On November 10, 2021 Kaleido Biosciences, Inc. (Nasdaq: KLDO), a clinical-stage biotech company with a differentiated, small-molecule approach to treating inflammatory conditions and diseases by selectively targeting the resident microbiome to restore gut-immune homeostasis, reported the appointment of Alison Long, M.B.B.Ch., Ph.D., to its leadership team as Chief Medical Officer, effective December 15, 2021 (Press release, Kaleido Biosciences, NOV 10, 2021, View Source [SID1234595120]). In her new role, Dr. Long will be responsible for leading the development of Kaleido’s ongoing and future clinical programs, including the development of KB295 and KB109 in ulcerative colitis and chronic obstructive pulmonary disease, respectively.

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"Alison is an exciting addition to our team who will play a critical role as we continue preparations to advance our two lead programs into Phase 2 clinical trials under IND and CTA next year," said Dan Menichella, President and Chief Executive Officer of Kaleido. "Her extensive experience in drug development, which includes leading five clinical programs to regulatory approvals, will be invaluable as Kaleido moves towards advancing our Microbiome Metabolic Therapies into multiple indications. Additionally, she will lead our medical affairs team as well as support translational microbiome research and the development of further new drug development candidates."

"I am honored to be joining this talented team at Kaleido during a pivotal stage of growth for the Company," said Dr. Long. "There are significant opportunities to leverage the immunomodulatory potential of the human microbiome to treat disease. The data thus far has demonstrated Kaleido’s differentiated Microbiome Metabolic Therapy approach is the key to unlocking that potential. I look forward to working with the Kaleido team and applying important learnings from recent clinical readouts to continue this forward momentum and advancement of our clinical development activities."

Dr. Long has almost two decades of experience working in the pharmaceutical and biotechnology industry, and a proven track record developing therapies, which include five successful regulatory approvals over her career. She most recently served as interim Chief Medical Officer and Senior Vice President, Head of Clinical Development at Freeline Therapeutics, and was responsible for the clinical development, clinical operations, medical affairs, and regulatory functions of Freeline’s development programs. Prior to her role at Freeline, she served as Head of Clinical Research and Development at Spark Therapeutics, where she oversaw the scientific and clinical development of all programs, including gene therapy in Huntington’s and Pompe diseases, as well as Inherited Retinal Disorders. Dr. Long has also previously served as Vice President, Clinical Development, Hemophilia at uniQure, Vice President, Head of Clinical at Aegerion Pharmaceuticals, and Medical Director with Biogen, where she focused on the development and subsequent EU approval of Elocta. Prior to her executive positions, Dr. Long was a physician scientist at AFG Biosolutions and The Institute for Ethnomedicine, after spending 12 years as a practicing physician. She received her medical degree from the University of Witwatersrand, and Ph.D. in biodefense from George Mason University.

On November 10, 2021 Boundless Bio, a next-generation precision oncology company developing innovative therapeutics directed against extrachromosomal DNA (ecDNA) in aggressive cancers, reported that Chief Business Officer, Neil Abdollahian, will present at the Stifel 2021 Virtual Healthcare Conference which will be webcast on Wednesday, November 17th, 2021, at 12:20 p.m. PST/3:20 p.m. EST (Press release, Boundless Bio, NOV 10, 2021, View Source [SID1234595137]).

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On November 10, 2021 Ampio Pharmaceuticals, Inc. (NYSE American: AMPE), a biopharmaceutical company focused on the advancement of immunomodulatory therapies for common inflammatory conditions, reported results for the three- and nine-month periods ended September 30, 2021 and provided a corporate overview and business update (Press release, Ampio, NOV 10, 2021, View Source [SID1234595153]).

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Ms. Holli Cherevka, President and Chief Operating Officer, commented, "This quarter marked an exciting period of growth for drug development in the Ampion platform therapy, both in clinical and preclinical development.

We have locked the osteoarthritis Phase 3 pivotal trial database, and are currently analyzing the data, which may provide a significant treatment option for an unmet medical need in severely disabled patients.

We have commenced the enrollment and treatment of COVID-19 patients in India for the Phase 2 AP-019 study utilizing inhaled Ampion therapy compared to control.

Furthermore, we continue to investigate Ampion’s potential in new indications within the preclinical space, most recently publishing data supportive of application in acute kidney injury, and in the autoimmune space relating to lupus nephritis. This early data suggests we may still be just scratching the surface of Ampion’s potential."

Ms. Holli Cherevka, President and Chief Operating Officer, Howard Levy, M.B.B.Ch., Ph.D., M.M.M., Chief Medical Officer, David Bar-Or, MD, Director and Founder, and Mr. Daniel Stokely, Chief Financial Officer will be hosting a Conference Call for the Investment Community this afternoon beginning at 4:30 PM ET (see details below).

