On August 13, 2021 Recursion (Nasdaq: RXRX), a clinical-stage biotechnology company decoding biology by integrating technological innovations across biology, chemistry, automation, data science, and engineering, reported financial results and business updates for its second quarter ending June 30, 2021 (Press release, Recursion Pharmaceuticals, AUG 13, 2021, View Source [SID1234586552]).

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"We are excited with how Recursion is expanding across many fronts in order to deliver on our mission to decode biology to radically improve lives," said Recursion Co-Founder & CEO Chris Gibson, PhD. "Not only is the company continuing to advance and expand the total number of its research and development programs, but we are expanding our operations to Canada to grow our capabilities and workforce and we are enhancing our expertise in research and development by forming a Therapeutics Advisory Board. Moreover, the company continues to build on its medicinal chemistry expertise, resulting in our first internally-developed new chemical entity being advanced to IND-enabling studies for potential treatment of C. difficile colitis."

Recursion finished the second quarter of 2021 with a portfolio of 4 clinical stage programs, 4 preclinical programs, 7 late discovery programs, and 33 early discovery programs, for a total of 48 research and development programs. Additionally, Recursion continued scaling the total number of executed phenomic experiments to over 82 million, the size of its proprietary data universe to approximately 9 petabytes, and the number of biological inferences to over 179 billion. Data have been generated across 37 human cell types, an in-house chemical library of over 706 thousand compounds, an in silico library of over 12 billion small molecules, and a growing team of more than 270 Recursionauts that is balanced between life scientists and computational and technical experts. The power of the Recursion OS is exemplified by the breadth of active research and development programs.

Summary of Business Highlights

Clinical Programs
Familial adenomatous polyposis (FAP) (REC-4881): We plan to initiate a Phase 2, randomized, double-blind, placebo-controlled study to evaluate safety, pharmacokinetics, and efficacy of REC-4881 in classical FAP patients within the next 3 to 4 quarters.
Cerebral cavernous malformation (REC-994): We plan to initiate a Phase 2, double-blind, placebo-controlled safety, tolerability and exploratory efficacy study of REC-994 in the next 3 to 4 quarters.
Neurofibromatosis type 2 (REC-2282): We plan to initiate a parallel group, two stage, Phase 2/3, randomized, multicenter study within the next 3 to 4 quarters.
GM2 gangliosidosis (REC-3599): We plan to initiate a Phase 2 trial in the next 3 to 4 quarters.
Notable Preclinical Programs
Clostridium difficile colitis (REC-3964): REC-3964 is an orally active, gut biased, small molecule C. difficile toxin B inhibitor, selected as Recursion’s first internally-developed new chemical entity (NCE) to advance to investigational new drug (IND)-enabling studies.
Immune checkpoint resistance in STK11-mutant non-small cell lung cancer (NSCLC): The lead molecule has completed dose optimization studies and has advanced into pharmacodynamic studies in rodent NSCLC models of STK11-mediated checkpoint resistance.
Notable Late Discovery Programs
Cancer immunotherapy, target ‘alpha’: Undisclosed target ‘alpha’ was selected based on an inferential assessment of the strength of its relationship to known genes impacting immunotherapy response. A small molecule inhibitor of target alpha demonstrated robust single agent and combination activity with anti-PD1 in a CT26 model of immune checkpoint resistance, achieving 40% complete response in the combination arm.
Neuroinflammation: Multiple molecules from the lead chemical series demonstrated attenuated anti-inflammatory cytokine responses in a mouse pharmacodynamic model of neuroinflammation.
Oncology – small molecule MYC Inhibitors: Digital chemistry tools expanded multiple hit series with evidence of structure activity relationship. Multiple series are prioritized and undergoing optimization.
Batten disease: Multiple small molecule candidates are being evaluated in rodent pharmacodynamic models of Batten disease.
Charcot-Marie-Tooth type 2A (CMT2A): Multiple small molecule mechanistic classes will be assessed in a rodent model of CMT2A.
Bayer AG Partnership: We continue to make progress in our collaboration with Bayer to discover small molecule drug candidates with the potential to treat fibrotic diseases. In the collaboration’s first year we have developed novel disease models and successfully leveraged the Recursion Operating System, or Recursion OS, to identify numerous active molecules and promising chemical families.
Platform
PhenoMap Extensions: We began generating arrayed whole genome knockout and compound library PhenoMaps in two additional cell types. Additionally, we have made substantial progress in onboarding astrocytes as our first neuronal cell type.
Chemical Technology: Over the past quarter, we have incorporated additional virtual chemical library search methods into our digital chemistry tools and have begun reading out positive results from our first large-scale expansion searches for our NCE programs.
Orthogonomics: We have more than doubled the total number of genes and proteins measured in transcriptomic and proteomic experiments during the past quarter, leveraging these studies across multiple programs to discover new in vitro disease biomarkers that we may use to assess the efficacy of compounds.
Facilities and Manufacturing: We have two construction projects in progress to expand our current headquarters and create a chemistry, manufacturing and controls (CMC) site in Salt Lake City. The expansion will allow us to improve our current platform by increasing capacity and automation, growing our compound and biobank libraries, further scaling proteomics and transcriptomics capabilities, and beginning the buildout of automated chemical compound microsynthesis. The CMC site will bolster our capabilities in analytical and formulation chemistry as well as small molecule manufacturing for early clinical trials for a subset of our key programs.
Expanding Operations to Canada: We announced our intention to launch our first major expansion beyond our Salt Lake City headquarters, with Toronto to serve as a multidisciplinary hub across data science, machine learning, engineering and computational biology. Additionally, we announced a multi-year collaboration with Mila, the Quebec Artificial Intelligence Institute, to accelerate Recursion’s machine learning capabilities.
Second Quarter 2021 Financial Results

