1stOncology™: Cancer Intelligence Service – Page 12234 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

SCYNEXIS and Aspire Capital Enter into $20 Million Common Stock Purchase Agreement

On April 13, 2020 SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, reported that it has entered into a Common Stock Purchase Agreement ("Purchase Agreement") of up to $20 million with Aspire Capital Fund, LLC ("Aspire Capital") (Press release, Scynexis, APR 13, 2020, View Source [SID1234556263]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

Schedule Your 30 min Free Demo!

Under the terms of the agreement, SCYNEXIS has the right to sell to Aspire Capital, from time to time and in its sole discretion, up to $20 million in shares of SCYNEXIS’s common stock over the next 30 months, subject to certain limits.

There are no warrants, options, financing swaps, derivatives or other securities associated with this Purchase Agreement. SCYNEXIS will control the timing and amount of sales of common stock to Aspire Capital, if any. There are no limitations on use of proceeds, financial or business covenants, restrictions on future financings, rights of first refusal, participation rights, penalties or liquidated damages in the Purchase Agreement. In addition, the Purchase Agreement may be terminated by SCYNEXIS at any time, at its discretion, without any cost to SCYNEXIS.

"We are excited to enter into this agreement with Aspire Capital, a well-established, healthcare-focused institutional investor. The deal provides us with significant flexibility to efficiently bolster our balance sheet and further support the advancement of ibrexafungerp’s clinical programs and commercialization preparedness," said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. "This agreement, coupled with our strong cash position entering 2020 and the $10 million in proceeds from our recent sale of convertible notes, positions us well as we look to achieve key milestones in 2020 and beyond."

"Ibrexafungerp is a promising novel antifungal with a recent series of positive clinical trial read-outs. Additionally, SCYNEXIS is on the cusp of an important catalyst with the pending release of top-line data from its second Phase 3 trial for the treatment of vaginal yeast infections," stated Steven G. Martin, managing member of Aspire Capital. "Aspire Capital is pleased to partner with SCYNEXIS at this transformational time for the company as it plans for NDA submission later this year and commercial launch in 2021."

As consideration for Aspire Capital’s obligation under the Purchase Agreement, SCYNEXIS issued 709,103 shares to Aspire Capital as a commitment fee. SCYNEXIS also entered into a registration rights agreement with Aspire Capital in connection with its entry into the Purchase Agreement. A complete and detailed description of the Purchase Agreement and the related registration rights agreement is set forth in SCYNEXIS’s Current Report on the Form 8-K filed today with the U.S. Securities and Exchange Commission (SEC).

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities nor will there be any sale of these securities in any state or other 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 other jurisdiction.

Seattle Genetics to Host Conference Call and Webcast Discussion of First Quarter 2020 Financial Results on April 30, 2020

On April 13, 2020 Seattle Genetics, Inc. (Nasdaq: SGEN) reported that it will report its first quarter 2020 financial results on Thursday, April 30, 2020 after the close of financial markets (Press release, Seattle Genetics, APR 13, 2020, View Source [SID1234556262]). Following the announcement, company management will host a conference call and webcast discussion of the results and provide a general corporate update. Access to the event can be obtained as follows:

LIVE access on Thursday, April 30, 2020
1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time

Telephone 888-220-8474 (domestic) or +1 720-452-9217 (international); conference ID 7835915
Webcast with slides available at www.seattlegenetics.com in the Investors section
REPLAY access

Telephone replay will be available beginning at approximately 4:30 p.m. PT on Thursday, April 30, 2020 through 5:00 p.m. PT on Sunday, May 3, 2020 by calling 888-203-1112 (domestic) or +1 719-457-0820 (international); conference ID 7835915
Webcast replay will be available on the Seattle Genetics website at www.seattlegenetics.com in the Investors section

IntegraGen Achieves CE Mark for Its MERCURY™ Cloud-based Software Tool Which Supports Molecular Tumor Profiling for Cancer Patients

On April 13, 2020 IntegraGen reported the company’s MERCURY cloud-based analytical software tool has achieved Conformité Européenne (CE) marking (Press release, Integragen, APR 13, 2020, View Source [SID1234556260]). This registration enhances the ability for IntegraGen sell MERCURY throughout the European Union (EU). MERCURY is utilized by researchers and clinicians to assist with the analysis of sequencing data derived from small and large gene sequencing panels as well as whole exome, RNA-Seq and whole genome sequencing.

CE-IVD marking of MERCURY indicates that it meets the provisions of the Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices. Click here to view MERCURY’s CE Declaration of Conformity certificate.

The cloud-based platform utilized by MERCURY also regularly undergoes independent veriﬁcation of security, privacy, and compliance controls, achieving certiﬁcations in line with global standards. Learn more about how IntegraGen ensures the security and privacy of genomic data.

FENNEC PHARMACEUTICALS ANNOUNCES FDA FILING ACCEPTANCE AND PRIORITY REVIEW OF NEW DRUG APPLICATION FOR PEDMARKTM

On April 13, 2020 Fennec Pharmaceuticals Inc. (Nasdaq: FENC; TSX: FRX), a specialty pharmaceutical company, reported that the U.S. Food and Drug Administration (FDA) has accepted for filing and granted Priority Review for the company’s New Drug Application (NDA) for PEDMARK (a unique formulation of sodium thiosulfate) (Press release, Fennec Pharmaceuticals, APR 13, 2020, View Source [SID1234556259]). PEDMARK is an investigational drug for the prevention of ototoxicity induced by cisplatin chemotherapy in patients one month to <18 years of age with localized, non-metastatic, solid tumors.

