On November 12, 2021 Vaccitech plc (NASDAQ: VACC) reported its financial results for the third quarter, ended September 30, 2021, and provided an overview of the Company’s recent corporate developments (Press release, Vaccitech, NOV 12, 2021, View Source [SID1234595510]). Vaccitech is a clinical-stage biopharmaceutical company engaged in the discovery and development of novel immunotherapeutics and vaccines for the treatment and prevention of infectious diseases and cancer.

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"We continue to advance our promising pipeline with the recent publication of data on our MERS vaccine program. We also anticipate that initial clinical data on two of our chronic infectious disease therapeutic programs will be presented at scientific conferences next week," commented Bill Enright, Vaccitech’s CEO. "As we continue to expand and advance our programs, we will need additional lab and office space for our talented staff so we have planned a move mid next year into a new, state of the art facility."

Third Quarter and Recent Corporate Developments

Signed a clinical trial collaboration agreement with Arbutus Biopharma Corporation to evaluate an innovative therapeutic combination for the treatment of subjects with chronic hepatitis B virus infection (CHB) who are already receiving standard-of-care nucleoside or nucleotide analog (NA) therapy. The Phase 2a clinical trial will evaluate the safety, pharmacokinetics, immunogenicity, and antiviral activity of Arbutus’s RNAi therapeutic, AB-729, followed by the Company’s immunotherapy candidate, VTP-300, in NA-suppressed subjects with CHB.
Preclinical research demonstrated that VTP-600, a ChAdOx1/MVA prime-boost immunotherapeutic, demonstrated potential as an anti-cancer therapeutic. The research was conducted by scientists at the University of Oxford and the Ludwig Institute for Cancer Research.
Signed a lease for 31,000 square feet within the Zeus development at Harwell Science and Innovation Campus. The site will house the Company’s headquarters, state-of-the-art wet laboratory and offices. Vaccitech anticipates completing the relocation by mid-2022.
Announced online publication in The Lancet Microbe of the results of a Phase 1 clinical trial of VTP-500, a vaccine candidate in development to prevent Middle East Respiratory Syndrome (MERS). The study, conducted by researchers at The King Abdullah International Medical Research Centre and Oxford University, showed that the vaccine candidate was generally well tolerated and induced both humoral and cellular immune responses.
Upcoming Milestones

At the virtual AASLD’s The Liver Meeting in November, two posters will present safety and immunogenicity data from the Phase 1 and Phase 1b/2a trials of VTP-300: HBV001, in healthy volunteers and patients with chronic hepatitis B (CHB) infection and HBV002 in patients with CHB infection. The posters become available for viewing by attendees at 8 a.m. EST on November 12.
At the virtual 34th International Papillomavirus Conference in November, the Company expects to present safety and immunogenicity data from the lead-in portion of the Phase 1/2a clinical trial of VTP-200.
In the fourth quarter, the Company expects to initiate dosing in a Phase 1/2a trial of VTP-600 in patients with non-small cell lung cancer in combination with a checkpoint inhibitor and chemotherapy. The trial is currently open for enrollment.
In the first quarter of 2022, the Company intends to conduct an interim efficacy review of HBV002, the Phase 1b/2a clinical trial of VTP-300 in patients with chronic HBV infection.
In the second quarter of 2022, the Company expects to initiate dosing in a Phase 1/2a clinical trial of VTP-800/850, in combination with a checkpoint inhibitor, in patients with prostate cancer.
In the third quarter of 2022, the Company intends to conduct an interim efficacy review of HPV001, a Phase 1/2a clinical trial of VTP-200, a potential non-invasive treatment for persistent high-risk HPV infection.
Third Quarter 2021 Financial Highlights:

Cash position: As of September 30, 2021, cash and cash equivalents were $233.9 million, compared to $43.3 million as of December 31, 2021. The increase was primarily due to completion of the Series B financing in the first quarter of 2021, which raised $168 million including the conversion of our previously issued convertible loan notes, and to the initial public offering in the second quarter, which raised gross proceeds of $110.5 million. The Company believes its cash and cash equivalents are sufficient to fund operations into the first half of 2024.
Research and development (R&D) expenses: Research and development expenses were $4.4 million for the third quarter of 2021 compared to $3.7 million for the comparable period of the prior year. The increase in R&D expenses was primarily due to increased spending on progressing the development of VTP-300 and VTP-850.
General and administrative expenses: General and administrative expenses were $1.2 million for the third quarter of 2021 compared to $1.0 million for the comparable period of the prior year. The third quarter of 2021 expense includes a $5.8 million unrealized foreign exchange gain on revaluation of Company’s cash balances. Net of this gain, the increase in general and administrative expenses between the periods was attributable to higher personnel costs, reflecting an increase in the Company’s headcount over the prior period and higher insurance costs associated with operating as a public company.
Net loss: The Company generated a net loss attributable to its shareholders of $4.6 million, or ($0.13) per share on both basic and fully diluted bases, for the third quarter of 2021 compared to a net income of $0.2 million, or $0.02 per share a basic basis and $0.01 on a fully diluted basis, for the same period of the prior year.

On November 12, 2021 Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") reported the peer-reviewed publication of significant results from a pivotal study of abivertinib on 227 heavily pretreated NSCLC patients in the journal Clinical Cancer Research, authored by Dr. Yi-Long Wu, distinguished professor of Guangdong Lung Cancer Institute, awardee of the prestigious "International Association for the Study of Lung Cancer (IASLC) Scientific Award" in 2017, and the principal investigator of the study (Press release, Sorrento Therapeutics, NOV 12, 2021, View Source [SID1234595509]).

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The full manuscript is available at: View Source

Abivertinib is a pyrrolopyrimidine-based, third-generation EGFR/BTK inhibitor, which is structurally distinct from osimertinib. Abivertinib selectively inhibits EGFR-activating and resistant mutation with nearly 300-fold potency as compared with wild-type EGFR. The 300 mg BID abivertinib dose was based upon the pharmacokinetics, efficacy and safety profiles characterized in prior studies. In the pivotal study, 227 patients received this dose for a median treatment duration of 24.6 weeks (0.43-129). Among 209 response evaluable patients, confirmed ORR was 52.2% (109/209; 95% CI: 45.2%, 59.1%) and the DCR was 88.0% (184/209, 95% CI: 82.9%, 92.1%). The median DoR and PFS were 8.5 months (95% CI: 6.1, 9.2) and 7.5 months (95% CI: 6.0, 8.8), respectively. The median OS was 24.9 months (95% CI: 22.4, NR). All patients (N=227) reported at least 1 AE, with 96.9% (220/227) reporting treatment-related AEs. Treatment-related serious AEs were reported in 13.7% (31/227) of patients. Death was reported in 4.4% (10/227) of patients, and none was deemed related to abivertinib.

With the ORR of 52.2%, and OS of 24.9 months, comparable to approved 3rd generation EGFR inhibitors, abivertinib demonstrated significantly efficacious effects in overcoming resistant mutation in NSCLC. Based on these results, Sorrento is conducting an independent review process with long-term follow up data and intends to request a pre-NDA meeting with FDA. "We are very encouraged by the publication of these significant positive results of abivertinib on the treatment of advanced and heavily pretreated NSCLC lung cancer in Clinical Cancer Research and look forward to bringing abivertinib into the armamentarium of this multi-billion dollar indication," said Dr. Henry Ji, Chairman and CEO of Sorrento.

On November 12, 2021 PLx Pharma Inc. (NASDAQ: PLXP) ("PLx" or the "Company"), reported that it is a commercial-stage drug delivery platform technology company focused on its clinically-validated and patent-protected PLxGuard that has the potential to improve the absorption of many drugs currently on the market and to reduce the risk of stomach injury associated with certain drugs (Press release, Vincerx Pharma, NOV 12, 2021, View Source [SID1234595508]). The Company, with its lead products VAZALORE 325 mg and VAZALORE 81 mg liquid-filled aspirin capsules (referred to together as "VAZALORE"), announced today certain financial and operational results for the three and nine months ended September 30, 2021.