Cash Position: Cash and cash equivalents were $632.7 million as of June 30, 2021 and included net proceeds of $462.4 million from the company’s April 2021 initial public offering.
Revenue: Total revenue, consisting primarily of revenue from collaborative agreements, was $2.5 million for the second quarter of 2021, compared to $186 thousand for the second quarter of 2020. The increase was primarily due to progress in our collaboration with Bayer.
Research and Development Expenses: Research and development expenses were $29.6 million for the second quarter of 2021, compared to $13.2 million for the second quarter of 2020. The increase in research and development expenses was primarily due to an increased number of experiments run through the Recursion OS, an increased number of preclinical assets being validated, and increased clinical study-related costs.
General and Administrative Expenses: General and administrative expenses were $13.9 million for the second quarter of 2021, compared to $5.2 million for the second quarter of 2020. The increase in general and administrative expenses was due to growth in size of the company’s operations, including an increase in salaries and wages of $5.7 million, equipment costs, human resources-related costs, facilities costs, finance costs and other administrative costs associated with operating a high-growth company.
Net Loss: Net loss was $43.4 million for the second quarter of 2021, compared to a net loss of $18.9 million for the second quarter of 2020.
Other Corporate Updates

Therapeutics Advisory Board: A Therapeutics Advisory Board is being formed to advise Recursion’s executive team and Board of Directors regarding key research and development issues. The Therapeutics Advisory Board is chaired by Joseph Miletich, MD, PhD, who previously was Merck Research Laboratories’ Senior Vice President of Research Sciences and is currently Senior Scientific Advisor to Merck’s CEO.
Altitude Lab: Altitude Lab, a healthcare and life sciences incubator co-founded by Recursion in 2020, announced the launch of its Investor Coalition to fund, mentor, and provide resources for Altitude-incubated startups in Utah. The Investor Coalition aims to collectively invest $50 million in Altitude’s startups over the next three years.
Equity Index Inclusion: In Q2 2021, Recursion was added to a number of equity indices including the CRSP US Total Market, NASDAQ Composite, Russell 2000, Russell 3000, and S&P Total Market indices. These indices determine membership primarily by objective, market-capitalization rankings and style attributes.

On August 13, 2021 PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a clinical-stage biotherapeutics company dedicated to discovering, developing and commercializing highly differentiated medicines for devastating diseases, reported the appointment of Julie Krop, M.D., as Chief Medical Officer (Press release, PureTech Health, AUG 13, 2021, View Source [SID1234586551]). Dr. Krop will oversee all clinical development, regulatory, CMC, and medical affairs for the Company’s advancing Wholly Owned Pipeline.

