On May 11, 2022 Vaccitech plc (NASDAQ: VACC) reported its financial results for the first quarter ended March 31, 2022, and provided an overview of the Company’s recent corporate developments (Press release, Vaccitech, MAY 11, 2022, View Source [SID1234614262]). 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, autoimmunity, and cancer .

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"We’ve already made solid progress across the Company this year and are excited to share our plans to advance our recently acquired SNAPvax platform into the clinic in multiple disease indications including HPV cancer and celiac disease," said Bill Enright, Vaccitech’s CEO. "These are devastating diseases where we believe this novel platform provides a unique opportunity for potential cures. In addition, we expect to announce efficacy data in our chronic infectious disease programs in both HBV and HPV later this year. Finally, the royalty and milestone payments that we have begun to receive related to the sales of AstraZeneca’s SARS CoV2 vaccine will contribute non-dilutive capital to these efforts."

First Quarter 2022 and Recent Corporate Developments

·On April 6, 2022, the Company announced the notification of the commencement of royalty payments relating to commercial sales of Vaxzevria. The Company’s share of milestone and royalty payments received by OUI from AstraZeneca in the first quarter of 2022 amounted to $15.0 million.

·In April, the Company launched a program in HPV-associated cancer utilizing the SNAPvax platform and moved forward with an immunotherapeutic designed to induce regulatory T cells in patients with celiac disease. IND applications are expected to be filed for both programs during the first quarter of 2023.

·On April 29, 2022, the Company received scientific advice from the EMA defining a licensure pathway for the candidate MERS vaccine, VTP-500, which allows the Company to estimate expenses of the development pathway more accurately.

Upcoming Milestones

·In the second quarter of 2022, the Company expects to present additional Phase 1b/2a interim efficacy data on VTP-300 in patients with chronic HBV infection at the European Association for the Study of the Liver (EASL) International Liver Congress on June 22 to 26, 2022, which is also expected to be followed by full efficacy data in the second half of this year.

·In the third quarter of 2022, the Company expects to initiate dosing in a Phase 1/2 clinical trial of VTP-850 in patients with prostate cancer.

·In the fourth quarter of 2022, the Company intends to conduct an interim efficacy review of HPV001, a Phase 1b/2 clinical trial of VTP-200, a potential non-invasive treatment for low grade HPV-related cervical lesions.

First Quarter 2022 Financial Highlights:

·Cash position: As of March 31, 2022, cash and cash equivalents were $200.6 million, compared to $214.1 million as of December 31, 2021. The decrease in cash was primarily due to $6.6 million of net cash being used in operating activities and a $5.6 million negative effect of exchange rates on cash and cash equivalents.

·Research and development expenses: Research and development expenses were $10.7 million in the first quarter of 2022 compared to $4.6 million in the comparable period of the prior year. The increase in R&D expenses was primarily due to increased spending on the development of VTP-200, VTP-300, VTP-850 and VTP-600 and an increase in R&D personnel-related costs.

·General and administrative expenses: General and administrative expenses were $3.7 million in the first quarter of 2022 compared to $1.8 million in the comparable period of the prior year. The first quarter of 2022 includes $4.3 million of personnel expenses, including a share-based payment charge of $3.1 million, and a $5.3 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 mainly attributable to higher personnel costs, reflecting an increase in the Company’s headcount over the period, and higher insurance costs associated with operating as a public company.

·Net Income: For the first quarter of 2022, the Company generated a net income of $2.6 million, or $0.07 per share on both basic and fully diluted bases, compared to a net loss of $15.4 million, or $1.90 per share on both basic and fully diluted bases, for the comparable period of the prior year.

On May 11, 2022 Kiromic BioPharma, Inc. (NASDAQ: KRBP) ("Kiromic" or the "Company"), a clinical-stage fully integrated biotherapeutics company using its proprietary DIAMOND artificial intelligence (AI) and data mining platform to discover and develop cell and gene therapies with a therapeutic focus on immuno-oncology, reported the Company will submit an amended Investigational New Drug Application (IND) for its first oncology cell therapy candidate Procel directly to the FDA in the second half of 2022 (Press release, Kiromic, MAY 11, 2022, View Source [SID1234614223]).

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Over the course of the last ten months, the Company has developed a solid plan to address the previously outlined chemistry, manufacturing, and control (CMC) issues cited in the FDA’s July 2021 letter regarding the clinical hold on the Company’s INDs. Based on the unanimous advice from independent regulatory experts, the Company has determined that it is not necessary to proceed with the previously contemplated Type A meeting with the FDA to further address the CMC issues and instead will move forward with a submission of an amended IND for Procel directly to the FDA during the second half of this year.

The Company also announces ongoing progress toward the implementation of a current good manufacturing practice (cGMP) mammalian master cell bank (mMCB), which will provide a GMP-grade retroviral vector for gamma delta T (GDT) cell engineering. A cGMP mammalian master cell bank is a significant step forward in the Company’s clinical pathway and would address a key issue identified by the FDA in the clinical hold letter.

"We are very pleased to share these significant regulatory updates, reflecting the progress we have been making as a Company. In addition, progress toward establishing the master cell bank will enable us to create the GMP-grade retroviral vector for gamma delta cell engineering – a cornerstone of our clinical program" stated Pietro Bersani, Kiromic BioPharma’s Chief Executive Officer. "These achievements demonstrate our team’s execution efforts toward our goal of beginning the activation of the clinical trial for our first oncology cell therapy candidate Procel by the end of the fourth quarter of 2022."

