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Vaccitech Reports Second Quarter 2021 Financial Results and Recent Corporate Developments

On August 12, 2021 Vaccitech plc (NASDAQ: VACC) reported its financial results for the second quarter, ended June 30, 2021, and provided an overview of the Company’s recent corporate developments (Press release, Vaccitech, AUG 12, 2021, View Source [SID1234586514]). 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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"The second quarter of 2021 was our first as a public company following our initial public offering that closed in May," said Bill Enright, CEO of Vaccitech. "Capital raised by that transaction as well as from a Series B private round earlier this year is being applied to our chronic infectious disease and oncology programs. We continue to make significant progress across all of our ongoing programs, including the recent announcement of our clinical collaboration with Arbutus."

Second Quarter and Recent Corporate Developments

Closed an initial public offering of American Depository Shares for total gross proceeds of $110.5 million.
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 (HBV) 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.
Upcoming Milestones

In the fourth quarter of 2021, the Company expects to announce topline safety and immunogenicity data from the Phase 1 trial of VTP-300, HBV001, in healthy volunteers and patients with chronic HBV infection.
In the same quarter, the Company expects to initiate dosing in the Phase 1/2a trial of VTP-600 in patients with non-small cell lung cancer in combination with a checkpoint inhibitor and chemotherapy.
In the first quarter of 2022, the Company intends to conduct an interim efficacy review, of HBV002, the Phase 1/2a clinical trial of VTP-300 in patients with chronic HBV infection.
In the second quarter of 2022, the Company intends to conduct an interim efficacy review of HPV001, the Phase 1/2a clinical trial of VTP-200 in patients with high-risk and persistent HPV infection.
Second Quarter 2021 Financial Highlights:

Cash position: As of June 30, 2021, cash and cash equivalents were $243.6 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 a further $125.3 million, 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 $4.5 million for the second quarter of 2021 compared to $3.9 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 $12.4 million for the second quarter of 2021 compared to $1.0 million for the comparable period of the prior year. The increase was primarily attributable to higher personnel costs, reflecting mainly an increase in the Company’s headcount over the prior period and vesting of certain share awards upon IPO, and higher insurance costs associated with operating as a public company.
Net loss: The Company generated a net loss attributable to shareholders of $15.9 million, or $0.64 per share on both basic and fully diluted bases, for the second quarter of 2021 compared to a net loss of $3.6 million, or $0.45 per share on both basic and fully diluted bases, for the same period of the prior year.

Century Therapeutics Reports Second Quarter 2021 Financial Results and Business Updates

On August 12, 2021 Century Therapeutics, (NASDAQ: IPSC), an innovative biotechnology company developing induced pluripotent stem cell (iPSC)-derived cell therapies in immuno-oncology, reported financial results and business highlights for the second quarter ended June 30, 2021 (Press release, Century Therapeutics, AUG 12, 2021, View Source [SID1234586513]).

"With the proceeds raised from our IPO in June, we are well positioned to advance our lead candidate CNTY-101 toward clinical development, targeting IND filing in mid-2022," said Lalo Flores, Chief Executive Officer, Century Therapeutics. "We continue our investment in our iPSC platforms and are pleased with the progress achieved in developing iPSC-derived cell product candidates for the treatment of cancers with high unmet clinical need. We look forward to providing scientific updates on our programs and platform in the second half of 2021."

Recent Highlights

Raised $221 million in public offering of common stock: In June 2021, the company announced a public offering of 10,550,000 shares of its common stock at a price of $20 per share. The underwriters also exercised their option to purchase an additional 1,582,500 shares of common stock for total offering net proceeds of $221 million.
Expanded our Board of Directors: The Company appointed pharmaceutical industry veterans Alessandro Riva, M.D. and Kimberly Blackwell, M.D., as new Independent Directors.
Continued manufacturing and technical operations investment: Our US manufacturing facility is expected to be operational by end of 2021.
Second Quarter 2021 Financial Results

Cash Position: Cash, cash equivalents and marketable securities were $440.0 million as of June 30, 2021, as compared to $246.1 million as of March 31, 2021. This includes $221.2 million in net proceeds from the company’s public offering in June 2021.

