On August 10, 2021 Beyond Air, Inc. (NASDAQ: XAIR), a clinical-stage medical device and biopharmaceutical company focused on developing inhaled nitric oxide (NO) for the treatment of patients with respiratory conditions, including serious lung infections and pulmonary hypertension, and gaseous NO (gNO) for the treatment of solid tumors, reported financial results for its first fiscal quarter ended June 30, 2021 (Press release, Beyond Air, AUG 10, 2021, View Source [SID1234586344]).

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"Our commercial team is ready to introduce the LungFit PH system to hospitals across the United States, with FDA approval anticipated to be received at the end of next month. I am confident in our ability to successfully bring to market what will be the first-ever FDA approved generator and delivery system that produces NO from ambient air. LungFit PH is designed to offer a simple, safe, cost effective and convenient alternative to the NO delivery systems that are currently available to treat PPHN," said Steve Lisi, Chairman and Chief Executive Officer of Beyond Air. "We are making progress in our other programs and anticipate reporting interim data from our at-home NTM pilot study using LungFit GO in the fall. Our LungFit PRO acute viral pneumonia study in adults, which includes COVID-19 patients, remains open and we expect to discuss our progress with FDA this fall in order to plan next steps. We also expect to receive regulatory clearance to start human studies in our solid tumor program using ultra-high concentration gNO around the end of calendar year 2021 and begin enrolling patients in early 2022."

Duncan Fatkin, Chief Commercial Officer of Beyond Air, stated, "Our initial commercial launch team is in place with experienced leaders to head our sales and marketing efforts in the US, and our partnership efforts internationally. We established our supply chain well in advance and are now in the process of finalizing our marketing plan. As we get closer to the anticipated approval date, we are increasingly excited to fulfill Beyond Air’s vision of harnessing the power of nitric oxide to transform the lives of patients."

Recent Highlights and Upcoming Milestones

• LungFit PH

FDA review of the PMA to treat PPHN is ongoing
Commercial launch in the United States planned for the fourth quarter of calendar year 2021
Expect to secure CE Mark in the European Union around the end of calendar year 2021; followed by ex-U.S. commercial partnership in 2022
• LungFit PRO
Acute Viral Pneumonia Data

Initiated a pilot study for acute viral pneumonia in adults, including COVID-19 patients, in Israel using LungFit PRO at 150 ppm NO; patient enrollment began in November 2020 and is ongoing
Upcoming Study (pending discussions with FDA in Fall 2021)

Plan on initiating a pivotal trial for patients hospitalized with viral lung infections, either for acute viral pneumonia or bronchiolitis, in the fourth quarter of calendar year 2022
• LungFit GO

Initiated an at-home pilot study in Australia using LungFit GO for self-administration of up to 250 ppm NO for the treatment of refractory NTM lung disease in adult patients
Expect to report interim data for the at-home NTM lung infection pilot study at a medical or scientific conference in Fall 2021 with the trial completing in the first half of calendar year 2022
• Solid Tumor Program

Anticipate receiving regulatory clearance to initiate human studies around the end of calendar year 2021
Anticipate beginning the enrollment of patients in the first quarter of calendar year 2022
Financial results for the fiscal quarter ended June 30, 2021

Revenue for the fiscal quarter ended June 30, 2021 was $0 as compared to $229,000 for the fiscal quarter ended June 30, 2020, all of which was licensing revenue.

Research and development expenses for the fiscal quarter ended June 30, 2021 were $2.7 million, compared to $4.3 million for the fiscal quarter ended June 30, 2020.

General and administrative expenses for the fiscal quarter ended June 30, 2021 were $3.9 million, compared to $2.5 million for the fiscal quarter ended June 30, 2020.

For the fiscal quarter ended June 30, 2021, the Company had a net loss of $6.7 million, or ($0.31) per share, compared to a net loss of $6.7 million, or ($0.41) per share for the fiscal quarter ended June 30, 2020.

As of June 30, 2021, the Company had cash, cash equivalents and restricted cash of $39.6 million.

On August 10, 2021 Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, reported financial results for the three- and six-months ending June 30, 2021 and provided a corporate update (Press release, Altimmune, AUG 10, 2021, View Source [SID1234586343]).

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"Following data readouts in Q2, Altimmune has focused its efforts on our NASH and emerging obesity pipeline with the encouraging interim data from the ALT-801 Phase 1 trial reinforcing the potential of these programs," remarked Vipin K. Garg, Ph.D., President and Chief Executive Officer at Altimmune. "Our strong financial position enables us to proceed with a robust ALT-801 development program in the second half of 2021 with the goal of initiating Phase 2 trials in early 2022 for both obesity and NASH indications."