The key areas of focus during the call will be clinical and preclinical updates, as well as the financial results for the three and nine-month period ended September 30, 2021.

SEPTEMBER 30, 2021 FINANCIAL RESULTS

Cash and cash equivalents totaled $17.1 million as of September 30, 2021, compared to $17.3 million on December 31, 2020. The decrease of $0.2 million, or 1%, is primarily attributable to cash required to fund the operating activities of $10.4 million; partially offset by net proceeds received from the utilization of the at-the-market equity offering program and stock option / warrant exercises of $10.0 million and $0.2 million, respectively.

Research and Development Expenses: R&D expenses for the three months ended September 30, 2021 increased by $0.9 million, or 57%, from R&D expenses for the three months ended September 30, 2020. The increase was primarily attributable to costs associated with the continuation of the Phase I / II COVID studies and outsourced CRO efforts focused on finalizing the validation and quality review of the AP-013 study database.

R&D expenses for the nine months ended September 30, 2021 increased by $0.1 million, or 2%, from R&D expenses for the nine months ended September 30, 2020. The net increase was primarily attributable to an overall increase in pre-clinical research and production of clinical trial product totaling $ 0.8 million. These increases were partially offset by a decrease in clinical trial and sponsored research expenses during the current period of $0.5 million, attributable to the pause of the AP-013 study in April 2020, which was partially offset by the incremental costs associated with the validation and quality review of AP-013 database and incremental costs associated with the Phase I / II COVID-19 studies conducted during the current period.

General and Administrative Expenses: G&A expenses for the three months ended September 30, 2021, decreased by approximately $0.4 million, or 24%, from G&A expenses for the three months ended September 30, 2020. G&A expenses for the nine months ended September 30, 2021, decreased by approximately $0.7 million, or 15%, from G&A expenses for the nine months ended September 30, 2020. The decrease for both periods was primarily attributable to a decrease in litigation-related legal costs and commercial insurance costs.

The total shares of common stock outstanding were 200,458,263 on September 30, 2021, compared to 193,378,996 on December 31, 2020.

Financial Guidance

Based on its current projection and expected access to equity financing, Ampio expects to have cash and cash equivalents along with access to external sources of liquidity sufficient to fund its business operations through the first quarter of 2023.

Conference Call & Webcast:

In order to submit questions, participants must have internet connectivity, as questions will only be addressed via the webcast. The conference call line will be in listen only mode.

The conference call and webcast can also be accessed from the Investor Relations section of the Company’s website at www.ampiopharma.com and will be archived there shortly after the live event.

On November 10, 2021 Recursion (Nasdaq : RXRX), a clinical-stage biotechnology company decoding biology by integrating technological innovations across biology, chemistry, automation, data science and engineering, reported business updates and financial results for its third quarter ending September 30, 2021 (Press release, Recursion Pharmaceuticals, NOV 10, 2021, View Source [SID1234595223]).

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"In Q3, our team made progress towards our vision to industrialize drug discovery. We are now harvesting the efforts of the past few years to build a map of human cellular biology through the continued refinement and increased usage of our inference-based approach to drug discovery. With the power of our Recursion Map illuminating new and exciting relationships in biology, we are now deeply focused on extending our chemistry capabilities to significantly improve, scale and speed up new chemical entity development to address the plethora of novel biological relationships we are discovering," said Recursion Co-Founder & CEO Chris Gibson, Ph.D. "In addition, our rapidly growing development team is preparing for our four clinical-stage programs to initiate Phase 2 or Phase 2/3 studies in the first half of 2022, including two of the programs that we expect will enroll their first patients in early 2022. To facilitate our broad ambition, we continue to rapidly grow our workforce while nurturing Recursion’s culture and community."

Recursion finished the third quarter of 2021 with a portfolio of 4 clinical stage programs, 4 preclinical programs, 7 late discovery programs, and 41 early discovery programs. Additionally, Recursion continued scaling the total number of executed phenomic experiments to approximately 95 million, the size of its proprietary data universe to over 11 petabytes, and the number of biological inferences to approximately 200 billion. Data have been generated on the Recursion OS across 38 human cell types, an in-house chemical library of over 717 thousand compounds, and an in silico library of 12 billion small molecules, by a growing team of more than 330 Recursionauts that is balanced between life scientists and computational and technical experts.

