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.

On August 13, 2021 HCW Biologics Inc. (the "Company") (NASDAQ: HCWB), an innovative, biopharmaceutical company focused on discovering and developing novel immunotherapies to lengthen health span by disrupting the link between chronic, low-grade inflammation and age-related diseases, reported financial results and recent business highlights for its second quarter ended June 30, 2021 (Press release, HCW Biologics, AUG 13, 2021, View Source [SID1234586547]).

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"HCW Biologics delivered on a milestone as we achieved our goal of closing our initial public offering on July 22 to raise capital to advance the clinical development of our lead molecules," stated Hing C. Wong, Ph.D., founder and CEO of HCW Biologics Inc. "We started HCW Biologics three years ago with an idea to develop immunotherapeutic treatments for age-related diseases. Since that time, we applied our expertise in advanced protein engineering to internally develop our TOBITM (Tissue factOr-Based fusIon) discovery platform and successfully developed immunotherapeutic molecules based on TOBITM technology that can be administered by subcutaneous injection as well as used in adoptive cell therapy approaches. After extensive studies to assess the molecules we created, we selected two lead molecules, HCW9218 and HCW9302 for clinical development."

"HCW Biologics’ clinical development strategy is to prove the safety and efficacy of both lead molecules individually in future clinical trials, and eventually combine them as an immunotherapeutic for some of the most difficult to treat age-related diseases. Our gateway indication for our lead molecule, HCW9218, is cancer. Several scientific studies have revealed that increased normal tissue cellular senescence can promote tumor progression, creating a link between aging and cancer. In preclinical studies, HCW9218 has shown it can reduce chemotherapy-induced tumor and normal tissue senescence and decrease senescence associated secretory phenotype (i.e., proinflammatory) factors that senescent cells secrete, in particular TGF-ß. We are wrapping up IND-enabling activities and expect to submit an Investigational New Drug (IND) application for a Phase 1b/2 clinical trial to assess HCW9218 in the treatment of pancreatic cancer by the end of 2021."

Business Highlights:

Initial Public Offering: On July 22, 2021, the Company closed on its IPO with the sale of 7,000,000 shares of common stock at a public offering price of $8.00 per share, resulting in net proceeds of approximately $49.0 million, after deducting underwriting discounts and commissions and estimated offering-associated expenses.

As part of the preparations of becoming a public company, HCW Biologics shareholders elected two new independent board members in May 2021. Mr. Scott Garrett serves as the Chairman of the Board and Chairman of the Compensation Committee. His experience as a Chief Executive Officer and in other senior leadership positions with biomedical and diagnostics companies enables him to bring to the Board of Directors an operational perspective as well as valuable insights and experience. Mr. Rick Greene serves as the Chairman of the Audit Committee. His experience as a Chief Financial Officer and in other financial management and reporting, operations and business development positions in the healthcare industry enables him to bring financial expertise to the Board of Directors. The Company is committed to expanding the size of its Board of Directors to bring additional diversity and operational expertise.

As of June 30, 2021, the Company completed good laboratory practice (GLP) toxicology studies on nonhuman primates and mice to understand the onset, degree of severity, and time length up to which a particular dose of a drug demonstrates any toxic effects. The Company will continue to complete IND-enabling activities for HCW9218 and prepare for the IND filing in the second half of 2021.

The Company launched the execution of its strategy to use pivotal publications to establish its leadership in oncology and age-related diseases in scientific and clinical communities. The Company currently has two articles published online:

An article published online by Cancer Immunology Research describing the TOBITM discovery platform: Becker-Hapak MK, et al. A Fusion Protein Complex Combines IL-12, IL-15, and IL-18 Signaling to Induce Memory-like NK Cells for Cancer Immunotherapy. July 9, 2021.
An article published online by Molecular Therapy on the characterization of the Company’s lead molecules, HCW9218: Liu B et al. Bifunctional TGF-β Trap/IL-15 Protein Complex Elicits Potent NK Cell and CD8+ T Cell Immunity Against Solid Tumors. June 3, 2021.
Second Quarter Financial Results:

Cash and cash equivalents: On June 30, 2021, the Company’s cash balance was $5.1 million. Together with net proceeds of $49.0 million from the IPO, the Company estimates that it has sufficient cash to fund operations and capital expenditures for at least the next 24 months. This does not include potential sources of non-dilutive financing, which may be obtained as a result of entering out-licenses, such as upfront cash payment and shares of Wugen common stock that were received as a result of entering a license agreement with Wugen for limited rights to two of the Company’s molecules.
Research and development expenses: Research and development expenses were $1.7 million in the second quarter of 2021, as compared to $2.1 million for the second quarter of 2020. Higher costs in the second quarter of 2020 were a result of the ramp up costs required for initiation of cGMP manufacturing for five of the Company’s internally developed molecules.
General and administrative expenses: General and administrative expenses were $1.1 million in the second quarter of 2021, as compared to $0.7 million for the second quarter of 2020. The difference reflects additional general and administrative costs arising primarily from additional patent filings to broaden the protection of the Company’s intellectual property and performance-based bonuses.
Net loss: Net loss was $2.8 million in the second quarter of 2021, as compared to $2.8 million for the second quarter of 2020.

On August 13, 2021 Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, and TRIUMF, Canada’s particle accelerator centre, reported that the companies have entered into the next phase of their collaboration agreement for the development, production, and supply of actinium-225 (Press release, Fusion Pharmaceuticals, AUG 13, 2021, View Source [SID1234586546]). Fusion will provide to TRIUMF funding to further develop technology to produce actinium-225 and in return Fusion will have rights, including preferred access and pricing, to the resulting alpha-emitting medical isotope.

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"As we advance our growing pipeline of actinium-based targeted alpha therapies (TATs), we are focused on expanding our manufacturing capabilities and continuing to proactively address and prioritize actinium supply. This supports our strategic plans to develop differentiated radiopharmaceuticals to treat a broad range of cancers with high unmet medical need," said Fusion Chief Executive Officer John Valliant, Ph.D. "We are excited to expand our collaborative relationship with TRIUMF, a leader in isotope production, marking an important step to further expand actinium-225 production and supply."

"Through its TAT platform technology, Fusion has the opportunity to unlock the full potential of actinium, an alpha-emitting isotope with the ability to deliver a potent, highly localized payload to cancer cells, " said TRIUMF Innovations CEO, Kathryn Hayashi. "With this next phase, we are solidifying our partnership with a premier developer of innovative actinium radiopharmaceuticals to deepen TRIUMF’s leadership position in isotope production and impact the cancer treatment landscape."

TRIUMF Director and CEO, Nigel Smith, Ph.D. added, "This marks an important milestone in the existing collaboration between Fusion and TRIUMF. Our partnership is generating new ideas and innovations that validate the important role TRIUMF has at the forefront of the global medical isotope ecosystem. Together TRIUMF and Fusion are laying the groundwork for major breakthroughs that will benefit the lives of countless patients around the world."

In December 2020, Fusion and TRIUMF entered a collaboration and supply agreement to develop, produce and procure the supply of actinium-225 to Fusion. As part of this agreement, Fusion will continue its investment of up to $25 million (CAD) in TRIUMF to advance technology and processes for actinium-225 production.