On August 8, 2022 POINT Biopharma Global Inc. (NASDAQ: PNT) (the "Company" or "POINT"), a company accelerating the discovery, development and global access to life-changing radiopharmaceuticals, reported that next week, on Thursday, August 18, 2022 at 12:00 PM ET, the Company will be presenting a 45-minute educational webinar entitled "Understanding the PNT2002 Phase 3 SPLASH Trial Control Arm" (Press release, Point Biopharma, AUG 8, 2022, View Source [SID1234617810]).

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Topics to be presented at the webinar include:

Overview of SPLASH trial design (including lead-in phase) and rationale for hormone switches
What is a control arm benchmark, why PROfound1 & IMbassador2502 were selected as SPLASH benchmarks
Review current treatment patterns, including sequencing considerations, in real-world clinical settings for mCRPC patients
The webinar will feature presentations from two Thought Leaders: Dr. Oliver Sartor & Dr. Kim Chi. They will be joined by members of the Company’s executive leadership team including Dr. Neil Fleshner, Chief Medical Officer, and Dr. Sherin Al-Safadi, VP Medical Affairs.

About Dr. Oliver Sartor
Dr. Oliver Sartor is an internationally recognized expert in prostate cancer. His medical practice and research have focused on prostate cancer since 1990 when he finished a medical oncology fellowship at the National Cancer Institute (NCI). He has published over 400 peer-reviewed articles, led or co-led multiple national and international clinical studies, including three radiopharmaceutical phase III studies pivotal for FDA approval in prostate cancer. He has lectured widely, and at last count has given invited lectures in 33 countries. He is currently the Associate Dean for Oncology, Medical Director of the Tulane Cancer Center, and serves as the Laborde Professor for Cancer Research at Tulane Medical School with appointments in both the Medicine and Urology Departments. He is the Medical Oncology Chair of the GU committee of NRG, a national cancer research group. He is also a past member of the National Cancer Institute Board of Scientific Counselors (Clinical Sciences and Epidemiology).

About Dr. Kim Chi
Dr. Kim Chi, MD is the Vice President and Chief Medical Officer of BC Cancer. His research is focused in the area of genitourinary cancers with a special interest in prostate cancer and investigational new drugs. This includes phase I, II and III clinical trials, therapeutic use of antisense oligonucleotides and mechanisms of treatment resistance. Nationally and internationally he has led a number of multi-center Phase I, II and III clinical trials, and has also contributed to clinical trials that established new standard of care for patients with advanced prostate cancer (docetaxel, abiraterone acetate, enzalutamide).

On August 8, 2022 Applied DNA Sciences, Inc. (NASDAQ: APDN) ("Applied DNA" or the "Company"), a leader in polymerase chain reaction ("PCR")-based technologies, reported that Dr. James A. Hayward, president and CEO, and Beth Jantzen, chief financial officer, will host a conference call and webcast on Thursday, August 11, 2022, at 4:30 p.m. ET to provide financial results and corporate updates for the fiscal third quarter of 2022 v.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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To access the conference call:

Participants should ask to be connected to the Applied DNA Earnings Conference Call.
The conference call and accompanying presentation slides will also be webcast and can be accessed from the "News & Events" section of the Applied DNA website at View Source The webcast replay of the call will be available at the same site approximately one hour after the end of the call.

On August 8, 2022 Salarius Pharmaceuticals, Inc. (Nasdaq: SLRX), a clinical-stage biopharmaceutical company developing cancer therapies for patients in need of new treatment options, reported financial results for the three and six months ended June 30, 2022, and provided a business update (Press release, Salarius Pharmaceuticals, AUG 8, 2022, View Source [SID1234618307]). Highlights of the quarter and recent weeks included:

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Financial Highlights

Cash and equivalents were $22.6 million as of June 30, 2022, compared with $29.2 million as of December 31, 2021
Tightly managed expenses while progressing toward multiple near-term milestones
Net loss of $4.7 million, or $0.09 per share, compared with net loss of $3.1 million, or $0.07 per share, for the second quarter of 2021
Seclidemstat (Targeted Protein Inhibitor) Highlights