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Highlights of, and certain events during and subsequent to, the third quarter of 2021 include:

Extensive VAZALORE commercial launch activities under way:
Successfully supplied three stock keeping units ("SKUs") of VAZALORE into more than 30,000 retail drugstores, supermarkets, mass merchandisers and e-commerce sites nationwide;
Deployed a cardiovascular specialty field force to engage with healthcare professionals at leading heart/stroke hospitals and affiliated clinical practices;
Launched a national media television campaign to raise awareness among providers and consumers;
Implemented a nationwide pharmacist outreach campaign including email alerts and education kits with information and coupon incentives;
Continue to receive very positive feedback from consumers and healthcare providers about the benefits of VAZALORE;
Reported third quarter 2021 revenue of $6.6 million and a net loss of ($0.80) per basic and diluted share; adjusted non-GAAP net loss was ($0.37) per basic and diluted share;
Preliminary results of study titled, Pharmacokinetic and Pharmacodynamic Profile of PL-ASA, a Novel Phospholipid-Aspirin Complex Liquid Formulation, Compared to Enteric-coated Aspirin at an 81 mg Dose – Results from a Prospective, Randomized Crossover Study (F. Franchi et al.), were included in a virtual poster presentation during the Transcatheter Cardiovascular Therapeutics Meeting of the Cardiovascular Research Foundation (TCT 2021) in Orlando, FL.; and
Cardiovascular thought leaders held a virtual town hall meeting on October 29, 2021 titled "Should You Stop (or Start) Aspirin? Ask Your Doctor" as a public health service for patients to help clarify the continued critical role of aspirin in secondary prevention.
"We remain focused on executing our VAZALORE commercial strategy with retailers, professionals and consumers," said Natasha Giordano, Chief Executive Officer of PLx. "The overwhelmingly positive feedback we have received strengthens our confidence in the potential of this brand," stated Natasha Giordano, Chief Executive Officer of PLx.

"Key thought leaders in the field have been pro-actively engaged in clarifying the foundational role of aspirin in secondary prevention of cardiovascular disease. Also, the availability of new scientifc data on VAZALORE, which is consistent with previous studies that supported the approvals of VAZALORE 81 mg and 325 mg, continues to demonstrate that VAZALORE delivers fast, reliable absorption that patients depend on to help prevent another heart attack or clot-related stroke," concluded Giordano.

Third Quarter 2021 Financial Highlights

Total revenues for the third quarter of 2021 were $6.6 million, compared to no revenue in the third quarter of 2020 and reflected the launch of VAZALORE 81 mg and 325 mg dose strengths with initial distribution to US retail channels. Net sales were led by 81 mg dose strength (consisting of two SKUs), which represented approximately two-thirds of total revenues in the third quarter of 2021.

Gross margin of 41% reflects outsourced manufacturing and packaging costs, shipping and warehousing costs, expenses related to order processing, quality assurance and royalties.

Total operating expenses were $12.6 million during the third quarter of 2021, compared to operating expenses of $3.2 million for the prior period, reflected the promotional activities and associated expenses for the commercial launch of VAZALORE.

Research and development expenses were $1.6 million for the third quarter of 2021, compared to $1.2 million in the third quarter of 2020. The increase reflects the rise in pre-commercial manufacturing-related activities for VAZALORE. Both periods included spending for VAZALORE clinical trials (81mg dose in 2021 and 325 mg dose in 2020).

Selling, marketing and administrative expenses totaled $11.0 million in the third quarter of 2021 compared to $2.0 million in the prior period, primarily due to VAZALORE launch expenses and increased non-cash stock-based compensation. During the third quarter of 2021, the Company launched a cardiovascular specialty field force and a national media television campaign to raise awareness for VAZALORE among healthcare professionals and consumers.

Other income (expense), net totaled $11.8 million of other expense and $61,847 of other income during the third quarter of 2021 and 2020, respectively. The variance is largely attributable to the non-cash change in fair value of warrant liability primarily due to the fluctuation of the price of the Company’s common stock offset by lower net interest due to the payoff of the term loan.

Net loss attributable to common stockholders for the third quarter of 2021 was $21.6 million, or ($0.80) per basic and diluted share, compared to $3.6 million, or ($0.40) per basic and diluted share, for the third quarter of 2020.

Adjusted non-GAAP net loss per basic and diluted per share was ($0.37) in the third quarter of 2021 compared to ($0.36) in the third quarter of 2020. See table for reconciliation of GAAP to adjusted non-GAAP net loss per basic and diluted share.

