On August 16, 2021 ImmunityBio, Inc. (NASDAQ: IBRX), a clinical-stage immunotherapy company, reported that appointed Patrick Soon-Shiong, M.D., to the newly created role of Global Chief Scientific and Medical Officer, effective as of August 11, 2021 (Press release, ImmunityBio, AUG 16, 2021, View Source [SID1234586620]). In this additional role, Dr. Soon-Shiong will oversee the company’s global research and development programs and pipeline investments in support of its ambitious growth plans, which include bringing advanced technology to a broad global marketplace.

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"As both the founder of ImmunityBio and a visionary biotech innovator, Patrick’s expertise has always been an invaluable asset to the organization," said Richard Adcock, President and CEO of ImmunityBio. "We are grateful for his leadership and commitment to drive the scientific agenda of our business forward. His unwavering focus on advancing potential breakthrough therapies for cancer and infectious disease has already improved the quality of life for thousands of patients."

"My entire life’s work has been to discover and bring to market better treatments for cancer and other difficult-to-treat diseases, and thanks to incredible innovations over the last few years, we’re closer than ever to that goal," said Dr. Soon-Shiong. "Our growing knowledge of the immune system will serve as the foundation for the research priorities we’re setting at ImmunityBio. These priorities will guide our ongoing quest for life-saving and life-extending therapeutics, including a commitment to ensure they are available to people in underserved nations in Africa and elsewhere. That’s my goal and the goal of everyone on our highly experienced research, clinical development, and medical teams."

On August 16, 2021 Clovis Oncology, Inc. (NASDAQ:CLVS) reported that it has filed a prospectus supplement with the U.S. Securities and Exchange Commission ("SEC") to renew its previously established ATM facility under which it may offer and sell, from time to time, additional shares of its common stock having an aggregate offering price of up to $125,000,000 through an "at-the-market" equity offering program (the "ATM Program") (Press release, Clovis Oncology, AUG 16, 2021, View Source [SID1234586637]). The timing and amount of any sales will be determined by a variety of factors considered by Clovis Oncology.

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Shares of Clovis Oncology common stock will be offered through J.P. Morgan Securities LLC ("JPM") and BofA Securities, Inc. ("BofA Securities"), who are serving as the distribution agents. JPM and BofA Securities may sell the shares of our common stock by any method deemed to be an "at-the-market offering" defined by Rule 415(a)(4) of the Securities Act of 1933, as amended, including without limitation, sales in ordinary brokers’ transactions, including directly on the Nasdaq Global Select Market or into any other existing trading market for the shares, or to or through a market maker, in block transactions or by any other method permitted by law, including privately negotiated transactions and to JPM and BofA Securities as principals for their own account. Sales may be made at market prices prevailing at the time of a sale or at prices related to prevailing market prices or at negotiated prices. As a result, sales prices may vary.

Clovis Oncology intends to use the net proceeds from any sales of its common stock under the ATM Program for general corporate purposes, including funding of its development programs, sales and marketing expenses associated with Rubraca (rucaparib), repayment, repurchase or refinance of its debt obligations, payment of milestones pursuant to its license agreements, general and administrative expenses, acquisition or licensing of additional product candidates or businesses and working capital.