Recent Highlights:

Reported encouraging 6-week interim data from the ongoing Phase 1 clinical trial of ALT-801 in Australia

In the study of overweight and obese subjects, a placebo-adjusted weight loss of 6.3% was achieved at 6 weeks of treatment with 1.8 mg once weekly dose, surpassing the 2% pre-established treatment target
The multi-dose regimen was well-tolerated without the need for dose titration
No subject dropouts related to drug administration reported within the first 6 weeks of treatment

Advancing to ALT-801 12-week data readout on three cohorts, expected in September 2021

12-week data on three dose cohorts at the 1.2mg, 1.8mg and 2.4mg dose levels are expected to be reported. The final 12-week dose for all cohorts has been administered
Data readouts are expected to include update on weight loss and adverse events, in addition to the following measures:
Pharmacokinetics (PK)
Lean body mass, calorie intake, resting energy expenditure (REE)
Glucose homeostasis
Insulin resistance—HOMA-IR2, adiponectin
Lipids (HDL, LDL, TG, & lipoprotein (a))
Markers of inflammation
Filing of ALT-801 investigational new drug (IND) application for non-alcoholic steatohepatitis (NASH) on track for Q3 2021, which will be followed by the initiation of a clinical trial in non-alcoholic fatty liver disease (NAFLD)

The Phase 1b, 12-week NAFLD study will include diabetic and non-diabetic subjects and is expected to be conducted at approximately 10 US sites
Primary efficacy end point will be reduction in liver fat by MRI-PDFF
Study expected to enable a 52-week biopsy driven NASH study in Q1 2022

IND in obesity expected to be filed in Q4 2021

Phase 2 obesity trial is expected to initiate in Q1 2022
Development program expected to include diabetic and non-diabetic subjects
Additional clinical development to support NASH and obesity programs during 2021

Phase 1 drug-drug interaction study to initiate in Q4 2021 to evaluate ALT-801 interaction with commonly used drugs
12-week Phase 1 study to initiate in Q4 2021 to evaluate ALT-801 effects on glucose control, hemoglobin A1C and insulin resistance in subjects with type 2 diabetes
Initiated development of an oral formulation for ALT-801

Molecular weight and potency of ALT-801 are well-suited for oral administration
Financial Results for the Three and Six Months Ended June 30, 2021

Altimmune had cash, cash equivalents, short-term investments and restricted cash totaling $217.9 million at June 30, 2021 compared to $216.0 million at December 31, 2020. Through utilization of at-the-market (ATM) offerings during the second quarter of 2021, Altimmune raised net proceeds of $18.2 million and a total of $52.4 million since the beginning of the year.
Revenue was $0.1 million for the three months ended June 30, 2021 compared to $0.7 million in the same period in 2020. The change in revenue quarter over quarter was primarily due to a decrease in BARDA revenue during the current period due to the timing of clinical trials and development activities for NasoShield.
Research and development expenses were $13.3 million for the three months ended June 30, 2021, compared to $16.6 million in the same period in 2020. The change was primarily the result of increased expenses of $9.7 million primarily related to development activities for the Company’s COVID-19 programs, offset by a decrease of $13.0 million resulting from changes in the fair value of contingent consideration liability connected with the acquisition and development of ALT-801.
General and administrative expenses were $3.7 million for the three months ended June 30, 2021 compared to $2.5 million in the same period in 2020. The increase during the quarter is primarily due to increased stock compensation expense and additional labor related costs.
An impairment on construction-in-progress of $8.1 million was recognized for the three months ended June 30, 2021 related to the build out of a commercial scale manufacturing suite for the Company’s recently terminated COVID-19 vaccine program. No impairment was recognized in the prior year.
Net loss for the three months ended June 30, 2021 was $24.8 million, or $0.60 net loss per share, compared to $16.8 million in the same period in 2020, or $0.94 net loss per share. Net loss for the six months ended June 30, 2021 was $39.7 million, or $0.99 net loss per share, compared to $20.7 million in the same period in 2020, or $1.25 net loss per share.
Conference Call Information

Following the conclusion of the call, the webcast will be available for replay on the Investor Relations page of the Company’s website at www.altimmune.com. The Company has used, and intends to continue to use, the IR portion of its website as a means of disclosing material non-public information and for complying with disclosure obligations under Regulation FD.

On August 10, 2021 Pacira BioSciences, Inc. (Nasdaq: PCRX), the industry leader in its commitment to non-opioid pain management and regenerative health solutions, reported preliminary unaudited net product sales of EXPAREL (bupivacaine liposome injectable suspension) and iovera° of $40.9 million and $1.0 million, respectively, for the month of July 2021 (Press release, Pacira Pharmaceuticals, AUG 10, 2021, View Source [SID1234586281]). EXPAREL average daily sales for the month of July 2021 were 117 percent of July 2020. The company reports average daily growth rates for EXPAREL to account for differences in the number of selling days per reporting period. EXPAREL selling days were 21 in July 2021 and 23 in July 2020.

