On February 22, 2022 Cerus Corporation (Nasdaq: CERS) reported financial results for the fourth quarter and full year ended December 31, 2021 (Press release, Cerus, FEB 22, 2022, View Source [SID1234608796]).

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Recent developments and highlights include:

Fourth quarter 2021 total revenue of $50.1 million, reflecting a 49% increase over the prior year period. For the full year, 2021 total revenue was $159.5 million, reflecting a 40% increase over the prior year period. Total revenue was composed of (in thousands, except %):

As of the date of this release, the Company is reiterating its 2022 annual product revenue guidance range of $157 million to $164 million, representing a 20% to 25% increase over full-year 2021 reported product revenue.
This year, Cerus Corporation celebrates its 30th anniversary. Since its foundation, Cerus has recognized the critical unmet need to protect the world’s blood supply. With the INTERCEPT Blood System, Cerus hopes to continue to deliver innovative solutions in support of making safe blood products accessible globally.
Two of the Company’s blood center production partners, Gulf Coast Regional Blood Center and Central California Blood Center (CCBC), have recently obtained BLA approvals for the INTERCEPT Blood System for Cryoprecipitation, which is approved for the production of Pathogen Reduced Cryoprecipitated Fibrinogen Complex, or INTERCEPT Fibrinogen Complex (IFC). With these BLA approvals, the Company and these blood center production partners have the ability to sell IFC across state lines.
Cash, cash equivalents, and short-term investments were $129.4 million at December 31, 2021.
"2021 was a breakout year for Cerus. We solidified a leadership position in the U.S. platelet market with blood centers and their hospital customers that chose INTERCEPT platelets for their patients to comply with the FDA’s platelet bacterial safety guidance," said William ‘Obi’ Greenman, Cerus’ president and chief executive officer. "With the INTERCEPT Blood System now established in many blood centers in the U.S., we are confident that 2022 will be another year of strong growth led by sales of INTERCEPT platelet kits. At the same time, we are excited to continue our IFC launch across the country on the heels of the recent first BLA approvals as well as collaborations with BCA and OneBlood. We look forward to continuing to expand patient access to INTERCEPT treated blood components and updating our stakeholders on our progress throughout the year."

Revenue

Product revenue during the fourth quarter of 2021 was $39.9 million, compared to $28.2 million during the prior year period. Product revenue growth during the quarter and full year was driven by increased sales of INTERCEPT platelet kits to blood center customers across the U.S.

Fourth quarter 2021 government contract revenue was $10.2 million, compared to $5.4 million during the prior year period. Reported government contract revenue in the fourth quarter 2021 increased versus the prior year period following an agreement for allowable costs that the Company had previously been deferring. Our government contract revenue was comprised of funding associated with research and development (R&D) activities related to the INTERCEPT Blood System for Red Blood Cells as well as sponsored efforts related to the development of next-generation pathogen reduction technology to treat whole blood.

Product Gross Profit & Margin

Product gross profit for the fourth quarter 2021 was $20.4 million and, for the second consecutive quarter, was the highest in the Company’s history, increasing by $4.4 million over the prior year period. Product gross margin for the fourth quarter 2021 was 51.1% compared to 56.8% for the fourth quarter of 2020 and roughly flat compared to the second and third quarters of 2021.

Full-year 2021 product gross profit was $67.4 million and reflected growth of 33% over the prior year. Product gross margin for the full year 2021 was 51.5% compared to 55.2% for the prior year.

For both the fourth quarter and full year, the year-over-year decreases in product gross margin was anticipated. Currently, U.S. customers primarily use single dose platelet kits, which have a lower product gross margin percentage as compared to our double dose kits, which are more typically used by the Company’s international customers.

Operating Expenses

Total operating expenses for the fourth quarter of 2021 were $37.6 million compared to $35.8 million for the same period of the prior year, reflecting a year-over-year increase of 5%. For the full year, 2021 total operating expenses totaled $145.0 million, representing an increase of 10% when compared to 2020 total operating expenses of $131.4 million. On both a quarterly and full-year basis, lower R&D expenses versus the prior year periods were offset by higher commercial expenses, driven by sales incentive compensation.

