On August 5, 2021 Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, reported its financial results for the second quarter of fiscal year 2021 (Press release, Certara, AUG 5, 2021, View Source [SID1234586604]).

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Highlights:
Revenue was $70.1 million, representing growth of 15% over the second quarter of 2020
Net loss was ($2.9) million, compared to a net income of $2.8 million in the second quarter of 2020
Adjusted EBITDA was $25.5 million, representing growth of 1% over the second quarter of 2020
Announced agreement to acquire Pinnacle 21, a leader in data standardization software for pharmaceutical clinical data, for $310 million in cash and stock, with a closing expected in early Q4 of 2021
Raised 2021 guidance from $283 million to $289 million of revenue, $101 million to $103 million of Adjusted EBITDA, and $0.21 to $0.25 of Adjusted Diluted Earnings Per Share. Updated guidance does not include the impact of the Pinnacle 21 acquisition
"Our second quarter results reflect continued momentum from increased adoption of our proprietary end-to-end platform and the launch of new software capabilities to expand use cases of biosimulation worldwide," said William F. Feehery, Chief Executive Officer of Certara. "Earlier today, we announced the strategic and accretive deal to acquire Pinnacle 21, our largest to date. This expansion of Certara’s quantitative tools and solutions will further help researchers and regulators answer critical questions throughout the drug development life cycle."

Second Quarter 2021 Results
"In the second quarter, Certara’s differentiated portfolio of software and technology-driven services delivered strong financial performance. Looking forward, we remain well-positioned to achieve our stated long-term goals of mid-teens revenue growth and Adjusted EBITDA margin expansion. With reported trailing twelve-month bookings growth of 26%, we have a high level of visibility towards realizing our business and financial plans for the year," said Andrew Schemick, Chief Financial Officer.

Total revenue for the second quarter of 2021 was $70.1 million, representing year-over-year growth of 15%. The revenue growth was driven by both technology-driven services and software licenses and subscriptions.

Total cost of revenue for the second quarter of 2021 was $27.5 million, an increase from $20.6 million in the second quarter of 2020, primarily due to a $3.9 million increase in employee related costs and a $1.4 million increase in stock-based compensation costs.

Total operating expenses for the second quarter of 2021 were $37.3 million, an increase from $26.9 million in the second quarter of 2020, primarily due to a $5.6 million increase in stock-based compensation expense and a $2.1 million increase in employee related costs. The remaining increases were due to increases in refinancing costs, acquisition related costs and D&O insurance costs.

Net loss for the second quarter of 2021 was ($2.9) million, compared to a net income of $2.8 million in the second quarter of 2020. The loss was primarily due to a $7.0 million increase in stock-based compensation expense.

Diluted Earnings Per Share for the second quarter 2021 were ($0.02), as compared to $0.02 in the second quarter of 2020.

Adjusted EBITDA for the second quarter of 2021 was $25.5 million compared to $25.3 million for the second quarter of 2020, representing 1% growth. Adjusted EBITDA for the second quarter of 2020 included the benefit of the completion of high margin projects and lower SG&A costs during the start of the pandemic, which when combined with public company costs incurred in 2021, led to a challenging comparison in the quarter. See note (1) in the section A Note on Non-GAAP Financial Measures, below, for more information on Adjusted EBITDA. Adjusted Net Income for the second quarter of 2021 was $5.6 million compared to $3.8 million for the second quarter of 2020. Adjusted Diluted Earnings Per Share for the second quarter 2021 was $0.03 compared to $0.02 for the second quarter of 2020. See note (2) in the section A Note on Non-GAAP Financial Measures, below, for more information on Adjusted Net Income and Adjusted Diluted Earnings Per Share.

2021 Financial Outlook
Certara is updating its previously reported guidance for full year 2021, not including the impact of the Pinnacle 21 acquisition, by raising the ranges for revenue, Adjusted EBITDA and Adjusted Diluted Earnings Per Share. We expect the following:

Full year 2021 revenue to be in the range of $283 million to $289 million;

Full year 2021 Adjusted EBITDA to be in the range of $101 million to $103 million;

Full year 2021 Adjusted Diluted Earnings Per Share is expected to be in the range of $0.21 to $0.25;

Fully diluted shares for 2021 will be 153 million to 155 million; and

Effective annual tax rate for 2021 will be in the range of 40% to 45%.

Webcast and Conference Call Details
Certara will host a conference call today, August 5, 2021, at 5:00 p.m. ET to discuss its second quarter 2021 financial results and the impact of the Pinnacle 21 acquisition. The dial-in numbers are (833) 360-0946 for domestic callers or (914) 987-7661 for international callers, followed by Conference ID: 2728807. A live webcast of the conference call will be available on the "Investors" section of the Company’s website at View Source The webcast will be archived on the website following the completion of the call for approximately one year.

On August 5, 2021 IntelGenx Technologies Corp. (the "Company") reported that closed an offering by way of private placement in the United States (the "Private Placement") of unsecured convertible notes (the "Notes"). Each Note bears interest at a rate of 8% (payable quarterly, in arrears, with the first payment being due on September 1, 2021), matures on July 31, 2025 and is convertible, after a six-month holding period from the Initial Closing Date, into common stock of the Company (the "Common Shares") at a conversion price of $0.40 per share (the "Conversion Price") (Filing, 8-K, IntelGenx, AUG 5, 2021, View Source [SID1234586309]). The Notes issued on the Closing Date pursuant to the Private Placement were issued for gross proceeds of approximately $2.1 million.

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The Company intends to use the proceeds from the Private Placement for its Montelukast study, working capital and the Company’s expenses of the Offering.

Cantone Research, Inc. ("Cantone") acted as placement agent in respect of the Private Placement.