Added the Seattle Cancer Care Alliance – which is comprised of the Fred Hutchinson Cancer Research Center, Seattle Children’s Hospital and University of Washington Medical Center – and Oregon Health & Sciences University as clinical trial sites, bringing the total number of sites supporting the Phase 1/2 sarcoma clinical trial to 15 with 23 locations across the U.S.
Entered into a development collaboration with Volition Rx to advance rapid epigenetic profiling using Volition’s Nu.Q technology to support further development of seclidemstat
Continued patient enrollment in both the Salarius-sponsored seclidemstat sarcoma clinical trial and the M.D. Anderson Cancer Center investigator-initiated hematologic clinical trial
SP-3164 (Targeted Protein Degrader) Highlights

Advanced plans for filing an Investigational New Drug (IND) application in 1H23 after completing the pre-Investigational New Drug meeting process with the U.S. Food and Drug Administration (FDA)
Introduced SP-3164 to potential strategic partners at BIO International Conference
"The second quarter and recent weeks were extremely productive for Salarius as we advanced both our programs toward multiple near-term milestones. Our Phase 1/2 study with seclidemstat in Ewing’s and other FET-rearranged sarcomas is progressing and the investigator-initiated clinical trial with seclidemstat in hematologic or blood cancers at M.D. Anderson Cancer Center is also progressing. We continue to expect clinical updates from both these programs in the second half of the year," stated David Arthur, CEO of Salarius Pharmaceuticals. "In addition, our development collaboration with Volition Rx should support further development of seclidemstat by studying potential biomarkers to allow for a noninvasive method of determining target engagement and assessing potential drug activity in patients."

Mr. Arthur continued, "And, we were thrilled to add SP-3164 – a type of targeted protein degrader called a molecular glue – to our development pipeline earlier this year. We completed the pre-IND meeting process with the FDA and are proceeding with plans to file an IND in the first half of 2023 and begin clinical studies shortly thereafter. Protein degraders have recently received enormous attention based on their exceptional promise to selectively eliminate cancer-promoting proteins and provide the ability to pursue historically undruggable cancer-promoting targets. We believe protein degradation is an exciting area, in part driven by the commercial success of the first-generation molecular glues, Revlimid and Pomalyst, which together generated more than $16 billion in 2021 global sales. We look forward to providing pre-clinical data updates later this year."

Second Quarter Financial Results

Net loss for the second quarter of 2022 was $4.7 million, or $0.09 per share, compared with a net loss of $3.1 million, or $0.07 per share, for the second quarter of 2021. The increase in net loss was due to higher operating expenses, including development spending on SP-3164, our targeted protein degradation technologies purchased in January 2022. There was no grant revenue in the current quarter.

Net cash used for operating activities during the second quarter of 2022 was $3.6 million, compared with $3.2 million during the same quarter last year.

Six Month Financial Results

Net loss for the first half of 2022 was $10.8 million, or $0.22 per share, compared with a net loss of $4.9 million, or $0.13 per share, for the first half of 2021. The increase in net loss was primarily due to higher research and development expense, primarily resulting from the $2.0 million acquisition and development costs for the SP-3164 technology, seclidemstat development costs, and higher general and administrative expenses, when compared to the prior year. Additionally, there was no grant revenue in the current year, compared with grant revenue of $1.8 million in the first half of 2021.

Net cash used in operating activities for the first half of 2022 was $7.1 million, an increase of $1.2 million from the prior-year period. The increase is primarily due to higher research and development expense.

As of June 30, 2022, Salarius had cash, cash equivalents and restricted cash of $22.6 million, compared with $29.2 million as of December 31, 2021. Current cash and cash equivalents are expected to fund the company’s planned operations into 2023.

Conference Call

Salarius will host a conference call and webcast today, beginning at 11:00 a.m. ET to discuss financial results for the second quarter of 2022 and provide a business update.

Participants are encouraged to pre-register for the conference call here to receive a dedicated dial-in number and personal PIN.

Alternatively, participants may access the conference call by dialing:

Following the conclusion of the conference call, a replay will be available until August 15, 2022, and can be accessed by dialing 877-344-7529 (U.S. toll-free), 855-669-9658 (Canada toll-free) or 412-317-0088 (International) with replay access code 2762786. An archive of the webcast will remain available for a period of time.

