On August 10, 2021 Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic solutions company with a focus in lung disease, reported its financial and operating results for the second quarter ended June 30, 2021 and provided a corporate update (Press release, Biodesix, AUG 10, 2021, View Source [SID1234586221]).

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"It was a productive quarter with 180% year over year growth in total revenue. Our first four blood-based tests which make up our core lung diagnostic testing, grew 109% year over year and 20% over the prior quarter," said Scott Hutton, CEO of Biodesix. "We expect growth in core lung diagnostic testing to continue through 2021 driven by the U.S.’s emergence from the pandemic, productivity from our growing salesforce, and our efforts to build on the body of evidence supporting the use of our tests. Beyond our currently marketed products, we also continue to develop our Diagnostic Cortex Artificial Intelligence (AI) platform and expand our pipeline of products capable of providing broad lung diagnostics to address patients’ needs over the course of their disease. The launch of our 72-hour liquid NGS test is now projected for the first quarter of 2022 and will supplement our 36-hour VeriStrat and GeneStrat tests. With this accelerated launch and multiple studies underway for our Risk of Recurrence (ROR) and Primary Immune Response (PIR) tests as well as our ALTITUDE, BEACON, INSIGHT, and ORACLE prospective studies actively enrolling or following patients, we look forward to a productive and exciting second half of the year."

Second Quarter 2021 Financial Results

For the three-month period ended June 30, 2021, as compared to the same period of 2020 (where applicable):

Total revenue of $11.9 million, an increase of 180%;

Core lung diagnostic revenue of $4.8 million, an increase of 109%;
Continued sequential recovery from initial rapid uptake of COVID-19 immunizations.
Growth driven primarily by Nodify XL2 and Nodify CDT.
Nodify XL2 growth triggered the previously disclosed milestone resulting in a $37 million obligation payable by us over six quarterly installments of approximately $4.6 million beginning January 2022 and a final payment of approximately $9.3 million in July 2023.
COVID-19 testing revenue of $6.1 million, an increase of 345%;
Sequential quarter over quarter decline commensurate with our prior commentary as US immunizations accelerated in second quarter.
Services revenue of $1.0 million, an increase of 76%;
Clinical trial services showed improvement and we expect further recovery in clinical trial enrollments in second half of 2021.

Gross profit of $4.8 million, an increase of 103%, and gross margin percentage of 40% as compared to 56% representing a decline primarily attributable to the lower gross margin COVID-19 testing;

Operating expenses (excluding direct costs and expenses) of $15.4 million, which includes an investment in the planned expansion of our sales force, increased 93% over second quarter 2020;
On track to double size of lung focused direct and dedicated sales force in 2021.
Non-cash stock compensation expense of $0.5 million as compared to $0.1 million.
Non-cash expense for change in fair value of contingent consideration of $0.6 million as compared to a gain of $1.0 million.

Net loss of $11.4 million, an increase of 38% over second quarter of 2020; and

Maintained fiscal discipline and strong liquidity with cash and cash equivalents of $56.3 million as of June 30, 2021 and expect to qualify for PPP loan forgiveness of $3.1 million later in 2021.
For a full list of Biodesix’s press releases and webinars, please visit Biodesix.com.

Conference call and webcast information

Management will host an investor conference call and webcast today, August 10, 2021 at 4:30 p.m. Eastern Time.

On August 10, 2021 BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) reported that it has withdrawn its proposed public offering (Press release, BioCryst Pharmaceuticals, AUG 10, 2021, View Source [SID1234586244]). With our strong balance sheet, and increasing revenues from ORLADEYO (berotralstat), we believe that current market conditions are not conducive to an offering on terms that would be in the best interests of our current stockholders. We are well capitalized, with cash, cash equivalents, restricted cash and investments of $222.8 million as of June 30, 2021. Based on our expectations for revenue, operating expenses, and our option to access an additional $75 million from our existing credit facility, we believe our current cash runway takes us into 2023.

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On August 10, 2021 ImmVira reported that it has initiated its lead oncolytic virus therapy program MVR-T3011 IV (also known as T3011) (Press release, Immvira, AUG 10, 2021, View Source [SID1234586259]). The first patient has been dosed, receiving MVR-T3011 intravenous (IV) administration in the U.S. on August 10, 2021. The Phase I clinical trial is being conducted at multiple well-established clinical institutions, including Sarah Cannon Research Institute, Mary Crowley Cancer Research, and Prisma Health (ClinicalTrials.gov Identifier: NCT04780217).

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Dr. Joy Zhu, Chief Medical Officer of ImmVira, stated that "MVR-T3011 IV officially entering clinical study is a breakthrough in the administration of the oncolytic herpes simplex virus. We are hopeful that MVR-T3011 IV will demonstrate good safety profile and promising clinical results. Systemic delivery of MVR-T3011 IV provides an opportunity to treat many advanced cancers that cannot be reached via intratumoral injection."

Dr. Joy Zhu joined ImmVira with more than 25 years of drug development experience. She held leadership positions in several biotech companies, as well as several start-up companies, including legacy SUGEN, Amgen, and Halozyme Therapeutics. Dr. Zhu has broad and in-depth experience in pre-IND planning, IND filings, and NDA submissions with the U.S. FDA and many other regulatory agencies. She was responsible for the clinical development of two blockbuster drugs, SUTENT (sunitinib malate) and XGEVA (denosumab), which are widely recognized in the broad market.

"We are excited about the prospects of IV administration of MVR-T3011 IV. After MVR-T3011 IV’s NMPA clinical trial approval in China, the completion of first dosing in the U.S. marks another significant step for ImmVira’s pipeline development. Leveraging the OvPENS new drug R&D platform aimed at next-generation cancer therapy evolution, ImmVira is expected to reshape the future of oncolytic virotherapy and bring hope to cancer patients and their families," Dr. Grace Zhou, CEO of ImmVira, concluded.

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

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.