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"We are pleased to welcome Julie to our senior leadership team as our Wholly Owned Pipeline rapidly grows and advances across multiple areas of significant patient need," said Daphne Zohar, Founder and Chief Executive Officer of PureTech. "Julie is a biopharmaceutical industry veteran with a wide breadth of expertise across multiple therapeutic areas and orphan indications. Over the course of her career, she has overseen development of eight therapeutics that advanced through Phase 3, including three FDA approvals. We believe her expertise in mid- to late-stage clinical development, in addition to her extensive experience as a board-certified physician and leader in regulatory affairs, will be important assets as we advance our lead program, LYT-100, towards potential registration-enabling development in idiopathic pulmonary fibrosis and potentially other progressive fibrosing interstitial lung diseases."

Dr. Krop joins PureTech from Freeline Therapeutics, a clinical-stage gene therapy company, where she served as Chief Medical Officer. Prior to this role, Dr. Krop served as Chief Medical Officer of AMAG Pharmaceuticals (acquired by Covis group for $647 million), where she oversaw clinical development, regulatory affairs, clinical operations, medical affairs, program management and pharmacovigilance. During her time at AMAG, Dr. Krop was responsible for the oversight of three FDA approvals. Earlier in her career, she held leadership positions at Vertex Pharmaceuticals, Stryker Regenerative Medicine, Peptimmune, Millennium Pharmaceuticals and Pfizer. Dr. Krop received her M.D. from Brown University School of Medicine and completed an internal medicine residency at Georgetown University Hospital. Additionally, she completed fellowships in epidemiology, clinical trial design and endocrinology as a Robert Wood Johnson Foundation Clinical Scholar at the Johns Hopkins School of Medicine.

"I am thrilled to join the leadership team at PureTech during such an exciting time in the Company’s growth and clinical development," said Dr. Krop. "PureTech’s research and development model is a truly unique approach that has fostered a broad wealth of expertise within the Company that now powers the team’s innovative development efforts across multiple therapeutic candidates. I look forward to helping drive PureTech’s mission and advancing an incredibly promising pipeline of investigational therapies for patients in need."

On August 13, 2021 Protalix BioTherapeutics, Inc. (NYSE American:PLX) (TASE:PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx plant cell-based protein expression system, reported the entry into definitive agreements (the "Exchange Agreements") relating to exchanges (the "Exchanges") of an aggregate of $54.65 million principal amount of the Company’s outstanding 7.50% Senior Secured Convertible Notes due 2021 (the "Existing Notes") for an aggregate of $28.75 million principal amount of newly issued 7.50% Senior Secured Convertible Notes due 2024 (the "Exchange Notes"), $25.90 million in cash and accrued and unpaid interest through the closing date (Press release, Protalix, AUG 13, 2021, View Source [SID1234586550]). The Exchanges are expected to close as soon as practicable, subject to satisfaction of certain closing conditions. Following the closing of the Exchanges, the Company expects that $3.27 million aggregate principal amount of the Existing Notes will remain outstanding.

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"The exchange of the notes underscores Protalix’s commitment to addressing our capital structure while continuing development of our pegunigalsidase alfa program and our early pipeline," said Dror Bashan, Protalix’s President and Chief Executive Officer. "We believe that the participation of so many of our institutional note holders, including funds managed by Highbridge Capital Management, LLC, UBS O’Connor LLC, Citigroup Global Markets, Whitebox Advisors, and Tulip Capital, is a telling vote of confidence in Protalix."

Like the Existing Notes and at equal priority, the Exchange Notes will be secured by perfected liens on all of the material assets of the Company and its subsidiaries. Interest on the Exchange Notes will be payable semi-annually at a rate of 7.50% per annum. The Exchange Notes will mature three years after issuance, unless earlier purchased, converted, exchanged or redeemed, and will be guaranteed by the Company’s subsidiaries.

Holders may require the Company to repurchase their Exchange Notes upon the occurrence of certain events that constitute a fundamental change under the indenture that will govern the Exchange Notes (the "Indenture") at a purchase price equal to the principal amount thereof plus accrued and unpaid interest to, but excluding, the fundamental change purchase date.

