On November 6, 2020 SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to potentially overcome and prevent difficult-to-treat and drug-resistant infections, reported financial results for the third quarter ended on September 30, 2020 and provided an update on recent clinical and corporate developments.

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"We submitted our NDA for ibrexafungerp for the treatment of vaginal yeast infections ahead of schedule and, with approval anticipated in mid-2021, we continue to progress towards our transition into a fully integrated commercial-stage antifungal company with an initial focus on women’s health," said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. "In parallel, we are also advancing clinical trials evaluating ibrexafungerp’s potential to treat invasive fungal infections in the hospital setting, with additional data read-outs expected in 2021."

Ibrexafungerp Update

SCYNEXIS recently announced the submission of its NDA to the U.S. Food and Drug Administration (FDA) for oral ibrexafungerp for the treatment of VVC, also known as vaginal yeast infection. The submission occurred in October and SCYNEXIS expects to receive FDA feedback on the acceptability of this submission in December. As a qualified infectious disease product (QIDP), ibrexafungerp is expected to receive a six-month priority review following NDA acceptance with a PDUFA date anticipated in mid-2021.

Enrollment is ongoing in the Phase 3 CANDLE study, investigating the efficacy and safety of oral ibrexafungerp for the prevention of recurrent VVC, for which there is no approved therapy in the U.S. 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.

Enrollment is ongoing in our refractory invasive fungal infections (rIFI) program, which comprises two open-label Phase 3 studies (FURI and CARES). Similar to the two interim analyses of previously reported data, SCYNEXIS intends to analyze the outcomes from the next cohort of patients that have completed their treatment course in both FURI and CARES studies and announce these findings when available.

Enrollment is ongoing in the Phase 2 SCYNERGIA study for patients with invasive aspergillosis evaluating oral ibrexafungerp in combination with voriconazole. Top-line data from this study are expected in the second half of 2021.

Pre-clinical activities are also ongoing towards the development of a liposomal intravenous formulation of ibrexafungerp.

Data presentations. In October 2020, SCYNEXIS presented ibrexafungerp data at two scientific conferences. The first was the Nurse Practitioners in Women’s Health (NPWH) held virtually on October 15-17, where SCYNEXIS showcased in vitro activity of ibrexafungerp against fluconazole-susceptible and -resistant Candida species, as well as data from the Phase 3 VANISH-303 trial in VVC. The second October conference was IDWeek 2020 held virtually on October 21-25. At this conference SCYNEXIS presented an interim analysis from its ongoing Phase 3 FURI trial in refractory infections and pre-clinical data highlighting the potential for ibrexafungerp use in invasive fungal infections. In August 2020, SCYNEXIS presented its full data set from the Phase 3 VANISH-303 VVC trial at the Infectious Diseases Society for Obstetrics and Gynecology (IDSOG). Some of the posters presented are available here.
Corporate Developments

On July 17, 2020, SCYNEXIS executed a 1-for-10 reverse split of its issued and outstanding common stock.
Third Quarter Financial Results

Cash and cash equivalents totaled $29.5 million as of September 30, 2020, compared to $48.4 million in cash, cash equivalents, and short-term investments at December 31, 2019.

Research and development expense for the three months ended September 30, 2020 decreased to $8.0 million from $9.3 million for the three months ended September 30, 2019. The decrease of $1.2 million, or 13%, for the three months ended September 30, 2020, was primarily driven by a decrease of $2.0 million in clinical development expense, and a decrease of $0.5 million in preclinical expense, offset in part by an increase in regulatory expense of $0.6 million, an increase of $0.3 million in chemistry, manufacturing, and controls (CMC) expense, and a net increase in other research and development expense of $0.4 million.

Selling, general and administrative expenses for the quarter ended September 30, 2020 increased to $3.5 million from $2.5 million for the quarter ended September 30, 2019. The increase of $1.0 million, or 40%, for the three months ended September 30, 2020 was primarily driven by a $0.8 million increase in professional fees and commercial related expenses recognized during the three months ended September 30, 2020.