On August 8, 2022 Genmab A/S (Nasdaq: GMAB) reported that it is improving its 2022 financial guidance published on May 11, 2022 (Press release, Genmab, AUG 8, 2022, View Source [SID1234617764]). The improved guidance is driven primarily by increased royalty revenue due to higher net sales of DARZALEX and the positive net foreign exchange impact of the strong U.S. Dollar.

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Genmab expects its 2022 revenue to be in the range of DKK 12,000 – 13,000 million, an increase to the previous guidance of DKK 11,000 – 12,000 million, driven primarily by the continued strong growth of DARZALEX net sales as well as the positive impact of the strong U.S. Dollar. Genmab’s projected revenue for 2022 primarily consists of DARZALEX royalties. Such royalties are based on Genmab’s revised estimate of DARZALEX 2022 net sales of USD 7.8 – 8.2 billion compared to Genmab’s previous estimate of USD 7.5 – 8.0 billion.

Genmab anticipates its 2022 operating expenses to be in the range of DKK 7,600 – 8,200 million, an increase to the previous guidance of DKK 7,200 – 7,800 million, driven by increased investment related to pipeline progression and epcoritamab launch readiness activities as well as the negative impact of the strong U.S. Dollar.

Genmab now expects its 2022 operating profit to be in the range of DKK 3,800 – 5,400 million, an increase to the previous guidance of DKK 3,200 – 4,800 million, driven primarily by the items described above.

Genmab’s financial results for the first half of 2022 will be published on August 10, 2022.

The above expectations are based on assumptions including those described on pages 5 and 6 of the Interim Report for the First Quarter of 2022 (Company Announcement No. 17/2022) as well as an updated USD/DKK exchange rate of 6.8, compared to the previous exchange rate of 6.4.

On August 8, 2022 Vaxart, Inc. (NASDAQ: VXRT) reported it has begun working on vaccine candidate constructs that directly target new omicron variants of concern and is preparing to release top-line data in the third quarter of 2022 from its Phase II COVID-19 testing of a Wuhan strain vaccine construct (Press release, Vaxart, AUG 8, 2022, View Source [SID1234617780]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"We continue to be very excited about the cross-reactivity of our current vaccine candidates, as seen in preclinical and early clinical studies," said Andrei Floroiu, Chief Executive Officer. "The characteristics and prevalence of newer SARS-CoV-2 strains, along with our plans for a human omicron challenge study, led us to begin working on clinical vaccine candidates that directly target omicron variants of concern, which also conforms to recent Food and Drug Administration (FDA) guidance that boosters should target omicron BA.4/5.

"We plan to evaluate these new constructs both as omicron-only monovalent vaccine candidates and bivalent candidates in combination with our Wuhan constructs, and to compare the clinical results of our S-only and S+N constructs to determine the best path forward in developing a vaccine that can hinder viral infection and transmission for current and emerging variants. Our expectation is that the omicron vaccine candidates will be available to evaluate preclinically in the fourth quarter, and clinically in the first half of 2023. In addition, top-line Phase II results from our Wuhan S-only construct are expected in the third quarter of 2022.

"During the second quarter, we also continued to make progress on our norovirus program," Floroiu said. "The data from our trial in elderly adults is very encouraging, as it suggests similar activity to that in younger adults, which is often not the case with injectable vaccines. This adds to the already compelling clinical data on this program and increases our confidence as we continue our development."

Recent Business Highlights

COVID-19 Vaccine Developments

Reported multiple data sets supporting the potential of Vaxart’s COVID-19 vaccine candidates to tackle the challenge of an evolving virus that evades immune protection provided by approved vaccines or natural infection.

In May 2022, announced data from a preclinical hamster study conducted by researchers at Duke University and published in Science Translational Medicine, which demonstrated that Vaxart’s S-only COVID-19 candidate reduced disease and airborne transmission.

In June 2022, announced preclinical data demonstrating that two COVID-19 vaccine candidates targeting either the SARS-CoV-2 spike (S) protein for Wuhan or S protein for omicron protected hamsters when challenged with the omicron BA.1 variant.

In July 2022, updated Phase I data showing Vaxart’s Spike/Nucleocapsid (S+N) candidate induced long-lasting mucosal IgA antibodies in saliva and nasal samples against SARS-CoV-2 and was cross-reactive to many different coronaviruses that are more divergent than circulating variants of SARS-CoV-2.