Holders may convert their Exchange Notes at any time prior to the close of business on the business day immediately preceding the stated maturity date of the Exchange Notes. Upon conversion, the Company may, at its election, deliver shares of the Company’s common stock ("Common Stock"), cash or a combination of shares of Common Stock and cash based on the applicable conversion rate. However, until the Company obtains stockholder approval to issue additional shares of Common Stock upon conversion of the Exchange Notes, the Company will be required to settle at least a portion of its conversion obligation in cash. The Company intends to seek stockholder approval promptly in order to be able to settle conversions of the Exchange Notes in Common Stock.

The initial conversion rate will be based on a 32.5% premium to the closing price of the Common Stock on the NYSE American at the close of trading on August 13, 2021.

The Indenture includes covenants customary for instruments of this type, including, without limitation, restrictions on the Company’s ability to incur additional indebtedness, create liens on its properties, pay dividends and make restricted payments or certain investments, and also requires the Company to apply a portion of the proceeds from certain asset sales or licensing arrangements to repay the Exchange Notes, in each case subject to certain exceptions.

"This exchange transaction allows us to continue to advance our lead drug candidate, PRX-102, towards approval and to progress our early stage pipeline candidates," said Eyal Rubin, Protalix’s Sr. Vice President and Chief Financial Officer.

This announcement is neither an offer to sell nor a solicitation of an offer to buy any of these securities and shall not constitute an offer, solicitation, or sale in any jurisdiction in which such offer, solicitation, or sale is unlawful. The offer and sale of the Exchange Notes and the shares of Common Stock issuable upon conversion of the Exchange Notes, if any, will not be registered under the Securities Act of 1933 or any state securities laws, and unless so registered, the Exchange Notes and such shares may not be offered or sold in the United States except pursuant to an exemption from the registration requirements of the Securities Act of 1933 and applicable state laws.

On August 13, 2021 Leap Therapeutics, Inc. (Nasdaq: LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, reported financial results for the second quarter ended June 30, 2021 and provided upcoming company milestones (Press release, Leap Therapeutics, AUG 13, 2021, View Source [SID1234586549]).

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"In the first half of the year, we made significant clinical progress in the DisTinGuish study of DKN-01 in combination with BeiGene’s tislelizumab, as we completed enrollment in the first-line patient cohort," said Douglas E. Onsi, President and Chief Executive Officer of Leap. "We look forward to presenting initial data from the study in September, which we believe will show the important potential role DKN-01 can play for first-line gastric cancer patients, particularly those whose tumors express high levels of DKK1 where a great unmet medical need remains unaddressed."

Key DKN-01 2021 Clinical Milestones

DKN-01 is a humanized monoclonal antibody that binds to and blocks the activity of the Dickkopf-1 (DKK1) protein. DKK1 modulates the Wnt/Beta-catenin and PI3kinase/AKT signaling pathways, which play an important role in tumor cell signaling and in mediating an immuno-suppressive tumor microenvironment through enhancing the activity of myeloid-derived suppressor cells and downregulating NK cell ligands on tumor cells.

Leap made substantial progress with the clinical development of DKN-01 during the first half of 2021 and has an important clinical milestone ahead this quarter:

Completion of Enrollment in First-Line Cohort in the DisTinGuish Study of DKN-01 plus Tislelizumab and Chemotherapy in Gastric Cancer. The Company announced the completion of enrollment for the first-line patient cohort in the DisTinGuish study (NCT04363801), a Phase 2a, open-label, clinical trial evaluating DKN-01 in combination with tislelizumab, BeiGene Ltd.’s (BeiGene) anti-PD-1 antibody, with or without chemotherapy, in patients with gastric or gastroesophageal junction cancer (G/GEJ). The study, which is being conducted in two parts in the United States and the Republic of Korea, enrolled 25 patients with first-line G/GEJ cancer and is expected to enroll up to 48 patients with second-line G/GEJ cancer whose tumors express high levels of DKK1. Leap is conducting this study as part of an exclusive option and license agreement with BeiGene for the development of DKN-01 in Asia (excluding Japan), Australia, and New Zealand.