Research and Development (R&D) expenses: R&D expenses were $18.9 million for the three months ended June 30, 2021, compared to $8.5 million for the same period in 2020.

General and Administrative (G&A) expenses: G&A expenses were $4.1 million for the three months ended June 30, 2021, compared to $2.3 million for the same period in 2020.
Net loss: Net loss was $23.3 million for the three months ended June 30, 2021, compared to $15.3 million for the same period in 2020.

PDS Biotech Provides Business Update and Reports Second Quarter 2021 Financial Results

On August 12, 2021 PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies based on the Company’s proprietary Versamune T-cell activating technology, reported that it will discuss its financial results for the quarter ended June 30, 2021 and provide a business update on its conference call today (Press release, PDS Biotechnology, AUG 12, 2021, View Source [SID1234586512]).

Recent Business Highlights:

Presented interim Phase 2 clinical data for lead product PDS0101, in an oral presentation at the American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2021 Annual Meeting. In the National Cancer Institute-led study, tumor reduction was observed in 83% (5 of 6) of advanced HPV16-positive cancer patients who had relapsed or failed treatment with chemotherapy and radiation but had not been treated with checkpoint inhibitor therapy. Tumor reduction was reported in 58% (7 of 12) of HPV16-positive patients who in addition had also failed checkpoint inhibitor therapy.
Completed approximately $52 Million public offering that will support next phase of company growth through advancement of PDS0102 and PDS0103 into human clinical trials.
Received $4.5 Million from the sale of Net Operating Loss tax benefits through the New Jersey Economic Development Program.
Appointed immuno-oncology experts Dr. Olivera Finn and Dr. Mark Frohlich to Scientific Advisory Board.
Expanded VERSATILE-002 study of PDS0101 and KEYTRUDA in advanced head and neck cancer to include patients who have failed prior treatment with checkpoint inhibitors.
Added to Russell Microcap Index as part of the 2021 annual reconstitution based on market-capitalization rankings and style attributes.
"The second quarter has been quite significant for PDS Biotech in providing the first demonstration of the clinical potential of the Versamune-based products in treating advanced, treatment-resistant cancers. We believe the unprecedented objective responses and tumor reduction observed in our most advanced PDS0101 phase 2 clinical trial demonstrate the potential of the Versamune platform to overcome one of the most significant limitations preventing broadly effective cancer immunotherapy. Versamune has the potential to induce high levels of potent tumor-specific killer T-cells that may attack and eliminate the cancer," commented Dr. Frank Bedu-Addo, President and Chief Executive Officer of PDS Biotech. "Our capital raise of approximately $52M in June, further strengthens our balance sheet and provides us with the capital necessary to continue advancing our promising immuno-oncology pipeline. Renowned experts in fields of prostate and MUC1 associated cancers joined our Scientific Advisory Board to facilitate development of our pipeline products. The Company is well positioned and now has the momentum to move quickly to the next phase of growth by accelerating advancement of PDS0102 and PDS0103 into clinical trials."

Interim Study Results in NCI-Led Phase 2 Clinical Study of PDS0101 Highlight Potential of Versamune

In June, the Company reported interim Phase 2 clinical trial data from one of three ongoing PDS0101 Phase 2 trials at the American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2021 Annual Meeting. This Phase 2 trial is studying PDS0101 (Versamune-HPV16) in combination with two investigational immune-modulating agents: Bintrafusp alfa (M7824), a bifunctional "trap" fusion protein targeting TGF-β and PD-L1, and NHS-IL12 (M9241), a tumor-targeting immunocytokine. PDS0101 is an investigational immunotherapy designed to treat cancers caused by infection with HPV16 (HPV16-positive cancers) by training and activating the immune system to produce large numbers of in vivo CD8+ (killer) T-cells to target and kill tumors that are HPV16-positive.

