On August 5, 2021 Second Genome, a biotechnology company that leverages its proprietary platform sg-4-sight to discover and develop precision therapies and biomarkers from public and proprietary microbiome data, reported they are entering a strategic collaboration with Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) to identify microbiome biomarkers associated with clinical response for their lead program in gastroenterology, etrasimod (Press release, Second Genome, AUG 5, 2021, View Source [SID1234586037]).

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Under the terms of the agreement, Second Genome will utilize its proprietary sg-4-sight discovery engine to identify microbiome biomarkers associated with clinical benefit or adverse effects observed within data from the CULTIVATE clinical trial. Arena’s CULTIVATE trial is a Phase 2/3 clinical trial evaluating the efficacy and safety of etrasimod, a next-generation, once-daily, oral, highly selective sphingosine 1-phosphate (S1P) receptor modulator, in patients with moderately-to-severely active Crohn’s disease. This work will help inform patient stratification and optimize potential treatments for patients in the future.

"The multi-disciplinary capabilities of our sg-4-sight platform and our team’s deep expertise enable Second Genome to collaborate with partners as we continue to advance our own pipeline of precision therapeutics and biomarkers," said Karim Dabbagh, Ph.D., President and Chief Executive Officer of Second Genome. "Arena shares our commitment to unlocking innovative ways to improve human health. We look forward to working with Arena and applying our sg-4-sight platform to discover microbiome signals in Crohn’s disease patients."

"There is substantial evidence that gut microbiome is intricately involved in therapy response in gastrointestinal diseases," said Amit D. Munshi, President and Chief Executive Officer of Arena Pharmaceuticals. "We are pleased to collaborate with Second Genome to discover microbiome biomarkers predictive of clinical response as we continue to progress our CULTIVATE clinical trial."

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.

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]).

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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.

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]).

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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.

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.

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