Summary of Business Highlights

Clinical Programs
Neurofibromatosis type 2 (NF2) (REC-2282): In early October we received Fast Track Designation for REC-2282 from the FDA for the potential treatment of NF2 meningiomas. We plan to initiate a parallel group, two stage, Phase 2/3, randomized, multicenter study in early 2022.
Cerebral cavernous malformation (CCM) (REC-994): We plan to initiate a Phase 2, double-blind, placebo-controlled safety, tolerability and exploratory efficacy study of this candidate in early 2022.
Familial adenomatous polyposis (FAP) (REC-4881): In September we received Orphan Drug Designation for REC-4881 from the FDA for the potential treatment of Familial Adenomatous Polyposis. We plan to initiate a Phase 2, randomized, double-blind, placebo-controlled study to evaluate safety, pharmacokinetics and efficacy in the first half of 2022.
GM2 gangliosidosis (REC-3599): We plan to initiate a Phase 2 study of this candidate in the first half of 2022.
Preclinical Programs
Clostridium difficile colitis (REC-3964): We expanded our medicinal chemistry team and digital chemistry tools and made progress in IND-enabling studies for REC-3964, which is the most advanced New Chemical Entity developed by the Recursion OS.
Bayer AG Partnership: We continue to advance our collaboration with Bayer to discover small molecule drug candidates with the potential to treat fibrotic diseases. We have multiple programs progressing simultaneously with our partner.
Recursion OS
Biological Contexts: We advanced our capabilities to model diseases in multiple biological contexts, including new types of biological perturbations beyond CRISPR-based knockouts, complex cell type onboarding, and organoid model systems. Moreover, we made progress on multiple maps in iPSC-derived neural cell types.
Mechanisms of Action: We improved our computational methods to identify mechanisms of action and used this technology to increase our ability to screen out compounds with potentially toxic effects for multiple programs earlier than is possible with traditional approaches. We believe that such methods will better enable us to advance the most promising novel chemical compounds through discovery.
Transcriptomics Validation: We made significant improvements to our transcriptomics protocols to enable increases in throughput. Additionally, we have been optimizing our ability to use transcriptomics signatures for compound characterization.
Facilities and Manufacturing: We continued to make progress in expanding our current headquarters and creating a chemistry, manufacturing and controls (CMC) site in Salt Lake City. These spaces are designed with flexibility in mind to enable next-generation automated workflows and instruments for compound, tissue culture, and biobank management to further industrialize the drug discovery and development process.
Third Quarter 2021 Financial Results

Cash Position: Cash, cash equivalents, and investments were $578.9 million as of September 30, 2021.
Revenue: Total revenue, consisting primarily of revenue from collaborative agreements, was $2.5 million for the third quarter of 2021, compared to $1.0 million for the third quarter of 2020. The increase was due to revenue recognized from our collaboration with Bayer.
Research and Development Expenses: Research and development expenses were $33.2 million for the third quarter of 2021, compared to $16.5 million for the third quarter of 2020. The increase in research and development expenses was primarily due to an increased number of experiments run on the Recursion OS, an increased number of assets being validated, and increased clinical costs as studies progressed.
General and Administrative Expenses: General and administrative expenses were $15.7 million for the third quarter of 2021, compared to $7.0 million for the third quarter of 2020. The increase in general and administrative expenses was due to the growth in size of the company’s operations, including an increase in salaries and wages of $3.7 million, equipment costs, human resources-related costs, facilities costs, and other administrative costs associated with operating a high-growth company.
Net Loss: Net loss was $47.4 million for the third quarter of 2021, compared to a net loss of $23.9 million for the third quarter of 2020.
Additional Corporate Updates

Operations in Canada: Jordan Christensen joined Recursion as Vice President, Engineering and also became our Toronto Site Lead. Additionally, we opened our Montreal office and hired multiple machine learning research scientists.
Translational Biology: Alison O’Mahony, Ph.D., joined Recursion as Vice President, Discovery Platform and will be responsible for continued scaling and improvement of Recursion’s orthogonal validation and bespoke validation assays to continue driving down the time from initial discovery to clinical development. Dr. O’Mahony previously served as Vice President, Translational Biology at Eurofins Discovery.
Information Security: Ganesh Jagannathan joined Recursion as Chief Information Security Officer & Vice President, Information Technology and will be responsible for all strategic, innovative and operational aspects of Information Security and Information Technology. Mr. Jagannathan previously served as Chief Information Security Officer at Jazz Pharmaceuticals.
CEO Rule 10b5-1 Plans: Chris Gibson, Ph.D., the company’s Co-Founder and CEO, established personal stock trading plans in the second quarter of 2021 in accordance with Rule 10b5-1 under the Securities and Exchange Act of 1934 and Recursion’s insider trading policy. Under the plans, all outstanding stock options may be exercised and we anticipate shares representing up to approximately 4% of Dr. Gibson’s holdings may be sold or transferred to donor-advised philanthropic funds. We anticipate the Rule 10b5-1 transactions may take place over the next 13 months. Any such transactions will be disclosed through public filings as required by the SEC.

On November 10, 2021 aTyr Pharma, Inc. (Nasdaq: LIFE), a biotherapeutics company engaged in the discovery and development of innovative medicines based on novel biological pathways, reported third quarter 2021 results and provided a corporate update (Press release, aTyr Pharma, NOV 10, 2021, View Source [SID1234595274]).