Initial Data from the DisTinGuish Study of DKN-01 Plus Tislelizumab and Chemotherapy to be Presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2021. The Company will be presenting initial data from the cohort of 25 first-line G/GEJ cancer patients treated with DKN-01 in combination with tiselizumab and chemotherapy at the ESMO (Free ESMO Whitepaper) Congress 2021, being held virtually on September 16-21, 2021. Leap plans to host a conference call on Friday, September 17, 2021 to further discuss the data.

Selected Second Quarter 2021 Financial Results

Net loss was $9.5 million for the second quarter 2021, compared to $6.5 million for the same period in 2020.

License revenues were $0.4 million for each of the second quarter 2021 and the same period in 2020, and relate to the exclusive option and license agreement with BeiGene for the development and commercialization of DKN-01 in Asia (excluding Japan), Australia, and New Zealand.

Research and development expenses were $7.2 million for the second quarter 2021, compared to $5.4 million for the same period in 2020. The increase of $1.8 million in research and development expenses was primarily due to an increase of $0.8 million in payroll and other related expenses due to an increase in headcount of research and development full-time employees, an increase of $0.6 million in manufacturing costs related to clinical trial material due to timing of manufacturing campaigns, an increase of $0.3 million in clinical trial costs due to timing of patient enrollment, and an increase of $0.1 million in stock based compensation expense due to new stock options granted to research and development full-time employees in 2021.

General and administrative expenses were $2.8 million for the second quarter 2021, compared to $2.5 million for the second quarter 2020. The increase of $0.3 million in general and administrative expenses was due to a $0.2 million increase in payroll and other related expenses, a $0.2 million increase in stock-based compensation expense due to new stock options granted to general and administrative full-time employees in 2021, and a $0.1 million increase in insurance costs primarily related to an increase in our directors and officers insurance. These increases were partially offset by a $0.2 million decrease in professional fees primarily due to lower recruiting and information technology costs.

Cash and cash equivalents totaled $35.7 million at June 30, 2021. Research and development incentive receivables totaled $0.2 million at June 30, 2021.

On August 13, 2021 Kiromic BioPharma (NASDAQ: KRBP), a pre-clinical stage biotechnology company using its proprietary DIAMOND artificial intelligence ("A.I.") platform to improve drug discovery and development with a therapeutic focus on immune-oncology, reported its quarterly results for the three and six months ended June 30, 2021, and provided an update on its corporate developments (Press release, Kiromic, AUG 13, 2021, View Source [SID1234586548]).

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"Kiromic achieved important scientific and operational milestones during the first half of the year that we believe have us well positioned for preparing our staff and our facilities for the first in-human dosing during the first quarter of 2022," said Dr. Maurizio Chiriva-Internati, PhD, CEO and President of Kiromic BioPharma.

"We are thankful to our employees and collaborators who have maintained this high level of execution this year. From their efforts, we submitted two investigational new drug applications to the United States Food and Drug Administration in May 2021."

Our approach and goal are to defeat cancer by developing immunotherapies by improving target discovery and validation. With better targets, we believe our therapies will be more effective than the current array of immunotherapies using older targets.

Corporate and Scientific Highlights

Events that occurred during the three months ended June 30, 2021

Re-Submission of Two IND Applications – On May 17, 2021 and May 24, 2021, we announced re-submission of two investigational new drug ("IND") applications to the United States Food and Drug Administration. These INDs were for our ALEXIS-PRO-1 and ALEXIS-ISO-1 product candidates, respectively. ALEXIS-PRO-1 is our allogeneic gamma delta chimeric T cell therapy product candidate targeting PD-L1. ALEXIS-ISO-1 is our allogenic gamma delta CAR-T cell therapy product candidate targeting Isomesothelin (the isoform of Mesothelin).

Since re-submitting the INDs, the FDA returned with comments on our allogeneic CAR-T products with respect to:
Tracing of all reagents used in manufacturing
Flow chart of manufacturing processes
Certificate of Analysis (COA) for the Company’s CAR-T products (allogeneic CAR-T)

We have an FDA response taskforce, staffed with sufficient and appropriate personnel to prepare the response to the FDA. The company’s plans to submit the prepared response by the first half of September 2021. The commencement of the dosing of its first in human clinical trial is expected to be delivered in the first quarter of 2022.

