On May 11, 2020 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 quarter ended on March 31, 2020 and provided an update on recent clinical and corporate developments (Press release, Scynexis, MAY 11, 2020, View Source [SID1234557524]).

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!

"The past several months have seen major accomplishments by SCYNEXIS, as we continued to generate positive clinical data from both our vaginal yeast infection and hospital-based programs, while also enhancing both our current cash position and our financial flexibility going forward," said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. "With the successful completion of our Phase 3 VANISH program, we remain on track to submit an NDA for ibrexafungerp as a treatment for vaginal yeast infections in the second half of this year, as we continue SCYNEXIS’s transition to a fully-integrated research and commercial entity. If approved, ibrexafungerp could represent the first new class of antifungals in over 20 years – a particularly significant achievement at a time when the need for novel anti-infectives has become devastatingly clear."

Ibrexafungerp Update

Completed the Phase 3 VANISH program with announcement of positive top-line results for the VANISH-306 study investigating the safety and efficacy of oral ibrexafungerp as a treatment for women with VVC (vaginal yeast infections). In the VANISH-306 study, ibrexafungerp achieved superiority over placebo with high statistical significance (p≤0.01) for the key endpoints required to support the New Drug Application (NDA) filing for this indication. The VANISH-306 study results were consistent with the prior positive efficacy findings observed in the VANISH-303 and the Phase 2b DOVE studies. Additionally, ibrexafungerp had a favorable tolerability profile throughout its Phase 3 program in VVC.

Enrollment is ongoing in the Phase 3 CANDLE study, investigating the safety and efficacy of oral ibrexafungerp for the prevention of recurrent VVC, for which there is no approved therapies in the U.S.. Pending successful completion of this trial, SCYNEXIS anticipates top-line results and the submission of a supplemental NDA for this indication in the second half of 2021.

Announced positive results from the second interim analysis of the ongoing Phase 3 open-label FURI study, evaluating oral ibrexafungerp as a salvage treatment in patients with difficult-to-treat mucocutaneous and invasive fungal infections. In the 41 patients analyzed to date, oral ibrexafungerp showed clinical benefits in 83% of patients, with 56% of patients achieving a complete or partial response and 27% a stable disease response. Of the 41 treated patients, only six did not respond to ibrexafungerp treatment and one patient was considered indeterminate. The protocol was amended to include a larger group of patients with diverse complex fungal infections and to extend the treatment duration beyond 90 days.

Enrollment is ongoing in the Phase 2 SCYNERGIA study for patients with invasive aspergillosis and activities are also ongoing in the development of a liposomal intravenous formulation for ibrexafungerp.

Data presentations. SCYNEXIS continues to educate the scientific community about ibrexafungerp’s clinical potential against a number of pathogens. In February 2020, SCYNEXIS presented in vitro data of ibrexafungerp that showed synergistic activity against Aspergillus isolates from lung transplant recipients at the Advances Against Aspergillosis and Mucormycosis Conference. SCYNEXIS also presented on the Candida auris landscape at the Superbugs and Superdrugs conference in March. Finally, in May 2020, SCYNEXIS announced the publication of six abstracts highlighting the potential clinical utility of ibrexafungerp in the 30th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) abstract book, now available online.
Corporate Developments Subsequent to March 31, 2020

On April 9, 2020, SCYNEXIS entered into a Senior Convertible Note Purchase Agreement with Puissance Life Science Opportunities Fund VI and issued and sold to Puissance $10 million of 6.0% Senior Convertible Notes due 2026.

On April 10, 2020, SCYNEXIS entered into a Common Stock Purchase Agreement with Aspire Capital Fund, LLC, pursuant to which it may sell to Aspire Capital up to $20.0 million in shares of its common stock over the next 30 months.

In April 2020, SCYNEXIS received a cash receipt of $3.1 million from the sale of a portion of its unused Net Operating Losses (NOLs) and R&D credits.
First Quarter Financial Results

Cash, cash equivalents and short-term investments totaled $34.5 million as of March 31, 2020, compared to $48.4 million in cash, cash equivalents, and short-term investments at December 31, 2019.

Research and development expenses for the quarter ended March 31, 2020 increased to $9.9 million from $9.7 million for the quarter ended March 31, 2019. The increase of $0.2 million, or 2%, was primarily driven by an increase of $2.1 million in clinical development costs, an increase of $1.6 million in chemistry, manufacturing, and controls (CMC) costs, and a net increase in other research and development expenses of $0.5 million, mostly offset by a milestone payment made to Merck during the three months ended March 31, 2019.