Selling, general, and administrative (SG&A) expenses for the fourth quarter of 2021 totaled $22.0 million, compared to $18.7 million for the fourth quarter of 2020. For the full year 2021, SG&A expenses totaled $81.3 million, compared to $67.0 million for the full year 2020. The year-over-year increase in SG&A expenses for the fourth quarter and full year was tied to higher non-cash stock-based compensation expense, increased sales incentive costs and continued investments in the Company’s therapeutics business unit.

R&D expenses for the fourth quarter of 2021 were $15.6 million, compared to $17.1 million for the fourth quarter of 2020. For the full year, 2021 R&D expenses totaled $63.7 million, compared to $64.4 million for the full year 2020. For both the fourth quarter and full year, the Company’s R&D expenses continued to advance the Company’s key pipeline programs, including development of the Company’s LED illuminator and INTERCEPT Red Blood Cell program, but were offset by lower R&D costs versus the prior year periods as other projects reached completion.

Net Loss Attributable to Cerus Corporation

Net loss attributable to Cerus Corporation for the fourth quarter of 2021 was $9.1 million, or $0.05 per basic and diluted share, compared to a net loss attributable to Cerus Corporation of $14.4 million, or $0.09 per basic and diluted share, for the fourth quarter of 2020.

For the full year 2021, net loss attributable to Cerus Corporation was $54.4 million, or $0.32 per basic and diluted share, compared to a net loss attributable to Cerus Corporation of $59.9 million, or $0.37 per basic and diluted share for the full year 2020.

Balance Sheet & Cash Use

At December 31, 2021, the Company had cash, cash equivalents and short-term investments of $129.4 million, compared to $120.0 million at September 30, 2021, and $133.6 million at December 31, 2020.

As of December 31, 2021, the Company carried $54.7 million of notes due and a balance on its revolving line of credit of $14.7 million. The Company continues to have access to $5 million under its revolving line of credit.

For the fourth quarter of 2021, net cash used in operating activities totaled $1.2 million as compared to $8.9 million during the prior year period, continuing a trend of strong capital management as higher revenues and significant operating leverage offset investments in inventory to continue to meet growing customer demand. For the full year 2021, net cash used in operating activities totaled $33.9 million, compared with $41.8 million for the full year 2020.

Reiterating 2022 Product Revenue Guidance

The Company expects full-year 2022 product revenue will be in the range of $157-$164 million, representing strong growth of approximately 20%-25% compared to full-year 2021 product revenue of $130.9 million.

Quarterly Conference Call

The Company will host a conference call at 4:30 P.M. EST this afternoon, during which management will discuss the Company’s financial results and provide a general business overview and outlook. To listen to the live webcast, please visit the Investor Relations page of the Cerus website at View Source Alternatively, you may access the live conference call by dialing (866) 235-9006 (U.S.) or (631) 291-4549 (international).

A replay will be available on Cerus’ website, or by dialing (855) 859-2056 (U.S.) or (404) 537-3406 (international) and entering conference ID number 8851919. The replay will be available approximately three hours after the call through March 8, 2022.

On February 22, 2022 Biodesix, Inc. (NASDAQ: BDSX) a leading data-driven diagnostic solutions company with a focus in lung disease, reported that its Chief Executive Officer was named in The Healthcare Technology Report’s list of Top 25 Biotech CEOs of 2022 (Press release, Biodesix, FEB 22, 2022, View Source [SID1234608795]). The annual list recognizes the most accomplished executives in the biotech industry.

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An extensive process was run to evaluate the hundreds of CEOs who were nominated this year. These CEOs lead exemplary organizations in the fields of gene therapy to vaccine development, cancer treatment, proteomics, diagnostics, mRNA-based therapeutics, and other related areas. Read the full report here.

Hutton’s profile provides insight as to how his personal leadership philosophy emphasizes ‘helping people, giving back, and positively impacting and improving people’s health and lives’. Under his direction and leadership, Biodesix has grown into a leading patient-centric lung disease diagnostics company with a mission to unite biopharma, physicians, and patients to transform the standard of care and improve outcomes with personalized diagnostics.

