On November 9, 2020 Morphic Therapeutic (Nasdaq: MORF), a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, reported corporate highlights and third quarter 2020 financial results (Press release, Morphic Therapeutic, NOV 9, 2020, View Source [SID1234570467]).

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"During the third quarter, Morphic made the most noteworthy progress yet in our mission to deliver the first generation of oral medicines targeting integrin receptors. In September, we announced that the first healthy volunteers received MORF-057 in a phase 1 clinical trial designed to generate safety and pharmacokinetic data, as well as to measure levels of α4β7 receptor occupancy, a key potential proof-of-concept biomarker in inflammatory bowel disease," said Praveen Tipirneni, M.D., president and chief executive officer of Morphic Therapeutic. "MORF-057 is the first in our pipeline of selective integrin inhibitor candidates generated by the MInT Platform to enter clinical trials. Further, AbbVie recently exercised its option to exclusively license our αvβ6 integrin inhibitor program for the treatment of fibrotic diseases. AbbVie’s decision further validates the MInT Platform and our team’s ability to generate high quality small molecule integrin inhibitors and to design and execute rigorous discovery and development programs."

Morphic is developing MORF-057 as a selective, oral small molecule inhibitor of the α4β7 integrin, a target for the treatment of inflammatory bowel disease (IBD) with an initial focus on moderate-to-severe ulcerative colitis (UC). The mechanism of α4β7 inhibition to treat IBD has been clinically validated by the approved infused antibody therapy, vedolizumab.

Third quarter and recent corporate highlights:

Initiated a phase 1 clinical trial of MORF-057 in healthy volunteers
The randomized, double-blind, placebo-controlled, single and multiple ascending dose study in healthy adults will evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic properties of MORF-057; a concurrent food effect study will also be conducted
The full data set from the trial is expected to be presented at a major medical conference by mid-2021 with potential release of initial single-ascending dose cohort results in first quarter 2021, including key safety and receptor occupancy data

Announced AbbVie exercised its option to exclusively license the αvβ6 integrin inhibitor program for fibrotic diseases

AbbVie paid Morphic a license fee of $20.0 million, with future potential regulatory and commercial milestones and royalties from the sales of any commercialized candidates
The exclusive license covers Morphic’s αvβ6 integrin specific program, including the compounds MORF-720 and MORF-627, discovered from the MInT Platform, Morphic’s proprietary platform for the discovery of oral integrin drugs

Presented additional preclinical data on the MORF-057 program at United European Gastroenterology (UEG) Week Virtual 2020

The UEG data reinforce the high potency and selectivity of MORF-057 for its integrin target, α4β7, through ex vivo human translational biomarkers
These data further reinforce the potential for MORF-057 to act through the same clinically validated mechanism as the approved injectable, infused antibody, vedolizumab, but using a potentially more convenient oral small molecule
Notably, these data also validated a novel physiologically relevant assay to measure α4β7 receptor occupancy in human whole blood, a key pharmacodynamic marker being studied in the ongoing phase 1 clinical trial of MORF-057
Financial Results for Third Quarter 2020

Net income for the quarter ended September 30, 2020 was $5.4 million or $0.17 per share, diluted compared to a net loss of $8.9 million or $0.30 per share, basic and diluted for the same quarter last year.

Revenue was $25.8 million for the quarter ended September 30, 2020 compared to $5.7 million for the same quarter last year. The increase was primarily due the receipt of a $20.0 million payment triggered by AbbVie exercising their option to Morphic’s αvβ6 program
Research and development expenses were $16.0 million for the quarter ended September 30, 2020, compared to $12.6 million in the same quarter last year. The $3.4 million increase year-over-year reflects clinical, development and manufacturing costs associated with our lead wholly owned α4β7 clinical program; and increased personnel-related costs to support continued progress with the company’s pipeline
General and administrative expenses were $4.8 million for the quarter ended September 30, 2020, compared to $2.9 million in the same quarter last year. The $1.9 million increase year-over-year was primarily attributable to increased headcount and higher professional fees to operate as a public company along with consulting fees associated with ongoing business development activities
As of September 30, 2020, Morphic had cash, cash equivalents, and marketable securities of $213.1 million, compared to $237.0 million at the end of 2019. Through utilization of at-the-market (ATM) offerings during the third quarter of 2020, Morphic raised net proceeds of $6.3 million. Morphic believes its cash, cash equivalents, and marketable securities balance as of September 30, 2020 will be sufficient to fund operating expenses and capital expenditure requirements into at least the end of 2022.

