oral PL8177 is currently expected in the first calendar quarter of 2023, with topline data expected in the third calendar quarter of 2023," stated Carl Spana, Ph.D., President and CEO of Palatin. "We closed on a $10 million equity offering earlier this month, which strengthened our balance sheet, providing us an operating cash runway through calendar year 2023."

Dr. Spana further commented, "Vyleesi brand value metrics continue to reflect significant growth. In fact, prescription refills, which is a top indicator of patient satisfaction, exceeds 50% of total prescriptions dispensed. Furthermore, net product revenue increased 13% and prescriptions dispensed increased 17% over the last quarter."

Financial Highlights for the Fiscal First Quarter Ended September 30, 2022

The Company reported a net loss for the quarter ended September 30, 2022, of $8.3 million, or $(0.86) per common share, compared to a net loss of $7.1 million, or $(0.75) per common share, for the same period in 2021.
The Company had $21.2 million in cash and cash equivalents as of September 30, 2022, compared to $29.9 million as of June 30, 2022.
Vyleesi (bremelanotide injection) for the treatment of Hypoactive Sexual Desire Disorder (HSDD): Gross product sales to pharmacy distributors amounted to $2.3 million, while net product revenue increased 13% and prescriptions dispensed increased 17%, over the prior quarter.
Business Highlights and Recent Updates

Anti-Inflammatory / Autoimmune Programs
PL9643 melanocortin agonist for the treatment of dry eye disease (DED)
Positive interim analysis in ongoing pivotal Phase 3 clinical study in patients with DED.
The independent data monitoring committee (DMC) performed their assessment on the first 120 patients to complete the study and based on their recommendation, Palatin plans to enroll a total of 350 patients.
No safety concerns were identified by the DMC.
Topline data readout expected in the second quarter of calendar year 2023.
Additional trial information, including inclusion and exclusion criteria, can be found at View Source via the identifier NCT04268069.
PL8177 oral melanocortin agonist for the treatment of ulcerative colitis (UC):
Commenced patient enrollment in a Phase 2 oral formulation study of PL8177 in patients with UC.
Interim assessment is currently expected to occur in the first quarter of calendar year 2023.
Topline data readout is currently expected in the third quarter of calendar year 2023.
Additional trial information, including inclusion and exclusion criteria, can be found at View Source via the identifier NCT05466890.
Vyleesi (bremelanotide injection) / Hypoactive Sexual Desire Disorder (HSDD): Goal of the Vyleesi program is to demonstrate commercial product value in the marketplace with an objective of re-licensing the U.S. rights to a committed women’s healthcare company.
For the fiscal first quarter ended September 30, 2022:
Gross product sales were $2.3 million for the quarter ended September 30, 2022 and the prior quarter, increased 64% over the comparable quarter in 2021.
Net product revenue increased 13% over the prior quarter, increased 445% over the comparable quarter in 2021.
Total prescriptions dispensed increased 17% over the prior quarter, increased 108% 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:
Registered Direct Offering: On October 31, 2022, Palatin entered into a securities purchase agreement with a certain institutional investor, selling and issuing an aggregate of (i) 1,020,000 shares of Palatin common stock, $0.01 par value per share, (ii) prefunded warrants (the "Pre-Funded Warrants") to purchase up to 798,182 shares of Palatin common stock, and (iii) common warrants (the "Common Warrants") to purchase up to 1,818,182 shares of Palatin common stock. Each share of common stock was offered with one accompanying Common Warrant for a combined offering price of $5.50. Each Pre-Funded Warrant was offered with one accompanying Common Warrant for a combined offering price of $5.4999. The Offering was completed on November 2, 2022. The Common Warrants have an exercise price of $5.83 per share, are exercisable beginning six months after the date of issuance and will expire five and one-half years from the date of issuance. The Pre-Funded Warrants have an exercise price of $0.0001 per share, are exercisable upon issuance, and will expire when exercised in full.
Reverse Stock Split: The Board of Directors approved the implementation of a 1-for-25 reverse stock split effective as of 5:00 p.m. Eastern Time on August 30, 2022. The reverse stock split reduced the number of shares of Palatin’s common stock outstanding from approximately 231,774,000 shares to approximately 9,271,000 shares but did not change the authorized number of shares of Common Stock, which remain at 300,000,000 shares of Common Stock.
Fiscal First Quarter Ended September 30, 2022 Financial Results

All share and per share amounts are presented on a post-reverse-split basis, giving effect to the 1- for-25 reverse stock split.

Revenue
Total revenue consists of gross product sales of Vyleesi, net of allowances and accruals. Vyleesi gross product sales to pharmacy distributors for the quarter ended September 30, 2022, were $2.3 million, with net product revenue of $869,654, compared to gross product sales of $1.4 million, with net product revenue of $159,482, for the comparable quarter in 2021. Gross product sales increased 64% and net product revenue increased 445% over the comparable quarter in 2021.

Operating Expenses
Total operating expenses for the quarter ended September 30, 2022, were $9.6 million, compared to $7.4 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 and Phase 2 clinical trial of oral PL8177, offset by decreased commercial expenses related to Vyleesi.

Other Income / (Expenses)
Total other income, net, consist mainly of unrealized foreign currency transaction gains, of $418,376 for the quarter ended September 30, 2022, compared to $107,359 for the comparable quarter in 2021.

Cash Flows
Palatin’s net cash used in operations for the quarter ended September 30, 2022, was $8.6 million, compared to net cash used in operations of $6.4 million for the same period in 2021. The difference in net cash used in operations is mainly due to increased operating expenses in the quarter ended September 30, 2022.

Net Loss
Palatin’s net loss for the quarter ended September 30, 2022, was $8.3 million, or $(0.86) per basic and diluted common share, compared to a net loss of $7.1 million, or $(0.75) per basic and diluted common share for the same period in 2021.

The increase in net loss for the quarter ended September 30, 2022 over the quarter ended September 30, 2021, was mainly due to the increase in operating expenses offset by an increase in net product revenue of Vyleesi.

Cash Position
As of September 30, 2022, Palatin’s cash and cash equivalents were $21.2 million with $2.0 million of accounts receivable, compared to cash and cash equivalents of $29.9 million with $1.8 million of accounts receivable as of June 30, 2022.

The $21.1 million of cash and cash equivalents as of September 30, 2022, does not include $9.1 million of net proceeds from the Registered Direct Offering, which closed in November 2022, and the $15 Million Private Placement of Redeemable Convertible Preferred Stock. This $15 million is being held in an escrow account, pending the investors’ election to redeem the shares for cash or in notes, or convert the shares to common stock. Palatin currently expects an operating cash runway through calendar year 2023.

Conference Call / Webcast

Palatin will host a conference call and audio webcast on November 14, 2022, at 11:00 a.m. Eastern Time to discuss the results of operations in greater detail and provide an update on corporate developments. Individuals interested in listening to the conference call live can dial 1-866-580-3963 (US) or 1-786-697-3501 (International), conference ID 5980994#. 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 1-866-583-1035 (US) or +44 (0) 20 8196 1480 (International), passcode 5980994#. The webcast and telephone replay will be available through November 21, 2022.

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