On May 17, 2021 Milestone Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines,reported financial results for the first quarter ended March 31, 2021 and provided a clinical, regulatory, and corporate update (Press release, Milestone Pharmaceuticals, MAY 17, 2021, View Source [SID1234580174]).

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"We continue to work closely with our existing clinical trial sites, as well as add new sites, to address the impact that the COVID-19 pandemic has had on patient enrollment in the pivotal Phase 3 RAPID trial of etripamil in patients with PSVT. While we are encouraged by recent improvements in enrollment rates, we now expect to report topline data from the RAPID trial in the second half of 2022," said Joseph Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals. "We are also pleased to announce that following FDA’s review of the etripamil program’s interim safety data, including that from the initial repeat dose experience from the RAPID trial, we will be adding the higher exposure, repeat dose regimen into the ongoing NODE-303 open-label safety study. We continue to believe etripamil has the potential to serve as an important new option for patients with PSVT, and we are committed to ensuring it is able to realize its full potential."

Mr. Oliveto added, "Earlier today, we were excited to announce that we have entered into an exclusive license agreement with Ji Xing Pharmaceuticals to develop and, if approved, commercialize the investigational drug etripamil for PSVT in greater China. This agreement strengthens both our balance sheet and our executional capabilities, and we look forward to working with the Ji Xing team to expand the potential reach of etripamil to patients in the greater China region."

Recent Updates

Announced Exclusive License Agreement with Ji Xing Pharmaceuticals to Develop and Commercialize Etripamil for PSVT in Greater China. Milestone reported that it has entered an exclusive license and collaboration agreement with Ji Xing Pharmaceuticals (Ji Xing), a biotechnology company headquartered in Shanghai and backed by RTW Investments, LP (RTW) focused on advancing innovative medicines in China, to develop and, if approved, commercialize the investigational drug etripamil in patients with paroxysmal supraventricular tachycardia (PSVT) and additional cardiovascular conditions in Greater China. Milestone will receive an upfront cash payment consisting of $15 million and a $5 million equity investment by RTW Investments. In addition, Milestone is eligible to receive up to $107.5 million in milestone payments and royalties on future sales of etripamil in Greater China. Milestone will supply etripamil and delivery devices to Ji Xing. Ji Xing will be responsible for development and commercialization costs in Greater China.
Company Expects to Report Topline Data from Pivotal Phase 3 RAPID Trial in 2H22. Enrollment remains ongoing in the pivotal Phase 3 RAPID trial of etripamil nasal spray in patients with PSVT. The ongoing COVID-19 pandemic has restricted access to many medical centers, reduced visits to physician offices, and caused patients to delay medical care. The Company continues to work diligently with investigators to identify potential site-specific solutions to mitigate these COVID-related delays, and has also increased the number of participating centers. Milestone now expects to report topline data in the second half of 2022. The Company believes its current cash resources, including the upfront payment from Ji Xing and proceeds from the equity investment from RTW, will be sufficient to support operations beyond the data readout into mid-2023.
The RAPID trial, which is targeting a total of 180 adjudicated paroxysmal supraventricular tachycardia (PSVT) events, is expected to randomize approximately 500 patients 1:1 to receive either etripamil nasal spray or placebo. As previously announced, to maximize the potential treatment effect of etripamil, patients will be directed to administer a second dose of study drug if they do not experience symptom relief within 10 minutes of the first study drug administration. The primary efficacy analysis for both the RAPID trial and the completed NODE-301 trial will be time to conversion of SVT over the first 30 minutes following initial study drug administration, with a target p-value of less than 0.05 for each trial. The RAPID and NODE-301 trials could potentially serve to fulfill the efficacy requirement for a future New Drug Application (NDA) for etripamil in patients with PSVT.
NODE-303 Open-Label Safety Study Amended to Include Repeat Dose of Etripamil. Following an interim safety data analysis of the RAPID study, the Company requested and the U.S. Food and Drug Administration (FDA) agreed to amend the ongoing NODE-303 study to allow a repeat dose of etripamil if symptoms persist for 10 minutes after the first dose. NODE-303 is a global open-label study which primarily evaluates the safety of etripamil when self-administered without medical supervision during single or multiple SVT episodes. Important secondary measures include efficacy, patient quality of life, and pharmacoeconomic assessments.
Data from NODE-301 Trial Featured During Oral Presentation at the American College of Cardiology 70th Annual Scientific Session and Expo (ACC.21). An oral presentation titled, "Etripamil Nasal Spray Relieves Symptoms And Reduces Emergency Room Interventions In Patients With Paroxysmal Supraventricular Tachycardia (PSVT): Analysis Of Clinical Outcomes In The NODE-301 Trial" (#403-13), was featured at the recent ACC.21 virtual meeting. The presentation was delivered by Bruce Stambler, MD, FHRS, Piedmont Heart Institute, Atlanta, GA, and investigator in the NODE-301 trial.
Enrollment Continues in ReVeRA Phase 2 Proof-of-Concept Trial Evaluating Etripamil in Patients with Atrial Fibrillation and Rapid Ventricular Rate (AFib-RVR). In March 2021, Milestone announced that the first patient was enrolled in ReVeRA, its Phase 2 proof-of-concept study of etripamil nasal spray in patients experiencing AFib-RVR. Patient enrollment is ongoing, with the trial expected to enroll approximately 50 patients randomized 1:1 to receive either 70 mg of etripamil nasal spray or placebo. The Phase 2 double blind, placebo controlled, proof-of-concept study is designed to assess the safety and efficacy of etripamil nasal spray to reduce ventricular rate in patients with AFib-RVR experiencing an episode of elevated heart rate requiring treatment. The trial will be conducted in Canada in collaboration with the Montreal Heart Institute and other research centers. The primary endpoint will assess reduction in ventricular rate, with key secondary endpoints including the time to achieve the maximum reduction in rate and duration of the effect.
First Quarter 2021 Financial Results