On May 11, 2022 Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq: SNDX), a clinical-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, reported that Michael A. Metzger, Chief Executive Officer of Syndax, will participate in a panel discussion on targeted oncology at Citi’s Biopharma Virtual Co-Panel Day on Wednesday, May 18, 2022 at 1:30 p.m. ET (Press release, Syndax, MAY 11, 2022, View Source [SID1234614224]).

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A live webcast of the panel can be accessed from the Investor section of the Company’s website at www.syndax.com, where a replay of the events will also be available for a limited time.

On May 11, 2022 Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT), a leading late-stage, clinical biotechnology company advancing an integrated and sustainable pipeline of genetic therapies for rare childhood disorders with high unmet need, reported that Gaurav Shah, M.D., Chief Executive Officer, will deliver a company presentation at the UBS Global Healthcare Conference on Tuesday, May 24 at 7:45 a.m. ET, in New York (Press release, Rocket Pharmaceuticals, MAY 11, 2022, View Source [SID1234614241]).

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A live audio webcast of the presentation will be available under "Events" in the Investors section of the Company’s website at View Source The webcast replay will be available on the Rocket website following the conference.

On May 11, 2022 PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of molecularly targeted cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary Versamune and Infectimune T-cell activating technologies, reported that it will discuss its financial results for the quarter ended March 31, 2022, and provide a business update on its conference call today (Press release, PDS Biotechnology, MAY 11, 2022, View Source [SID1234614181]).

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"2022 is shaping up to be an incredibly productive year for PDS Biotech," commented Dr. Frank Bedu-Addo, President and Chief Executive Officer of the Company. "As we continue to make significant clinical progress on our lead oncology candidate, PDS0101, we’re looking ahead to presentations of preliminary data from our two most advanced Phase 2 clinical trials at this year’s ASCO (Free ASCO Whitepaper) meeting in early June. We believe ASCO (Free ASCO Whitepaper)’s selection of the preliminary data from both trials for presentation at the June meeting is a testament to the quality of work being done by our team and our partners, as well as the potential demonstrated by PDS0101 in treating advanced HPV-associated cancers. We look forward to sharing these efficacy and safety data in the near term. In addition, we continue to leverage our proprietary platforms to advance our pre-clinical pipeline into clinical studies, focused on a variety of cancer targets and infectious diseases. Lastly, due to our partnering model and our financial discipline, we finished the quarter with a strong cash balance which we project to fund our current operations into 2024."

Recent Business Highlights:

Announced two abstracts accepted for poster presentation during the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place June 3-7 in Chicago:

The poster presentation of Abstract # 6041 will summarize updates to the preliminary efficacy and safety data from the PDS-sponsored VERSATILE-002 Phase 2 clinical trial, which is evaluating PDS0101 in combination with Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) for the treatment of recurrent or metastatic HPV16-positive head and neck cancer.

The poster presentation of Abstract # 2518 will summarize updates from last year’s ASCO (Free ASCO Whitepaper) presentation to efficacy and survival data, as well as new findings from the ongoing National Cancer Institute (NCI)-led Triple Combination Phase 2 clinical trial. This trial is evaluating PDS0101 in combination with two investigational immune-modulating agents across the range of HPV16-positive advanced relapsed refractory cancers.

In April, received $1.2 million from the net sale of tax benefits to an unrelated, profitable New Jersey corporation pursuant to the Company’s participation in the New Jersey Technology Business Tax Certificate Transfer Net Operating Loss (NOL) program for State Fiscal Year 2021.

Announced that the NCI achieved the enrollment objective of 30 patients in the checkpoint inhibitor (CPI) refractory arm of the Triple Combination Phase 2 clinical trial for PDS0101.

First Quarter 2022 Financial Results
PDS Biotech reported a net loss of approximately $8.5 million, or $0.32 per basic share and diluted share, for the three months ended March 31, 2022 compared to a net loss of approximately $3.0 million, or $0.14 per basic share and diluted share, for the three months ended March 31, 2021.

Research and development (R&D) expenses increased to approximately $5.2 million for the three months ended March 31, 2022 from approximately $1.4 million for the three months ended March 31, 2021. The increase of approximately $3.7 million in 2022 was primarily attributable to an increase of $1.8 million in manufacturing services and quality costs, $1.04 million in clinical study and regulatory costs, $0.8 million in personnel costs and $0.06 million in facilities.

General and administrative expenses increased to approximately $3.3 million for the three months ended March 31, 2022 from approximately $1.6 million for the three months ended March 31, 2021. The increase of approximately $1.7 million is primarily attributable to an increase of $1.0 million in personnel costs, $0.6 million in legal fees and $0.1 in marketing expenses.

Total operating expenses increased to approximately $8.5 million for the three months ended March 31, 2022 from approximately $3.0 million for the three months ended March 31, 2021 for the reasons described above.

PDS Biotech’s cash balance as of March 31, 2022 was approximately $58.9 million.

Conference Call and Webcast
The conference call is scheduled to begin at 8:00 AM EDT on Wednesday, May 11, 2022. Participants should dial 877-407-3088 (United States) or 201-389-0927 (International) and reference conference ID 13728184. To access the webcast, please use the following link PDS Biotech Earnings Webcast. The event will be archived in the investor relations section of PDS Biotech’s website for six months.