On May 13, 2021 PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company’s proprietary Versamune T-cell activating technology, reported that it will discuss its financial results for the quarter ended March 31, 2021 and provide a business update on its conference call today (Press release, PDS Biotechnology, MAY 13, 2021, View Source [SID1234579982]).

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Recent Business Highlights:

National Cancer Institute to present interim efficacy and safety data of PDS0101 Phase 2 clinical trial in an oral presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2021 Annual Meeting on June 7, 2021. This trial is evaluating PDS0101 with two clinical stage immunotherapies from EMD Serono, a first in class bifunctional checkpoint inhibitor Bintrafusp Alfa (M7824) and an antibody conjugated cytokine M9241 (NHS-IL12), in patients with all types of advanced HPV-associated cancers, whose cancer has returned or spread after treatment.
COVID-19 consortium received a commitment from the Secretary for Research and Scientific Training of The Ministry of Science, Technology and Innovation of Brazil (MCTI) to fund up to approximately US$60 million to support the clinical development and commercialization of a Versamune-based COVID-19 vaccine by Farmacore in Brazil.
"We look forward to the presentation of preliminary efficacy and safety data from the National Cancer Institute (NCI)-led Phase 2 combination study of PDS0101 at the ASCO (Free ASCO Whitepaper) conference in early June. ASCO (Free ASCO Whitepaper) provides an important opportunity to present the potential of PDS0101 and the Versamune platform in oncology to the research and medical community," commented Dr. Frank Bedu-Addo, President and Chief Executive Officer of PDS Biotech, "The presentation of the human clinical efficacy data at ASCO (Free ASCO Whitepaper) is an important milestone both for PDS0101 and our entire Versamune-based oncology pipeline."

First Quarter 2021 Financial Results
PDS Biotech reported 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 compared to a net loss of approximately $4.0 million, or $0.39 per basic share and diluted share, for the three months ended March 31, 2020.

Research and development (R&D) expenses decreased 28% to approximately $1.4 million for the three months ended March 31, 2021 from approximately $2.0 million for the three months ended March 31, 2020. The decrease of approximately $0.6 million in 2021 was primarily attributable to a decrease of $0.3 million in professional services and $0.3 million in clinical studies.

General and administrative expenses decreased 21% to approximately $1.6 million for the three months ended March 31, 2021 from approximately $2.1 million for the three months ended March 31, 2020. The decrease of approximately $0.5 million is primarily attributable to a decrease in professional services of approximately $0.7 million which includes legal fees of approximately $0.2 million, offset by an increase of approximately $0.2 million in personnel costs.

Total operating expenses decreased 24% to approximately $3.0 million for the three months ended March 31, 2021 from approximately $4.0 million for the three months ended March 31, 2020.

PDS Biotech’s cash balance as of March 31, 2021 was approximately $25.0 million.

Conference Call and Webcast
The conference call is scheduled to begin at 8:00 am ET on Thursday, May 13, 2021. Participants should dial 877-407-3088 (United States) or 201-389-0927 (International) and mention PDS Biotech. Participants can also access the conference call via webcast on the investor relations page of the Company’s corporate website (link).

The event will be archived in the investor relations section of PDS Biotech’s website for 6 months. In addition, a telephonic replay of the call will be available for 6 months. The replay can be accessed by dialing 877-660-6853 (United States) or 201-612-7415 (International) with confirmation code 13716518.

On May 13, 2021 IntelGenx Technologies Corp. (TSX V:IGX)(OTCQB:IGXT) (the "Company" or "IntelGenx") today reported financial results for the first quarter ended March 31, 2021. All dollar amounts are expressed in U.S. currency, unless otherwise indicated, and results are reported in accordance with United States generally accepted accounting principles except where noted otherwise (Press release, IntelGenx, MAY 13, 2021, View Source [SID1234580044]).