Selling, general and administrative expenses for the quarter ended March 31, 2020 increased to $2.6 million from $2.2 million for the quarter ended March 31, 2019. The increase of $0.4 million, or 17%, was primarily driven by a $0.3 million increase in professional fees and commercial related expenses.

Total other income increased to $5.5 million for the quarter ended March 31, 2020, compared to total other expense of $11.0 million for the quarter ended March 31, 2019. The increase in other income is primarily attributable to a $4.8 million non-cash gain recorded on the fair value adjustment of the warrant liabilities during the quarter ended March 31, 2020 in comparison to $6.5 million and $3.4 million non-cash losses recognized during the quarter ended March 31, 2019 on the fair value adjustments of the warrants liabilities and derivative liability, respectively.

Net loss for the quarter ended March 31, 2020 was $7.0 million, or ($0.07) net loss per basic and diluted share, compared to a net loss of $22.9 million, or ($0.46) net loss per basic and diluted share, for the quarter ended March 31, 2019.

COVID-19 Update

COVID-19, a novel strain of coronavirus, was first identified in December 2019, and subsequently declared a global pandemic by the World Health Organization on March 11, 2020. SCYNEXIS has been monitoring the COVID-19 pandemic closely and has not identified any significant adverse impacts of COVID-19 to SCYNEXIS’s operations or estimated timelines for the development efforts of ibrexafungerp, including the expected NDA submission for the treatment of vaginal yeast infection in the second half of 2020. The ultimate impact of the COVID-19 health pandemic is highly uncertain and subject to change and SCYNEXIS will continue to monitor the COVID-19 situation closely.

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, the ‘fungerps’. This agent combines the well-established activity of glucan synthase inhibitors with the potential flexibility of having oral and IV formulations. Ibrexafungerp is currently in development for the treatment of fungal infections caused primarily by Candida (including C. auris) and Aspergillus species. 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 granted Qualified Infectious Disease Product (QIDP) and Fast Track designations for the formulations of ibrexafungerp for the indications of invasive candidiasis (IC) (including candidemia), invasive aspergillosis (IA) and vulvovaginal candidiasis (VVC) and has granted Orphan Drug Designation for the IC and IA indications. Ibrexafungerp is formerly known as SCY-078.

On May 11, 2020 TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted cancer therapeutics and utilizing a cost efficient, CRO-independent product development platform to partner with ex-U.S. companies to develop and commercialize innovative products in the U.S., reported the successful completion of a Type B pre-IND meeting with the U.S. Food and Drug Administration (FDA) (Press release, Tracon Pharmaceuticals, MAY 11, 2020, View Source [SID1234557523]). The FDA agreed with TRACON’s proposals regarding key elements of the pivotal ENVASARC trial for envafolimab in the soft tissue sarcoma subtypes of undifferentiated pleomorphic sarcoma (UPS) and myxofibrosarcoma (MFS). TRACON expects to initiate enrollment in the ENVASARC trial in the second half of 2020.

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!

"We appreciate the valuable discussions and guidance from our Type B meeting discussion with the FDA and concurrence on the design for the pivotal trials of envafolimab in sarcoma," said Charles Theuer, M.D., Ph.D., President and CEO. "Following the successful completion of the regulatory meeting, we are focused on advancing envafolimab as a single agent and in combination with Yervoy (ipilimumab) for the treatment of the sarcoma subtypes of UPS and MFS, both of which have been shown to be responsive to immune checkpoint inhibition treatment. We look forward to initiating ENVASARC later this year."

Type B Meeting and ENVASARC Study Design

The FDA determined the acceptability of the following key aspects of the proposed pivotal trial:

Multi-center, open-label, randomized, non-comparative, parallel cohort study.
Planned total enrollment of 160 patients, with 80 patients enrolled into cohort A of treatment with single agent envafolimab and 80 patients enrolled in cohort B with envafolimab and Yervoy.
Primary endpoint of objective response rate (ORR) with duration of response a key secondary endpoint.
Open-label format with blinded independent central review of endpoint data.
Eligible patients will have received one prior cancer therapy, but no prior checkpoint inhibitor therapy.
About Envafolimab

Envafolimab is a novel, single-domain antibody against PD-L1 that is administered by subcutaneous injection without the need for an adjuvant. Envafolimab is currently dosing in Phase 1 trials in the U.S. and Japan and is being studied in China in a Phase 2 registration trial as a single agent in MSI-H tumor patients, and in a Phase 3 registration trial in combination with gemcitabine and oxaliplatin in biliary tract cancer. Subject to positive data from the MSI-H registrational trial, 3D Medicines, TRACON’s corporate partner for this program, plans to file a BLA in China for envafolimab in 2020 based on ORR in MSI-H patients. The filing would be based on the principle that the response rate required for approval in China is similar to the response rate seen with Keytruda and Opdivo in MSI-H patients from separate clinical trials per their U.S. product package inserts.