As of March 31, 2021, Milestone had cash, cash equivalents, and short-term investments of $129.9 million and 29.8 million common shares and 11.4 million common shares issuable upon exercise of pre-funded warrants outstanding.
Research and development expense for the first quarter of 2021 was $8.6 million compared with $11.9 million for the prior year period. The COVID-19 pandemic contributed to delays in new clinical site initiation and patient enrollment, which translated into lower than expected research and development spending in the quarter ended March 31, 2021.
General and administrative expense for the first quarter of 2021 was $2.6 million compared with $2.7 million for the prior year period.
Commercial expense for the first quarter of 2021 was $1.4 million compared with $2.2 million for the prior year period. The decrease of commercial expense in the quarter ended March 31, 2021 reflects efforts in reducing operating expenses affecting primarily pre-commercialization activities as Milestone focused its efforts on an optimized clinical development pathway for etripamil.
For the first quarter of 2021, operating loss was $12.6 million compared to $16.8 million for the prior year period.
About Paroxysmal Supraventricular Tachycardia

Paroxysmal supraventricular tachycardia (PSVT) is a rapid heart rate condition characterized by intermittent episodes of supraventricular tachycardia (SVT) that start and stop suddenly and without warning which affects approximately two million Americans. Episodes of SVT are often associated with symptoms including palpitations, sweating, chest pressure or pain, shortness of breath, sudden onset of fatigue, lightheadedness or dizziness, fainting, and anxiety. Certain calcium channel blockers have long been approved for the treatment of PSVT as well as other cardiac conditions. However, calcium channel blockers approved for the termination of SVT episodes must be administered intravenously under medical supervision, usually in an emergency department or other acute care setting.

About Atrial Fibrillation and Rapid Ventricular Rate

Atrial fibrillation (AFib) is a common arrhythmia marked by an irregular and often rapid heartbeat. AFib is estimated to affect five million patients in the United States, a prevalence projected by the Centers for Disease Control to increase to twelve million patients within the next 10 years. Atrial fibrillation and rapid ventricular rate (AFib-RVR) is a condition in which patients with AFib experience episodes of abnormally high heart rate, often with symptoms such as palpitations, shortness of breath, dizziness, and weakness. Oral calcium channel blockers and/or beta blockers are commonly used to manage heart rate in this condition. When episodes do occur, the corresponding symptoms often cause patients to seek care in the acute care setting such as the emergency department, where standard of care procedures include intravenous administration of calcium channel blockers or beta blockers under medical supervision. Milestone’s initial qualitative market research indicates approximately 40% of patients with AFib experience one or more symptomatic episodes of AFib-RVR per year that require treatment, suggesting a target addressable market for etripamil in patients with AFib of approximately two million patients.