On November 9, 2020 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 September 30, 2020 (Press release, Galectin Therapeutics, NOV 9, 2020, View Source [SID1234570466]). 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, "With the June launch of our innovative NASH-RX clinical trial, we now have one of the very few, if not only, active late stage trial of patients with compensated NASH-cirrhosis, where the medical need is greatest. Continuing our progress, the first patient was randomized in August and we are enrolling patients and adding sites to this global clinical trial of belapectin, our proprietary galectin-3 inhibiting compound. We believe our innovative trial design, experienced medical and clinical teams and clear primary endpoint provide a strong foundation for success. A positive result will be very clinically relevant. If the trial shows that belapectin is effective and safe, it will be a medical breakthrough for patients with NASH cirrhosis."

"As I close out my first quarter as the head of Galectin Therapeutics, I want to reiterate how excited I am to be leading this team," concluded Lewis. "I also want to thank the investigators and patients who will participate in our NASH-RX trial. Without your commitment, there is no way the company would be where we are today nor would we have a future."

Richard E. Uihlein, Chairman of the Board, added, "Galectin Therapeutics is competitively well-positioned in the industry, and we are fortunate to have Joel leading these efforts. I am also glad to welcome Mr. Richard Zordani and Dr. Elissa Schwartz to our Board of Directors, both seasoned professionals that will strengthen our financial and clinical capabilities, respectively."

"Success in NASH cirrhosis potentially opens new treatment possibilities for belapectin’s use in other types of liver cirrhosis and in other forms of organ fibrosis affecting kidney, lung, as well as other organs. More research is warranted to expand our understanding of galectins and the role that a galectin-3 inhibitor like belapectin may play in preventing and treating disease. Thus, our NASH-RX trial will set the stage for realizing the full potential of our proprietary compound, belapectin."

Summary of Key Development Programs and Updates

On June 30 announced that we had enrolled our first patients in the NASH-RX trial. NASH-RX is an international, seamless, adaptively-designed Phase 2b/3 trial of our galectin-3 inhibitor belapectin (GR-MD-02), the company’s lead compound, in nonalcoholic steatohepatitis (NASH) cirrhosis patients who have clinical signs of portal hypertension and are at risk of developing esophageal varices. Belapectin had previously been shown that it could prevent the development of new varices in this patient population in the Phase 2 NASH-CX clinical trial (Gastroenterology 2020;158:1334–1345 or View Source).

Announced the appointment of current board member, Joel Lewis, to the position of Chief Executive Officer (CEO) and President. In this position, Mr. Lewis will set corporate strategy and oversee operations, most importantly the Company’s global NASH-RX adaptively-designed trial for the prevention of varices in NASH cirrhosis patients using its proprietary galectin-3 inhibiting compound, belapectin (GR-MD-02).

Engaged Dr. Harold Shlevin, who retired from the CEO position, to a consulting agreement through which he has agreed to devote significant effort to advancing the NASH-RX trial and will remain a member of the Board of Directors.

Enhanced its Board of Directors with the addition of two additional directors, Mr. Richard Zordani and Dr. Elissa Schwartz. Mr. Zordani is a seasoned financial executive with extensive public accounting and Family Office experience and has assumed the role of Audit Committee Chairman. Dr. Schwartz has extensive experience in epidemiology and clinical research, biomathematics, and biostatistics, which complements the Company’s clinical development capabilities.

Hosted a virtual conference call and webinar with the investment community on September 29th that provided a comprehensive description and update on the status of the NASH-RX trial and introduced our new CEO, Joel Lewis.
A replay of the Investor Call can be accessed at this link: View Source
About the NASH-RX Trial

The NASH-RX trial will use a seamless, adaptive design to confirm dose selection and reaffirm the observed efficacy of belapectin to prevent the development of esophageal varices in the NASH-CX trial. Pre-planned adaptations will inform the larger Phase 3 trial component. NASH-RX is expected to enroll approximately 315 NASH cirrhotic patients in the Phase 2b part of the trial at approximately 130 sites in 12 countries in North America, Europe, Asia and Australia.
Financial Results

For the three months ended September 30, 2020, the Company reported a net loss applicable to common stockholders of $5.955 million, or ($0.10) per share, compared to a net loss applicable to common stockholders of $2.819 million, or ($0.05) per share for the three months ended September 30, 2019. The increase is due to 2020 research and development expense related to the Company’s NASH-RX trial.

