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Trillium Therapeutics Reports Second Quarter 2021 Operating and Financial Results

On August 13, 2021 Trillium Therapeutics Inc. (NASDAQ/TSX: TRIL), a clinical stage immuno-oncology company developing innovative therapies for the treatment of cancer, reported financial and operating results for the three and six months ended June 30, 2021 (Press release, Trillium Therapeutics, AUG 13, 2021, View Source [SID1234586554]). All financial amounts in this news release are in United States dollars, unless otherwise stated.

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"The second quarter 2021 was an important period for Trillium, during which time we communicated our go-forward strategy and began executing against it," said Jan Skvarka, Trillium’s President and CEO. "We announced seven priority indications and nine patient settings, with six studies expected to initiate in 2021. As of today, we have already initiated four studies, including in multiple myeloma, acute myeloid leukemia (p53 mutated and wild type), and leiomyosarcoma. With our operating plan being on track, our focus is on strong execution, to ensure a robust flow of new data starting in 4Q 2021 and 2022. We continue to be very excited about Trillium’s position as a leading CD47 company."

Second Quarter 2021 Financial Results

Cash position: As of June 30, 2021, Trillium had cash and cash equivalents and marketable securities of $264.5 million, compared to $291.2 million at December 31, 2020. The decrease in cash and cash equivalents and marketable securities was due mainly to cash used in support of operating activities of $28.6 million during the 6 months ended June 30, 2021.
Research and development expenses: Research and development expenses for the six months ended June 30, 2021 of $19.9 million were higher than the research and development expenses of $12.2 million for the six months ended June 30, 2020. The increase was due mainly to higher manufacturing costs to support our expanded clinical operations, and higher clinical trial costs related to the initiation of new trials and increased patient enrollment in the TTI-622-01 trial.
General and administrative expenses: General and administrative expenses for the six months ended June 30, 2021 of $10.1 million were lower than general and administrative expenses of $28.4 million for the six months ended June 30, 2020. The decrease is due mainly to a non-cash loss of $22.4 million on the revaluation of the deferred share unit liability in the prior period, partially offset by $2.4 million of increased stock-based compensation expense in the current period mainly relating to higher weighted average fair values of stock options outstanding and the fair valuation of stock option liabilities.
Net loss: Net loss for the six months ended June 30, 2021 of $29.3 million was lower than the loss of $39.5 million for the six months ended June 30, 2020. The net loss was lower due mainly to a non-cash loss of $22.4 million on the revaluation of the deferred share unit liability in the prior period. This was partially offset by higher stock-based compensation, manufacturing, and clinical trial expenses.

Soligenix Announces Recent Accomplishments And Second Quarter 2021 Financial Results

On August 13, 2021 Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, reported its recent accomplishments and financial results for the quarter ended June 30, 2021 (Press release, Soligenix, AUG 13, 2021, View Source [SID1234586553]).

Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix stated, "2021 remains a crucial year for Soligenix. Under our Specialized BioTherapeutics business segment, our HyBryte (SGX301) positive pivotal Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) study in cutaneous T-cell lymphoma (CTCL) was recently selected for presentation at the United States Cutaneous Lymphoma Consortium (USCLC) Annual Meeting. Additionally, HyBryte received a Pediatric Investigation Plan (PIP) waiver from the European Medicines Agency (EMA), which is a key component of the regulatory process for marketing authorization in Europe. We continue to move our pipeline forward with multiple data readouts expected this year under our Public Health Solutions business segment. This data is critial in our efforts to advance our therapeutic and vaccine candidates such as CiVax, our heat stable COVID-19 vaccine."

Dr. Schaber continued, "With approximately $29 million in cash, not including our non-dilutive government funding, we anticipate having sufficient capital to achieve multiple inflection points as we advance our rare disease pipeline, including NDA filing in the first half of 2022 and U.S. commercialization of HyBryte in CTCL, where we estimate peak U.S. annual net sales to exceed $90 million and the total U.S. revenues during the 10-year forecast period to be greater than $700 million. We are also aggressively exploring and evaluating multiple strategic options moving forward, including but not limited to, partnership and merger and acquisition opportunities."

Soligenix Recent Accomplishments

On June 22, 2021, the Company announced that Ellen Kim, MD, Medical Director, Dermatology Clinic, Perelman Center for Advanced Medicine, Professor of Dermatology at the Hospital of the University of Pennsylvania, and the Lead Principal Investigator for the Phase 3 FLASH study in CTCL, would present key details of HyBryte (hypericin ointment 0.25%) efficacy and safety profile demonstrated in the FLASH study at the USCLC Annual Meeting, to be held on June 26, 2021. To view this press release, please click here.
On June 10, 2021, the Company announced that it had received a PIP waiver from the EMA for HyBryte, which has recently and successfully concluded a Phase 3, pivotal clinical study for the treatment of early stage CTCL. To view this press release, please click here.
On June 9, 2021, the Company announced that it had received approximately $865,000, net of transaction costs, in non-dilutive financing via the state of New Jersey’s Technology Business Tax Certificate Transfer Program. To view this press release, please click here.
On May 20, 2021, the Company announced that the Japan Patent Office had allowed the patent application titled "Systems and Methods for Producing Synthetic Hypericin". The allowed claims are directed to unique, proprietary methods to produce a novel, highly purified form of synthetic hypericin, and are similar to those previously allowed in the United States. To view this press release, please click here.
Financial Results – Quarter Ended June 30, 2021
Soligenix’s revenues for the quarter ended June 30, 2021 were $0.2 million as compared to $0.5 million for the quarter ended June 30, 2020. Revenues included payments on grants received to support the development of: SGX943 for treatment of emerging and/or antibiotic-resistant infectious diseases; ThermoVax, our thermostabilization technology; and CiVax, our vaccine candidate for the prevention of COVID-19.

Soligenix’s basic net loss was $1.9 million, or ($0.05) per share, for the quarter ended June 30, 2021, as compared to $2.8 million, or ($0.10) per share, for the quarter ended June 30, 2020. This decrease in net loss was primarily due to the gain on the forgiveness of the Payroll Protection Program loan and the sale of New Jersey NOL carryforwards offset by reduced contract revenues and the interest expense on convertible debt.

Research and development expenses were $2.1 million as compared to $2.2 million for the quarters ended June 30, 2021 and 2020, respectively. The decrease in research and development spending for the quarter ended June 30, 2021 was primarily attributable to the reduction in expense due to the completion of the HyBryte and SGX942 clinical trials.

General and administrative expenses were $0.9 million and $0.8 million for the three months ended June 30, 2021 and 2020, respectively.

As of June 30, 2021, the Company’s cash position was approximately $29.0 million.

Recursion Reports Second Quarter 2021 Financials and Provides Business Updates

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]).

"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.

PureTech Announces the Appointment Julie Krop, M.D., as Chief Medical Officer

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.

"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."

Protalix BioTherapeutics Announces Private Note Exchange

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.

"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.