Analysis of the interim clinical data showed that of the initial six HPV16-positive patients who had not been treated with checkpoint inhibitors, 83% (5 of 6) of the patients demonstrated an objective response (tumor reduction >30%). One patient had achieved a complete response. The reported objective response rate with current standard of care checkpoint inhibitor treatment is 12-24%. It was also reported that 100% (6/6) of the patients were still alive (median 8 months). The historical average (median) survival or life span for this patient population is 7-11 months.

Of the twelve HPV16-positive patients who had also failed treatment with checkpoint inhibitors after failing chemotherapy and radiation treatment, tumor reduction was observed in 58% (7/12). An objective response rate of 42% (5/12) and one complete response had already been achieved at the time of reporting in June. The objective response rate reported with the standard of care in this population is 5-12%. It was also reported that 83% (10/12) were still alive (median 8 months). The historical median survival or life span for this patient population is only 3-4 months.

Second Quarter 2021 Financial Results

PDS Biotech reported a net loss of approximately $0.6 million, or ($.03) per basic share and diluted share, for the three months ended June 30, 2021 compared to a net loss of approximately $2.9 million, or ($0.19) per basic share and diluted share, for the three months ended June 30, 2020. The lower net loss reported for the three months ended June 2021 is primarily due to $4.5 million received from the sale of our NJ tax benefits pursuant to the New Jersey Technology Business Tax Certificate Transfer Net Operating Loss program.

Research and development (R&D) expenses increased 95% to approximately $2.8 million for the three months ended June 30, 2021 from approximately $1.4 million for the three months ended June 30, 2020. A significant portion of the increase is attributable to clinical expenses related to VERSATILE-002 which is enrolling and progressing according to schedule. Preliminary data on the trial is expected as previously projected in Q4 2021 or Q1 2022.

The increase of $1.3 million in 2021 was primarily attributable to an increase of $0.2 million in personnel costs, $1.0 in clinical studies and $0.1 million in manufacturing.

General and administrative expenses increased to $2.3 million for the three months ended June 30, 2021 from $1.5 million for the three months ended June 30, 2020. The increase of $0.8 million is primarily attributable to an increase in personnel costs of $0.6 million and an increase in professional services of $0.2 million..

Total operating expenses increased 74% to approximately $5.1 million for the three months ended June 30, 2021 from approximately $2.9 million for the three months ended June 30, 2020.

PDS Biotech’s cash balance as of June 30, 2021 was approximately $74.7 million.

Conference Call and Webcast

The conference call is scheduled to begin at 8:00 am ET on Thursday, August 12, 2021. Participants should dial 877-407-3088 (United States) or 201-389-0927 (International) and mention PDS Biotechnology. A live webcast of the conference call will also be available on the investor relations page of the Company’s corporate website at www.pdsbiotech.com.

After the live webcast, the event will be archived on 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 13721612.

INmune Bio, Inc. to Present at the Canaccord Genuity 41st Annual Growth Conference

On August 12, 2021 INmune Bio, Inc. (NASDAQ: INMB) (the "Company"), a clinical-stage immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease, reported that Raymond J. Tesi, MD, President and CEO, will present at the Canaccord Genuity 41st Annual Growth Conference being held August 10 – 12 (Press release, INmune Bio, AUG 12, 2021, View Source [SID1234586511]).

Canaccord Genuity 41st Annual Growth Conference

Presentation Date: Wednesday, August 11, 2021
Presentation Time: 9:00 AM Eastern Time
Webcast: View Source

Please contact your representative at Canaccord Genuity to schedule a virtual one-on-one meeting with INmune Bio during the respective conference.

Sosei Heptares Operational Highlights and Consolidated Results for the Second Quarter and First Half 2021

On August 12, 2021 Sosei Group Corporation ("the Company") (TSE: 4565) reported its consolidated results for the second quarter and first half ended 30 June 2021 (Press release, Sosei Heptares, AUG 12, 2021, View Source [SID1234586488]).