"The FDA filing acceptance of our NDA and granting of Priority Review represents a significant milestone in the development of PEDMARK and we look forward to working closely with the Agency during this review process," said Rosty Raykov, chief executive officer of Fennec.

The FDA grants Priority Review to applications for medicines that treat a serious condition, and, if approved, would demonstrate the potential to be a significant improvement in the safety or effectiveness of the treatment, diagnosis, or prevention of a serious condition. Priority Review designation shortens the review period from the standard ten months to six months from the submission of the NDA. The FDA set a Prescription Drug User Fee Act (PDUFA) target action date of August 10, 2020 for the completion of FDA’s review.

About PEDMARK

Cisplatin and other platinum compounds are essential chemotherapeutic agents for many pediatric malignancies. Unfortunately, platinum-based therapies cause ototoxicity, or hearing loss, which is permanent, irreversible and particularly harmful to the survivors of pediatric cancer.

In the U.S. and Europe, it is estimated that, annually, over 10,000 children may receive platinum-based chemotherapy. The incidence of ototoxicity depends upon the dose and duration of chemotherapy, and many of these children require lifelong hearing aids. There is currently no established preventive agent for this hearing loss and only expensive, technically difficult and sub-optimal cochlear (inner ear) implants have been shown to provide some benefit. Infants and young children that suffer ototoxicity at critical stages of development lack speech language development and literacy, and older children and adolescents lack social-emotional development and educational achievement.

PEDMARK has been studied by cooperative groups in two Phase 3 clinical studies of survival and reduction of ototoxicity, The Clinical Oncology Group Protocol ACCL0431 and SIOPEL 6. Both studies have been completed. The COG ACCL0431 protocol enrolled one of five childhood cancers typically treated with intensive cisplatin therapy for localized and disseminated disease, including newly diagnosed hepatoblastoma, germ cell tumor, osteosarcoma, neuroblastoma, and medulloblastoma. SIOPEL 6 enrolled only hepatoblastoma patients with localized tumors.

The FDA has accepted for filing the Company’s New Drug Application (NDA) for PEDMARK and has granted Priority Review. The Marketing Authorization Application (MAA) for sodium thiosulfate (tradename to be determined) is currently under evaluation by the European Medicines Agency (EMA). PEDMARK has received Breakthrough Therapy and Fast Track Designation by the FDA in March 2018.

Coherus BioSciences Provides First Quarter 2020 Financial Update and Fiscal Year 2020 COVID-19 Impact Insights

On April 13, 2020 Coherus BioSciences, Inc. ("Coherus" or "the Company", Nasdaq: CHRS), reported preliminary unaudited revenue for UDENYCA and net income for the quarter ended March 31, 2020 (Press release, Coherus Biosciences, APR 13, 2020, View Source [SID1234556258]). Coherus also provided an update on the impact of COVID-19 for first quarter 2020 as well as additional insights on COVID-19 impact for the balance of 2020.

First Quarter 2020 Financials and Update

The Company expects preliminary unaudited first quarter 2020 net product revenue to be between $115.0 million and $117.5 million, a 210% to 217% increase compared to the net product revenue of $37.1 million for the first quarter of 2019. Preliminary unaudited first quarter 2020 net income is expected to be between $33.5 million and $38.0 million, compared to a net loss of $(20.0) million for the first quarter of 2019. These financial results reflect a modest COVID-19 impact in March 2020.

First quarter 2020 showed good unit growth for the pegfilgrastim class with the last four weeks of March having 6% growth over the previous four weeks according to the IQVIA March 27, 2020 report. A 6% increase, year-over-year, for pegfilgrastim was also seen according to the report. Specifically, UDENYCA saw a 7% unit growth in the last four weeks ending March 27, 2020 over the previous four weeks as the COVID-19 crisis accelerated.

Second Quarter 2020 and Second Half 2020 Insights

There are reasons to expect that the adverse effects we are experiencing and expect to continue to experience from COVID-19 in the second quarter and second half of 2020 will be transient and most significant during the period that the COVID-19 pandemic is having its greatest impact on the medical system and personal behaviors. We expect that patients and physicians will balance the need for the administration of drugs, such as pegfilgrastim, which are indicated for curable cancer treatment or other serious diseases against the risks associated with COVID-19.

Patients who have already initiated chemotherapy, especially with curative intent, appear to be continuing on therapy, as any dose reduction or delay could have a significant impact on survival.

Coherus believes referrals and cancer diagnoses could recover as referring providers determine ways to navigate the new environment and previously delayed treatments are initiated.

"We think it’s important when projecting second quarter COVID-19 impact to look primarily at recent pegfilgrastim sales and demand data in the context of current customer feedback, and not to impute trends from other drugs such as antiemetics. Additionally, any preliminary usage trends for such drugs at an early stage of the Covid-19 crisis may not be good predictive models for overall pegfilgrastim use, or pegfilgrastim use during the second quarter of 2020," stated Chris Thompson, Senior Vice President, Sales at Coherus.

Declines in referrals and cancer diagnoses are potentially compensated for by revised National Comprehensive Cancer Network ("NCCN") treatment guidelines that recommend growth factor use in chemotherapy regimens where there is at least a 10% risk of febrile neutropenia. This new guidance expands the previous guidelines of a greater than 20% risk of febrile neutropenia, thereby potentially increasing overall usage of pegfilgrastim.