"I am honored to be named as a leading CEO in The Healthcare Technology Report and included on a list with so many resilient, entrepreneurial industry leaders who are making a meaningful impact on patients," said Hutton. "The recognition also highlights the commitment and work that the entire team at Biodesix accomplishes every day to impact patients with critical diseases."

On February 22, 2022 BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide, reported that the European Medicines Agency (EMA) has accepted for review two new indication applications for its BTK inhibitor BRUKINSA (zanubrutinib) for the treatment of patients with chronic lymphocytic leukemia (CLL) and for the treatment of patients with marginal zone lymphoma (MZL) (Press release, BeiGene, FEB 22, 2022, View Source [SID1234608794]).

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"As a BTK inhibitor designed to maximize BTK occupancy and minimize off-target binding, BRUKINSA demonstrated improvements in ORR and advantages in overall cardiac safety compared to ibrutinib in the ALPINE study in patients with relapsed or refractory CLL. Together with results from the SEQUOIA study in front-line CLL, BRUKINSA has the potential to become a preferred treatment option for patients with CLL and MZL in the European Union," commented Peter Hillmen, MBChB, Ph.D., Professor of Experimental Haematology at University of Leeds, and principal investigator of the ALPINE trial.

In November 2021, BRUKINSA received its first approval in the European Union (EU) for the treatment of adult patients with Waldenström’s macroglobulinemia (WM) who have received at least one prior therapy or for the first-line treatment of patients unsuitable for chemo-immunotherapy.

"Following BRUKINSA’s recent EU approval in WM, we are pleased that BRUKINSA is now under review for two more indications—CLL and MZL. We are confident in the broad clinical evidence from its global clinical development program and hope to bring this next-generation BTK inhibitor to CLL and MZL patients in the EU," said Jane Huang, M.D., Chief Medical Officer of Hematology at BeiGene.

The application for in CLL is based on data included from two global Phase 3 trials of BRUKINSA in CLL—ALPINE (NCT03734016) comparing BRUKINSA to ibrutinib in relapsed or refractory (R/R) patients and SEQUOIA (NCT03336333) comparing BRUKINSA to bendamustine and rituximab in treatment-naïve (TN) patients. These two studies enrolled patients from a total of 17 countries, including the United States, China, Australia, New Zealand and multiple countries in Europe.

Results from the ALPINE trial and the SEQUOIA trial were reported at the 26th European Hematology Association (EHA) (Free EHA Whitepaper) (EHA2021) Virtual Congress in June 2021 and at the 63rd American Society for Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2021, respectively.

The application for MZL is based on efficacy results from two single-arm clinical trials—MAGNOLIA (NCT03846427), a global pivotal Phase 2 trial in patients with R/R MZL who received at least one anti-CD20-based regimen, and BGB-3111-AU-003 (NCT02343120), a global Phase 1/2 trial. These two studies enrolled patients from a total of nine countries, including sites in the United States, China, Europe, Australia, and New Zealand. Results from the MAGNOLIA trial were reported at the 62nd ASH (Free ASH Whitepaper) Annual Meeting in December 2020.

Added Gerwin Winter, Senior Vice President, Head of Commercial, Europe at BeiGene, "We are proud of the progress BeiGene has made in Europe over the past year, with a growing team across the continent. The acceptance of our applications for MZL and CLL bring us a step closer to broadening access to patients."

About Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma

Chronic lymphocytic leukemia (CLL) is the most common form of leukemia in the Western countries, accounting for approximately one third of all leukemia cases.1,2 In 2020, an estimated 30,000 new CLL patients were diagnosed in Europe.2,3 CLL begins in cells that become certain white blood cells (lymphocytes) in the bone marrow but then go into the blood. Proliferation of cancer cells (leukemia) in the marrow result in reduced ability to fight infection and spread into the blood, which affects other parts of the body including the lymph nodes, liver and spleen.4,5,6 The BTK pathway is a known route that signals malignant B cells and contributes to the onset of CLL.7 Small lymphocytic lymphoma (SLL) is a non-Hodgkin’s lymphoma affecting the B-lymphocytes of the immune system, which shares many similarities to CLL but with cancer cells found mostly in lymph nodes.8