The Company will host a webinar presentation today with Shinichi Tamura, Chairman, President and CEO, Chris Cargill, Group Chief Operating and Financial Officer, and Dr. Tim Tasker, Chief Medical Officer, at 5 pm JST (9 am BST). The webinar is open to all existing and potential investors as well as sell-/buy-side analysts and will consist of a presentation followed by a Q&A session. Please click here to register and receive a link to access the webinar.

Presentation slides will be made available by 4 pm JST (8 am BST) on the 12 August 2021 through the investor section of the Company’s Home Page here.

Shinichi Tamura, Chairman, President and CEO of Sosei Heptares, commented: "We are pleased with the progress we have made during 2021. This year’s focus is on increasing investment in R&D and in strategic growth initiatives, as we continue to explore revenue-generating business opportunities for acquisition to support our medium-term plan for corporate expansion. Investments in R&D are focused on advancing our portfolio of muscarinic agonists for schizophrenia and other neurological disorders, and to partner this portfolio in the near term with a well-capitalized global partner to accelerate late-stage development of these programs. In addition, we continue to make good progress advancing our inhouse and partnered programs, as well as enhancing our world-leading platform for identifying and exploiting new druggable target opportunities. We are confident that we have the right overall corporate strategy to deliver continued success and value creation for all stakeholders."

Operational Highlights for H1 2021

Worldwide rights to out-licensed muscarinic agonist programs regained from AbbVie/Allergan – independent review of programs has completed, with increased investment allocated to advance the HTL’878 selective muscarinic M4 receptor agonist through clinical studies and build value ahead of future partnering. HTL’878 represents a unique opportunity to develop a novel therapeutic with a new mechanism of action for neurological disorders including schizophrenia. Negotiations for collaborations on this and other muscarinic programs are now in progress.
Third novel drug candidate resulting from multi-target drug discovery collaboration with Pfizer entered clinical trials – dosing of first subject with PF-07258669 (an MC4 receptor antagonist for Anorexia) by Pfizer triggered a US$5 million payment to Sosei Heptares.
Three milestone payments totalling US$6 million received from Genentech during H1 2021 – milestones achieved from the delivery of StaR proteins based on nominated targets under the 2019 multi-target agreement.
Sosei Heptares initiated a Phase 1 trial with the 10th candidate to be generated from its structure-based drug design (SBDD) platform – first healthy subjects dosed with HTL’22562 (also known as BHV3100), a novel, small molecule CGRP receptor antagonist targeting CGRP-mediated disorders, under its collaboration with Biohaven.
Spin-off company Orexia Therapeutics merged into Centessa Pharmaceuticals, a new asset-centric company – Orexia became one of ten private companies merged into Centessa, which launched in February 2021 and raised US$250 million. Sosei Heptares’ equity holding in Orexia was converted into a proportional shareholding (1.03%) in Centessa, which completed an Initial Public Offering on Nasdaq Global Market in June 2021 at a market capitalization of US$1.7 billion and raising an additional US$379.5 million, driving an increase in the value of the Company’s Other Financial Assets on balance sheet.
New strategic technology collaboration with PharmEnable for AI-driven drug discovery – aim to identify new leads against a challenging "peptidergic" GPCR target.
First strategic collaboration to explore SBDD approaches beyond GPCRs with Metrion Biosciences – drug discovery collaboration to identify novel, highly specific leads for further development against an ion channel associated with neurological diseases.
US$2.5 million milestone received from Formosa Pharmaceuticals – based on progression of APP13007, a divested asset, into Phase 3 trials as a new potential treatment for pain and inflammation following cataract surgery.
Post-period Highlights