On May 11, 2020 BioSpecifics Technologies Corp. (NASDAQ: BSTC), a biopharmaceutical company that originated and continues to develop collagenase-based therapies with a first-in-class collagenase-based product marketed as XIAFLEX in North America, reported its financial results for the first quarter ended March 31, 2020 (Press release, BioSpecifics Technologies, MAY 11, 2020, View Source [SID1234557521]).

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!

"Our royalty revenue from XIALFLEX was up 19% over last year, and while XIAFLEX had a strong first quarter of 2020, we expect to start to see an impact from COVID-19 in the second quarter due to office closures and patients not electing to be treated. While we don’t yet know the far reaching implications of this pandemic, the focus remains on patients and how they can best be served by XIAFLEX and the future potential of the CCH development pipeline," said Joseph Truitt, Chief Executive Officer of BioSpecifics. "In my new role as CEO, I am very confident in the deep value of the company and the many growth opportunities and I look forward to building an even greater future for BioSpecifics."

First Quarter 2020 Financial Results
BioSpecifics reported net income of $4.5 million for the first quarter ended March 31, 2020, or $0.61 per basic share and $0.61 per share on a fully diluted basis, compared to net income of $4.4 million, or $0.61 per basic share and $0.60 per share on a fully diluted basis, for the same period in 2019.

Total revenue for the first quarter ended March 31, 2020 was $9.7 million, compared to $8.1 million for the same period in 2019. The increase in total revenues for the quarterly period was primarily due to increased royalties from sales of both Peyronie’s disease and Dupuytren’s contracture.

Research and development expenses for the first quarter ended March 31, 2020 were $0.1 million compared to $0.1 million for the same period in 2019.

General and administrative expenses for the first quarter ended March 31, 2020 were $3.2 million, compared to $2.9 million for the same period in 2019.

Restructuring charges related to the relocation of the Company’s headquarters and the separation of certain employees were $1.1 million for the first quarter ended March 31, 2020.

Provision for income taxes for the first quarter ended March 31, 2020 were $1.2 million, compared to $1.1 million for the same period in 2019.

As of March 31, 2020, BioSpecifics had cash and cash equivalents and investments of $113.6 million, compared to $105.8 million as of December 31, 2019.

As of March 31, 2020, BioSpecifics had 7,337,511 shares of common stock outstanding.

Collagenase Clostridium Histolyticum (CCH) Commercial & Pipeline Highlights

BioSpecifics’ royalty revenues from the XIAFLEX commercial franchise grew by 19% year-over-year: XIAFLEX royalty revenue growth was attributable to royalties associated with higher net sales of XIAFLEX by BioSpecifics’ partner Endo International plc (Endo), for Dupuytren’s contracture and Peyronie’s disease.
Endo’s Biologics License Application (BLA) filing for CCH for the treatment of cellulite under U.S. Food and Drug Administration (FDA) review : The Prescription Drug User Fee Act (PDUFA) date for CCH for the treatment of cellulite is July 6, 2020. Endo’s anticipated commercial launch has been delayed in connection with the impacts of COVID-19, and is now expected to occur in the first quarter of 2021.
Initiation of CCH studies for plantar fibromatosis and adhesive capsulitis in second half of 2020: Endo expects to initiate clinical trials in adhesive capsulitis and plantar fibromatosis in the second half of 2020. Adhesive capsulitis, also known as frozen shoulder, is an inflammation and thickening of the shoulder capsule due to collagen which causes decreased motion in the shoulder. Plantar fibromatosis is a non-malignant thickening of the feet’s deep connective tissue or fascia. There are currently no FDA-approved pharmaceutical therapies available to treat either condition.
Recent Corporate Highlights

Joseph Truitt appointed Chief Executive Officer: Today, BioSpecifics announced the appointment of Joseph Truitt as Chief Executive Officer. Mr. Truitt has a strong track record of clinical, commercial and operational leadership. Mr. Truitt had served as the Company’s interim Chief Executive Officer since April 6, 2020.
Strengthened the Board of Directors with new independent directors Mike Sherman and Corey Fishman: In April 2020, BioSpecifics announced the appointments of Mike Sherman and Corey Fishman to the Board of Directors. Mr. Sherman serves on the Audit Committee and as financial expert, and also on the Strategy Committee and Corey serves on the Audit Committee and as Chair of the Strategy Committee. Mr. Sherman is currently Chief Executive Officer of Chimerix, Inc. Mr. Fishman has served as Chief Executive Officer and Director of Iterum Therapeutics plc, since he founded the company in 2015.
Anticipated Impact of COVID-19