Research and development expense for the three months ended September 30, 2020 was $4.780 million compared with $1.503 million for the three months ended September 30, 2019. The increase was primarily due to costs related to our NASH-RX clinical trial, along with preparations and some preclinical activities incurred in support of the clinical program, such as development and reproductive toxicity studies, clinical supplies and other supportive activities. General and administrative expenses for the three months ended September 30, 2020, were $1.146 million, down from $1.360 million for the three months ended September 30, 2019, primarily due to a decrease in stock-based compensation expenses.

As of September 30, 2020, the Company had $32.6 million of cash and cash equivalents. 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 December 31, 2021.

The Company expects that it will require more cash to fund operations after December 31, 2021 and believes it will be able to obtain additional financing as needed. Currently, we expect to require an additional approximately $40 million to cover costs of the trial to reach the planned interim analysis estimated to occur in the second quarter of 2023 along with drug manufacturing and other scientific support activities and general and administrative costs. These costs will require additional funding. There can be no assurance that we will be successful in obtaining financing to support our operations beyond December 31, 2021, or, if available, that any such financing will be on terms acceptable 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. Galectin-3 has a significant role in cancer and the Company is supporting a Phase 1 study in combined immunotherapy of belapectin and Keytruda in treatment of advanced melanoma and in head and neck cancer.

About Non-alcoholic steatohepatitis (NASH) with Advanced Fibrosis and Cirrhosis
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 currently the only curative treatment available. There are no drug therapies approved for the treatment of liver fibrosis or cirrhosis.

On November 9, 2020 Verrica Pharmaceuticals Inc. ("Verrica") (Nasdaq: VRCA), a dermatology therapeutics company developing medications for skin diseases requiring medical interventions, reported financial results for the third quarter ended September 30, 2020 (Press release, Verrica Pharmaceuticals, NOV 9, 2020, View Source [SID1234570465]).

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"We are encouraged by our recent Type A meeting with the FDA in which we discussed the steps required for resubmission of the NDA for VP-102, our lead product candidate, for the treatment of molluscum," said Ted White, Verrica’s President and Chief Executive Officer. "We have also received feedback from the FDA on our Human Factors study protocol, and believe we have clear alignment on the path forward to resubmit the NDA, which we anticipate in the first quarter of 2021. In addition, we have continued to engage with Torii as they evaluate the option to exclusively license VP-102 in Japan for the treatment of molluscum contagiosum and common warts. We also strategically expanded our product portfolio into dermatologic cancers, with an initial focus on non-melanoma skin cancers, one of the most common disease states in dermatology."

Business Highlights and Recent Developments

In October 2020, Verrica participated in a Type A meeting with the FDA to discuss issues raised in the Complete Response Letter for the NDA for VP-102 for the treatment of molluscum. Verrica expects to receive the minutes from the meeting in the coming weeks, followed by resubmission of the NDA pursuant to the statutory 505(b)(1) regulatory pathway in the first quarter of 2021.

The positive results from the Company’s two pivotal Phase 3 CAMP studies evaluating the safety and efficacy of VP-102 in children and adults with molluscum were published in the Journal of the American Medical Association (JAMA) Dermatology on September 23, 2020. The results were previously presented at the 2019 American Academy of Dermatology (AAD) annual meeting in a late-breaking oral presentation.

In August 2020, Verrica was granted a United States utility patent (US 10,745,413) protecting synthetic methods for manufacturing cantharidin. Also in August 2020, a U.S. design patent application protecting the design of Verrica’s VP-102 applicator device received an allowance from the United States Patent and Trademark Office (USPTO). The resulting United States design patent (US D900,312) was granted in October 2020.
Financial Results

Third Quarter 2020 Financial Results

Verrica reported a net loss of $10.5 million for the third quarter of 2020, compared to a $6.1 million net loss for the same period in 2019.
Research and development expenses were $5.0 million in the third quarter of 2020, compared to $3.0 million for the same period in 2019. The increase was primarily attributable to increased CMC (Chemistry, Manufacturing, and Controls) costs related to Verrica’s development of VP-102 for molluscum contagiosum and increased compensation costs, partially offset by decreased clinical costs related to Verrica’s development of VP-102 for molluscum contagiosum, external genital warts, and common warts.
General and administrative expenses were $4.6 million in the third quarter of 2020, compared to $3.5 million for the same period in 2019. The increase was primarily a result of expenses related to increased headcount, an increase in insurance, professional fees and other operating costs, and an increase in expenses related to pre-commercial activities for VP-102.
Year-to-Date September 2020 Financial Results

