On August 3, 2021 Tango Therapeutics Inc., a biotechnology company committed to discovering and delivering the next generation of precision cancer medicines, reported that Barbara Weber, MD, President and Chief Executive Officer of Tango Therapeutics, is scheduled to participate in a panel on synthetic lethality in cancer therapeutics at the 12th Annual Wedbush PacGrow Healthcare Conference on Tuesday, August 10 at 11:30 AM ET (Press release, Tango Therapeutics, AUG 3, 2021, View Source [SID1234585638]).

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A live webcast of the event will be available under the "Events & Presentations" tab on the "Investors" page on the Company’s website on the day of the event. A replay of the webcast will be archived on the Company’s website for 30 days following the presentation.

On August 3, 2021 Ryvu Therapeutics (WSE: RVU), a clinical stage drug discovery and development company focusing on novel small molecule therapies that address emerging targets in oncology, reported that it is scheduled to participate in the following investor conferences (Press release, Ryvu Therapeutics, AUG 3, 2021, View Source [SID1234585654]):

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12th Annual Wedbush PacGrow Healthcare Conference on Tuesday, August 10 – Wednesday, August 11, 2021. Ryvu will participate in a panel entitled "Synthetic Lethal (Weapon)" on August 10 at 11:30am-12pm EDT and host investor meetings during the conference.

Morgan Stanley 19th Annual Global Healthcare Conference on Thursday, September 9, 2021 – Wednesday, September 15, 2021. Ryvu will host investor meetings during the conference.

H.C. Wainwright 23rd Annual Global Investment Conference, on Monday, September 13 – Wednesday, September 15, 2021. Ryvu’s corporate presentation will be available on-demand starting on September 13 at 7:00 AM (ET), and Ryvu will host investor meetings during the conference

On August 3, 2021 Prescient Therapeutics Limited (ASX:PTX) reported its June 2021 results, marked by impressive progress in its cancer programs and a robust financial position to support and drive further clinical development (Press release, Prescient Therapeutics, AUG 3, 2021, View Source;utm_medium=rss&utm_campaign=prescient-ends-june-quarter-with-notable-progress-in-cancer-programs-and-a-healthy-financial-position [SID1234585681]). Notably, the Company ended the quarter with a healthy cash balance of AU$16.1 million.

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As the Company continues to advance the development of its targeted cancer therapies, a strong cash position, coupled with prudent financial management, would help Prescient aim for several value-generating milestones.

Prescient-Peter Mac research partnership
Prescient and Peter MacCallum Cancer Centre (Peter Mac) entered into a crucial research partnership to advance PTX’s next-generation CAR-T therapy using the OmniCAR platform. The collaboration builds on an earlier agreement between the two parties, announced in August 2020 and will now include OmniCAR. International CAR-T expert Professor Phil Darcy is leading PTX’s work in the CAR-T space.

RELATED: Prescient Therapeutics inks new deal with Peter Mac to rev up its OmniCAR programs

It is worth mentioning that Prescient would own any resulting intellectual property (IP) from this research partnership. The Company has also secured a grant funding worth AU$100K from the Innovation Connections scheme of the Australian Federal Government for this vital research.

After the June quarter, Prescient hit another major milestone, having confirmed the non-immunogenic profile of key components of the OmniCAR platform. The firm conducted immunogenicity testing to assess the immune response against OmniCAR’s components – SpyTag and SpyCatcher, which demonstrated positive responses.

The results showed both SpyTag and SpyCatcher have incredibly low predicted immunogenicity compared to a panel of humanised therapeutic antibodies already approved for human use.

Source: PTX Update, 5 July 2021

TO KNOW MORE, DO READ: Positive results from immunogenicity testing send Prescient’s shares higher

Consolidation of Cell Therapy Enhancement programs
Prescient has been undertaking Cell Therapy Enhancement (CTE) programs at Carina Biotech as well as Peter Mac. During the quarter, the Company consolidated these two programs, which are now being undertaken at Peter Mac, another testament to the growing relationship between the two parties.

Prescient also expressed its gratitude to Carina Biotech and its partners at the University of Adelaide for their contribution to the collaboration.