About Etripamil

Etripamil, Milestone’s lead investigational product, is a novel calcium channel blocker designed to be a rapid-response therapy for episodic cardiovascular conditions. As a nasal spray that is self-administered by the patient, etripamil has the potential to shift the current treatment experience for many patients from the emergency department to the at-home setting. Milestone is conducting a comprehensive development program for etripamil, with Phase 3 trials ongoing in paroxysmal supraventricular tachycardia (PSVT) and now a Phase 2 proof-of-concept trial underway in patients with atrial fibrillation and rapid ventricular rate (AFib-RVR).

On May 17, 2021 Clovis Oncology, Inc. (NASDAQ:CLVS) reported that it has filed a prospectus supplement with the U.S. Securities and Exchange Commission ("SEC"), under which it may offer and sell, from time to time, shares of its common stock having an aggregate offering price of up to $75,000,000 million through an "at-the-market" equity offering program (the "ATM Program") (Press release, Clovis Oncology, MAY 17, 2021, View Source [SID1234580117]). The timing and amount of any sales will be determined by a variety of factors considered by Clovis Oncology.

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Shares of Clovis Oncology common stock will be offered through J.P. Morgan Securities LLC ("JPM") and BofA Securities, Inc. ("BofA Securities"), who are serving as the distribution agents. JPM and BofA Securities may sell the shares of our common stock by any method deemed to be an "at-the-market offering" defined by Rule 415(a)(4) of the Securities Act of 1933, as amended, including without limitation, sales in ordinary brokers’ transactions, including directly on the Nasdaq Global Select Market or into any other existing trading market for the shares, or to or through a market maker, in block transactions or by any other method permitted by law, including negotiated transactions and to JPM and BofA Securities as principals for their own account. Sales may be made at market prices prevailing at the time of a sale or at prices related to prevailing market prices or at negotiated prices. As a result, sales prices may vary.

Clovis Oncology intends to use the net proceeds from any sales of its common stock under the ATM Program for general corporate purposes, including funding of its development programs, sales and marketing expenses associated with Rubraca (rucaparib), repayment, repurchase or refinance of its debt obligations, payment of milestones pursuant to its license agreements, general and administrative expenses, acquisition or licensing of additional product candidates or businesses and working capital.

Clovis Oncology’s prospectus supplement filed today with the SEC supplements information contained in the accompanying prospectus contained in the shelf registration statement on Form S-3 (File No. 333-253485), as amended for the offering. Prospective investors should read the prospectus in that registration statement, the prospectus supplement and all other documents that Clovis Oncology has filed with the SEC for more complete information about Clovis Oncology, including information pertaining to the ATM Program and the risks associated with investing in Clovis Oncology. Copies of the prospectus supplement and related prospectus may be obtained from J. P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by email to [email protected], or from BofA Securities, NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte NC 28255-0001, Attn: Prospectus Department or by email to [email protected]. You may also obtain these documents free of charge when they are available by visiting EDGAR on the SEC’s website at www.sec.gov.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor will there be any sale of these securities, in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On May 17, 2021 Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, reported its recent accomplishments and financial results for the quarter ended March 31, 2021 (Press release, Soligenix, MAY 17, 2021, View Source,quarter%20ended%20March%2031%2C%202020. [SID1234580157]).

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"This year continues to be an exciting year of progress for Soligenix," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "We recently announced presentation of clinical data from our successful pivotal Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) clinical trial for HyBryte (SGX301) in the treatment of cutaneous T-cell lymphoma (CTCL) at both the American Academy of Dermatology, where HyBryte was designated "Top 12 late-breaking research," and the Society for Investigative Dermatology. We also received U.S. Food and Drug Administration (FDA) conditional acceptance of HyBryte as the proposed brand name for SGX301 (synthetic hypericin), as we continue to prepare for a new drug application (NDA) submission and U.S. commercialization for this novel first-in-class photodynamic therapy for treatment of early stage CTCL. Under our Public Health Solutions business segment, supported by non-dilutive government funding, we continue to advance multiple therapeutic and vaccine candidates. CiVax, our heat stable COVID-19 vaccine, recently demonstrated that the proprietary subunit protein antigen, locked into its receptor-binding configuration, was immunogenic in both mice and non-human primates, which is an important step in advancing CiVax towards human clinical trials."

