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Imugene and Celularity Announce an Exclusive Strategic Partnership to Develop a Novel Oncolytic Virus – Allogeneic CAR T-Cell Immunotherapy Combination for the Treatment of Solid Tumors

On August 5, 2021 Imugene Ltd ("Imugene") (ASX: IMU), a clinical stage immuno-oncology company and Celularity Inc. ("Celularity") (Nasdaq: CELU), a clinical-stage biotechnology company developing off-the-shelf placental-derived allogeneic therapies, reported they have entered into a research collaboration in 2021 (Press release, Celularity, AUG 5, 2021, View Source [SID1234591814]). As part of the partnership, Imugene and Celularity will initially collaborate to develop the combination of Imugene’s CD19 oncolytic virus technology and Celularity’s CD19 targeting allogeneic chimeric antigen receptor (CAR) T cellular therapy, CYCART-19, for the treatment of solid tumors. CYCART-19 is a placental-derived T-cell therapy engineered with a CAR that is cryopreserved, allogeneic and available off-the-shelf to clinicians.

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Imugene exclusively licensed the CD19 oncolytic virus technology from City of Hope, a world-renowned independent cancer research and treatment center near Los Angeles. Imugene’s novel strategy to treat solid tumors uses an oncolytic virus to prime the tumor cells for destruction by eliciting the expression of a validated tumor marker, CD19, that can then be used as a target for CAR T cellular therapy.

"We believe the synergy between Celularity’s placental derived cells and our OnCARlytic platform has the potential to shift the cellular medicine paradigm," said Leslie Chong, Managing Director & Chief Executive Officer of Imugene. "In preclinical studies Celularity’s cellular therapies have shown the ability to overcome limitations that have hindered other approaches, including increased proliferation and persistence in vivo, resistance to T-cell exhaustion and low immunogenicity, which allows for repeated dosing. These unique characteristics perfectly align with our vision for a combination treatment strategy, and we look forward to closely working together to bring this treatment strategy to the clinic and patients in need."

Robert J. Hariri, M.D., Ph.D., founder, Chairperson and Chief Executive Officer of Celularity, said, "We are excited to initiate this research collaboration, which we believe will lay the foundation for a new approach to the treatment of solid tumors. Most solid tumors have variable targetable antigens, limiting CAR T-cell therapy efficacy. This treatment strategy with Imugene has the potential to apply to a new range of indications by enabling CD 19 targeted cellular medicine to expand from its current effective usage in CD19 positive lymphomas and leukemia and potentially become applicable to a variety of solid tumors through inducing uniform expression of CD19 in solid tumors.

Apexigen Receives Orphan Drug Designation from the FDA for Sotigalimab (APX005M) for the Treatment of Soft Tissue Sarcoma

On August 5, 2021 Apexigen, Inc., a clinical-stage biopharmaceutical company focused on discovering and developing a new generation of antibody therapeutics for oncology, reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to sotigalimab (APX005M) for the treatment of soft tissue sarcoma (Press release, Apexigen, AUG 5, 2021, View Source [SID1234590987]). Sotigalimab, Apexigen’s lead therapeutic candidate, is a potentially first-in-class and best-in-class CD40 agonist, with unique epitope specificity and Fc receptor engagement for optimal therapeutic effect and tolerability. In an ongoing Phase 2 clinical trial, sotigalimab is being evaluated in advanced soft tissue sarcoma in combination with doxorubicin, a chemotherapy that is currently considered standard-of-care treatment.

"We are very pleased to receive Orphan Drug Designation for sotigalimab, an important step toward addressing the medical need that exists for patients with sarcoma," said Xiaodong Yang, M.D., Ph.D., President and Chief Executive Officer. "There are currently limited treatment options available for patients with soft tissue sarcoma, so we are excited by the emerging data from our ongoing Phase 2 study in this indication, coupled with data across our broad clinical development program, that suggest sotigalimab may provide a superior clinical benefit. We will continue to advance our development plans to overcome outstanding challenges in oncology and work with the FDA to bring sotigalimab to patients as efficiently as possible."

The FDA’s Office of Orphan Drug Products grants orphan status to support the development of medicines for underserved patient populations, or rare disorders, that affect fewer than 200,000 people in the United States. Orphan drug designation qualifies the sponsor for various development incentives, including tax credits for qualified clinical testing, up to seven years of marketing exclusivity for the orphan indication and waiver of certain FDA fees.

Apexigen has also received FDA Orphan Drug Designation for sotigalimab for the treatment of esophageal and gastroesophageal junction cancer and for the treatment of pancreatic cancer.

About Sotigalimab (APX005M)
Sotigalimab is a novel, humanized monoclonal antibody that stimulates the anti-tumor immune response. Sotigalimab targets CD40, a co-stimulatory receptor that is essential for activating both innate and adaptive immune systems. Binding of sotigalimab to CD40 on antigen presenting cells (i.e., dendritic cells, monocytes and B-cells) initiates a multi-faceted immune response bringing multiple components of the immune system (e.g., T cells, macrophages) to work in concert against cancer. Sotigalimab is currently in& Phase 2 clinical development for the treatment of cancers such as esophageal and gastroesophageal junction cancers, melanoma, rectal cancer and sarcoma in various combinations with immunotherapy, chemotherapy, radiation therapy or a cancer vaccine. Additional information on clinical trials for sotigalimab can be found at www.clinicaltrials.gov.

Half-Year Financial Report 2021

Certara Reports Second Quarter 2021 Financial Results

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]).

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.

Entry Into a Material Definitive Agreement

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.

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.