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Biodesix Announces Fourth Quarter and Year End 2021 Results and Highlights

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 [SID1234610063]).

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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 compaable 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.

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.

Impact Therapeutics Announces Completion of Series D1 Financing

On March 14, 2022 IMPACT Therapeutics, a biopharmaceutical company dedicated to the discovery and development of targeted anti-cancer therapeutics based on synthetic lethality, reported the successful completion of its Series D1 financing (Press release, Impact Therapeutics, MAR 14, 2022, View Source [SID1234610060]). Institutional investors that participated in this round include new investors Dingxin Capital, CCBT, C&D EMERGING CAPITAL, Bestride, Exome Asset Management led by Sam Isaly, along with existing shareholders LAV (Lilly Asia Ventures), China Summit, and Yuexiu. Proceeds will be used to accelerate the development of its synthetic lethality programs, many of which are showing best-in-class potential.

IMPACT Therapeutics is a biopharmaceutical company dedicated to the discovery and development of targeted anti-cancer therapeutics based on synthetic lethality. In 2021, IMPACT achieved breakthroughs on multiple targets including PARP, Wee1, and ATR, becoming one of the biotech companies with the widest DDR pipelines in the world and is expanding to other novel synthetic lethality targets to broaden its pipelines. Today, the company already has three synthetic lethality compounds in the clinical stage.

Dr. Jun Bao, President and CEO of IMPACT Therapeutics said: "We thank these excellent investment institutions for their support and trust in IMPACT. The successful closing gave us more confidence to implement our global development strategy and advance various clinical trials at full speed. We look forward to working with clinical investigators and other partners to bring more efficacious therapies to patients around the world."

IDEAYA and Pfizer Expand Clinical Trial Collaboration and Supply Agreements for Evaluation of Darovasertib and Crizotinib Combination in Metastatic Uveal Melanoma and Additional cMET-Driven Tumors

On March 14, 2022 IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a synthetic lethality focused precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported that it has entered into additional clinical trial collaboration and supply agreements with Pfizer Inc. (NYSE: PFE) to support further evaluation of darovasertib and crizotinib combination therapy in a Phase 2 potential registration-enabling clinical trial in patients with metastatic uveal melanoma (MUM) and in a Phase 1 clinical trial in patients with cMET-driven tumors, such as hepatocellular carcinoma (HCC) and/or non-small cell lung cancer (NSCLC) (Press release, Ideaya Biosciences, MAR 14, 2022, View Source [SID1234610059]).

IDEAYA is currently evaluating the combination of darovasertib, a PKC inhibitor, and crizotinib, a cMET inhibitor, in patients with metastatic uveal melanoma (MUM) and in patients with GNAQ or GNA11 mutant skin melanoma in an ongoing Phase 1/2 clinical trial, pursuant to a clinical trial collaboration and supply agreement with Pfizer.

"We are pleased to have Pfizer’s support in connection with a potential registrational clinical trial as our clinical data on the darovasertib / crizotinib combination in MUM continues to mature. Our preliminary clinical data on the darovasertib and crizotinib combination in MUM, reported in December 2021, showed robust clinical activity with a manageable side effect profile. We have an opportunity to positively impact the treatment of patients in this high unmet medical need population," said Dr. Matthew Maurer, M.D., Vice President and Head of Clinical Oncology and Medical Affairs at IDEAYA Biosciences.

"The clinical efficacy of the combination therapy in MUM patients provides proof of concept for potential expansion opportunities in other cMET-driven tumors. We believe that the darovasertib and crizotinib combination therapy can potentially improve on current standard of care treatment paradigms, for example in HCC, where response rates are modest," added Michael White, Ph.D., Senior Vice President and Chief Scientific Officer at IDEAYA Biosciences.

IDEAYA is targeting a clinical data update for its Phase 1/2 clinical trial evaluating the darovasertib and crizotinib combination in MUM in mid-year 2022, including tolerability and clinical efficacy. IDEAYA is also planning to seek FDA regulatory guidance for potential registration-enabling trial design to evaluate darovasertib and crizotinib combination in MUM in mid-year 2022. The timing of the clinical data and FDA regulatory guidance may be influenced by data maturity, including for example, appropriate interim assessments of supportive median duration of response (DoR) and/or median progression free survival (mPFS).

NuclixBio Announces a Collaborative Research Agreement with PharmAbcine

On March 14, 2022 NuclixBio Inc., a South Korean biotech company that focuses on research and development of mRNA therapeutics, reported that it has signed a Collaborative Research Agreement with PharmAbcine Inc. (KOSDAQ: 208340ks), a clinical-stage biotech company focusing on the development of next-generation antibody therapeutics (Press release, PharmAbcine, MAR 14, 2022, View Source [SID1234610058]).

