On March 14, 2022 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 fourth quarter and year ended December 31, 2021 (fiscal 2021) and provided a corporate update (Press release, Biodesix, MAR 14, 2022, View Source [SID1234610049]).

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"Despite the ongoing challenges caused by the global pandemic, the fourth quarter and fiscal 2021 were very productive," said Scott Hutton, CEO of Biodesix. "Most notably, we successfully executed on our revenue growth strategy by doubling our direct, dedicated sales force, which significantly contributed to our core lung diagnostic revenue growth of 48% and 49% for fourth quarter and fiscal 2021, respectively. We further executed on our third quarter 2021 commitment to a commercial launch of our GeneStrat NGS test in January 2022. From the clinical data standpoint, we presented new data during the fourth quarter of 2021 on our NodifyXL2 test from the prospective ORACLE study, and on our VeriStrat test from the prospective INSIGHT study. This new data truly underscores the value of both products in the real-world setting and adds to the body of evidence. We continue to be excited about the trajectory of the business, despite the challenges from the ongoing pandemic, which gives us confidence heading into 2022."

Fourth Quarter and Full Year 2021 Financial Results

Total revenue of $7.2 million and $54.5 million for the fourth quarter and fiscal 2021, respectively;
Continued lung diagnostic year over year growth despite COVID-19 variant surges;
Core lung diagnostic revenue of $5.4 million and $18.7 million for the fourth quarter and fiscal 2021, respectively, an increase of 48% and 49% over the respective prior year comparable periods;
Nodify nodule management tests and sales force expansion continue to drive lung diagnostic growth;
BioPharma Services revenue of $1.4 million and $5.6 million for the fourth quarter and fiscal 2021, respectively, a decrease of 29% and increase 20% over the respective prior year comparable periods;
COVID-19 testing revenue of $0.4 million and $30.2 million for the fourth quarter and fiscal 2021, respectively, a decrease of 98% and increase 7% over the respective comparable periods in 2020;
Decline over the fourth quarter of 2020 commensurate with the shift away from lab-based testing and towards point-of-care and at-home rapid antigen testing during much of the back half of 2021;
Fourth quarter 2021 gross margin of $4.7 million or 65% as a percentage of revenue as compared to 46% in the comparable prior year period primarily driven by the mix shift of sales to higher-margin core lung diagnostics and away from lower-margin COVID-19 testing;
Operating expenses (excluding direct costs and expenses) of $16.4 million and $64.9 million for the fourth quarter and fiscal 2021, an increase of 9% and 40% over the comparable prior year periods;
Doubled the size of lung focused direct and dedicated sales force in 2021;
Includes non-cash stock compensation expense of $1.3 million and $4.9 million during fourth quarter and fiscal 2021, respectively;
Net loss of $13.3 million and $43.2 million for the fourth quarter and fiscal 2021, respectively, an increase of 193% and 38% over the respective comparable periods in 2020;
Cash and cash equivalents of $32.7 million, inclusive of a fourth quarter 2021 equity capital issuance of $15.7 million in net proceeds and the prepayment of $20 million of the 2021 Term Loan;
Announced a Common Stock Purchase Agreement for up to $50 million.
2022 Financial Outlook

The Company anticipates generating between $37.5 million to $39.5 million in total revenue in 2022.

Conference call and webcast information

Management will host an investor conference call and webcast today, March 14, 2022 at 8:30 a.m. Eastern Time.

Investor dial-in (domestic):

An archived replay of the webcast will be available on the Company’s website for a period of 90 days.

For a full list of Biodesix’s press releases and webinars, please visit Biodesix.com.

