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Cytocom Inc. Provides Update on Completed Merger with Cleveland BioLabs

On August 5, 2021 Cytocom Inc. (NASDAQ: CBLI), a leading biopharmaceutical company creating next-generation immune therapies that focus on immune restoration and homeostasis, reported shareholders with an update regarding its recent merger with Cleveland BioLabs (Press release, Cleveland BioLabs, AUG 5, 2021, https://www.prnewswire.com/news-releases/cytocom-inc-provides-update-on-completed-merger-with-cleveland-biolabs-301349236.html [SID1234586036]). The all-stock transaction, first announced in October 2020, was formally completed on July 27, 2021.

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"With the Cleveland BioLabs merger completed and Cytocom now operating as a publicly-traded company, the management team at Cytocom is in the process of integrating both companies as we are rapidly advancing our late-stage clinical programs and expanding our toll-like receptor platforms," stated Michael K. Handley, President and CEO of Cytocom Inc. "Furthermore, we believe, through the combination of the two companies, we have created one of the most compelling platforms in the immunotherapy space with 21 programs utilizing eight different assets."

Mr. Handley continued, "We expect to achieve a number of financial and developmental milestones over the next 12 to 18 months that support our goal of becoming a recognized leader in immune-modulating treatments including neutropenia/anemia, emergent viruses, cancer, and autoimmune diseases. We intend to showcase the power of our drug development platform and further generate shareholder value."

Additional information related to the merger close can be found in the Form 8-K filed with the U.S. Securities and Exchange Commission (SEC) on July 28, 2021, including the exchange ratio of private Cytocom stock to the new public stock. Continental Stock Transfer & Trust is responsible for implementing the issuance of shares of public Cytocom common stock in accordance with the exchange ratio. Continental Transfer & Trust is in the process of completing these activities and will then initiate communication directly to shareholders to provide the necessary forms for former shareholders to receive their new registered freely tradable shares of common Cytocom Inc. stock.

Cytocom acquired ImQuest Life Sciences in an all-stock deal, first announced on July 20, 2020, and completed on June 23, 2021. Pursuant to the terms of the acquisition agreement, Cytocom escrowed stock that is accounted for in the current public company’s capital structure that will be used to provide an aggregate of $12 million in value of Cytocom shares based on the volume-weighted-average trading price of such shares over the period beginning 30 trading days following the closing of such merger. Continental Stock Transfer & Trust is responsible for implementing the issuance of shares of Cytocom common stock to former shareholders of ImQuest in accordance with the exchange ratio.

All other aspects related to merger integration and stock conversion are proceeding as expected. Management will provide a detailed update of the post-merger activities on the company’s quarterly earnings call later this month. All questions regarding the distribution of Cytocom common stock should be directed to Continental Stock Transfer & Trust. Continental Stock Transfer & Trust may be contacted by mail at 1 State St., 30th Floor, New York, NY, 10004-1561 or by phone at (212) 509-4000.

Lipocine Announces Financial Results for the Second Quarter Ended June 30, 2021

On August 5, 2021 Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, reported financial results for the second quarter ended June 30, 2021, and provided a corporate update (Press release, Lipocine, AUG 5, 2021, View Source [SID1234586034]).