Dr. Schaber continued, "With approximately $30 million in cash, not including our non-dilutive government funding, we anticipate having sufficient capital to achieve multiple inflection points as we advance our rare disease pipeline, including NDA filing and U.S. commercialization of HyBryte in CTCL, where we estimate peak U.S. annual net sales to exceed $90 million and the total U.S. revenues during the 10-year forecast period to be greater than $700 million."

Soligenix Recent Accomplishments

On May 10, 2021, the Company announced that HyBryte (hypericin) was awarded an "Innovation Passport" for the treatment of early stage CTCL in adults under the United Kingdom’s (UK’s) Innovative Licensing and Access Pathway (ILAP). To view this press release, please click here.
On April 28, 2021, the Company announced that its Senior Vice President and Chief Scientific Officer, Oreola Donini, PhD, delivered a presentation demonstrating the potency of the CiVax (COVID-19 vaccine) development program in mice and non-human primates (NHPs), at the Annual Conference on Vaccinology Research, held April 26-27, 2021. To view this press release, please click here.
On April 26, 2021, the Company announced that Ellen Kim, MD, Medical Director, Dermatology Clinic, Perelman Center for Advanced Medicine, Professor of Dermatology at the Hospital of the University of Pennsylvania, and the Lead Principal Investigator for the Phase 3 FLASH study, delivered a presentation at the American Academy of Dermatology Association Virtual Meeting Experience, held April 23-25, 2021, expanding on data related to the efficacy and safety of HyBryte in the treatment of CTCL. To view this press release, please click here.
On April 7, 2021, the Company announced that the FDA had conditionally accepted HyBryte as the proposed brand name for SGX301 (synthetic hypericin), the Company’s novel first-in-class photodynamic therapy for first-line treatment of early stage CTCL. To view this press release, please click here.
On March 30, 2021, the Company announced its recent accomplishments and financial results for the year ended December 31, 2020. To view this press release, please click here.
Financial Results – Quarter Ended March 31, 2021

Soligenix’s revenues for the quarter ended March 31, 2021 were $0.1 million as compared to $0.9 million for the quarter ended March 31, 2020. Revenues included payments on a contract in support of RiVax, our ricin toxin vaccine candidate, and grants received to support the development of: SGX943 for treatment of emerging and/or antibiotic-resistant infectious diseases; ThermoVax, our thermostabilization technology; and CiVax, our vaccine candidate for the prevention of COVID-19.

Soligenix’s basic net loss was $2.4 million, or ($0.06) per share, for the quarter ended March 31, 2021, as compared to $7.6 million, or ($0.32) per share, for the quarter ended March 31, 2020. This decrease in net loss was primarily due to a $5.0 million success milestone due to Hy Biopharma that was paid in common stock (based upon an effective per share price of $2.56) as a result of SGX301 demonstrating statistically significant treatment response in the pivotal Phase 3 clinical trial Inc. during the three months ended March 31, 2020.

Research and development expenses were $1.4 million as compared to $2.7 million for the quarters ended March 31, 2021 and 2020, respectively. The decrease in research and development spending for the quarter ended March 31, 2021 was primarily attributable to the reduction in expense due to the completion of the HyBryte and SGX942 clinical trials.

General and administrative expenses were $0.9 million for both the three months ended March 31, 2021 and 2020.

As of March 31, 2021, the Company’s cash position was approximately $30.5 million.

On May 17, 2021 Everest Medicines (HKEX 1952.HK), a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products in Greater China and other parts of Asia, reported that the China National Medical Products Administration (NMPA) has accepted for review its Biologics License Application for sacituzumab govitecan-hziy (SG), an investigational therapy for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease (Press release, Everest Medicines, MAY 17, 2021, View Source [SID1234580175]).

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"This aggressive and difficult-to-treat disease has historically had very limited treatment options, with overall survival remaining unchanged among patients for nearly two decades," said Yang Shi, Chief Medical Officer for Oncology at Everest Medicines. "The outstanding and robust efficacy and safety results from the global Phase 3 ASCENT study demonstrate SG is an important potential new treatment option for people in China with metastatic TNBC."