XIAFLEX revenues are expected to decline in the second quarter of 2020 due to significant office closures and less office visits for physician-administered products.
Endo expects to see a gradual increase in demand beginning in the second half of 2020.
Full year 2020 XIAFLEX revenues are expected to be lower than full year revenues in 2019.
The Company’s partner, Endo, has withdrawn its financial guidance for 2020.
Endo’s anticipated commercial launch for CCH for cellulite, pending FDA approval, is now expected in the first quarter of 2021. This delay decision was made in connection with the anticipated impact of COVID-19 on medical aesthetics physician office closures and decreased consumer spending.
Endo currently anticipates modest delays in patient recruitment and site selection for new clinical trials and ongoing studies.

On May 11, 2020 BioSpecifics Technologies Corp. (NASDAQ: BSTC), a biopharmaceutical company that originated and continues to develop collagenase-based therapies with a first-in-class collagenase-based product marketed as XIAFLEX in North America, reported the appointment of Joseph Truitt as Chief Executive Officer (Press release, BioSpecifics Technologies, MAY 11, 2020, View Source [SID1234557520]). Mr. Truitt was appointed interim Chief Executive Officer by the Company’s Board of Directors on April 6, 2020 and assumed this permanent role on May 7, 2020.

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!

"Joe is a high performing, experienced biopharma executive with an exceptional track record of building successful organizations. Joe’s appointment as Chief Executive Officer comes at a crucial inflection point in the Company’s evolution, as we have set forth a clear, twofold value creation strategy for maximizing the CCH portfolio of commercial and clinical assets and as we begin to take well-considered steps toward identifying external strategic opportunities," said Jennifer Chao, Chairman of the Board of Directors. "Joe has made important contributions over the last month and we look forward to the strong leadership he will bring to BioSpecifics."

Prior to joining BioSpecifics, Mr. Truitt was most recently Chief Executive Officer of Achillion Pharmaceuticals, Inc. He joined the company in 2009 and had previous roles of Chief Operations Officer and Chief Commercial Officer. Under his leadership, Achillion was acquired by Alexion Pharmaceuticals, Inc. for $1.2 billion.

"Over the last month, I have become even more confident in the deep value of the Company and the many growth opportunities, which were what originally drew me to the Company. I look forward to building an even greater future for BioSpecifics and improving many more patients’ lives," said Joseph Truitt, Chief Executive Officer of BioSpecifics.

On May 11, 2020 Heat Biologics, Inc. ("Heat") (NASDAQ:HTBX), a clinical-stage biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, including multiple oncology product candidates and a novel coronavirus COVID-19 vaccine, reported an update on its Phase 2 trial of its T-cell activating HS-110, in combination with Opdivo (nivolumab) in advanced non-small cell lung cancer (NSCLC) (Press release, Heat Biologics, MAY 11, 2020, View Source [SID1234557519]).

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!

Recent highlights:

American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) poster presentation on "Tumor antigen expression and survival of patients with previously treated advanced non-small cell lung cancer (NSCLC) receiving viagenpumatucel-L (HS-110) plus nivolumab" on May 29th presenting latest survival data of HS-110 in combination with nivolumab in previously treated, immunotherapy naïve patients with advanced non-small cell lung cancer (NSCLC)
Established partnership for biomarker development with Earle A. Chiles Research Institute of the Providence Cancer Institute in Portland, Oregon
Plan to initiate Type B end of Phase 2 meeting with the FDA to discuss registration strategy
Jeff Wolf, Chief Executive Officer of Heat, commented, "We continue to make good progress on our clinical-stage portfolio, as well as our COVID-19 vaccine platform, and look forward to presenting additional HS-110 data on May 29 at ASCO (Free ASCO Whitepaper). Additionally, we are excited to proceed with our partnership for biomarker development with the Providence Cancer Institute to find a tissue-based marker that will help predict patient treatment response with HS-110 and nivolumab. Finally, we are in the process of preparing a data package for an End of Phase 2 Meeting (EOP2) with the FDA. This meeting will represent an important milestone in finalizing our registrational strategy for HS-110. We are highly encouraged by the data thus far and look forward to providing the latest study results at ASCO (Free ASCO Whitepaper)."