On March 14, 2022 NexImmune, Inc. (Nasdaq: NEXI), a clinical-stage biotechnology company developing a novel approach to immunotherapy designed to orchestrate a targeted immune response by directing the function of antigen-specific T cells, reported a research and evaluation collaboration with The Laura and Isaac Perlmutter Cancer Center, a National Cancer Institute designated Comprehensive Cancer Center and part of NYU Langone Health (Press release, NexImmune, MAR 14, 2022, View Source [SID1234610048]). The collaboration is centered around NexImmune’s artificial antigen presenting cells’ (aAPCs) ability to expand neoantigen-specific CD8+ T cells in apheresis material provided by melanoma patients. Dr. Jeffrey S. Weber, Deputy Director of the Laura and Isaac Perlmutter Cancer Center will guide the research and evaluation.

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"NexImmune is excited to have Dr. Weber and NYU, one of the nation’s leading academic cancer centers, as a partner on this collaboration," said Kristi Jones, Chief Executive Officer of NexImmune. "The AIM technology platform offers a way to explore the expansion of neoantigens not only in melanoma, but a myriad of other cancers. This step will help validate our approach to these novel targets. Collaboration in this field will continue to help us deliver novel and impactful therapies to people suffering with cancer."

"I look forward to working with NexImmune on this important work, with the goal of advancing these technologies and delivering next-generation immunotherapies to patients suffering with cancer," stated Dr. Weber. "NexImmune’s platform has proven it can consistently expand antigen specific T cells for known tumor and viral antigens. This work could help us create T cell products that directly target disease specific neoantigens by utilizing the AIM platform."

Further terms of this evaluation agreement have not been disclosed.

On March 14, 2022 Novo Nordisk reported that initiated a share repurchase programme in accordance with Article 5 of Regulation No 596/2014 of the European Parliament and Council of 16 April 2014 (MAR) and the Commission Delegated Regulation (EU) 2016/1052 of 8 March 2016 (the "Safe Harbour Rules") (Press release, Novo Nordisk, MAR 14, 2022, View Source [SID1234610047]). This programme is part of the overall share repurchase programme of up to DKK 22 billion to be executed during a 12-month period beginning 2 February 2022.

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Under the programme initiated 2 February 2022, Novo Nordisk will repurchase B shares for an amount up to DKK 4.4 billion in the period from 2 February 2022 to 2 May 2022.

Since the announcement 7 March 2022, the following transactions have been made:

Number of

B shares

Average

purchase price

Transaction

value, DKK

Accumulated, last announcement 2,494,151 1,672,029,156
7 March 2022 110,000 693.55 76,290,472
8 March 2022 110,000 699.04 76,894,538
9 March 2022 105,000 689.72 72,420,439
10 March 2022 110,000 704.36 77,479,852
11 March 2022 100,000 691.13 69,112,536
Accumulated under the programme 3,029,151 2,044,226,993

The details for each transaction made under the share repurchase programme are published on novonordisk.com.

With the transactions stated above, Novo Nordisk owns a total of 34,815,319 B shares of DKK 0.20 as treasury shares, corresponding to 1.5% of the share capital. The total amount of A and B shares in the company is 2,310,000,000 including treasury shares.

Novo Nordisk expects to repurchase B shares for an amount up to DKK 22 billion during a 12- month period beginning 2 February 2022. As of 11 March 2022, Novo Nordisk has since 2 February 2022 repurchased a total of 3,029,151 B shares at an average share price of DKK 674.85 per B share equal to a transaction value of DKK 2,044,226,993.

On March 14, 2022 Elektrofi (ELEKTROFI, INC) & IPA (IMMUNOPRECISE ANTIBODIES LTD.) (NASDAQ: IPA) (TSXV: IPA) reported they are entering into a collaboration to explore a high-concentration formulation of IPA’s COVID-19 antibody cocktail, PolyTope TATX-03 (Press release, ImmunoPrecise Antibodies, MAR 14, 2022, View Source [SID1234610046]). This collaboration aims to generate an IND-enabling data package for the FDA for an alternatively formulated version of TATX-03, named TATX-03E, that could be easily self-administered in a non-healthcare setting. By joining forces, the parties anticipate formulating TATX-03E for stable and rapid distribution to the consumer, a drug product ideally suited to serve unmet needs for rapid deployment, field use, and higher frequency dosing for immunocompromised individuals requiring on-going access to therapies and prophylaxis.