Under the agreement, both companies will conduct collaborative research utilizing NuclixBio’s proprietary circular mRNA platform named ‘ringRNA’ to develop novel mRNA therapeutics that can generate PharmAbcine’s antibodies. These novel therapeutics will express antibodies intracellularly to target human TIE2 receptors present on epithelial cells.

The newly developed drugs based on circular mRNA can have a better therapeutic effect compared to conventional linear mRNA-based therapies due to the proven prolonged half-life of circular mRNA. The circular form of mRNA also allows ribosomes, the particles that function to synthesize proteins, to continuously circulate around the loop of mRNA to produce a greater quantity of polypeptides, including therapeutic antibodies. Thus, the elongated half-life and therapeutic efficiency can improve patient convenience in terms of drug administration routes and intervals.

"This partnership will give both parties an extraordinary opportunity to utilize advanced proprietary technologies and provide tremendous growth opportunities," said Dr. Jin-San Yoo, CEO of PharmAbcine. "We are thankful for this strategic partnership and are looking forward to developing breakthrough therapeutic approaches that can both expand our pipeline and help patients with unmet medical needs."

"The distinctive feature of our mRNA platform is that we circularize the linear precursor RNAs and make them into circular mRNAs. This method allows more desirable protein expressions in in vivo settings, with higher stability and efficiency. Our ringRNA can be used in a wide range of indications," said Dr. Hoyoung Kang, CEO of NuclixBio. "We are thrilled to have entered this collaborative agreement with PharmAbcine, one of the leading antibody-based therapeutic companies. We hope our collaborative work will show many possibilities and result in the rapid development and expansion of the pipeline assets."

Kairos Pharma Receives FDA Approval of Investigational New Drug (IND) Application for Its Phase 1 Clinical Trial of KROS 201 for the Treatment of Glioblastoma; Announces New Patent for KROS 401

On March 14, 2022 Kairos Pharma, Ltd. ("Kairos"), a privately held clinical stage biotechnology company focused on drug resistance and immunotherapy for cancer, reported that its activated T cell therapy, KROS 201, has received FDA approval to proceed with a Phase 1 clinical trial in patients with recurrent glioblastoma, a type of brain cancer (Press release, Kairos Pharma, MAR 14, 2022, View Source [SID1234610057]). The phase I trial is sponsored by Kairos Pharma and will be conducted at Cedars Sinai Medical Center in Los Angeles.

Kairos CEO John Yu, M.D. commented, "This IND acceptance is the second substantial clinical milestone within the past month as Kairos accelerates toward its clinical goals for 2022. This first-in-man Phase 1 clinical trial will activate T cells against the cancer stem cells at the root of glioblastoma."

Kairos Chief Scientific Officer Neil Bhowmick, Ph.D. added, "This achievement pushes the envelope of immune therapies designed to target T cells against devastating cancers."

KROS 201 activated T cells (ATCs) are killer T cells that are developed in a cell culture by activating a a patient’s white blood cells with cytokines or T cell activating signals and by priming dendritic cells loaded with glioblastoma cancer stem cell specific antigens. The potent activated T cells are infused intravenously into patients with recurrent glioblastoma. These cells have been shown to kill cancer stem cells, the root cause of cancer.

In addition to the upcoming Phase 1 trial of activated T cell therapy for KROS 201, a Phase 2 trial of ENV105 with apalutamide was recently granted an IND by the FDA in February. A Phase 1 trial of ENV105 with Tagrisso (AstraZeneca) for lung cancer is planned to start in 2022.

Along with this advancement of its clinical milestones, Kairos Pharma announced a notice of allowance of the United States Patent and Trademark Office of their patent Compositions and Methods for Treating Fibrosis. This patent covers the method of treating fibrosis and certain forms of cancer, the composition of matter, and administering a therapy using KROS-401, a cyclic peptide inhibitor of the IL-4 and IL-13 cytokine receptor complex. This therapeutic has been shown to treat both fibrosis and cancer by reversing the M1 to M2 immunosuppressive macrophage transition in both cancers and fibrosis.

Dr. John Yu, CEO of Kairos Pharma stated, "This milestone further supports the already substantial and diversified intellectual property portfolio of Kairos and enables the unfettered clinical development of this novel and transformative therapeutic."

Kairos VP of Research and Development Dr. Ramachandran Murali, inventor of the KROS 401 molecule, commented, "KROS-401, in addition to fibrosis and cancer, opens a new avenue in therapeutic development for neurological disorders such as Alzheimer’s disease."