Earlier this year, Vaxart released non-human primate data that demonstrated that administration of Vaxart’s S-only or S+N COVID-19 vaccine candidates to the nasal mucosa of non-human primates produced significant increases in serum IgG and IgA and up to 1,000-fold increases in nasal IgA.

All vaccinated animals challenged with SARS-CoV-2 B.1.351 (beta variant) had a significant reduction in viral titers in the nasal passages compared to unvaccinated controls.

In June 2022, established an agreement with hVIVO Services Limited, a subsidiary of Open Orphan, a research company specializing in human challenge clinical trials for infectious and respiratory disease products, under which hVIVO will conduct a characterization study and, if successful, develop a human challenge model based on the omicron variant of SARS-CoV-2, with the intent to conduct a subsequent Phase II Human Challenge Trial (HCT) of Vaxart’s oral COVID-19 vaccine candidate.

Norovirus Vaccine Developments

In June 2022, Vaxart reported positive top-line data about its norovirus vaccine candidate. No vaccine exists in the United States to treat norovirus, a virus that causes up to 21 million cases, 109,000 hospitalizations and 900 deaths annually in the United States. The June data, from Vaxart’s Phase Ib trial in subjects aged 55-80, demonstrated that Vaxart’s oral norovirus vaccine candidate stimulated a robust immune response across all doses, with a dose-dependent production of IgA antibody secreting cells.

Results were consistent with previous studies conducted in younger populations, which is typically not the case, as the immune system often weakens with age, and older people tend to have less robust responses to vaccination than younger people.

Vaxart also reported in June 2022 on top-line data from a Phase I trial evaluating different boosting regimens with Vaxart’s oral norovirus vaccine candidate. The data showed that the candidate was able to successfully boost antibody responses, with antibody responses trending better with administration spread out over three months versus a shorter interval.

This data and previous results support the continued development of Vaxart’s oral norovirus vaccine candidate in adult populations, including elderly adults, and add to the growing body of evidence supporting its clinical utility.

Planned Clinical Milestones in the COVID-19 and Norovirus Pipelines

Selection of COVID-19 vaccine constructs expected in Q4 2022 with clinical trials to start in 1H 2023of COVID-19 vaccine constructs expected in Q4 2022 with clinical trials to start in 1H 2023.

After determining which COVID-19 vaccine candidate to advance, Vaxart anticipates updating its plans for its India trials.

Planned start of Phase II trial of Vaxart’s bivalent norovirus vaccine candidate in Q4 2022.

Preliminary data from ongoing Phase II norovirus challenge study expected at the end of Q1 2023 or early Q2 2023.

Omicron Human Challenge Study in the UK starting in the 2H 2023 using selected vaccine construct.

Financial Results for the Three Months Ended June 30, 2022

Vaxart ended the second quarter with cash, cash equivalents and available-for-sale debt securities of $131.5 million, compared to $157.0 million as of March 31, 2022. The decrease was primarily due to $25.9 million of cash used in operations. The Company’s existing funds are expected to be sufficient to fund its operations into the second half of 2023.

The Company reported a net loss of $29.4 million for the second quarter of 2022, compared to $16.1 million for the second quarter of 2021. Net loss per share for the second quarter of 2022 was $0.23, compared to a net loss of $0.13 per share in the second quarter of 2021. The increase in net loss was primarily due to a significant increase in research and development expenses.

Research and development expenses were $19.9 million for the second quarter of 2022, compared to $10.7 million for the second quarter of 2021. The increase was mainly due to increases in headcount and related costs, and in manufacturing and clinical trial expenses related to our COVID-19 and norovirus vaccine candidates.

General and administrative expenses were $9.3 million for the second quarter of 2022, compared to $5.2 million the second quarter of 2021. The increase was mainly due to the cost of settling shareholder litigation and increases in legal and professional costs and in headcount and related costs.

Conference Call

The Vaxart senior management team will host a conference call to discuss the business update and financial results for the second quarter of 2022 today, beginning at 4:30 p.m. ET.

The conference call can be accessed using the following information:

A replay of the webcast will be available on the Company’s website at www.vaxart.com following the conclusion of the event.