Appointment of Chief Operating and Manufacturing Officer – On June 7, 2021, we entered into an Executive Agreement with Mr. Ignacio Nunez to be our Chief Operating and Manufacturing Officer ("COMO"). The COMO will lead and manage the Company’s functions/departments assigned by the CEO. The COMO will be responsible for the manufacturing function and will provide vision, leadership, and management to ensure we effectively and efficiently deliver research, clinical and commercial cell therapies. This position involves direct oversight and management of the manufacturing function to ensure the successful establishment of a new GMP facility and the commencement of manufacturing operations.
Membership Purchase Agreement with InSilico Solutions, LLC – On June 14, 2021, we entered into a Membership Interest Purchase Agreement (the "Purchase Agreement") with InSilico Solutions, LLC ("InSilico") and Michael Ryan (the "Seller") pursuant to which the Company acquired all of the outstanding membership interests of In Silico from the Seller for an aggregate purchase price of $540,000 (the "Purchase Price"). The Purchase Price is payable in full through (i) the delivery to the Seller of a number of shares of the Company’s stock that is equal to $400,000 and (i) the delivery to the employees of In Silico of the Company’s restricted stock units under the Company’s 2021 Omnibus Equity Incentive Plan that is equal to $140,000.

InSilico is a bioinformatics services company that performs data analysis and software tool development for genome-wide research projects. Their headquarters is located in Fairfax, VA. InSilico performs contract research and collaborate on grant funded research with academic, government, and commercial organizations located throughout the United States.

With this acquisition, Kiromic will bring in-house a team of experts in bioinformatics and AI in order to lengthen its lead in the race for an AI technology with the capability to select the optimal bio-markers needed for cutting edge immunotherapeutics such as CAR-T cell therapy.
Events occurring after June 30, 2021 until August 13, 2021

Closing of Public Offering – On July 2, 2021, we received net proceeds of $37,121,200 from a public offering, after deducting underwriting discounts and commissions of $2,399,900 and other offering expenses of $478,900 incurred. The Company issued and sold 8,000,000 shares of common stock in the public offering at a price of $5.00 per share. In connection with the public offering, 400,000 representative warrants were issued with a price of $6.25 per share.

This public offering significantly strengthens the Company’s balance sheet to support clinical trials for our ALEXIS-ISO-1 and ALEXIS-PRO-1 product candidates, GMP facility expansion, intellectual property protection and reinforcement, IND applications and IND enabling trials and working capital and general corporate purposes.
Completion of InSilico Acquisition – On July 26, 2021, we announced the completion of the InSilico acquisition.
Communications with the FDA – Supported by IQVIA, instead of simply addressing the FDA’s questions with a written response only (WRO), we took the decision to apply for a Type A meeting with the FDA. The Type A meeting will address the clinical hold issues and will allow us to discuss path toward our first-in-human dosing.
Q2 2021 Financial Highlights

Cash Position: Cash and cash equivalents were $3,070,400 as of June 30, 2021, compared to $10,150,500 as of December 31, 2020. The difference is attributable to cash outflows of $6,344,100, $590,600, and $145,400 for operating activities, investing activities, and financing activities respectively.

R&D Expenses: Our research and development expenses increased by $1,385,800, or 108.92%, to $2,658,100 for the three months ended June 30, 2021, from $1,272,300 for the three months ended June 30, 2020. Our research and development expenses increased by $2,243,300, or 97.52%, to $4,543,700 for the six months ended June 30, 2021, from $2,300,400 for the six months ended June 30, 2020. The increase was attributable to increased headcount, manufacturing, and experimentation costs for our ALEXIS-ISO-1 product candidate.

G&A Expenses: Our general and administrative expenses decreased by $7,780,500, or 77.08%, to $2,314,100 for the three months ended June 30, 2021 from $10,094,600 for the three months ended June 30, 2020. Our general and administrative expenses decreased by $6,534,100, or 59.54%, to $4,385,100 for the six months ended June 30, 2021 from $10,919,200 for the six months ended June 30, 2020. This decrease was primarily due to reduced stock compensation expenses.

Net Loss: Our net loss decreased to $8,928,800 during the six months ended June 30, 2021 compared to $13,219,600 during the six months ended June 30, 2020.