"We are excited to achieve this important milestone as we work to advance access to this first-of-its-kind therapy for patients with metastatic TNBC in China and the Asia Pacific region. The speed at which this milestone is achieved is a testament to our steadfast commitment to accelerating global pharmaceutical innovation in diseases with critical unmet needs," said Kerry Blanchard, MD, PhD, CEO of Everest Medicines.

Under the trade name Trodelvy, the U.S. Food and Drug Administration previously granted accelerated approval to SG in April 2020 and full approval in April 2021 for adult patients with unresectable locally advanced or metastatic TNBC who have received two or more prior systemic therapies, at least one of them for metastatic disease.

The Ministry of Food and Drug Safety in South Korea has also recently granted Fast Track Designation and Orphan Drug Designation to SG for the treatment of metastatic TNBC. In addition, Everest announced in January 2021 that it submitted a New Drug Application to the Health Sciences Authority of Singapore for SG for the treatment of patients with metastatic TNBC who have received at least two prior therapies for metastatic disease. That application is currently under review.

About Triple-Negative Breast Cancer

Triple-negative breast cancer (TNBC) is a highly aggressive disease and accounts for approximately 15% of all breast cancer types worldwide. The median age of breast cancer diagnoses tends to be younger in Asian than western countries, and the percentage of the TNBC molecular subtype has been increasing in the past 10 years. TNBC cells lack sufficient estrogen, progesterone or HER2 receptor expression to benefit from the use of hormonal or HER2-directed therapy. Overall survival among patients with this form of breast cancer has not changed in the past 20 years, which highlights the need for advances in therapeutic options for these patients.

About Sacituzumab Govitecan-hziy

Sacituzumab govitecan-hziy (SG) is a first-in-class antibody and topoisomerase inhibitor conjugate directed at TROP-2, a protein frequently expressed in multiple types of epithelial cancers. SG is approved in the United States under the trade name Trodelvy. The U.S. approval was supported by data from the Phase 3 ASCENT study, which demonstrated a statistically significant and clinically meaningful 57% reduction in the risk of disease worsening or death (progression-free survival or PFS), extending median PFS to 4.8 months from 1.7 months with chemotherapy (HR: 0.43; 95% CI: 0.35-0.54; p<0.0001). SG also extended median overall survival (OS) to 11.8 months vs. 6.9 months (HR: 0.51; 95% CI: 0.41-0.62; p<0.0001), representing a 49% reduction in the risk of death.

The most frequent Grade ≥3 adverse reactions for SG compared to single-agent chemotherapy in the study were neutropenia (52% vs. 34%), diarrhea (11% vs. 1%), leukopenia (11% vs. 6%) and anemia (9% vs. 6%). Adverse reactions leading to treatment discontinuation occurred in 5% of patients receiving SG. The Trodelvy U.S. Prescribing Information has a BOXED WARNING for severe or life-threatening neutropenia and severe diarrhea.

Under a licensing agreement with Gilead Sciences, Inc., Everest Medicines has exclusive rights to develop, register, and commercialize SG for all cancer indications in Greater China, South Korea, and certain Southeast Asian countries. In October 2020, SG was included in the updated 2020 China Guidelines for the Standardized Diagnosis and Treatment of Advanced Breast Cancer, compiled by the Breast Cancer Expert Committee of the National Cancer Control Center, the Breast Cancer Professional Committee of the Chinese Anti-Cancer Association, and the Cancer Drug Clinical Research Professional Committee of the Chinese Anti-Cancer Association.

On May 17, 2021 Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) reported that it is postponing its previously announced investor conference call scheduled to be held on Monday, May 17, 2021, at 2 p.m. Pacific Time (Press release, Adamis Pharmaceuticals, MAY 17, 2021, View Source [SID1234580214]). The company filed a Form 12b-25 with the Securities and Exchange Commission today in order to extend the due date of its Quarterly Report on Form 10-Q for the three months ended March 31, 2021, by five calendar days as permitted by Rule 12b-25 under the Securities Exchange Act of 1934, and is postponing the investor call in light of that filing delay. The company will announce a new date and time for a rescheduled investor call.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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