Clovis Oncology’s prospectus supplement filed today with the SEC supplements information contained in the accompanying prospectus contained in the shelf registration statement on Form S-3 (File No. 333-253485), as amended for the offering. Prospective investors should read the prospectus in that registration statement, the prospectus supplement and all other documents that Clovis Oncology has filed with the SEC for more complete information about Clovis Oncology, including information pertaining to the ATM Program and the risks associated with investing in Clovis Oncology. Copies of the prospectus supplement and related prospectus may be obtained from J. P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by email to [email protected], or from BofA Securities, NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte NC 28255-0001, Attn: Prospectus Department or by email to [email protected]. You may also obtain these documents free of charge when they are available by visiting EDGAR on the SEC’s website at www.sec.gov.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor will there be any sale of these securities, in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On August 16, 2021 Immunicom, Inc., a clinical stage biotech pioneering non-pharmaceutical immunotherapies, reported that progresses with its cancer clinical trial to evaluate the clinical effectiveness of Immunopheresis in partnership with Acibadem University conducted in Acibadem Healthcare Group hospitals (Press release, Immunicom, AUG 16, 2021, View Source [SID1234586653]). This multi-arm study has been recruiting patients since October 2020 and evaluates Immunicom’s oncology platform for non-small cell lung cancer (NSCLC) in combination with Roche’s pharmaceutical checkpoint inhibitor, Tecentriq (atezolizumab). This is Immunicom’s third clinical trial assessing Immunopheresis for solid cancers.

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The Immunopheresis therapy employs Immunicom’s lead product, the proprietary LW-02 subtractive column, to remove targeted immune-suppressive cytokines that block the natural immune response to attack malignant tumors. Immunopheresis is intended to treat cancer while avoiding the typical side-effects, toxicity, and negative impacts on quality of life that are frequently associated with other cancer treatments.

Immunicom’s LW-02 column has received U.S. FDA Breakthrough Device designation for stage IV metastatic cancer and has received European regulatory clearance (CE Mark certification) for use in adults with advanced, refractory, triple negative breast cancer (TNBC).

"Lung cancer is one of the most common cancers in the world and the most prevalent cancer in Turkey. Currently available therapies for lung cancer are commonly associated with serious side-effects and often patient’s tumors become resistant to even the newer immunotherapies. Moreover, the presently available immunotherapies are prohibitively expensive which precludes this option for many patients," said Ahmet Şahin, MD., Prof., Chairman of the Medical Executive Board of Acibadem Healthcare Group. "We are highly optimistic that Immunicom’s Immunopheresis therapy will provide physicians with a novel breakthrough cancer immunotherapy that should be markedly better tolerated, improve patient’s quality of life, and its cost-effectiveness will make it widely available to many patients who might otherwise not be able to benefit from an immunotherapy."

The multicenter, multi-arm clinical study led by Gökhan Demir, MD, Prof., Acibadem University School of Medicine, Department of Internal Diseases Medical Oncology who serves as the Principal Investigator, and conducted by Mustafa Bozkurt, MD tests the clinical effectiveness of the LW-02 Immunopheresis column to treat stage IIIB/IV non-small cell lung cancer patients whose disease has progressed after at least one first-line chemotherapy round of treatment. The clinical study is divided into three treatment arms, each with the LW-02 column; the first in combination with Tecentriq (atezolizumab), the second in combination with Taxol (paclitaxel), and the third with Immunopheresis as a monotherapy for patients who have disease progression after a second-line of chemotherapy treatment.

"With this clinical trial, Immunicom and Acibadem are centered on demonstrating the effectiveness of Immunicom’s Immunopheresis therapy for treating patients facing a highly aggressive form of non-small cell lung cancer. This important study assesses Immunopheresis in combination with both Roche’s Tecentriq, one of the world’s leading PD-L1 checkpoint inhibitor immunotherapy drugs, and with paclitaxel, a very commonly used chemotherapy agent," said Amir Jafri, Founder and CEO of Immunicom, Inc.

"We have developed Immunopheresis intending that it could be used with many different oncology regimens and the growing array of promising immunotherapy drugs, while keeping in the forefront our mission of preserving patients’ quality of life to ensure that they can fight cancer in a compassionate and dignified way. We are confident that our breakthrough Immunopheresis technology will provide patients the benefits associated with upregulation of their immune system to attack resistant cancers. Immunicom’s motto of ‘Healing Reimagined,’ reflects our mission to improve quality-of-life for all patients in a meaningful way and expedite their path to a healthy recovery," continued Mr. Jafri.

For an overview of how this breakthrough technology works, visit View Source Immunopheresis is an investigational therapy that has not yet been approved for use by the FDA.