About Marginal Zone Lymphoma

Marginal Zone lymphoma (MZL) is a group of indolent non-Hodgkin’s lymphomas (NHL) that begin in the marginal zones of lymph tissue, representing approximately 5-15 percent of all NHL cases in the Western world.9 There are three different subtypes of MZL: extranodal marginal zone B-cell lymphoma or mucosa-associated lymphoid tissue (MALT) which is most common; nodal marginal zone B-cell lymphoma which develops in the lymph nodes and is rare; and splenic marginal zone B-cell lymphoma which develops in the spleen, bone marrow, or both and is the rarest form of the disease.10

About BRUKINSA

BRUKINSA is a small molecule inhibitor of Bruton’s tyrosine kinase (BTK) discovered by BeiGene scientists that is currently being evaluated globally in a broad clinical program as a monotherapy and in combination with other therapies to treat various B-cell malignancies. Because new BTK is continuously synthesized, BRUKINSA was specifically designed to deliver complete and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity. With differentiated pharmacokinetics compared to other approved BTK inhibitors, BRUKINSA has been demonstrated to inhibit the proliferation of malignant B cells within a number of disease relevant tissues.

BRUKINSA is supported by a broad clinical program which includes more than 3,900 subjects in 35 trials across 28 markets. In November 2021, the European Commission approved BRUKINSA for the treatment of adult patients with Waldenström’s macroglobulinemia (WM) who have received at least one prior therapy or for the first-line treatment of patients unsuitable for chemo-immunotherapy. To date, BRUKINSA has received more than 20 approvals covering more than 40 countries and regions, including the United States, China, the EU and Great Britain, Canada, Australia and additional international markets. Currently, more than 40 additional regulatory submissions are in review around the world.

BeiGene Oncology

BeiGene is committed to advancing best- and first-in-class clinical candidates internally or with like-minded partners to develop impactful and affordable medicines for patients across the globe. We have a growing R&D and medical affairs team of approximately 2,900 colleagues dedicated to advancing more than 100 clinical trials that have involved more than 14,500 subjects. Our expansive portfolio is directed predominantly by our internal colleagues supporting clinical trials in more than 45 countries and regions. Hematology-oncology and solid tumor targeted therapies and immuno-oncology are key focus areas for the Company, with both mono- and combination therapies prioritized in our research and development. BeiGene currently has three approved medicines discovered and developed in our own labs: BTK inhibitor BRUKINSA in the United States, China, the EU and U.K., Canada, Australia and additional international markets; and the non-FC-gamma receptor binding anti-PD-1 antibody tislelizumab as well as the PARP inhibitor pamiparib in China.

BeiGene also partners with innovative companies who share our goal of developing therapies to address global health needs. We commercialize a range of oncology medicines in China licensed from Amgen, Bristol Myers Squibb, EUSA Pharma and Bio-Thera. We also plan to address greater areas of unmet need globally through our other collaborations including with Mirati Therapeutics, Seagen, and Zymeworks.

In January 2021 BeiGene and Novartis announced a collaboration granting Novartis rights to co-develop, manufacture, and commercialize BeiGene’s anti-PD1 antibody tislelizumab in North America, Europe, and Japan. Building upon this productive collaboration, including a biologics license application (BLA) under FDA review, BeiGene and Novartis announced an option, collaboration and license agreement in December 2021 for BeiGene’s TIGIT inhibitor ociperlimab that is in Phase 3 development. Novartis and BeiGene also entered into a strategic commercial agreement through which BeiGene will promote five approved Novartis Oncology products across designated regions of China.

On February 22, 2022 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) ("Actinium" or the "Company"), a leader in the development of targeted radiotherapies and AVEO Oncology (NASDAQ: AVEO) ("AVEO"), a commercial stage, oncology-focused biopharmaceutical company, reported that they have entered into a research collaboration to develop and study a first-in-class antibody radio-conjugate (ARC) targeting ErbB3, also known as HER3 (Press release, AVEO, FEB 22, 2022, View Source [SID1234608793]). Actinium will utilize its AWE technology platform and extensive radiotherapy know-how to conjugate one of AVEO’s ErbB3 targeted antibodies, with the potent alpha-emitting radioisotope Actinium-225 (Ac-225).