Progress of PTX’s targeted therapies – PTX-100 & PTX-200
During the quarter, Prescient’s targeted therapy studies for PTX-100 and PTX-200 continued making excellent progress and enrolled patients without any reported safety issues.

On 23 April 2021, the Company reported that its Phase 1b study of PTX-200 and cytarabine in acute myeloid leukemia (AML) patients had completed the second cohort at a dose level of 35 mg/m2 under a modified study protocol, with no safety or toxicity-related issues observed. The study is now progressing at the higher dose level of 45 mg/m2, and Prescient anticipates providing updates in the upcoming months.

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

After the June quarter, the Company announced that the Phase 1b basket trial of PTX-100 in a mix of solid and haematological cancers had completed patient recruitment for the highest dose level of 2,000 mg/m2 without any safety issues reported.

As highlighted on 27 July 2021, PTX-100 was well-tolerated and exhibited an excellent safety profile in Phase 1b basket trial without any related serious adverse events. These findings have encouraged Prescient and Professor H. Miles Prince, principal investigator of the study, to conduct a new expansion study with up to 12 patients with T-cell lymphoma. Prescient looks forward to providing further details about the exciting development in the coming months.

TO KNOW MORE, DO READ: Prescient takes its PTX-100 trial to next level after Phase 1b success

Overall, Prescient has been making great strides in developing multiple cancer programs to treat challenging cancers with unmet medical needs. The Company is thankful to all its shareholders for their support and looks forward to updating them as it works to bring effective, innovative personalised cancer therapies to clinicians and patients who need them.

On August 3, 2021 Pacira BioSciences, Inc. (Nasdaq: PCRX), the industry leader in its commitment to non-opioid pain management and regenerative health solutions, reported financial results for the second quarter of 2021 (Press release, Pacira Pharmaceuticals, AUG 3, 2021, View Source;991.htm [SID1234585591]).

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Second Quarter 2021 Financial Highlights

Total revenues of $135.6 million
GAAP net income of $19.1 million, or $0.43 per share (basic) and $0.42 (diluted)
Non-GAAP Adjusted EBITDA of $50.3 million
"We made terrific progress in the first half of 2021 with strong sales momentum in the second quarter and continuing in recent weeks," said Dave Stack, chairman and chief executive officer of Pacira BioSciences. "Record revenue in the second quarter significantly ramped our bottom line, allowing us to achieve our highest-ever adjusted EBITDA for a quarter. Market dynamics remain highly favorable and leave us confident that we will deliver robust topline growth, improved margins, and accelerating earnings for the remainder of 2021, leaving us well-positioned to achieve the goals laid out within our five-year plan."

Second Quarter 2021 Financial Results

Total revenues were $135.6 million in the second quarter of 2021, versus the $75.5 million reported for the second quarter of 2020.
EXPAREL net product sales were $130.1 million in the second quarter of 2021, versus the $73.0 million reported for the second quarter of 2020.
Second quarter 2021 iovera° net product sales were $3.8 million, versus the $1.4 million reported for the second quarter of 2020.
Sales of bupivacaine liposome injectable suspension to a third-party licensee for use in veterinary practice were $1.0 million in the second quarter of 2021, versus the $0.8 million in the second quarter of 2020.
Second quarter 2021 royalty and collaborative licensing and milestone revenues were $0.7 million, versus the $0.3 million in the second quarter of 2020.
Total operating expenses were $100.7 million in the second quarter of 2021, compared to $82.7 million in the second quarter of 2020.
Research and development (R&D) expenses were $12.6 million in the second quarter of 2021, compared to $13.6 million in the second quarter of 2020. R&D expenses included $4.6 million and $6.1 million of product development and manufacturing capacity expansion costs in the second quarters of 2021 and 2020, respectively.
Selling, general and administrative (SG&A) expenses were $50.8 million in the second quarter of 2021, compared to $43.3 million in the second quarter of 2020.
GAAP net income was $19.1 million, or $0.43 per share (basic) and $0.42 (diluted), in the second quarter of 2021, compared to a GAAP net loss of $7.3 million, or $0.17 per share (basic and diluted), in the second quarter of 2020.
Non-GAAP net income was $35.3 million, or $0.80 per share (basic) and $0.77 (diluted), in the second quarter of 2021, compared to non-GAAP net income of $5.0 million, or $0.12 per share (basic and diluted), in the second quarter of 2020.
Adjusted EBITDA was $50.3 million in the second quarter of 2021, compared to $8.5 million in the second quarter of 2020.
Pacira ended the second quarter of 2021 with cash, cash equivalents and short-term investments ("cash") of $646.6 million. Cash provided by operations was $30.1 million in the second quarter of 2021, compared to cash used in operations of $15.6 million in the second quarter of 2020.
Pacira had 44.1 million basic and 45.6 million diluted weighted average shares of common stock outstanding in the second quarter of 2021.
See "Non-GAAP Financial Information" below.