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The collaboration between Elektrofi and IPA will be supported by Elektrofi’s contract with the DHA Small Business Innovation Research (SBIR) Program within the Department of Defense (DoD). The companies will begin by conducting formulation feasibility studies followed by IND-enabling, non-clinical studies to establish safety and efficacy with the novel formulation.

"We are impressed by the neutralizing activity demonstrated by ImmunoPrecise’s antibody cocktail against current variants of concern, including Omicron. Nearly all other programs we have looked into partnering with do not demonstrate the ability to neutralize so many variants," said Daniel Dadon, Director of Scientific Strategy at Elektrofi. "We look forward to working with IPA to develop a product that could potentially improve access to this class of life saving medicines and reduce the burden on healthcare systems."

"Antibodies have been an essential asset for COVID-19 patients since their introduction earlier in the pandemic," said Dr. Jennifer Bath, CEO and President of IPA. "We are excited to be working with Elektrofi and applying their formulation technology to these critical therapies, as self-administration could significantly alleviate the burden associated with COVID-19 and future pandemics, as well as other diseases."

On March 14, 2022 F-star Therapeutics, Inc. (NASDAQ: FSTX), a clinical-stage biopharmaceutical company dedicated to developing next generation immunotherapies to transform the lives of patients with cancer, reported full-year 2021 financial results and will provide a corporate update (Press release, F-star, MAR 14, 2022, View Source [SID1234610045]).

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"Bispecifics have come of age, and F-star is exceptionally well positioned in this field with our unique tetravalent bispecific platform," said Eliot Forster, Chief Executive Officer of F-star Therapeutics. "With all four of our clinical programs poised to generate clinical data later this year, F-star is now entering a period with multiple, data-driven inflection points, each of which has the potential to be transformative to our company. Reaching these important readouts is possible as a result of diligence, tenacity and execution by the F-star team. During 2021, we successfully navigated the challenges of COVID-19 to advance our clinical programs, secured two new partnerships, closed a significant financing, strengthened our patent portfolio, and added even more depth and experience to our leadership team. We want to thank investors, our staff, partners and patients and look forward to continuing our important work together this year and beyond."

Highlights:

FS222 Trial-in-Progress update at ESMO (Free ESMO Whitepaper) Immuno-Oncology Congress 2021: The clinical study (Part A) comprised an Accelerated Dose Titration (ADT) component, followed by a 3+3 dose escalation and dose-expansion cohorts. FS222 targets CD137 (4-1BB) and PD-L1 in patients with advanced malignancies. Part B consists of tumor-specific efficacy expansion cohorts. The ADT component of Part A was completed successfully, and identification of optimal patient groups, dose and schedule is ongoing. FS222 is a potentially best in class bispecific antibody targeting CD137 and PD-L1 and is designed to improve treatment outcomes in patients with cancer, including those with low PD-L1 tumors. FS222 is currently in Part A of a Phase 1 study that will assess safety, PK/PD, biomarkers and preliminary efficacy.

FS120 poster presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2021 Conference highlighting the benefits of triple immune activation: FS120 in combination with anti-PD-1 (pembrolizumab) was shown to enhance T cell activity in multiple human primary immune assays. In combination with an anti-PD-1, FS120 surrogate increased antitumor efficacy in a mouse tumor model with pharmacodynamic changes related specifically to T cell activation, when compared to monotherapies supporting the development of FS120 in combination with Keytruda in patients with cancers that are resistant to checkpoint inhibitor therapy. FS120 is a first-in-class conditional OX40/CD137 (4-1BB) dual stimulator bispecific antibody which has been designed to improve check point inhibitor (CPI) and chemotherapy outcomes. FS120 is currently in Part A of a Phase 1 trial as a monotherapy in patients with solid tumors to determine the optimal pharmacologically active dose. Part B of the Phase 1 study will evaluate FS120 in combination with Merck’s KEYTRUDA (pembrolizumab) and will assess safety, PK/PD, and biomarker data.