On August 16, 2021 Galectin Therapeutics Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin proteins, reported financial results and provided a business update for the quarter ended June 30, 2021 (Press release, Galectin Therapeutics, AUG 16, 2021, View Source [SID1234586621]). These results are included in the Company’s Quarterly Report on Form 10-Q, which has been filed with the U.S. Securities and Exchange Commission and is available at www.sec.gov.

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Joel Lewis, Chief Executive Officer and President of Galectin Therapeutics, said, "Galectin continued its progress on our strategic initiatives this quarter, actively working towards achieving our goals for the Company, which include advancing our NASH cirrhosis program through global registration trials and expanding our research. We reported positive new results in a cancer immunotherapy extension trial of belapectin in combination with KEYTRUDA in a patient cohort with more advanced disease compared to earlier results, and our NASH cirrhosis trial continues to initiate new sites and increase enrollment despite the continued challenges arising from COVID-19. Organizationally, we have added and will continue to add talented and experienced professionals in key leadership roles that will strengthen the company, preparing us for significant new milestones. As my new team, including employees and external consultants, reshapes our culture internally, we continue to engage our strategic consultant, Dr. Ben Carson, in formulating new opportunities. These are exciting times, and we expect the second half of the year to bring continued success."

Richard E. Uihlein, Chairman of the Board, added, "I am excited by the idea that we have the opportunity to potentially save thousands of lives, not just in NASH cirrhosis but in cancer and other areas where galectins have been implicated. I encourage you to visit our website to study and learn more from Dr. Carson and our talented team, who have just created a series of new videos to help educate our various constituencies and provide a better understanding of why our work is so important."

Program Review

Cancer Immunotherapy

In our cancer immunotherapy program, we announced on July 9, 2021, positive top-line results in our Phase 1b clinical trial extension of belapectin in combination with KEYTRUDA in advanced metastatic melanoma and head and neck cancer. The study provided further clinical evidence that using belapectin, a potent galectin-3 inhibitor, in combination with pembrolizumab (KEYTRUDA), a PD-1 inhibitor, significantly enhances tumor response to immunotherapy in patients with advanced metastatic melanoma (MM) and head and neck squamous cell carcinoma (HNSCC). The results demonstrated that belapectin potentially improves treatment response while simultaneously reducing adverse effects often seen with KEYTRUDA alone. Most impressive, these results were obtained despite the patients in this extension cohort having a significantly higher tumor burden when enrolled as compared to the initial study – especially the melanoma patients. Furthermore, there were no toxicities deemed related, probably related, or possibly related to belapectin and the severity of toxicities in this trial were less than the anticipated toxicity with KEYTRUDA alone. Dr. Brendan Curti, M.D., the study’s principal investigator at the Earle A. Chiles Research Institute, a division of Portland Providence Cancer Institute, observed that these results highlight the potential benefit and immunological effects of this combination and were sufficiently encouraging to strengthen the rationale to conduct a larger, randomized controlled Phase 2 study.

NAVIGATE Study (NASH Cirrhosis)

Enrollment in our NAVIGATE trial in NASH cirrhosis continues, with new sites coming online in both the U.S. and Europe. A protocol amendment aimed at refining criteria for patients with portal hypertension, based on input from investigators, has been approved by institutional review boards and implemented globally resulting in an improved quality of screening and, importantly, more patients qualifying for enrollment.

Our relationship with Dr. Ben Carson as a Senior Consultant is helping increase awareness of Galectin Therapeutics, which is expected to help attract additional clinical trial sites and patients.

Our innovative NAVIGATE study web portal, NAVIGATEnash.com, has experienced a strong response. Many clinicians from our various study sites have registered for the site’s steady stream of new information and resources about NASH cirrhosis and the NAVIGATE study for both patients and physicians. NAVIGATEnash.com is also attracting significant web traffic as we build a community where NASH cirrhosis patients and the physicians can share information.