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2021 First Quarter Financial Summary:

Revenue was $286,000, compared to $202,000 in the 2020 first quarter.
Net comprehensive loss was $2.3 million, compared to 2.9 million in Q1-2020.
Adjusted EBITDA loss was $1.7 million, compared to $1.9 million in the 2020 first quarter.
First Quarter and Recent Developments:

Entered into a second feasibility agreement with ATAI Life Sciences AG ("atai") for the development of novel formulations of Salvinorin A, a naturally occurring psychedelic compound being developed for the treatment of treatment-resistant depression and other indications based on IntelGenx’s polymeric film technologies.
Completed the first shipment, consisting of 75,000 CBD Filmstrips, to Heritage Cannabis Holdings Corp. (CSE:CANN).
Announced a strategic partnership with atai, including a proposed equity investment in IntelGenx by atai. The Company’s wholly owned subsidiary, IntelGenx Corp., also received a $2.0 million secured loan from atai, of which $636,000 was used to fully repay the Company’s outstanding credit facilities with the Bank of Montreal. Subsequent to quarter-end, IntelGenx Corp. receive a second secured loan of $500,000 from atai.
Received a Notice of Allowance for US Patent Application 16/110.737, entitled "Film Dosage Form with Extended Release Mucoadhesive Particle," covering novel disintegrating oral film formulations designed for the transmucosal absorption of drug, especially tetrahydrocannabinol (THC), which protects its DisinteQTM products.
Filed a new provisional patent application at the United States Patent and Trademark Office entitled "High Loading Oral Film Formulation," which covers the incorporation of high concentrations of active ingredients in products based on its VetaFilm proprietary veterinary oral film technology.
Announced the appointment of Mr. Tommy Kenny as Vice President, Intellectual Property and Legal Affairs, General Counsel of IntelGenx Corp.
"We would like to take this opportunity to thank our shareholders for their support of our transformative strategic partnership with atai, demonstrated by the approval of all related proposals at our Annual Meeting held earlier this week," commented Dr. Horst G. Zerbe, CEO of IntelGenx. "This transaction positions IntelGenx as a leader within the novel therapeutics field of psychedelics and also provides us with the financial resources needed to continue to advance our robust portfolio of other innovative pharmaceutical film product candidates towards commercialization. We look forward to updating investors as we progress."

The atai partnership and investment are subject to the approval of the TSX Venture Exchange, in addition to certain customary closing conditions. The transaction is expected to close on or about March 14, 2021.

Financial Results:

Total revenues for the three-month period ended March 31, 2021 amounted to $286,000, an increase of $84,000, or 42%, compared to $202,000 for the three-month period ended March 31, 2020. The change is mainly attributable to an increase in product revenues of $160,000, partially offset by a decrease in research and development ("R&D") revenues of $76,000.

Operating costs and expenses were $2.2 million for the first quarter of 2021, versus $2.4 million for the corresponding three-month period of 2020. The decrease for the three-month period ended March 31, 2021 is mainly attributable to a $379,000 decrease in R&D expenses, partially offset by a $143,000 increase in manufacturing expenses, an $83,000 increase in selling, general and administrative expenses, and an increase of $13,000 in depreciation of tangible assets.

For the first quarter of 2021, the Company had an operating loss of $1.9 million, compared to an operating loss of $2.2 million for the comparable period of 2020.

Net comprehensive loss for the three-month period ended March 31 2021 was $2.3 million, or $0.02 per basic and diluted share, compared to net comprehensive loss of $2.9 million, or $0.03 per basic and diluted share, for the comparable period of 2020.

As at March 31, 2021, the Company’s cash and short-term investments totalled $2.0 million, which did not include the $500,000 secured loan granted to IntelGenx Corp. by atai in May 2021.

Conference Call Details:

IntelGenx will host a conference call to discuss these first quarter 2021 financial results today at 4:30 p.m. ET. The dial-in number for the conference call is (877) 876-9176 (Canada and the United States) and (785) 424-1670 (International). The call will be also be webcast live and archived on the Company’s website at www.intelgenx.com under "Webcasts" in the Investors section.

On May 12, 2021 Aptose Biosciences Inc. (Nasdaq: APTO; TSX: APS), a clinical-stage company developing highly differentiated therapeutics that target the underlying mechanisms of cancer, reported that the Aptose management team will participate in upcoming investor conferences (Press release, Aptose Biosciences, MAY 12, 2021, View Source [SID1234579766]):

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2021 RBC Capital Markets Global Healthcare Virtual Conference

Date: Wednesday, May 19, 2021
Time: 11:30 AM – 11:55 AM EDT
Format: Fireside Chat moderated by Gregory J. Renza, M.D., Equity Research – Biotechnology

Conference Information: Link
Jefferies Virtual Healthcare Conference

Date: Wednesday, June 2, 2021
Time: 2:00 PM – 2:25 PM EDT
Format: Aptose Slide Presentation and Webcast

Conference Information: Link
The Aptose management team also will be hosting 1×1 meetings during the events.