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"Actinium has amassed extensive clinical experience, technical know-how and research capabilities for the development of next-generation targeted radiotherapies that we are excited to bring to this collaboration with AVEO, which has a portfolio of high-affinity antibodies and is currently commercializing FOTIVDA (tivozanib) in advanced RCC. We believe ErbB3 is a validated and differentiated target that is aptly suited for radio-conjugate development. Using our AWE platform, we will harness the powerful Ac-225 payload to enhance targeted cell killing against a target that is overexpressed in a number of cancers that are difficult to treat with traditional oncology therapies. A member of the epidermal growth factor family of receptors, ErbB3 has been gaining increasing recognition as a validated targeted, we are committed to rapidly advance and evaluate this novel Ac-225 ErbB3 targeted radiotherapy together with AVEO," said Sandesh Seth, Chairman and CEO of Actinium.

"While we focus on the commercialization of FOTIVDA in advanced RCC,, we are pleased to announce this collaboration with Actinium in an effort to leverage our high-affinity antibody program to expand our robust portfolio with a potential first-in-class targeted radiotherapy ," said Michael Bailey, president and chief executive officer of AVEO. "We are excited to advance this ErbB3 targeted compound which is expressed in multiple solid tumors and is the third in the family of clinically validated ErbB targets."

Actinium’s AWE technology platform has created a Ac-225 CD38 targeting ARC using the blockbuster myeloma antibody daratumumab (Darzalex), in collaboration with EpicentRx for targeted radiotherapy CD47-SIRPα immunotherapy combinations and in collaboration with Astellas Pharma, to create theranostics for solid tumors. Actinium employs a multidisciplinary approach leveraging its team’s expertise and experience in cancer cell biology, radiochemistry, radiation sciences, immunology and oncology drug development to R&D and collaborations.

AVEO’s ErbB3 targeting antibodies are designed to inhibit both ligand-dependent and ligand-independent ErbB3 signaling. ErbB3 is a receptor that is typically expressed in many human cancers and has demonstrated preclinical activity in multiple tumor models.

On February 22, 2022 Applied DNA Sciences, Inc. (NASDAQ: APDN) (the "Company"), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing, reported that it has entered into a securities purchase agreement with an institutional investor, providing for the purchase and sale of 1,496,400 shares of common stock (or common stock equivalents) at a price of $2.80 per share, in a registered direct offering, resulting in total gross proceeds of approximately $4.2 million, before deducting the placement agent’s fees and other estimated offering expenses (Press release, Applied DNA Sciences, FEB 22, 2022, View Source [SID1234608792]). The Company has also agreed to issue to the investor unregistered warrants to purchase up to an aggregate of 1,496,400 shares of common stock in a concurrent private placement. The warrants will have an exercise price of $2.84 per share, be exercisable six months from the date of issuance and will expire five years from the initial exercise date.

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The offering is expected to close on or about February 24, 2022, subject to the satisfaction of customary closing conditions.

The Company currently intends to use the net proceeds from the offering for general corporate purposes, including working capital, and to advance the adoption of its LinearDNA manufacturing platform.

Roth Capital Partners served as sole placement agent for the transaction.

The shares of common stock (or common stock equivalents) described above (but not the warrants or the shares of common stock underlying the warrants) are being made pursuant to a shelf registration statement on Form S-3 (File No. 333-238557) (including a prospectus) previously filed with the Securities and Exchange Commission (the "SEC") on May 21, 2020, and declared effective by the SEC on June 1, 2020. A prospectus supplement and the accompanying prospectus relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. When available, copies of the prospectus supplement and the accompanying prospectus relating to the offering may also be obtained by contacting Roth Capital Partners, LLC, 888 San Clemente Drive, Newport Beach, California 92660, by calling (800) 678-9147 or by e-mail at [email protected].

The warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.

This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.