Recent Business Highlights

FDA approval of enhanced EXPAREL manufacturing process. In July 2021, the U.S. Food and Drug Administration (FDA) approved the company’s enhanced manufacturing process for EXPAREL, which is housed at a custom facility in Swindon, England under a partnership with Thermo Fisher Scientific Pharma Services. The company expects to start selling commercial product manufactured in this 200-liter suite later this year.

Patent granted for EXPAREL. In June 2021, the United States Patent and Trademark Office issued U.S. Patent No. 11,033,495 related to EXPAREL. The patent, "Manufacturing of Bupivacaine Multivesicular Liposomes," claims composition of EXPAREL prepared by an improved manufacturing process and will have an expiration date of January 22, 2041. Pacira submitted this patent for listing in the FDA’s "Approved Drug Products with Therapeutic Equivalence Evaluations" (the Orange Book) in July 2021.

Distribution agreement with Eurofarma in Latin America. In June 2021, Pacira announced a distribution agreement with Eurofarma Laboratories S.A. (Eurofarma) for the development and commercialization of EXPAREL in Latin America. Under the terms of the agreement, Eurofarma obtained the exclusive right to market and distribute EXPAREL in 19 countries including Argentina, Brazil, Colombia, and Mexico.
Financial Guidance

The company’s net product sales were negatively impacted by the COVID-19 pandemic in 2020 due to the significant postponement or suspension in the scheduling of elective surgical procedures resulting from public health guidance and government directives. Elective surgery restrictions began to lift on a state-by-state basis in April 2020, allowing EXPAREL sales to return to year-over-year growth in June 2020. However, while many restrictions have since eased and COVID-19 vaccines become more widely available and administered to the general public, it is still unclear how long it will take the elective surgery market to normalize, or if restrictions on elective procedures will recur due to COVID-19 variant strains or otherwise. In order to provide greater transparency, the company is reporting monthly intra-quarter unaudited net product sales until it has gained enough visibility around the impacts of COVID-19. The company reports average daily growth rates for EXPAREL to normalize for differences in the number of selling days per reporting period. The company is also providing weekly EXPAREL utilization and elective surgery data within its investor presentation, which is accessible at investor.pacira.com.

Today’s Conference Call and Webcast Reminder

The Pacira management team will host a conference call to discuss the company’s financial results and recent developments today, Tuesday, August 3, 2021, at 8:30 a.m. ET. To participate in the conference call, dial 1-877-845-0779 and provide the passcode 9991311. International callers may dial 1-720-545-0035 and use the same passcode. In addition, a live audio of the conference call will be available as a webcast. Interested parties can access the event through the "Events" page on the Pacira website at investor.pacira.com.

For those unable to participate in the live call, a replay will be available at 1-855-859-2056 (domestic) or 1-404-537-3406 (international) using the passcode 9991311. The replay of the call will be available for one week from the date of the live call. The webcast will be available on the Pacira website for approximately two weeks following the call.

On August 3, 2021 ChromaDex Corp. (NASDAQ:CDXC) reported financial results for the second quarter of 2021 (Press release, ChromaDex, AUG 3, 2021, View Source [SID1234585606]).