Total other income was $12.4 million for the quarter ended September 30, 2020, compared to total other income of $3.8 million for the quarter ended September 30, 2019. During the quarter ended September 30, 2020 and 2019, SCYNEXIS recognized non-cash gains of $7.8 million and $1.8 million, respectively, on the fair value adjustment of the warrant liabilities and during the quarter ended September 30, 2020 and 2019, recognized non-cash gains of $5.3 million and $2.3 million on the fair value adjustment of the derivative liabilities, respectively.

Net income for the quarter ended September 30, 2020 was $0.9 million, or $0.09 per basic and ($0.28) per diluted share, compared to a net loss of $7.9 million, or ($1.43) per basic and ($1.45) per diluted share for the quarter ended September 30, 2019.

About Ibrexafungerp

Ibrexafungerp [pronounced eye-BREX-ah-FUN-jerp] is an investigational antifungal agent and the first representative of a novel class of structurally-distinct glucan synthase inhibitors, triterpenoids. This agent combines the well-established activity of glucan synthase inhibitors with the potential flexibility of having oral and intravenous (IV) formulations. Ibrexafungerp is currently 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 VVC, and has granted Orphan Drug Designation for the IC and IA indications. Ibrexafungerp is formerly known as SCY-078. (Press release, Scynexis, NOV 6, 2020, View Source [SID1234570270])

On November 6, 2020 FibroGen, Inc. (NASDAQ: FGEN) reported that Enrique Conterno, Chief Executive Officer, will participate in fireside chats at the following healthcare conferences (Press release, FibroGen, NOV 6, 2020, View Source [SID1234570269]):

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Stifel 2020 Virtual Healthcare Conference on Tuesday, November 17, 2020 at 1:20 PM Eastern Time
Jefferies Virtual London Healthcare Conference on Thursday, November 19, 2020 at 12:35 PM Eastern Time
A live audio webcast will be available on the "Events & Presentations" section of the FibroGen Investor webpage at View Source A replay will be available for approximately 30 days.

On November 6, 2020 Amyris, Inc. (Nasdaq: AMRS), a leading synthetic biotechnology company in Sustainable Health and Clean Beauty markets through its consumer brands and a top supplier of sustainably sourced natural ingredients, reported financial results for its third quarter ended September 30, 2020 (Press release, Amyris Biotechnologies, NOV 6, 2020, View Source [SID1234570237]).

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John Melo, President and Chief Executive Officer of Amyris said, "The third quarter of 2020 was another strong quarter for our company. Our ability to deliver record Product Revenue in these difficult and uncertain times is a testament to the resiliency of our team, the growing trend of consumers’ commitment to sustainable brands, our products, and the robustness of our business model."

Mr. Melo added, "During the quarter, we continued to execute across the strategic priorities we laid out in the beginning of the year. Our consumer business is growing at over three times 2019 revenue and delivered significantly expanded Gross Margin. We expect the combination of a strong fourth quarter along with the successful completion of strategic transactions to set us up for a profitable 2021."

Q3 2020 Financial Highlights

Sales Revenue: Product Revenue (Consumer & Ingredients) of $31 million was up 58% compared with the prior year quarter, with year-over-year revenue growth in Consumer (+203%) and Ingredients (+21%).
Cash operating expense of $43 million improved $5 million or 10% versus the prior year quarter, mostly due to lower G&A expense.
Adjusted EBITDA of -$33 million improved $10 million year-over-year due to strong revenue growth, improved gross margin and lower operating expense.
Interest expense of $7 million was down $10 million or 61% from Q3 2019 due to lower debt and an improved average interest rate.
Strategic Highlights

1. High growth consumer brands: above-market growth

Recent Progress:
Our wholly owned consumer brands delivered 220% growth on a year-to-date basis. Product Revenue demonstrated three consecutive quarters of >55% YoY growth.
Continued international growth of Biossance.
Upcoming milestone:
Pipette & fast-tracked to launch in China in November.
Biossance Entering China by year end
2. Scientific and commercial collaboration: fast time from lab to industrial scale

