On May 11, 2023 ImmuPharma PLC (LSE:IMM), ("ImmuPharma" or the "Company"), the specialist drug discovery and development company, reported its final results for the twelve months ended 31 December 2022 (the "Period") (Press release, ImmuPharma, MAY 11, 2023, View Source [SID1234631511]).

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Key Highlights (including post Period review)

Financial

Loss for the Period of £3.8m (2021: £8.2m)
Research and development expenses of £2.0m (2021: £3.7m)
Administrative expenses of £0.8m (2021: £1.0m)
Exceptional items of £nil (2021: £1.4m, representing corporate reorganisation costs)
Cash balance at 31 December 2022 of £0.7m (31 December 2021: £1.6m)
Successful subscription and placing, raising in total £2.0m (gross) – August 2022
Lanstead derivative financial asset of £0.3m (2021: £0.9m)
Incanthera financial asset of £0.7m (2021: £1.2m)
Warrants financial asset of £0.001 (2021: £0.2m)
Product Development

P140 Pharmokinetic ("PK") study successfully completed in April 2022 with key findings shared with the FDA*
In February 2023 an adaptive Phase 2/3 study for Lupuzor in SLE/Lupus patients was agreed with US partner, Avion Pharmaceuticals, following guidance from the FDA
Type C meeting confirmed with FDA for 7 June 2023 for consideration of the new protocol of the Phase 2/3 adaptive study for Lupuzor in SLE patients
Pre-IND meeting confirmed with FDA for 16 May 2023 for feedback on the new protocol of the Phase 2/3 adaptive study for CIDP
Collaboration with Orano – ImmuPharma peptide technology as a vector for cancer radiotherapy – an initial collaboration for 12 months
*FDA (Food and Drug Administration)

Commenting on the statement and outlook Tim McCarthy, CEO, said:

"As a Board, we remain focused on bringing our two key late stage clinical assets, Lupuzor for lupus and CIDP closer to the market. We now have a clinical roadmap for Lupuzor and remain on track to commence the Phase 2/3 adaptive trial in H2 2023, with potentially CIDP moving into clinical studies in parallel. This illustrates the potential franchise we have within our P140 autoimmune platform.

We will also continue to concentrate on further commercial and partnering opportunities. In conjunction with the above objectives, we continue to take prudent measures on managing our cost base.

In closing, we would like to thank our shareholders for their support as well as our staff, corporate and scientific advisers and our partners including CNRS and Avion."

On May 11, 2023 ImmunityBio, Inc. (the "Company") reported that it has received a complete response letter from the U.S. Food and Drug Administration ("FDA") on May 9, 2023 regarding its Biologics License Application ("BLA") for its product candidate, Anktiva (N-803) in combination with Bacillus Calmette-Guérin ("BCG") for the treatment of patients with BCG-unresponsive non-muscle invasive bladder cancer ("NMIBC") with carcinoma in situ ("CIS") with or without Ta or T1 disease (Press release, ImmunityBio, MAY 11, 2023, View Source [SID1234631510]). The letter indicates that the FDA has determined that it cannot approve the BLA in its present form, and the FDA has made recommendations to address the issues raised.

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The deficiencies relate to the FDA’s pre-license inspection of the Company’s third-party contract manufacturing organizations. Satisfactory resolution of the observations noted at the pre-license inspection is required before the BLA may be approved. The FDA further provided recommendations specific to additional Chemistry, Manufacturing and Controls ("CMC") issues and assays to be resolved.

No new preclinical studies or Phase 3 clinical trials to evaluate safety or efficacy were requested by the FDA. The FDA requested that the Company provide updated duration of response data of the efficacy population as identified by the FDA in the Company’s resubmission, as well as a safety update.
The Company plans to request a meeting with the FDA as soon as possible to address the subject matter of the letter and a response timeline, and plans to diligently address and resolve the issues identified and seek approval as expeditiously as possible.

Business Development Updates

On May 9, 2023, the Company’s Executive Chairman and Global Chief Scientific and Medical Officer agreed to provide immediate non-convertible debt financing to the Company in an amount of $30.0 million on substantially similar terms as prior financings, including an interest rate of Term Secured Overnight Financing Rate ("SOFR") plus 8% per annum and a maturity date of December 31, 2023.

As previously disclosed, the Company has been exploring partnering with a large biopharmaceutical company for commercialization of N-803 for intravesical administration. The Company has confirmed with the potential partner that these negotiations will continue notwithstanding the letter referenced above, with the view of completing such a transaction during 2023, though there can be no assurance that the Company will complete a transaction on acceptable terms in accordance with this timeline or at all.

On May 11, 2023 HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, reported its financial results and business highlights for the first quarter of 2023 (Press release, Hookipa Biotech, MAY 11, 2023, View Source [SID1234631509]).