Recent Corporate Highlights

Announced positive topline results from the Phase 2 LiFT ("Liver Fat intervention with oral Testosterone") clinical study, investigating LPCN 1144 in biopsy-confirmed NASH male subjects
36-week biopsy data from the LiFT clinical study are expected in August 2021
Continued enrolling patients into an open label extension to the LiFT clinical study in which all patients will have access to LPCN 1144
Clinical data from the LiFT clinical study were presented at The International Liver Congress 2021, the annual meeting of the European Association for the Study of the Liver ("EASL"), Digital Event, which took place June 23-26, 2021
Results from the LiFT clinical study showed that LPCN 1144 treatment significantly reduced liver fat and key liver injury markers in biopsy confirmed NASH subjects
Data from the LiFT clinical study showed high prevalence of low normal or overtly hypogonadal levels of testosterone in histologically established NASH subjects
LPCN 1144 was shown to improve body composition in biopsy-confirmed NASH patients
The U.S. Food and Drug Administration ("FDA") cleared the Company’s Investigational New Drug Application ("IND") to initiate a Phase 2 study to evaluate the therapeutic potential of LPCN 1154, an oral neuro-steroid product candidate, for the treatment of postpartum depression ("PPD") in adults
Top-line results from an ongoing pharmacokinetic ("PK") study to assess dose proportionality are expected in the third quarter of 2021
Following the PK study, a proof-of-concept study to evaluate the safety, tolerability, and efficacy of LPCN 1154 in adult female subjects diagnosed with PPD is expected to begin in the fourth quarter of 2021
Entered into a global settlement agreement with Clarus Therapeutics Inc. ("Clarus") to resolve all outstanding claims in the on-going intellectual property litigation between Lipocine and Clarus, as well as the on-going interference proceeding between the two companies
Continued business development activities surrounding TLANDO related to the commercialization of TLANDO upon approval by the FDA
Expect the first subject will be dosed in the proof-of-concept Phase 2 study in male cirrhotic subjects to evaluate the therapeutic potential of LPCN 1148 for the management of cirrhotic subjects in the fourth quarter of 2021
Second Quarter Ended June 30, 2021 Financial Results
Lipocine reported a net loss of $6.8 million, or ($0.08) per diluted share, for the second quarter ended June 30, 2021, compared with a net loss of $6.4 million, or ($0.13) per diluted share, for the second quarter ended June 30, 2020.

Research and development expenses were $1.5 million for the second quarter ended June 30 2021, compared with $2.3 million for the second quarter ended June 30, 2020. The decrease was primarily due to a decrease in contract research organization expense and outside consulting costs related to the LPCN 1144 Phase 2 LiFT clinical study in NASH subjects, a decrease in costs associated with TLANDO and a decrease in personnel expense, which was mainly due to a decrease in stock compensation and bonus expense. These decreases were offset by an increase in costs related to LPCN 1154 and LPCN 1107, as well as increases in other R&D expenses.

General and administrative expenses were $1.5 million for the second quarter ended June 30, 2021, compared with $2.0 million for the second quarter ended June 30, 2020. The decrease in general and administrative was primarily related to a decrease in personnel costs, which was mainly due to a decrease in stock compensation and bonus expense, and a decrease in legal expenses. These decreases were offset by increases in corporate insurance and other general and administrative expenses.

As of June 30, 2021, the Company had $46.6 million of unrestricted cash, cash equivalents, and marketable investments, compared to $19.7 million of unrestricted cash, cash equivalents and marketable investment securities as of December 31, 2020.

Six Months Ended June 30, 2021 Financial Results
Lipocine reported a net loss of $10.2 million, or ($0.12) per diluted share, for the six months ended June 30, 2021, compared with a net loss of $12.1 million, or ($0.27) per diluted share, for the six months ended June 30, 2020.

Research and development expenses were $3.0 million for the six months ended June 30, 2021, compared with $4.8 million for the six months ended June 30, 2020. The decrease in research and development expenses was primarily due to a decrease in contract research organization expense and outside consulting costs related to the LPCN 1144 Phase 2 LiFT clinical study in NASH subjects, a decrease in costs associated with TLANDO and a net decrease in personnel expense, which was mainly due to a decrease in stock compensation expense offset by increases in salaries. These decreases were offset by an increase in costs related to LPCN 1154 and LPCN 1107, as well as increases in other R&D expenses.

General and administrative expenses were $3.1 million for the six months ended June 30, 2021, compared with $4.0 million for the six months ended June 30, 2020. The decrease in general and administrative expenses was primarily due to a decrease in legal costs and a decrease in personnel costs, mainly due a reduction in stock compensation expense. These decreases were offset by an increase in corporate insurance expenses and an increase in other general and administrative expenses.