Corporate Development

The Company has been aggressively building out its management team and is in the process of making a number of key hires. Ezra R. Lowe, Ph.D. has joined as Executive Director, Clinical and Preclinical Pharmacology. Ezra Lowe brings a depth of experience in clinical pharmacology, drug metabolism, and pharmacokinetics. He has a broad base of experience working with various drug formats across a diverse array of therapeutic areas. Prior to Galectin, Ezra was Senior Director, Clinical Pharmacology in Global R&D with the Bausch Health Companies. He previously held Clinical and Nonclinical Pharmacology positions at Salix Pharmaceuticals, Bausch+Lomb, and Valeant Pharmaceuticals International, Inc. and spent time as Lead Scientist in Biotransformation and Toxicology at The Dow Chemical Company. In the course of his career, he has completed 10 different global drug approvals. The Company expects to add additional key senior resources in the remainder of 2021.

As a strategic consultant, Dr. Carson will also help amplify our story, by raising awareness with key constituencies. During a recent television appearance, in fact, he was asked about new and interesting projects he was working on, and he took the opportunity to discuss his involvement and support of Galectin. In addition, Dr. Carson was very much involved in a recent meeting of key members of the company’s leadership, where he participated in the taping of a number of videos discussing Galectin, belapectin, the management team and the road forward. His vision for the company can be seen on these videos on the company’s website: View Source .

Evolving Areas of Interest

Clinical and pre-clinical research shows the recently demonstrated mechanism of action for belapectin in cancer immunotherapy reinforces the potential for belapectin in NASH cirrhosis and other diseases driven by galectin-3. This has led to Galectin being approached by researchers from a variety of unrelated specialties that are interested in initiating collaborative research.

Dr. Carson observed, "Belapectin has broad potential applications as it pertains to galectin-3 and the whole family of galectins, which affect almost every organ system. Not just in oncology, where data has demonstrated the nefarious role that galectin-3 plays in the tumor micro-environment to stimulate tumor progression, but also in areas such as heart disease. Clearly, there are a whole host of processes that are affected, particularly those where the fibrotic and immunologic impact of galectin-3 are clinically relevant."

Mr. Lewis commented, "Having a respected physician and leader such as Dr. Carson is strategic. He is a great resource and uniquely qualified to seek out partnerships, such as collaborations that could rapidly advance additional trials in cancer immunotherapy where we already have strong Phase 1b data that encourages further study."

Financial Results

For the three months ended June 30, 2021, the Company reported a net loss applicable to common stockholders of $8.5 million, or ($0.15) per share, compared to a net loss applicable to common stockholders of $6.2 million, or ($0.11) per share for the three months ended June 30, 2020. The increase is largely due an increase in 2021 research and development expenses related to the Company’s NAVIGATE trial.

Research and development expense for the three months ended June 30, 2021, was $6.5 million compared with $4.7 million for the three months ended June 30, 2020. The increase was primarily due to costs related to our NAVIGATE clinical trial and other supportive activities. General and administrative expenses for the three months ended June 30, 2021, were $1.7 million, compared to $1.4 million for the three months ended June 30, 2020.

As of June 30, 2021, the Company had $31.6 million of cash and cash equivalents. On April 16, 2021, the Company received $10 million in proceeds from an unsecured convertible promissory note from its Board Chairman, Richard E. Uihlein. The Company also has a $10 million unsecured line of credit, under which no borrowings have been made to date. The Company believes it has sufficient cash, including availability under the line of credit, to fund currently planned operations and research and development activities through at least September 30, 2022.

The Company expects that it will require more cash to fund operations after September 30, 2022, and believes it will be able to obtain additional financing as needed. Currently, we expect to require an additional approximately $30-$35 million to cover costs of the NAVIGATE trial to reach the planned interim analysis estimated to occur in the second half of 2023, along with drug manufacturing and other scientific support activities and general and administrative costs. However, there can be no assurance that we will be successful in obtaining such new financing or, if available, that such financing will be on terms favorable to us.