Verrica reported a net loss of $29.7 million for the nine months ended September 30, 2020, compared to a $20.6 million net loss for the same period in 2019.
Research and development expenses were $13.4 million for the nine months ended September 30, 2020, compared to $11.5 million for the same period in 2019. The increase was primarily attributable to increased CMC costs related to Verrica’s development of VP-102 for molluscum contagiosum and increased compensation costs, partially offset by decreased clinical costs related to Verrica’s development of VP-102 for molluscum contagiosum.
General and administrative expenses were $14.7 million for the nine months ended September 30, 2020, compared to $10.6 million for the same period in 2019. The increase was primarily a result of expenses related to increased headcount, an increase in insurance, professional fees and other operating costs, and an increase in expenses related to pre-commercial activities for VP-102.
As of September 30, 2020, Verrica had aggregate cash, cash equivalents, and marketable securities of $71.9 million, which the Company believes will be sufficient to support planned operations at least through the fourth quarter of 2021.

On November 9, 2020 Kitov Pharma Ltd. ("Kitov") (NASDAQ/TASE: KTOV), a clinical-stage company advancing first-in-class therapies to overcome tumor immune evasion and drug resistance, reported that the company and Bristol Myers Squibb have amended their Clinical Trial Collaboration and Supply Agreement to reflect the expansion of the planned Phase 1/2 clinical trial evaluating CM24 in advanced non-small cell lung cancer (NSCLC) with a new cohort to also evaluate CM24 in patients with pancreatic cancer (Press release, Kitov Pharmaceuticals , NOV 9, 2020, View Source [SID1234570463]).

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The Phase 1/2 clinical trial will evaluate CM24, a monoclonal antibody targeting CEACAM1, in combination with nivolumab (Opdivo) in patients with advanced non-small cell lung cancer. With this expansion, the trial is now also planned to evaluate CM24 in combination with nivolumab in addition to nab-paclitaxel (ABRAXANE) in patients with pancreatic cancer.

In an initial Phase 1 study consisting of a monotherapy dose escalating IV administration of CM24 administered every two weeks, in 27 patients with advanced malignancies, CM24 was found to be safe and well-tolerated in all patients, with no discontinuations of study drug or dose limiting toxicities (up to 10mg/kg). In the efficacy evaluable patients (n=24), subjects were highly refractory to therapy, having received between two and eight prior therapies (with a median of four). Eight of the evaluable patients (33%) achieved stable disease, with most of these patients responding at the higher dose levels of 3mg/kg and 10mg/kg. Pharmacokinetic analysis revealed non-linearity, and modeling suggested that a higher dose level is required to achieve full saturation of CEACAM1 receptors.

"We are excited to announce this important expansion of our planned Phase 1/2 trial for CM24," said Bertrand Liang, M.D., Ph.D., Chief Medical Officer of Kitov. "Based on the encouraging Phase 1 results for CM24, which were presented in a poster presentation at this year’s American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2020 Virtual Scientific Program, we look forward to evaluating this compelling drug candidate at higher doses and in a larger clinical study. We anticipate starting this Phase 1/2 trial, which is being conducted with Bristol Myers Squibb, before the end of 2020. We expect the availability of top-line Phase 1 results from the study in the second half of 2021."

The Phase 1/2 clinical study will encompass a dose escalation of CM24 from 10mg/kg to 20mg/kg with nivolumab for the treatment of refractory cancer patients with NSCLC, pancreatic cancer, ovarian carcinoma, melanoma or thyroid carcinoma, in order to determine a recommended Phase 2 dose. Subsequently, two expansion arms will be opened: the first in patients with NSCLC who have become refractory to first-line immunotherapy, and will receive CM24 in combination with nivolumab, and the second in metastatic pancreatic adenocarcinoma patients who have progressed after first-line chemotherapy treatment, and will receive CM24 in combination with nab-paclitaxel and nivolumab. Study endpoints will include both safety and preliminary efficacy in these refractory patients.