ViewRay Reports Second Quarter 2021 Results

On August 5, 2021 ViewRay, Inc. (Nasdaq: VRAY) (the "Company") reported financial results for the second quarter ended June 30, 2021 (Press release, ViewRay, AUG 5, 2021, View Source [SID1234586033]).

Second Quarter 2021 Highlights

Received seven new orders for MRIdian systems totaling $37.9 million, compared to four new orders totaling $24.6 million in the second quarter of 2020.
Total backlog increased to $278.4 million as of June 30, 2021, compared to $232.2 million as of June 30, 2020.
Total revenue of $15.0 million primarily from two revenue units, compared to $14.2 million primarily from two revenue units in the second quarter of 2020.
Cash usage in the second quarter of 2021 was approximately $15 million compared to approximately $11 million in the second quarter of 2020.
Cash and cash equivalents were $166.9 million as of June 30, 2021.
"Our second quarter performance is a solid step forward and reflects progress on our commercial, innovation, and clinical pipelines. Our team has executed very well in an environment that continues to be challenging," said Scott Drake, President and CEO. "We are well positioned to drive further growth, therapy adoption, and extend our innovation lead."

Three Months Ended June 30, 2021 Financial Results

Total revenue for the three months ended June 30, 2021 was $15.0 million compared to $14.2 million for the same period last year.

Total gross profit (loss) for the three months ended June 30, 2021 was ($1.7) million, compared to ($1.0) million for the same period last year.

Total operating expenses for the three months ended June 30, 2021 were $24.8 million, compared to $24.5 million for the same period last year.

Net loss for the three months ended June 30, 2021 was $31.0 million, or $0.19 per share, compared to $26.2 million, or $0.18 per share, for the same period last year.

ViewRay had total cash and cash equivalents of $166.9 million at June 30, 2021.

Six Months Ended June 30, 2020 Financial Results:

Total revenue for the six months ended June 30, 2021 was $30.6 million compared to $28.5 million for the same period last year.

Total gross profit (loss) for the six months ended June 30, 2021 was $(1.4) million, compared to $(3.1) million for the same period last year.

Total operating expenses for the six months ended June 30, 2021 were $49.8 million, compared to $52.5 million for the same period last year.

Net loss for the six months ended June 30, 2021 was $57.7 million, or $0.36 per share, compared to $53.7 million, or $0.36 per share, for the same period last year.

Financial Guidance
For the full year 2021, ViewRay anticipates total revenue to be in the range of $63 million to $73 million, and total cash usage to be in the range of $58 million to $68 million.

Conference Call and Webcast
ViewRay will hold a conference call to discuss results on Thursday, August 5, 2021 at 4:30 p.m. ET / 1:30 p.m. PT. The dial-in numbers are (844) 277-1426 for domestic callers and (336) 525-7129 for international callers. The confirmation number is 8473598. A live webcast of the conference call will be available on the investor relations page of ViewRay’s corporate website at View Source

After the live webcast, a replay will remain available online on the investor relations page of ViewRay’s website, under "Financial Events and Webinars", for 14 days following the call. In addition, a telephonic replay of the call will be available for seven days after the call. The replay dial-in numbers are (855) 859-2056 for domestic callers and (404) 537-3406 for international callers. Please use the conference ID number 8473598.

Fusion Pharmaceuticals to Participate in the 2021 Wedbush PacGrow Healthcare Virtual Conference

On August 5, 2021 Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, reported that the Company will participate in the "Hot Topic – Radiopharmaceuticals" panel discussion at the 2021 Wedbush PacGrow Healthcare Virtual Conference on Wednesday, August 11, 2021 at 4:05pm EDT (Press release, Fusion Pharmaceuticals, AUG 5, 2021, View Source [SID1234586032]). Participating in the panel on behalf of Fusion will be Chief Executive Officer John Valliant, Ph.D.