About Belapectin (GR-MD-02)

Belapectin (GR-MD-02) is a complex carbohydrate drug that targets galectin-3, a critical protein in the pathogenesis of NASH and fibrosis. Galectin-3 plays a major role in diseases that involve scarring of organs including fibrotic disorders of the liver, lung, kidney, heart and vascular system. Belapectin binds to galectin-3 and disrupts its function. Preclinical data in animals have shown that belapectin has robust treatment effects in reversing liver fibrosis and cirrhosis. A Phase 2 study showed belapectin may prevent the development of esophageal varices in NASH cirrhosis, and these results provide the basis for the conduct of the NAVIGATE trial. The NAVIGATE trial (NAVIGATEnash.com), entitled "A Seamless Adaptive Phase 2b/3, Double-Blind, Randomized, Placebo-controlled Multicenter, International Study Evaluating the Efficacy and Safety of Belapectin (GR-MD-02) for the Prevention of Esophageal Varices in NASH Cirrhosis" began enrolling patients in June, 2020, and is posted on www.clinicaltrials.gov (NCT04365868). Galectin-3 has a significant role in cancer, and the Company has supported a Phase 1b study in combined immunotherapy of belapectin and KEYTRUDA in advanced melanoma and in head and neck cancer. This trial provided a strong rationale for moving forward into a Phase 2 development program which the company is considering.

About Fatty Liver Disease with Advanced Fibrosis and Cirrhosis

Non-alcoholic steatohepatitis (NASH) has become a common disease of the liver with the rise in obesity and other metabolic diseases. NASH is estimated to affect up to 28 million people in the U.S. It is characterized by the presence of excess fat in the liver along with inflammation and hepatocyte damage (ballooning) in people who consume little or no alcohol. Over time, patients with NASH can develop excessive fibrosis, or scarring of the liver, and ultimately liver cirrhosis. It is estimated that as many as 1 to 2 million individuals in the U.S. will develop cirrhosis as a result of NASH, for which liver transplantation is the only curative treatment available. Approximately 8,890 liver transplants are performed annually in the U.S. There are no drug therapies approved for the treatment of liver fibrosis or cirrhosis.

On August 16, 2021 Inhibikase Therapeutics, Inc. (Nasdaq: IKT) (Inhibikase), a clinical-stage pharmaceutical company developing therapeutics to modify the course of Parkinson’s disease and related disorders, reported financial results for the second quarter ended June 30, 2021 and highlighted recent developments (Press release, Inhibikase Therapeutics, AUG 16, 2021, View Source [SID1234586638]).

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Key Business and Clinical Highlights

Begin evaluation of IkT-148009 in Parkinson’s patients: Following a teleconference on July 22, 2021with the U.S. Food and Drug Administration (FDA), Inhibikase and the FDA agreed that the Company may begin a Phase 1b extension study to evaluate the safety, tolerability and pharmacokinetics of the Company’s lead drug candidate IkT-148009 in Parkinson’s patients. The Phase 1b extension study will also assess cognitive, motor function, gut motility and measures of alpha-synuclein aggregate clearance in multiple compartments, as exploratory endpoints.

Interim chronic toxicology studies of IkT-148009 will be submitted to the U.S. FDA to permit 13 week dosing in patients: Inhibikase expects to submit 13-week interim pivotal toxicology studies of IkT-148009 in rodent and primate to the FDA for regulatory review in the third quarter of 2021. Following the Agency’s review, the Company expects to extend dosing in patients out to 3 months. The Company expects to complete the remaining requirements for chronic dosing in the 4th quarter of 2021 and submit the data to the FDA for review early in the 1st quarter 2022.

Investigational New Drug (IND) application for IkT-001Pro in CML: IkT-001Pro is the Company’s prodrug formulation of Imatinib mesylate, designed as a potentially safer, better tolerated treatment for Imatinib-sensitive cancers such as stable-phase Chronic Myeloid Leukemia (CML). Inhibikase expects to file an IND application in the 3rd quarter of 2021, with initiation of clinical development as soon as practicable, subject to FDA acceptance of the IND.