Recent Progress:
Executed agreement with the Infectious Disease Research Institute (IDRI) to accelerate development of a mRNA vaccine platform, starting with COVID-19 as first application.
Scaled commercial production of Cannabigerol (CBG), leveraging our fermentation process capability.
Upcoming milestone:
On track to deliver four molecules at scale, surpassing 2020 target of two to three.
Q4 Ingredients revenue to benefit from new products to market.
3. Supply chain optimization: enhanced product margins

Recent Progress:
Year-to-date gross margins improved versus 2019 driven by both Consumer and Ingredients. Consumer margins were 67% year-to-date, well within the 60-70% anticipated target range.
Cosmetics Ingredient Business delivered 49% adjusted EBITDA margin.
Upcoming milestone:
Construction of integrated Brazil ingredients plant on track for Q4 2021 commissioning.
4. Improved balance sheet, earnings and cash flow: financial foundation for success

Recent Progress:
Improved margin profile of consumer brands and ingredients portfolio.
Q3 cash operating expense improved 10%, mostly due to lower G&A.
Q3 interest expense was down 61%. Debt was reduced 41% since the start of 2020.
Q3 reported Total Revenue of $34 million included strong Product Revenue growth compared to the prior year quarter.
Q3 Product Revenue of $31 million increased $11 million or 58% compared with the prior year quarter, with year-over-year revenue growth in Consumer (+203%) and Ingredients (+21%). Q3 marks the third consecutive quarter of tripled year-over-year Consumer Revenue.
YTD Sales Revenue also saw strong growth from Product Revenue, partly offset by lower Collaboration Revenue.
Q3 2020 and Year-to-Date (YTD) Other Key Financials

Q3 Gross margin of 41% was supported by strong improvement in Product margins. Q3 Product gross margin of 35% grew $11 million versus the prior year quarter with a $9 million year-over-year improvement from Consumer and $2 million from Ingredients. YTD Gross margin also reflected a strong improvement in Product margins. Prior year gross margins were helped by higher Collaboration Revenue and a one-off Vitamin E transaction.
Q3 Cash Operating Expense of $43 million improved $5 million or 10% versus the prior year quarter. Improvements in G&A and R&D expense were partly redirected to marketing investments to support Consumer brand growth. T&E expense was down due to COVID-19. Sequential cash operating expense was flat despite continued topline growth. YTD cash operating expense of $130 million was down $6 million or 4%.
Q3 Adjusted EBITDA of -$33 million improved $10 million versus the prior year quarter due to strong revenue growth, improved gross margins and lower expense. YTD adjusted EBITDA of -$101 million improved from -$131 million in the prior year driven by gross margin growth and lower operating expense. Adjusted EBITDA excludes one-time impact from Vitamin E, Lavvan revenue and a one-off credit loss.
Interest Expense of $7 million was down $10 million or 61% from Q3 2019 due to lower debt and an improved average interest rate. Q3 2020 finished with debt of $175m, which compares to $241m at the end of the prior year quarter. YTD interest expense of $42 million improved by $3 million.
Q3 GAAP Net Income of -$23 million compared with -$60 million in 2019. The year-over-year and year-to-date comparisons are impacted by various non-cash adjustments related to fair value of derivatives and debt.
Diluted EPS of -$0.41 compared with -$0.56 for Q3 of 2019. YTD diluted EPS was -$1.46, which compared to -$2.11 for YTD 2019.
Despite strong financial performance in the third quarter, the extent to which the COVID-19 pandemic could affect Amyris’ future financial results and operations is subject to a high degree of uncertainty, and therefore the company is not providing formal guidance at this time.