Synthetic Biologics Reports Second Quarter 2021 Operational Highlights and Financial Results; Conference Call to be Held Today at 4:30 PM ET

On August 5, 2021 Synthetic Biologics, Inc. (NYSE American: SYN), a diversified clinical-stage company leveraging the microbiome to develop therapeutics designed to prevent and treat gastrointestinal ("GI") diseases in areas of high unmet need, reported financial results for the second quarter ended June 30, 2021 (Press release, Synthetic Biologics, AUG 5, 2021, View Source [SID1234586031]).

Recent Developments:

Announced completion of patient dosing and observation in the Phase 1, open label, single-ascending dose ("SAD") clinical trial of SYN-020 intestinal alkaline phosphatase ("IAP")
Continuing enrollment in the Phase 1b/2a clinical trial of SYN-004 (ribaxamase) in allogeneic hematopoietic cell transplant ("HCT") recipients
Current cash position of approximately $74.3 million
Current cash runway expected to provide funding to complete Phase 1b/2a clinical trial of SYN-004, clinical trials of SYN-020 through proof-of-concept, and other key milestones into 2023
Anticipated Milestones:

Expect to commence second Phase 1 multiple-ascending dose ("MAD") clinical trial of SYN-020 during Q3 2021; topline data anticipated during Q2 2022
Topline data readout from the first antibiotic cohort of the SYN-004 Phase 1b/2a clinical trial is expected during Q4 2021
"During the second quarter, we remained focused on the advancement of our portfolio of gastrointestinal and microbiome-focused clinical programs," said Steven A. Shallcross, Chief Executive Officer of Synthetic Biologics. "We were pleased to complete patient dosing and observation in the Phase 1 SAD clinical trial of SYN-020 intestinal alkaline phosphatase with preliminary results demonstrating that SYN-020 maintained a favorable safety profile, was well tolerated at all dose levels, and no adverse events were attributed to SYN-020. Looking ahead, we intend to commence a second Phase 1 MAD clinical trial of SYN-020 in healthy adult volunteers during the third quarter of 2021 with topline results expected during the second quarter of 2022. Both the Phase 1 SAD and MAD studies are designed to support the advancement of SYN-020 in multiple potential therapeutic indications, including celiac disease, nonalcoholic fatty liver disease ("NAFLD"), radiation enteritis, and age-related metabolic and inflammatory diseases."

Mr. Shallcross continued, "Patient screening and enrollment in the SYN-004 Phase 1b/2a clinical trial in allogeneic HCT recipients remains ongoing at the Washington University School of Medicine in St. Louis ("Washington University"). At this time, enrollment is proceeding as expected and we anticipate announcing topline results from this first of three antibiotic cohorts during the fourth quarter of 2021. We believe SYN-004 has the potential to significantly improve outcomes for allogeneic HCT recipients by preventing downstream complications often caused by disruption of the gut microbiome by intravenous ("IV") beta-lactam antibiotics following conditioning therapy. We are very excited about the potential for our portfolio of clinical development programs to be long-term value drivers for our Company and look forward to sharing important updates as they become available."