Further strengthening of patent protection with the issuance of U.S. Patent to protect FS118: United States Patent and Trademark Office (USPTO) has granted a patent protecting the composition of matter of FS118, a tetravalent bispecific antibody which blocks PD-L1 and LAG-3 receptors. U.S. Patent No. 11,214,620 is entitled "Binding Molecules Binding PD-L1 and LAG-3"and is expected to provide F-star with exclusivity for FS118 until at least August 2038.

Additional partnership validation and potential revenue through Merck KGaA, Darmstadt, Germany exercising a Fourth Licensing Option: Under the terms of the agreement, Merck KGaA, Darmstadt, Germany will be responsible for all future development and commercialization costs of the bispecific program and will pay future success-based milestones and royalties on any net sales resulting from programs covered by the agreement.

License Agreement with Janssen to Develop and Commercialize Multiple Next Generation Bispecific Antibody Therapeutics: Under the terms of the agreement, F-star will grant Janssen a worldwide, exclusive royalty-bearing license to research, develop, and commercialize up to five novel bispecific antibodies directed to Janssen therapeutic targets using F-star’s proprietary Fcab and mAb2 platforms. Janssen will be responsible for all research, development, and commercialization activities under the agreement. F-star is entitled to receive potential future milestones of up to $1.35 billion.

Anticipated Program Milestones:

In 2022:

A clinical efficacy readout of FS118 in PD-1 acquired resistance head and neck cancer patients who have failed checkpoint therapies.

Clinical update on FS222 Phase 1 trial.

Program update on the Phase 1 trial of FS120.

FS120 trial part B initiation, in combination with Merck’s pembrolizumab.

Program update of the dose-escalation study of SB 11285, a next-generation intravenously administered novel STING agonist.

Full-Year 2021 Financial Update

Cash Position

Cash and cash equivalents totalled $78.5M for the year ended December 31, 2021, compared to $18.5M for the year ended December 31, 2020. The increase in cash and cash equivalents was driven primarily by proceeds from our ATM and equity financing, debt financing and collaboration revenue, offset by the Company’s operational needs during 2021.

R&D Expense

R&D expense was $28.8M for the year ended December 31, 2021, compared to $14.1 M for the 2020 year-end. The increase in R&D expense was due primarily to the expansion of our FS118 clinical trial into acquired resistance head & neck patients, as well as our CPI naïve trial in NSCLC and DLBCL, a full year of spend on the mono and combo SB11285 clinical trial, and continued progression of our FS120 and FS222 clinical programs.

G&A Expense

G&A expenses were $23.1M for the year ended December 31, 2021, compared to $19.5M for the full year 2020. This increase is primarily due to a $2.4M increase in stock-based compensation expense, $1.6M increase in public company Directors & Officers insurance for a full year, $1.0M in facilities and IT costs, offset by a $1.4M reduction in legal and professional fees and G&A staff costs.

Net Loss Attributable to Common Shareholders

Net loss attributable to common shareholders was $31.3million or ($1.88) per share, for the year ended December 31, 2021, as compared to a net loss of $25.6 million or ($9.69) per share for the year ended December 31, 2020.

Conference Call and Webcast

F-star will host a conference call today, March 14, 2021, beginning at 9:00 a.m. EST.

To access the call, participants may join via a live webcast on the Investors & News section of the F-star Therapeutics website, under Events and Presentations. To join by phone, participants may dial the following numbers at least 10 minutes prior to the start of the call:

A replay of the conference call will be available for 90 days from the call and may be accessed in the Investors & News/Events and Presentations section on the F-star Therapeutics website.