In connection with the Private Placement, Cantone is entitled to a cash commission of approximately $199,525 and non-transferable warrants entitling Cantone to purchase 613,000 Common Shares (the "Placement Agent Warrants"). The Placement Agent Warrants are exercisable into Common Shares at the Conversion Price and will expire in two years from the Closing Date.

On August 5, 2021 iCo Therapeutics Inc. ("iCo" or the "Company") (TSXV: iCo) (OTCQB: iCoTF) reported that the at an annual and special meeting of the Company held on August 3, 2021, shareholder of the Company have approved, among other matters, iCo’s proposed business combination (the "Transaction") with Satellos Bioscience Inc. ("Satellos") (Press release, iCo Therapeutics, AUG 5, 2021, View Source [SID1234586216]).

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The, the Company expects trading of the shares of the combined company to begin trading on the TSX Venture Exchange as Satellos Bioscience Inc. under the symbol MSCL during the week of August 9, 2021.

William Jarosz, the CEO of iCo noted, "The Satellos transaction was approved by 98.5% of the shareholders voting at the annual and special meeting of the shareholders. The shareholders recognized the tremendous value that the Satellos assets have brought to the business combination. We are grateful for this support and will work diligently going forward to ensure that this support is warranted. We are very excited about what lies ahead for iCo."

Exelixis has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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On August 5, 2021 Prescient Therapeutics Limited (ASX:PTX) reported that it is engaged in developing a robust drug pipeline comprising CAR-T and targeted therapies (PTX-100 & PTX-200) for various challenging cancers with unmet medical needs (Press release, Prescient Therapeutics, AUG 5, 2021, View Source;utm_medium=rss&utm_campaign=prescient-therapeutics-in-a-sweet-spot-with-significant-progress-in-multiple-cancer-programs [SID1234586072]). The personalised medicine approaches of the Company seek to improve patient outcomes in combating cancer.

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Furthermore, Prescient is working to rapidly expand the application of universal CAR-T therapies capable of addressing difficult-to-treat cancers.

On 4 August 2021, the Company announced its participation in Reach Markets’ ‘The Insider: Meet the CEO’ session, where PTX gave a presentation highlighting key developments in multiple cancer programs.

Prescient’s innovative pipeline in personalised medicine, Source: PTX Investor Presentation, 4 August 2021

ALSO READ: Prescient ends June quarter with notable progress in cancer programs and a healthy financial position

PTX-100 showed an excellent safety profile and exhibited encouraging activity in Phase 1b trial
In the Phase 1b basket trial, PTX-100 demonstrated an impressive safety profile and was well tolerated at the highest dose of 2,000mg/m2. In addition, no serious adverse events (SAEs) related to PTX-100 were observed during the study. Notably, the drug also exhibited clinical benefit in two T cell lymphoma (TCL) patients with aggressive disease that had not responded to 3-5 prior therapies.

The Company is now planning to conduct an expansion cohort study of PTX-100 concentrating on the treatment of TCL with a possibility of subsequent registration study. Currently, the Company anticipates enrolling up to 12 patients with T cell lymphoma (mainly Peripheral T-Cell Lymphoma or PTCL), which represents an area of considerable unmet need.

RELATED ARTICLE: Prescient takes its PTX-100 trial to next level after Phase 1b success

PTX-200 Phase 1b trial underway: Acute myeloid leukemia (AML)
The PTX-200 AML study is spearheaded by world-renowned leukemia specialist Professor Jeffrey Lancet at Moffitt Cancer Center and Dr Tara Lin at the University of Kansas Medical Center (KUMC).

Initially, PTX-200 was tested for 25 mg/m2. Having proved its safety, the AML study was advanced to a higher dose of to 35 mg/m2. The Company highlighted that the three patients treated with the 35 mg/m2 dose had achieved complete responses in the study so far. Currently, PTX is screening the second cohort at 45 mg/m2.

Moreover, PTX-200 has been granted Orphan Drug Designation (ODD) by the US Food and Drug Administration.

RELATED ARTICLE: Prescient Therapeutics’ (ASX:PTX) AML trial progresses to next dosing level

OmniCAR- A universal next-generation CAR-T
Prescient is developing next-generation products in-house. In January 2021, the oncology player disclosed its three OmniCAR programs-

In June, the Company completed another CAR-T milestone with the completion of manufacturing and delivery of crucial components of the OmniCAR platform. In addition, PTX highlighted that the binders against various cancer targets, including CLL-1, CD33, Her2, and EGFRviii, were produced by a US-based leading antibody manufacturer.

Additionally, in-silico evaluation confirmed the non-immunogenic profile of these crucial components. The results demonstrated that OmniCAR’s binding system components – SpyTag and SpyCatcher – have very low immunogenicity, lower than a panel of humanised therapeutic antibodies already approved for human use.

OnmiCAR also offers collaboration and licensing opportunities for third parties via partnerships based on targets, specific constructs as well as cell types.

Source: PTX Investor Presentation, 4 August 2021

RELATED ARTICLES:

Prescient Therapeutics reaches a major CAR-T manufacturing milestone
Positive results from immunogenicity testing send Prescient’s shares higher
Cell Therapy Enhancements (CTE) programs

Prescient has several other initiatives in progress to develop new cell therapy programs. The new programs overcome the efficiency challenges confronted by other CAR-T therapies.

CTE programs are now being undertaken at Peter MacCallum Cancer Centre, another sign of the fast-developing relationship between the two organisations. Notably, Prescient would have 100% ownership of intellectual property (IP) generated from the ongoing research on cell therapy enhancement programs.

On 4 August 2021, PTX shares closed at AU$0.185, up by 5.714%.