"Collaborating with Bristol Myers Squibb has allowed us to design a clinical study that reflects some of the most current available data in both NSCLC and pancreatic cancer," noted Michael Schickler, Ph.D., Head of Clinical and Regulatory Affairs of Kitov. "CM24 targets CEACAM1, which has been found to be correlated with poor prognosis in these tumor types, and the creation of neoantigens with the use of a cytotoxic agent, such as nab-paclitaxel, could potentiate the activity of immuno-oncology agents. I would like to thank the respective teams at Kitov and Bristol Myers Squibb for their significant efforts in preparing for this important study and I look forward to the initiation of the study before the end of the year. Our focus is on efficiently advancing the program, and establishing CM24 as a potential first-in-class anti-CEACAM1 therapy."

On November 9, 2020 Heat Biologics, Inc. ("Heat") (NASDAQ: HTBX), a clinical-stage biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, including multiple oncology product candidates and a novel COVID-19 vaccine, reported that financial, clinical and operational updates for the third quarter ended September 30, 2020 (Press release, Heat Biologics, NOV 9, 2020, View Source [SID1234570462]).

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Jeff Wolf, Chief Executive Officer of Heat, commented, "We continue to make progress on both our oncology and COVID-19 vaccine programs. We presented data for HS-110 in combination with Nivolumab in our Phase 2 lung cancer trial at the 2020 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting demonstrating a strong survival benefit in a cohort of previously treated checkpoint inhibitor naïve patients with advanced non-small cell lung cancer (NSCLC). We are actively pursuing a variety of strategies to maximize value for the program."

"At the same time, we continue to advance PTX-35, our potential first-in-class T-cell co-stimulatory antibody, through clinical development. Earlier this year, we initiated the first clinical trial site for PTX-35 in multiple solid tumors and began dosing patients in the Phase 1 clinical trial. PTX-35 is designed to harness the body’s natural antigen specific immune activation and tolerance mechanisms to reprogram immunity and provide a long-term, durable clinical effect. This study is expected to enroll up to 30 patients with advanced solid tumors refractory to standard of care."

"Importantly, we announced preclinical data for our gp96-based COVID-19 vaccine. The data, generated at the University of Miami Miller School of Medicine and published in bioRxiv, shows robust T-cell mediated immune response directed against the spike protein of SARS-CoV-2. Our gp96-based COVID-19 vaccine induced the expansion of both "killer" CD8+ T-cells that destroy virus infected cells, as well as "helper" CD4+ T-cells that assist in producing highly specific antibodies. As a result, we believe our vaccine has the potential to be used as either a standalone vaccine, or in combination with other antibody-focused vaccine approaches to enhance prophylactic protection. These results highlight the potential utility and versatility of our vaccine platform to address SARS-CoV-2, relevant mutations and other pathogens of interest."

"We continue to strengthen our IP portfolio and were recently awarded an additional U.S. patent covering Heat’s gp96 platform in combination with a T cell costimulatory agonist in a single therapy. We believe the combination of our gp96 platform in a single therapy holds enormous promise in the prevention and treatment of cancer and infectious diseases, such as COVID-19."

"Finally, we have maintained a solid balance sheet with over $117 million of cash and short-term investments as of September 30, 2020. We believe this capital will provide us significant runway to achieve a number of important clinical milestones that we believe will drive value for shareholders in the months and years ahead," concluded Mr. Wolf.

Third Quarter 2020 Financial Results

●Recognized $0.8 million of grant revenue for qualified expenditures under the CPRIT and NIH grants. No grant revenue was recognized under the respective grants for the three months ended September 30, 2019. The increase in grant revenue in the current-year period primarily reflects the expected timing of completion of deliveries under the current phase of the contracts. As of September 30, 2020, we had deferred revenue of $1.2 million for CPRIT proceeds received but for which the costs had not been incurred or the conditions of the award had not been met.
●Research and development expenses was $3.2 million and $3.1 million for the three months ended September 30, 2020 and 2019, respectively.
●General and administrative expense was $6.6 million and $2.0 million for the three months ended September 30, 2020 and 2019. General and administrative expenses primarily consist of personnel costs, including stock-based compensation expense, and consulting expenses to manage the business.
●Net loss attributable to Heat Biologics was approximately $8.9 million, or ($0.06) per basic and diluted share for the quarter ended September 30, 2020 compared to a net loss of approximately of $6.2 million, or ($0.18) per basic and diluted share for the quarter ended September 30, 2019.
●As of September 30, 2020, the Company had approximately $117.3 million in cash, cash equivalents and short investments.