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"The third quarter was a major inflection point for aTyr; we demonstrated, via clinical proof-of-concept data for ATYR1923, that our novel tRNA synthetase biology platform has the potential to treat serious diseases," said Sanjay S. Shukla, M.D., M.S., President and Chief Executive Officer of aTyr. "The positive results reported from our Phase 1b/2a study of ATYR1923 in pulmonary sarcoidosis, our initial interstitial lung disease (ILD) indication, suggest that ATYR1923 could be a transformative therapy for patients by reducing steroid burden while improving lung function and measures of sarcoidosis symptoms. We look forward to advancing ATYR1923 to a registrational trial in pulmonary sarcoidosis next year, which will bring us one step closer to delivering a potential new treatment to sarcoidosis patients with clinically meaningful outcomes."

Third Quarter 2021 and Subsequent Period Highlights

Reported positive results from a Phase 1b/2a multiple-ascending dose, placebo-controlled study of ATYR1923 in 37 patients with pulmonary sarcoidosis. ATYR1923 was safe and well-tolerated at all doses with no drug-related serious adverse events or signal of immunogenicity. Additionally, the study demonstrated consistent dose response for ATYR1923 on key efficacy endpoints and improvements compared to placebo, including measures of steroid reduction, lung function, sarcoidosis symptom measures and inflammatory biomarkers. Based on the results of the study, the company expects to initiate a registrational trial in pulmonary sarcoidosis next year. Furthermore, the data support the expansion of the development of ATYR1923 in other forms of ILD, such as connective tissue disease-related ILD and chronic hypersensitivity pneumonitis.
Announced the presentation of preclinical research demonstrating the effects of ATYR2810, the company’s lead anti-Neuropilin-2 (NRP2)/VEGF antibody and IND candidate, on tumor associated macrophages at the 2021 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting. Treatment of human triple-negative breast cancer cells with ATYR2810 was shown to modulate key immune cells suppressing T-cell mediated anti-tumor responses in the tumor microenvironment and decrease ZEB1 gene expression, a master transcription factor regulating epithelial-mesenchymal transition, a process that is of great importance in regulating tumor growth, progression and metastatic cascade. These data advance the understanding of ATYR2810’s mechanism of action and the process by which it may inhibit tumor progression and disrupt immune invasion and will support clinical development for ATYR2810, including a planned Phase 1 study in cancer next year.
Appointed Robert W. Ashworth, PhD, as Vice President of Regulatory Affairs. Dr. Ashworth is an industry veteran with more than 35 years of regulatory and drug development experience, including a track record of contributing to the FDA approval of more than 12 new drugs. Dr. Ashworth will serve as a member of the company’s executive leadership team, overseeing regulatory affairs functions and strategies.
Raised net proceeds of $80.6 million through the issuance of 10,781,250 shares of common stock in September 2021 from a public offering.
Third Quarter 2021 Financial Highlights

Cash & Investment Position: Cash, cash equivalents and investments as of September 30, 2021 were $116.4 million.
R&D Expenses: Research and development expenses were $5.1 million for the third quarter of 2021, which consisted primarily of product development costs for ATYR1923 and ATYR2810 programs.
G&A Expenses: General and administrative expenses were $2.6 million for the third quarter of 2021.
Shares Outstanding: Commons shares outstanding were 27,790,677 as of September 30, 2021.
Conference Call and Webcast Details

aTyr will host a conference call and webcast today at 5:00 p.m. Eastern Time / 2:00 p.m. Pacific Time to discuss its financial results and provide a corporate update. Interested parties may access the call by dialing toll-free 844-358-9116 from the US, or 209-905-5951 internationally and using conference ID 9134928. Links to a live audio webcast and replay may be accessed on the aTyr website events page at: View Source An audio replay will be available for at least 90 days following the event.

About ATYR1923

aTyr is developing ATYR1923 as a potential therapeutic for patients with severe inflammatory lung diseases. ATYR1923, a fusion protein comprised of the immuno-modulatory domain of histidyl-tRNA synthetase fused to the FC region of a human antibody, is a selective modulator of neuropilin-2 that downregulates innate and adaptive immune response in inflammatory disease states. aTyr’s lead indication for ATYR1923 is pulmonary sarcoidosis, a major form of interstitial lung disease. Clinical proof-of-concept for ATYR1923 was recently established in a Phase 1b/2a multiple-ascending dose, placebo-controlled study of ATYR1923 in patients with pulmonary sarcoidosis, which demonstrated safety and a consistent dose response and trends of benefit of ATYR1923 compared to placebo on key efficacy endpoints, including steroid reduction, lung function, clinical symptoms and inflammatory biomarkers.