On May 12, 2021 HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, reported financial results and business highlights for the first quarter of 2021 (Press release, Hookipa Pharma, MAY 12, 2021, View Source [SID1234579783]).

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"We had a strong start to the year as we drive our pipeline forward to deliver a new class of arenavirus-based immunotherapeutics. As we shared at AACR (Free AACR Whitepaper), one initial dose of our lead oncology candidates, HB-201 or HB-202, each induced a robust increase in antigen-specific T cells, including an increase of up to 8% of antigen-specific circulating CD8+ T cells, in people with advanced Human Papillomavirus 16-positive (HPV16+) cancers," said Joern Aldag, Chief Executive Officer at HOOKIPA. "We believe these data are impressive, and they are consistent with the pre-clinical data published in Cell Reports Medicine in March. Both data sets highlight the potential of our engineered arenavirus platform to redefine success in cancer immunotherapy. As our clinical programs progress, we’re excited about the oral abstract presentation at ASCO (Free ASCO Whitepaper) (#2502) and other future data presentations at upcoming conferences."

Program Highlights

In April 2021, HOOKIPA announced positive preliminary Phase 1 immunogenicity data for its lead oncology candidates, HB-201 and HB-202, for the treatment of advanced HPV16+ cancers, reinforcing the promising anti-tumor activity reported from the Phase 1/2 clinical trial in December 2020. The preliminary immunogenicity data demonstrated a robust increase in HPV16+-specific T cells, including an increase of up to 8% of antigen-specific circulating CD8+ T cells, after one dose of HB-201 or HB-202. Early HB-201 monotherapy data also highlighted immune system activation of increasing interferon-gamma and other immune stimulatory cytokines with a single dose. The data were presented at a late-breaker poster session at the virtual American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting.

In March, Cell Reports Medicine published pre-clinical data on HOOKIPA’s arenaviral therapeutics. The peer-reviewed article showed that intravenous HB-201 administration induced single digit percentage of antigen-specific CD8+ T cells, while alternating administration of HB-201 and HB-202 induced a potent CD8+ T cell response, exceeded 50% of the circulating T cell pool. The two-vector cancer therapeutic approach also resulted in tumor cures and long-term immunity in a pre-clinical setting.

HOOKIPA’s prophylactic Cytomegalovirus, or CMV, vaccine candidate, HB-101, continued to enroll patients awaiting kidney transplantation in a Phase 2 clinical trial. We expect to conclude trial enrollment in mid-2021 and to report additional safety, immunogenicity, and efficacy data from evaluable patients in the second half of 2021.
Upcoming Milestones

Oral abstract presentation at ASCO (Free ASCO Whitepaper) (#2502 at 3:00pm EDT on June 7): First report of the safety/tolerability and preliminary antitumor activity of HB-201 and HB-202, an arenavirus-based cancer immunotherapy, in patients with HPV16+ cancers
Initial HB-201/HB-202 Phase 1/2 efficacy data in HPV16+ cancers in mid-2021
Additional HB-101 CMV Phase 2 efficacy data in H2 2021
Advancing our HB-300 to IND for the treatment of metastatic prostate cancer
HBV and HIV collaboration with Gilead Sciences advancing towards clinical studies
First Quarter 2021 Financial Results

Cash Position: HOOKIPA’s cash, cash equivalents and restricted cash as of March 31, 2021 was $128.1 million compared to $143.2 million as of December 31, 2020. The decrease was primarily attributable to cash used in operating activities.

Revenue was $5.3 million for the three months ended March 31, 2021, and $3.7 million for the three months ended March 31, 2020. The increase was primarily due to higher cost reimbursements received under the Collaboration Agreement with Gilead and the recognition of cost reimbursements initially recognized as deferred revenue.

Research and Development Expenses: HOOKIPA’s research and development expenses were $20.2 million for the three months ended March 31, 2021, compared to $11.5 million for the three months ended March 31, 2020.

The primary drivers of the increase in direct research expenses were an increase in clinical trial expenses of $1.5 million and an increase in manufacturing and quality control expenses of $4.6 million.