Successfully completed $45 million follow-on public offering of common stock: In June, 2021 Inhibikase raised $45 million in gross proceeds from its follow-on offering of 15 million shares of its common stock. The company plans to use the net proceeds, together with existing funds, to fund the costs of its Phase 1b extension study for IkT-148009 in Parkinson’s patients, validate target engagement markers in the central and peripheral nervous system, and further support the clinical development of IkT-001Pro through Phase 2 studies.
"In the second quarter of 2021, we completed the financing necessary to validate the first mechanistically defined treatment for sporadic and inherited Parkinson’s disease and related disorders," commented Milton Werner, Ph.D., President and Chief Executive Officer of Inhibikase. "On the clinical front, following a successful Phase 1 program in older healthy adults, we are advancing into Parkinson’s patients with the initiation of our Phase 1b extension study. This study will provide the first opportunity to evaluate mechanistically-defined therapeutics for this devastating disease. This is an important step for the Company, as we believe IkT-148009 has the potential to drive functional recovery in the brain and gastrointestinal tract, clear pathologic alpha-synuclein aggregates, and block neurodegeneration and neuroinflammation in Parkinson’s disease. Looking ahead, we remain on track to file an IND for IkT-001Pro, our prodrug formulation of Imatinib for CML, in the third quarter and submit 13-week pivotal toxicology studies of IkT-148009 to the FDA."

Second Quarter Financial Results

Net Loss: Net loss for the quarter ended June 30, 2021, was $2.6 million or $0.22 per share, compared to a net loss of $0.4 million, or $0.05 per share in the second quarter 2020.

Net loss for the six months ended June 30, 2021, was $5.3 million or $0.47 per share, compared to a net loss of $1.0 million, or $0.12 per share in the six months ended June 30, 2020.

R&D Expenses: Research and development expenses were $2.4 million for the quarter ended June 30, 2021 compared to $0.3 million in the second quarter 2020. The increase was driven by a $1.0 million increase in grant related research expenditures and a $1.1 million increase in non-grant related research. The non-grant related research was incurred primarily in connection with the Company’s PD Phase I clinical trial.

Research and development expenses were $4.8 million for the six months ended June 30, 2021 compared to $0.5 million in the six months ended June 30, 2020. The increase was driven by a $2.1 million increase in grant related research expenditures and a $2.1 million increase in non-grant related research. The non-grant related research was expended primarily in connection with the Company’s Phase I clinical trial in older healthy subjects.

SG&A Expenses: Selling, general and administrative expenses for the quarter ended June 30, 2021 were $1.6 million compared to $0.4 million for the second quarter in 2020. The increase was primarily the result of increased non-cash stock compensation expense of $0.1 million, increased director and officer’s liability insurance of $0.3 million related to the Company’s IPO in December 2020, increased legal fees, board fees, investor relation and consulting fees of $0.3 million relating to operating as a public company registrant since December 2020 and a net increase of $0.5 million for other normal operating expenses

Selling, general and administrative expenses for the six months ended June 30, 2021 were $3.2 million compared to $0.9 million for the six months ended June 30, 2020. The increase was primarily the result of increased non-cash stock compensation expense of $0.5 million, increased director and officer’s liability insurance of $0.7 million related to the Company’s initial public offering in December 2020, increased legal fees, board fees, investor relation and consulting fees of $0.6 million relating to operating as a public company registrant since December 2020 and a net increase of $0.5 million for other normal operating expenses.

Cash Position: Cash and cash equivalents were $46.8 million as of June 30, 2021. This includes approximately $41.1 million of proceeds from Inhibikase’s June, 2021 public offering of common stock, after deducting underwriting discounts and commissions and offering expenses payable by Inhibikase. The Company expects that existing cash and cash equivalents will be sufficient to fund operations into the first-half of 2023.