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Second Quarter 2021 and Recent Highlights

Total net sales were $17.7 million, up 16% from the prior year quarter.
Tru Niagen net sales were $15.4 million, a 31% increase from the prior year quarter.
Gross margin was 61.1%, a 170 basis point increase from the prior year quarter.
Net loss was $(5.6) million or $(0.08) per share, down $0.02 per share from the prior year quarter.
Adjusted EBITDA excluding total legal expense, a non-GAAP measure, was a profit of $0.6 million, a $0.1 million improvement from the prior year quarter.
Launched Tru Niagen in 3,800 Walmart stores across the United States in June.
Research on nicotinamide riboside ("NR") continues to expand, with 49 clinical studies currently registered.
"This was an excellent quarter for ChromaDex, financially and strategically," said ChromaDex Chief Executive Officer, Rob Fried. "We delivered strong growth in our core e-Commerce business as well as with existing partners. We launched Tru Niagen in Walmart, our first mass retail launch for the brand and delivered our first shipment of Niagen to a new partner, Ro. We achieved record sales of $17.7 million and positive Adjusted EBITDA excluding legal of $0.6 million. I am very proud of our team’s execution and believe our long-term prospects look stronger than ever."

Results of operations for the three months ended June 30, 2021

For the three months ended June 30, 2021 ("Q2 2021"), ChromaDex reported net sales of $17.7 million, up $2.4 million or 16% compared to the second quarter of 2020 ("Q2 2020"). The increase in Q2 2021 revenues was largely driven by growth in sales of Tru Niagen, partially offset by lower Niagen and other ingredient sales.

Gross margin percentage improved by 170 basis points to 61.1% in Q2 2021 compared to 59.4% in Q2 2020. The improvement in gross margin percentage was driven by the positive impact of increased Tru Niagen consumer product sales and product cost savings initiatives.

Operating expenses increased by $3.6 million to $16.4 million in Q2 2021, compared to $12.8 million in Q2 2020. The increase in operating expenses was driven by $1.3 million of higher selling and marketing expenses and a $2.2 million increase in general and administrative expense. The increase in general and administrative expense was primarily driven by $2.3 million of higher legal expense.

The net loss for Q2 2021 was $(5.6) million or $(0.08) per share as reported compared to a net loss of $(3.7) million or $(0.06) per share for Q2 2020 as reported. Adjusted EBITDA excluding total legal expense, a non-GAAP measure, was a profit of $0.6 million for Q2 2021, compared to a profit of $0.5 million for Q2 2020, a $0.1 million improvement. See "Reconciliation of Non-GAAP Financial Measures" for a reconciliation of non-GAAP Adjusted EBITDA excluding total legal expense to net loss, the most directly comparable GAAP measure.

For Q2 2021, the net cash outflow from operating activities was $(7.9) million, compared to $(1.6) million in Q2 2020.

2021 Full Year Outlook

Looking forward, for the full year, the Company expects continued, steady revenue growth driven by its global e-commerce business, as well as growth with existing and new strategic partners. The Company expects slightly better than 60% gross margin and slightly higher general and administrative expense, excluding severance, restructuring and legal expense, for full year 2021. The Company plans to increase investments and resources to drive brand awareness and accelerate its research and development (R&D) pipeline to capitalize on growth in the nicotinamide adenine dinucleotide (NAD+) market globally. Accordingly, the Company expects higher R&D expense and higher selling and marketing expense as a percentage of net sales year-over-year.

Investor Conference Call

A live webcast will be held Tuesday, August 3, 2021 at 4:30 p.m. Eastern time (1:30 p.m. Pacific time) to discuss ChromaDex’s second-quarter financial results and provide a general business update.

To listen to the webcast, or to view the earnings press release and its accompanying financial exhibits, please visit the Investors Relations section of ChromaDex’s website at View Source The dial-in information for this call is 1-833-979-2703 (within the U.S.) and 236-714-2223 (outside the U.S.) with Conference ID: 9972229.

The webcast will be recorded, and will be available for replay via the website through 11:59 p.m. Eastern time on August 10, 2021. The replay of the call can also be accessed by dialing 800-585-8367, using the replay ID: 9972229.