On August 5, 2021 Aligos Therapeutics, Inc. (Nasdaq: ALGS), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in viral and liver diseases, reported recent business progress and financial results for the second quarter, June 30, 2021 (Press release, Aligos Therapeutics, AUG 5, 2021, View Source [SID1234591815]).

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"Over the past few months, in addition to completing our recent financing, we have made significant strides in advancing our CHB and NASH drug candidates," commented Lawrence Blatt, PhD, MBA, Chairman and CEO of Aligos. "At recent scientific conferences, healthy volunteer data from our STOPS program and initial antiviral data in CHB subjects from our CAM program, were presented. For both the STOPS and CAM programs, enrollment in the first CHB cohort is complete and is ongoing in the second cohort. Additionally, we recently filed the first clinical trial application (CTA) for our ASO drug candidate, ALG-020572, which is anticipated to begin dosing in healthy volunteers in Q4 2021. We are also on track to file a CTA in Q3 for ALG-055009, our NASH drug candidate, and start dosing in healthy volunteers in Q4 2021. We look forward to continuing to advance these important development programs."

Recent Business Progress

Aligos Portfolio of Drug Candidates:

Preliminary safety and pharmacokinetic data in healthy volunteers (HVs) from the ongoing Phase 1a/b multi-part dose range finding trial (NCT04485663) of our S-antigen Transport-inhibiting Oligonucleotide Polymers (STOPS) compound, ALG-010133, were presented at the European Association for the Study of the Liver (EASL) Digital International Liver Congress 2021 (ILC 2021) in June. These data showed that single and multiple doses up to 200 mg and 180 mg, respectively, were generally well tolerated.

Enrollment and dosing in our Phase 1b trial evaluating subjects with CHB is ongoing and we continue to initiate more clinical trial centers to support this study. However, recent delays to enrollment of chronic hepatitis B subjects have been encountered due to COVID-19 related logistical challenges and an increasing number of competitive phase 2 clinical trials. Consequently, data from the planned 3 cohorts, evaluating a range of doses, are expected to be available in the first half of 2022.

Given that STOPS molecules work by a novel mechanism and patient antiviral response characteristics are unknown, we believe it is important to generate a dataset from multiple cohorts. This should enable us to refine the PK-PD model to optimize dosing for evaluation in subsequent cohorts and studies. We plan to unblind virological data, including HBsAg, once dosing in the first three cohorts has been completed.

In addition, evaluation of ALG-000184, a small molecule class II capsid assembly modulator (CAM), was initiated in patients with CHB in April. This dose range finding study (NCT04536337) is evaluating 28 days of once daily oral dosing of ALG-000184 or placebo in treatment naïve/currently not treated CHB patients. Initial 14-day data from the first cohort demonstrated that a 100 mg dose was well tolerated and resulted in significant antiviral activity. These 14-day data were presented at the HBV-TAG 2021 meeting in June. Data from additional cohorts are expected to be presented at one or more scientific conferences in the second half of 2021.

The initial CTA for our third CHB drug candidate, ALG-020572, an antisense oligonucleotide (ASO), was recently filed. We expect to begin evaluating ALG-020572 in HVs in the fourth quarter of 2021.

The CTA for our first nonalcoholic steatohepatitis (NASH) drug candidate, ALG-055009, a thyroid hormone receptor beta agonist, remains on track to be filed in the third quarter of 2021 to enable evaluation in HVs to commence in the fourth quarter of 2021.

Aligos has a broad CHB portfolio that targets different clinically validated mechanisms of action in the hepatitis B virus life cycle. The portfolio includes ALG-000184, a class II CAM, ALG-010133, a STOPS molecule, ALG-020572, an ASO, and ALG-020755, a small interfering RNA (siRNA) drug candidate. The properties of these candidates indicate that their use in combination could yield potentially best-in-class treatment regimens that may achieve higher rates of functional cure than current standard of care. For each of these drug candidates, Aligos plans to initially establish proof of concept as monotherapy in Phase 1 dose range finding trials before evaluating them in combination in subsequent trials.

Corporate:

The company announced the pricing of its underwritten public offering of 4,400,000 shares of common stock at a public offering price of $19.00 per share. In addition, the company granted the underwriters a 30-day option to purchase up to an additional 660,000 shares of common stock at the same terms and conditions. All of the shares of common stock were offered by the company.

The gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Aligos, were $83.6 million, excluding any exercise of the underwriters’ option to purchase additional shares. The offering closed on July 6, 2021, subject to customary closing conditions.

Financial Results for the Second Quarter 2021

Net losses for the three months ended June 30, 2021 were $29.8 million or basic and diluted net loss per common share of $(0.79) compared to net losses of $20.8 million or basic and diluted net loss per common share of $(7.40) for the three months ended June 30, 2020.

Research and development (R&D) expenses for the three months ended June 30, 2021, were $24.6 million compared with $17.2 million for the same period of 2020. The increase in R&D expenses for this comparative period is primarily attributable to increased expenses related to the Company’s continued development of ALG-010133 and ALG-000184 clinical trial activities, as well as increases in salaries and employee-related expenses and preclinical programs. Total R&D stock-based compensation expense incurred for the three months ended June 30, 2021, was $2.0 million compared with $0.2 million for the same period for 2020.

General and administrative (G&A) expenses for the three months ended June 30, 2021, were $6.6 million compared with $4.1 million for the same periods of 2020. The increase in G&A expenses for this comparative period is primarily attributable to higher employee-related costs associated with the growth of the Company’s operations and additional professional and consulting services related to being a public company. Total G&A stock-based compensation expense incurred for the three months ended June 30, 2021, was $1.5 million compared with $0.1 million for the same period for 2020.

Cash, cash equivalents and short-term investments totaled $190.7 million as of June 30, 2021 compared with $243.5 million as of December 31, 2020.

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.

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.

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"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.

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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.