FINANCIAL RESULTS AND NON-GAAP INFORMATION

To supplement our financial results and guidance presented on a GAAP basis, we use non-GAAP measures that we believe are helpful in understanding our results. These non-GAAP measures are among the factors management uses in planning and forecasting future periods. These non-GAAP financial measures also facilitate management’s internal comparisons to Amyris’s historical performance as well as comparisons to the operating results of other companies. Management believes these non-GAAP financial measures are useful to investors because they allow for greater transparency into the indicators used by management to understand, manage, and evaluate our business and make operating decisions. Our non-GAAP financial measures include the following:

Non-GAAP net income (loss) is calculated as GAAP net income/loss excluding stock-based compensation expense, gains or losses from change in fair value of debt, gains and losses from changes in the fair value of derivatives, losses on debt extinguishment, losses allocated to participating securities, deemed dividends to preferred stockholders, contract asset credit loss reserve, inventory lower of cost or net realizable value adjustments, loss from investment in affiliate and other income/expense.

Adjusted diluted EPS is calculated by dividing Non-GAAP net income (loss) by the weighted average shares, basic and diluted outstanding for the period.

Non-GAAP Gross Margin (Gross Margin) is calculated as GAAP revenues divided by GAAP cost of products sold excluding excess capacity, depreciation and amortization, other costs/provisions and inventory lower of cost or net realizable value adjustments.

Non-GAAP Cash Operating Expense is calculated as GAAP Operating Expense minus non-cash stock-based compensation, depreciation and amortization. In Q3 2020 it also excluded a one-off credit loss.

EBITDA is calculated as GAAP net loss less interest, expense, income tax expense, depreciation and amortization, deemed dividends to preferred stockholders and losses allocated to participating securities.

Adjusted EBITDA is calculated as EBITDA less stock-based compensation expense, gains or losses from change in fair value of debt, gains and losses from changes in the fair value of derivatives, losses on debt extinguishment, other income/expense, net, loss from investment in affiliate, contract asset credit loss reserve and inventory lower of cost or net realizable value adjustments.

Non-GAAP financial information is not prepared under a comprehensive set of accounting rules, and therefore, should only be read in conjunction with financial information reported under U.S. GAAP in order to understand Amyris’s operating performance. A reconciliation of the non-GAAP financial measures presented in this release to the most directly comparable GAAP financial measure, is provided in the tables attached to this press release.

Conference Call
Amyris will host its third quarter 2020 conference call today at 9:00 am ET (6:00 am PT) to discuss its financial results and provide an update on the company’s business. Those who wish to listen to the conference call should dial into (877) 870-4263 (U.S.) or (412)-317-0790 (international) and ask to be joined to the Amyris, Inc. call. A live webcast of the call will be available online on the Amyris website. To listen via live webcast, please visit: View Source

A replay of the webcast will be available on the Investor Relations section of the company’s website approximately two hours after the conclusion of the call. Additional information on Amyris’ third quarter 2020 results can also be found on the Company’s website.

On November 6, 2020 Ampio Pharmaceuticals (NYSE American: AMPE), a biopharmaceutical company focused on the advancement of immunology based therapies for prevalent inflammatory conditions, reported, at 4:30pm EST, will provide an update and overview of its clinical development pipeline / activities and its financial results for the third quarter ended September 30, 2020 (Press release, Ampio, NOV 6, 2020, View Source [SID1234570228]).

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Attending the webinar from Ampio will be, Mr. Michael Macaluso (President and CEO), Dr. David Bar-Or (Director and Founder), Ms. Laura Goldberg (Vice President) and Mr. Daniel Stokely (CFO). The key areas of focus will be as follows:

COVID-19 Platform / Pipeline Overview and Update

AP-014 (inhaled) and AP-016 (intravenous) clinical trial update
Possibility of obtaining an Emergency Use Authorization (EUA) from the FDA for inhaled Ampion
Discussion of the differences between Ampion vs. other therapeutic options for COVID-19
OAK Clinical Trial 2020 Timeline / Update

Ampio’s Osteoarthritis of the Knee (OAK) Phase III trial being conducted under a Special Protocol Assessment (SPA) with the FDA has been paused as a result of COVID-19
FDA released "FDA Guidance on Conduct of Clinical Trials of Medical Products during the COVID-19 Pandemic" in April 2020
FDA released "Statistical Considerations for Clinical Trials During the COVID-19 Public Health Emergency" in June 2020
Ampio harmonizes steps for OAK Phase III trial with the FDA guidance and submitted an SPA amendment to the FDA
Financial Update

As of September 30, 2020, Ampio had $9.4 million of cash and cash equivalents, as compared to cash and cash equivalents of $6.5 million as of December 31, 2019.