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"The continued growth of EXPAREL reflects its accelerating deployment as the opioid-free local analgesic of choice given its enduring efficacy, excellent safety profile and proven ability to reliably facilitate surgical migration to outpatient sites of care," said Dave Stack, chairman and chief executive officer of Pacira BioSciences. "Following record-level revenue in the second quarter, EXPAREL demand remains strong leaving us confident in our ability to achieve our five-year goals of top line growth in at least the high teens and operating margins that exceed 50 percent."

The company’s net product sales were negatively impacted by the COVID-19 pandemic in 2020 due to the significant postponement or suspension in the scheduling of elective surgical procedures resulting from public health guidance and government directives. Elective surgery restrictions began to lift on a state-by-state basis in April 2020, allowing EXPAREL sales to return to year-over-year growth in June 2020. However, while many restrictions have since eased and COVID-19 vaccines become more widely available and administered to the general public, it is still unclear how long it will take the elective surgery market to normalize, or if restrictions on elective procedures will recur due to COVID-19 variant strains or otherwise.

To provide greater transparency, the company is reporting monthly intra-quarter unaudited net product sales until it has gained enough visibility around the impacts of COVID-19. The company is also providing weekly EXPAREL utilization and elective surgery data within its investor presentation, which is accessible at investor.pacira.com. The financial information included in this press release is preliminary, unaudited, and subject to adjustment. It does not present all information necessary for an understanding of the company’s financial results for the third quarter or full year 2021.

On August 10, 2021 Epigenomics AG (FSE: ECX, OTCQX: EPGNY, the "Company") reported financial results (IFRS, unaudited) for the second quarter and first half of 2021 (Press release, Epigenomics, AUG 10, 2021, View Source [SID1234586280]).

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OPERATIONAL DEVELOPMENTS

Epigenomics AG has two options to obtain reimbursement for Epi proColon after the disappointing negative NCD reimbursement decision by the Centers for Medicare & Medicaid Services (CMS) earlier this year: via legislation and by appealing the NCD decision. In the legislative process, the Donald Payne, Sr. Colorectal Cancer Detection Act of 2021 (H.R. 1655) was reintroduced in the new session of Congress and currently has 63 co-sponsors.
Epigenomic’s management is confident that the company’s new Next-Gen version of Epi proColon will meet the new CMS reimbursement criteria. The critical factor for the commercialization of the new test is the clinical study required to apply for marketing approval, which will take at least two years, and the subsequent duration of the FDA review. Epigenomics plan to initiate this trial in the first half of 2022.
As a result of the two capital measures carried out in the first half of 2021, Epigenomics AG received gross proceeds of approximately EUR 7.5 million, which will provide the Company with liquidity well into 2022. In addition, Epigenomics recently announced a further capital measure to raise up to EUR 18 million (gross proceeds) through the issuance of a convertible bond. The placement is back-stopped by the largest shareholder, Deutsche Balaton, and is expected to be issued in the third quarter of the year.
Greg Hamilton, CEO of Epigenomics AG: "We are determined to increase shareholder value. A prerequisite for this is that we continue to move the business forward. Therefore, our strategy at this point is to focus on both achieving CMS reimbursement of Epi proColon, possibly via legislation, while at the same time advancing the development of Epi proColon "Next-Gen". If we make discernible progress in this regard, we will move decisively closer to the goal of maximizing shareholder value."

6M 2021 FINANCIAL RESULTS

In the first six months of 2021, total revenue decreased from EUR 322 thousand in the first half of 2020 to EUR 223 thousand, with product revenue declining from EUR 293 thousand to EUR 210 thousand. In the current pandemic situation, many patients eligible for screening continue to postpone their screenings.
Research and development costs decreased from EUR 2,754 thousand in the prior year to EUR 1,545 thousand in the first half of 2021. The sharp decrease is mainly due to the fact that almost all clinical trials in the U.S.A. are continuing slowly or remain dormant.
Selling, general and administrative expenses decreased from EUR 3,901 thousand to EUR 3,021 thousand.
EBITDA before share-based payment expenses improved to EUR -3,165 thousand in the reporting period, compared with EUR -5,659 thousand in the same period of the previous year.
The net loss for the period was EUR -3,528 thousand (6M 2020: EUR -6,403 thousand); the loss per share decreased significantly from EUR 1.21 to EUR 0.41 compared to the same period of the previous year.
Cash consumption decreased to EUR 4,214 thousand in the first half of 2021 (6M 2020: EUR 5,510 thousand).
As of June 30, 2021, the Company had cash and cash equivalents of EUR 6,949 thousand (December 31, 2020: EUR 3,566 thousand).