¥29.8 billion raised from International Offering of Euro-Yen denominated convertible bonds due 2026. Strong demand from international investors – largest mid-cap convertible bond raise in Asia Pacific region since 2015. The Company intends to use the proceeds as follows:
repurchase of existing convertible bonds due 2025
to finance, together with current cash, strategic growth initiatives including (1) funding acquisitions of or investments in companies or technologies including in the areas of neurology, gastroenterology, immunology and rare diseases that complement and strengthen Sosei’s existing business foundation for drug candidate discovery and early development; and (2) funding potential introduction of drug products in the Japanese domestic market.
To finance research and development of new pipeline programs and working capital.
Entered multi-target AI-powered and GPCR-focused drug discovery collaboration with InveniAI – focus on identifying novel GPCR targets for multiple immune diseases
Financial Highlights for the Six-month Period ended 30 June 2021

Revenue totalled JPY 3,123 million (US$28.9 million*), an increase of JPY 607 million (US$5.7 million) vs. the prior corresponding period. The increase was due to the achievement of five progress milestone events from existing partners vs. one upfront fee and two milestone events in the prior corresponding period. In addition, there was an increase in deferred revenue releases from existing collaboration partners. Royalties from Novartis were stable.
Cash R&D expenses totalled JPY 2,382 million (US$22.0 million), an increase of JPY 882 million (US$8.1 million) vs. the prior corresponding period. The increase in R&D spend reflects higher activity levels on in-house programs (including the recently reverted muscarinic portfolio), participation in new co-development collaborations and the impact of a stronger GBP vs. JPY. Despite the relative increase in R&D spend vs. the prior corresponding period, the current period spend is in-line with our budgeted plans, and therefore our full year forecast cash R&D expenses remain unchanged, in the range of JPY 4,000 to JPY 5,000 million.
Cash G&A expenses totalled JPY 1,256 million (US$11.6 million), an increase of JPY 331 million (US$3.1 million) vs. the prior corresponding period. The increase in G&A spend is due to an increase in personnel related expenses and professional advisory fees as the Group continued to evaluate strategic growth opportunities. In addition, personnel related expenses in the prior corresponding period were lower than normal as a result of a reduction in the U.K. share-based payment related National Insurance liability, which was driven by share price movements in that particular period. Despite the relative increase in G&A spend vs. the prior corresponding period, the current period spend is in-line with our budgeted plans, and therefore our full year forecast cash G&A expenses remain unchanged, in the range of JPY 1,800 to 2,300 million.
Cash earnings loss** totalled JPY 800 million (US$7.4 million), vs. a cash earnings loss of JPY 181 million (US$1.7 million) in the prior corresponding period. The main reason for the increase in the cash earnings loss is that the increase in Cash R&D and G&A costs exceeded the increase in revenue, largely attributable to increased R&D investment (e.g. in the muscarinic portfolio and prioritized in-house programs) and professional advisory fees, as stated above.
Operating loss totalled JPY 1,849 million (US$17.1 million) vs. an operating loss of JPY 1,136 million (US$10.5 million) in the prior corresponding period. The main reason for the increase in the operating loss is that the increase in operating expenses exceeded the increase in revenue, including a small Oravi related impairment and higher stock-based compensation costs as the Company continued to roll out Restricted Stock Unit (RSU) plans for employees to drive greater long-term alignment with shareholders. Financing costs in the period were largely offset by contingent consideration and foreign exchange gains.
Loss for the six-month period ended 30 June 2021 totalled JPY 2,297 million (US$21.2 million) vs. a loss for the prior corresponding period of JPY 2,117 million (US$19.6 million). The main reason for the increase in net loss is the increase in the operating loss (for the reasons stated above), although the impact was largely mitigated by a gain relating to our investment in MiNA Therapeutics (driven by the receipt of a US$25 million upfront fee relating to an out-license with Lilly signed in May 2021).
Cash and cash equivalents as at 30 June 2021 increased by JPY 621 million (however decreased US$19 million) from the beginning of the year and amounted to JPY 40,629 million (US$367.5 million). Modest cash inflow achieved when balances aggregated in JPY, however weaker JPY in the period drove a reduction in total cash balance when aggregated in US$.
*Convenience conversion to US$ at the following rates: 2021: 1US$ =108.11 JPY; 2020: 1US$ =108.25 JPY

**Non-IFRS measure