For the third quarter of 2020, research and development costs were $1.7 million, down 52% from $3.4 million for the same period in 2019. This decrease was primarily attributable to a decrease in clinical trial and sponsored research costs. Ampio expects clinical trial and sponsored research costs to increase during the fourth quarter of fiscal 2020 due to the AP-014 inhaled Ampion study.

Operations / manufacturing expenses increased $190,000 in the current quarter, when compared to the same period in 2019.

General and administrative costs decreased $98,000, or 5.6%, from $1.7 million for the same period in 2019.

Ampio reported a net loss for the third quarter of $3.4 million compared to a net loss of $7.2 million for the same period in 2019.

To access the webinar, please log in to View Source approximately 10 minutes prior to the start of the call. To ask a question, please dial in to 888-632-3385 (U.S.) or 785-424-1673 (International) and use the Participant Entry Code: 47668. Please note that you can also ask a question through the webinar platform.

A replay of this presentation will be available two hours after the end of the call by dialing 877-481-4010 (U.S.) or 919-882-2331 (International). Replay Passcode: 38512

On November 6, 2020 Eiger BioPharmaceuticals, Inc. (Nasdaq:EIGR), focused on the development and commercialization of targeted therapies for serious rare and ultra-rare diseases, reported financial results for third quarter 2020 and provided a business update (Press release, Eiger Biopharmaceuticals, NOV 6, 2020, View Source [SID1234570223]).

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Recent Highlights and Upcoming Milestones

ZokinvyTM (lonafarnib) in Progeria and Progeroid Laminopathies

New Drug Application (NDA) Prescription Drug User Fee Act (PDUFA) target action date November 20, 2020
Lonafarnib in Hepatitis Delta Virus (HDV)

Phase 3 D-LIVR study full enrollment expected in 2021
Peginterferon Lambda (Lambda) in HDV

Phase 2 LIFT (combo with lonafarnib) end-of-study data expected at AASLD 2020
Agreement with FDA and EMA on single, Phase 3 Lambda monotherapy study design
Peginterferon Lambda (Lambda) in COVID-19

Toronto General Hospital, University Health Network (N=60)
Mean baseline viral load: 6.7 log copies/mL
79% (Lambda) vs 38% (placebo) (p=0.013) clear virus by Day 7
> 6 log copies/mL correlates with the threshold for infectivity
Stanford University School of Medicine (N=120)
Mean baseline viral load: < 4 log copies/mL
Median time to cessation of viral shedding was 7 days in both groups
Results of both studies support Lambda activity in high baseline viral load patients
Lambda was well tolerated in both studies with few adverse events, which included minimal elevations of transaminases which self-resolved
Plan to meet with FDA to discuss data and next steps
Third Quarter 2020 Financial Results

Cash, cash equivalents, and short-term investments as of September 30, 2020 totaled $125.3 million.

The Company reported net loss of $15.7 million, or $0.52 per share, for third quarter 2020, as compared to $18.6 million, or $0.76 per share, for third quarter 2019.

Research and Development expenses were $9.8 million for third quarter 2020, as compared to $14.1 million for third quarter 2019. The decrease was primarily due to a decrease in clinical trial related expenses, including clinical trial material costs.

General and Administrative expenses were $5.0 million for third quarter 2020, as compared to $4.2 million for third quarter 2019. The increase was primarily due to an increase in outside consulting, advisory and accounting services and an increase in personnel-related expenses.

Total operating expenses include total non-cash expenses of $1.9 million for third quarter 2020, as compared to $1.8 million for the same period in 2019.

As of September 30, 2020, the Company had 31.9 million of common shares outstanding.