OUTLOOK 2021

Revenue

The Company confirms its outlook for fiscal year 2021 and continues to expect revenue within the range of EUR 0.4 million to EUR 1.0 million.
EBITDA / Cash consumption

For EBITDA before share-based payment expenses, Epigenomics forecasts a range of EUR -7.0 million to EUR -9.0 million for full year 2021. Based on the Company’s 2021 business plan, cash consumption is expected to be in line with the EBITDA forecast (before share-based payment expenses).
Further information

The financial report for the first six months of 2021 is available on the Epigenomics’ website at: View Source

Conference call for analysts and investors

Epigenomics AG will host a conference call for analysts and investors today at 4.00 pm (CET) / 10.00 am (EDT). The webcast can be accessed at the following link: View Source

Participants are asked to dial in 10 minutes prior to the start of the conference call and to register using the link above.

An audio replay of the conference call will be provided on the Company’s website following the call.

On August 10, 2021 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809) reported its financial results for the first half-year of 2021 (Press release, Evotec, AUG 10, 2021, View Source;announcements/press-releases/p/evotec-se-reports-first-half-year-2021-results-and-corporate-updates-6086 [SID1234586279]).

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HIGHLIGHTS
ACCELERATED INVESTMENTS FOR FURTHER GROWTH AND CAPACITY EXPANSION
Group revenues up 17% to € 271.3 m (H1 2020: € 231.0 m), adjusted for portfolio and fx growth by 27%.
EVT Execute revenues up 18% to € 279.5 m (H1 2020: € 236.8 m, restated for material recharges)
EVT Innovate revenues up 27% to € 57.3 m (H1 2020: € 45.3 m, restated for material recharges)
Higher year-on-year milestone revenues of € 4.1 m (H1 2020: € 2.2 m), important milestones imminent
Just – Evotec Biologics added revenues of € 23.0 m (H1 2020: € 16.3 m), an increase of 41%
Adjusted EBITDA of € 36.2 m (H1 2020: € 47.3 m) affected by planned capacity build-up ahead of imminent production start of J.POD 1 US; increased R&D and SG&A expenses (€ 35.4 m and € 46.4 m) as expected. Adjusted for fx and Sanofi effects, growth of adjusted Group EBITDA would have reached 13%
Increase of expenses for unpartnered R&D by 29% to € 27.8 m (H1 2020: € 21.6 m) according to strategy
Strong balance sheet as comfortable basis for further growth

PICKING UP SPEED ON THE "DATA-DRIVEN R&D AUTOBAHN TO CURES": NEW AND EXTENDED PARTNERSHIPS; GRAND OPENING OF J.POD 1 US
Multiple new and extended partnerships (e.g. with Abivax, Awakn, 1ST Biotherapeutics, Interline, Related Sciences, Takeda, The Mark Foundation, …)
Just – Evotec Biologics continuing successful progress: opening of J.POD 1 US for biologics development and cGMP manufacturing facility on 18 August 2021; construction start of J.POD 2 EU expected for H2 2021
Bristol Myers Squibb partnership extension in protein degradation ahead of term, additionally, a new protein degradation collaboration in an undisclosed therapeutic area signed
Partnership on oncology project EVT801 with Kazia Therapeutics
New BRIDGEs ("Danube Labs", "beLAB2122" and "beLAB1407")
Launch of "PRROTECT", an Evotec initiative for pandemic preparedness
Positive results from Bayer’s Phase IIb clinical trial with eliapixant (BAY1817080) for the treatment of refractory chronic cough (after period-end)

CORPORATE
Implementation of next long-term strategic framework Action Plan 2025 "The data-driven R&D Autobahn to Cures"
Acquisition of the Verona site from GlaxoSmithKline SpA and renaming of the expanded Evotec Verona site in "Campus Levi-Montalcini"
Annual General Meeting 2021: Approval of all proposed agenda items; new authorized capital 2021 for future flexibility and further growth of the Company resolved
Submission of registration statement for proposed offering of American Depositary Shares ("ADS") in the U.S. (after period-end)

CONFIRMATION OF BUSINESS OUTLOOK FOR FULL-YEAR 2021 AND MID-TERM TARGETS 2025
Group revenues expected to be in a range of € 550 – 570 m
(€ 565 – 585 m at constant exchange rates) (2020: € 500.9 m)
Adjusted Group EBITDA expected to be in the range of € 105 – 120 m
(€ 115 – 130 m at constant exchange rates) (2020: € 106.6 m)
Unpartnered research and development expenses expected to be in a range of € 50 – 60 m (2020: € 46.4 m)
Mid-term goals target revenue growth to > € 1,000 m, adjusted EBITDA of ≥ € 300 m and unpartnered research and development expenses of > € 100 m by 2025

More detailed information and financial tables are available in our half-year report published on the Evotec website under the following link: View Source