The increase was mainly due to the progress in our HB-201 and HB-202 clinical trial, the increased patient recruitment in our HB-201 and HB-202 clinical trial, monitoring and testing activities and manufacturing and quality control work in preparation of a further extension of the trial. Manufacturing and quality control expenses were also driven by the progress towards clinical development in our Gilead partnered programs. This increase in HB-201/HB-202 and Gilead related direct expenses was partially offset by a decrease in direct costs related to our HB-101 program due to slower patient recruitment as a result of the COVID pandemic.

The increase in internal research and development expenses was mainly due to an increase of personnel-related research and development expenses, resulting primarily from a higher headcount, while stock-based compensation expenses included in personnel-related research and development expenses decreased. In addition, an increase in facility related costs and an increase in other internal costs contributed to the overall increase in internal research and development expenses.

General and Administrative Expenses: General and administrative expenses for the three months ended March 31, 2021 were $4.3 million, compared to $4.6 million for the three months ended March 31, 2020. The decrease was primarily due to a decrease in personnel-related expenses, partially offset by an increase in professional and consulting fees. The decrease in personnel-related expenses resulted from decreased stock compensation expenses, partially offset by increased salaries and a growth in headcount in our general and administrative functions.

Net Loss: HOOKIPA’s net loss was $17.2 million for the three months ended March 31, 2021 compared to a net loss of $10.9 million for the three months ended March 31, 2020. This increase was due to an increase in research and development expenses, partially offset by an increase in revenues from collaboration and licensing, a decrease in general and administrative expenses, and an increase in grant income.

On May 12, 2021 Qu Biologics Inc., a private clinical stage biopharmaceutical company developing Site Specific Immunomodulators (SSIs), a novel platform of immunotherapies designed to restore innate immune function, reported that expanded its patent portfolio to include the perioperative use of Qu’s SSIs to overcome immune dysfunction in patients undergoing cancer surgery (Press release, Qu Biologics, MAY 12, 2021, View Source [SID1234579799]).

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It has long been observed that "immune paralysis" is a phenomenon that occurs following the physical stress of surgery performed for the removal of cancer. During this post-surgical period, cells of the immune system are suppressed, and this immune suppression provides a dangerous window of opportunity for any cancer cells that have been left behind to spread or metastasize unchecked. As a result, post-operative immune dysfunction can lead to cancer recurrence in cancer patients who have undergone surgery to remove their tumours. There are currently no effective treatments that prevent or relieve this post-surgical immune suppression, leaving patients vulnerable to cancer recurrence and metastasis.

The unique ability of Qu’s SSIs to simultaneously program multiple important immune cells to effectively fight malignancy was hypothesized to offer a potential solution for this critical problem. To test this hypothesis, Qu scientists worked with Dr. Rebecca Auer, a world renown surgical oncologist at the Ottawa Hospital Research Institute, whose research is focused on determining how to overcome post-surgical immune dysfunction to improve outcomes of cancer patients. Preclinical studies performed in Dr. Auer’s lab showed that perioperative administration of Qu’s lung-directed SSI preserved anti-cancer immunity and markedly reduced lung metastases in a surgical model.

Dr. Auer is enthusiastic about the prospect of leading a clinical trial to test the perioperative application of SSIs to improve cancer outcomes, "Post-surgical immune suppression continues to present a critical challenge in oncology. To date very few trials have been conducted in the perioperative period, specifically designed to alleviate this immune dysfunction, which can adversely impact outcomes for patients having undergone cancer excision surgery. Given the large number of patients who undergo surgery for cancer every year, this is a significant unmet clinical need. I am hopeful that the SSI approach can transform perioperative management of cancer patients." Immunologist Dr. Shirin Kalyan, Qu’s Vice President of Scientific Innovation, said, "We have previously shown that SSI treatment, given in the absence of surgery, overcomes cancer-induced immune suppression through innate immune training and NK cell activation, and increases susceptibility of cancer cells to be targeted by immune effector cells. The new evidence from Dr. Auer’s lab that shows perioperative SSI treatment can also serve to overcome post-surgical immune suppression is really akin to hitting two birds with one stone for cancer immunotherapy."

Dr. Hal Gunn, Qu’s CEO, said, "We are very excited about this important discovery. Since the large majority of cancer patients undergo surgery, perioperative SSI treatment has the potential to transform outcomes for cancer surgery patients. Qu looks forward to working with Dr. Auer and her colleagues in conducting a Phase 2 clinical trial to assess the unique potential of SSIs in the context cancer surgery and we welcome discussions with potential investors and licensing partners."