Non-GAAP Measures

PLx Pharma’s management considers adjusted non-GAAP net loss and adjusted non-GAAP net loss per basic and diluted earnings per share to be important financial indicators of operating performance, providing investors and analysts with useful measures of operating results unaffected by the impact on the financial statements of the volatility of the change in the fair value of the warrant liability and non-cash and non-recurring dividends and beneficial conversion features on our preferred stock. Management uses adjusted non-GAAP net loss and adjusted non-GAAP net loss per share when analyzing performance. Adjusted non-GAAP net loss and adjusted non-GAAP net loss per share should be considered in addition to, but not in lieu of net loss or net loss per share reported under GAAP.

Liquidity

As of September 30, 2021, the Company had cash and cash equivalents of $82.6 million and $3.3 million in accounts receivable and zero debt on its balance sheet.

Conference Call

As previously announced, PLx management will host its third quarter 2021 conference call as follows

The archived webcast will be available for 30 days via the aforementioned URL.

About VAZALORE
VAZALORE is an FDA-approved liquid-filled aspirin capsule, available in 81 mg and 325 mg doses. VAZALORE delivers aspirin differently from plain and enteric coated aspirin products. The special complex inside the capsule allows for targeted release of aspirin, limiting its direct contact with the stomach. VAZALORE delivers fast, reliable absorption for pain relief plus the lifesaving benefits of aspirin. To learn more about VAZALORE, please visit www.vazalore.com.

On November 12, 2021 Sosei Group Corporation ("the Company") (TSE: 4565) reported that in AstraZeneca’s third quarter 2021 clinical trials appendix presentation (published today and available on www.astrazeneca.com), the oral, small molecule adenosine A2a receptor antagonist imaradenant (AZD4635) has been removed from its clinical development pipeline as part of its ongoing pipeline prioritization (Press release, Sosei Heptares, NOV 12, 2021, View Source [SID1234595499]). Imaradenant was discovered by Sosei Heptares and licensed to AstraZeneca in 2015.

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AstraZeneca has been evaluating imaradenant in Phase 1 and 2 clinical trials as a monotherapy and in combination with Imfinzi (durvalumab) in solid tumors. In these trials, imaradenant, with or without Imfinzi, was found to be safe and well tolerated and associated with clinical benefit in some immune checkpoint-naïve patients with metastatic castrate-resistant prostate cancer (mCRPC). Imaradenant has been extensively tested in patients with a range of different solid tumor types and has been demonstrated to be safe and well tolerated at escalating doses.

Targeting the production or action of adenosine is a promising strategy for overcoming immune suppression in the tumor microenvironment, and several companies have now disclosed positive results from early clinical trials.

AstraZeneca has a diverse oncology pipeline that requires it to regularly make strategic prioritization decisions regarding projects in its portfolio. Following the removal of the imaradenant program from AstraZeneca’s clinical pipeline, Sosei Heptares will discuss with its partner AstraZeneca the next steps for the future of imaradenant, including the possibility of the Company regaining worldwide rights to the licensed program.

The event reported today has no material impact on the consolidated financial results for the fourth quarter and full year accounting period ending 31 December 2021. Should any impacts or other matters that require an announcement be identified, the Company will announce such matters promptly.

Shinichi Tamura, President and CEO of Sosei Heptares, commented: "The imaradenant clinical program has generated encouraging clinical results in cancer patients under AstraZeneca’s guidance. We respect their decision on imaradenant, as a result of a pipeline portfolio review, and we are keen to assess the possibility of regaining the worldwide rights in order to evaluate the future clinical development and/or re-licensing potential of the program, as we have successfully done so on multiple occasions. AstraZeneca is one of our longest serving partners, and we have enjoyed a highly productive collaboration with them. We look forward to the ongoing discussions about the future of imaradenant and will report the outcome in due course."

On November 12, 2021 Nordic Nanovector ASA (OSE: NANOV) reported that it will report its results for the third quarter 2021 on Thursday, 18 November 2021 (Press release, Nordic Nanovector, NOV 12, 2021, prnewswire.com/news-releases/nordic-nanovector-asa-invitation-to-third-quarter-2021-results-presentation-and-webcast-301422901.html [SID1234595498]).

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A presentation by Nordic Nanovector’s senior management team will be held in-person and webcast live beginning at 8:30am CET.

The webcast can be accessed from www.nordicnanovector.com in the section: Investors & Media and a recording will also be available on this page after the event.

The results report and the presentation will be available at www.nordicnanovector.com in the section: Investors & Media/Reports and Presentation/Interim Reports/2021 from 7:00am CET the same day.