Clinical Development and Operational Update

Announced completion of patient dosing and observation in the Phase 1, open label, single-ascending dose clinical trial of SYN-020
The Phase 1 SAD study enrolled 24 healthy adult volunteers into four cohorts with SYN-020 given orally as single doses ranging from 5 mg to 150 mg.
Analyses of preliminary data demonstrated that SYN-020 maintained a favorable safety profile, was well tolerated at all dose levels, and no adverse events were attributed to the study drug. No serious adverse events were reported.
A second Phase 1 clinical trial evaluating multiple-ascending doses of SYN-020 in healthy volunteers is expected to commence during the third quarter of 2021. Topline data are anticipated during the second quarter of 2022, pandemic conditions permitting.
Both studies are intended to support the development of SYN-020 in multiple potential clinical indications including celiac disease, NAFLD, radiation enteritis, as well as indications supported by the Company’s collaboration with Massachusetts General Hospital.
Enrollment in the Company’s Phase 1b/2a clinical trial of SYN-004 in allogeneic HCT recipients for the prevention of acute graft-versus-host-disease ("aGVHD") remains ongoing
The Phase 1b/2a clinical trial comprises a single center, randomized, double-blind, placebo-controlled clinical trial of oral SYN-004 in up to 36 evaluable adult allogeneic HCT recipients.
The goal of this clinical trial is to evaluate the safety, tolerability, and potential absorption into the systemic circulation (if any) of oral SYN-004 administered to allogeneic HCT recipients who receive an IV beta-lactam antibiotic to treat fever.
Study participants will be enrolled into three sequential cohorts and administered a different study-assigned IV beta-lactam antibiotic. Eight participants in each cohort will receive SYN-004 and four will receive placebo.
Safety and pharmacokinetic data for each cohort will be reviewed by an independent Data and Safety Monitoring Committee ("DSMC"), which will make a recommendation on whether to proceed to the next IV beta-lactam antibiotic.
A topline data readout for the first antibiotic cohort is anticipated during the fourth quarter of 2021, pandemic conditions permitting.
Received notification from the NYSE American that the Company had regained compliance with all of the continued listing standards set forth in Part 10, Section 1003 of the NYSE American Company Guide (the "Company Guide") relating to the Exchange’s continued listing requirements.
Quarter Ended June 30, 2021 Financial Results

General and administrative expenses decreased by 2% to approximately $1.26 million for the three months ended June 30, 2021, from approximately $1.29 million for the three months ended June 30, 2020. This decrease is primarily due to lower legal costs and vacation expense offset by higher insurance costs, audit fees and registration fees. The charge related to stock-based compensation expense was $83,000 for the three months ended June 30, 2021, compared to $67,000 for the three months ended June 30, 2020.

Research and development expenses increased by 21% to approximately $1.9 million for the three months ended June 30, 2021, from approximately $1.6 million for the three months ended June 30, 2020. This increase is primarily the result of increased clinical trial expenses as we began dosing patients in the Phase 1b/2a clinical trial of SYN-004 and Phase 1 SAD clinical trial of SYN-020 during the three months ended June 30, 2021, offset by lower indirect program costs for the three months ended June 30, 2021, including salary and related expense reductions, a decrease in manufacturing costs for SYN-020 and market research. In addition, as a result of the global COVID-19 pandemic, our clinical development partner (Washington University) reduced their operating capacity during 2020 to include only essential activities as part of their pandemic response, which delayed the start of our clinical trial until 2021. We anticipate research and development expense to increase as our ongoing clinical trials continue to enroll patients. The charge related to stock-based compensation expense was $19,000 for the three months ended June 30, 2021, compared to $19,000 related to stock-based compensation expense for the three months ended June 30, 2020.

Other income was $2,000 for the three months ended June 30, 2021, compared to other income of $6,000 for the three months ended June 30, 2020. Other income for the three months ended June 30, 2021 and 2020 is primarily comprised of interest income.

Cash and cash equivalents as of June 30, 2021 totaled $74.3 million, an increase of $68.1 million from December 31, 2020.

Conference Call

Synthetic Biologics will hold a conference call today, Thursday, August 5, 2021, at 4:30 p.m. (EST). The dial-in information for the call is as follows, U.S. toll free: 1-888-347-5280 or International: +1 412-902-4280. Participants are asked to dial in 15 minutes before the start of the call to register. The call will also be webcast over the Internet at View Source." target="_blank" title="View Source." rel="nofollow">View Source An archive of the call will be available for replay at the same URL, View Source , for 90 days after the call.