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"We are happy to report continued progress across our oncology and infectious disease portfolios, as our HB-300 program for advanced prostate cancer and Gilead-partnered HB-400 program for the treatment of chronic hepatitis B both entered the clinic. Further, our HB-700 program in collaboration with Roche achieved a success-based milestone payment associated with manufacturing for our clinical supplies," said Joern Aldag, Chief Executive Officer at HOOKIPA. "We are on track to report Phase 2 data from our lead program, HB-200 in combination with pembrolizumab, in the second quarter of 2023, which is an exciting step forward as we expect the results to inform our next, potentially registrational trial."

Quarter highlights

Oncology

In February, HOOKIPA announced that it had achieved a $10 million milestone payment under its collaboration agreement with Roche to develop HB-700, a novel arenaviral immunotherapy for KRAS-mutated cancers. The success-based milestone payment reflects the start of the HB-700 manufacturing process to support a Phase 1 clinical trial.

In April, HOOKIPA announced the acceptance of a trial-in-progress presentation at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on its ongoing Phase 1/2 study of HB-300 for the treatment of advanced prostate cancer. Enrollment is ongoing and initial data are expected in the first half of 2024.
Infectious disease

In January, HOOKIPA received a $5 million milestone payment under its collaboration agreement with Gilead Sciences for the completion of the regulatory support package for Gilead’s Phase 1 clinical trial of HB-400, an alternating, 2-vector non-replicating arenaviral therapeutic vaccine for the treatment of chronic hepatitis B. The first participant was dosed in April 2023. Gilead is solely responsible for further development and commercialization of the hepatitis B product candidate.
Corporate

In March, HOOKIPA announced the appointment of Terry Coelho to its Board of Directors, Audit Committee and Compensation Committee. Terry brings more than 35 years of experience in business strategy, broad financial transactions and business development of large pharmaceutical and smaller biotechnology companies.
Upcoming Milestones

Phase 2 HB-200 in HPV16+ head and neck cancers
1st-line initial data in combination with pembrolizumab: 2Q 2023
2nd+-line initial data in combination with pembrolizumab: 2Q 2023
Post-standard of care monotherapy: additional data 2Q 2023
Randomized Phase 2 in 1st-line with pembrolizumab: study kick-off 2023 (Fast Track designation)
HB-300 in prostate cancer: preliminary safety, tolerability and immunogenicity data expected 1H 2024
HB-700 in KRAS-mutated cancers: submit IND 1H 2024
HB-500 in HIV: submit IND 2023
First Quarter 2023 Financial Results
Cash Position: HOOKIPA’s cash, cash equivalents and restricted cash as of March 31, 2023 was $110.0 million compared to $113.4 million as of December 31, 2022. The decrease was primarily attributable to cash used in operating activities, partly offset by funds resulting from the Gilead and Roche collaborations.

Revenue: Revenue was $3.2 million for the three months ended March 31, 2023 compared to $1.4 million for the three months ended March 31, 2022. The increase was primarily due to higher recognition of upfront and milestone payments under the Gilead and Roche collaborations, partially offset by lower cost reimbursements received under the Gilead collaboration.

Research and Development Expenses: HOOKIPA’s research and development expenses were $20.9 million for the three months ended March 31, 2023, compared to $16.6 million for the three months ended March 31, 2022. The primary drivers of the increase in research and development expenses by $4.3 million compared to the three months ended March 31, 2022 were higher clinical study expenses for our HB-200 program and higher expenses for research and development services for our HB-200 program, as well as increased spending for our Gilead and Roche partnered programs, partially offset by lower manufacturing expenses for our HB-200 and Gilead partnered programs.

General and Administrative Expenses: General and administrative expenses amounted to $4.9 million for the three months ended March 31, 2023, compared to $5.0 million for the three months ended March 31, 2022. The decrease compared to the three months ended March 31, 2022 was primarily due to a decrease in professional and consulting fees and in other expenses, partially offset by an increase in personnel-related expenses.

Net Loss: HOOKIPA’s net loss was $19.7 million for the three months ended March 31, 2023, compared to a net loss of $18.0 million for the three months ended March 31, 2022. This increase was primarily due to an increase in research and development expenses, partially offset by an increase in revenues from collaboration and licensing, and an increase in grant income, and a decrease in general and administrative expenses.

On May 11, 2023 Heron Therapeutics, Inc. (Nasdaq: HRTX) (the "Company"), a commercial-stage biotechnology company focused on improving the lives of patients by developing and commercializing therapeutic innovations that improve medical care, reported financial results for the three months ended March 31, 2023 and highlighted recent corporate updates (Press release, Heron Therapeutics, MAY 11, 2023, View Source [SID1234631508]).

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First quarter 2023 net product sales grew 26% to $29.6 million, compared to the first quarter of 2022. The sales growth was mainly driven by our oncology care franchise, which increased 15%, compared to the same period in 2022. First quarter also reflected continued advancement of our acute care franchise, with $3.5 million in net product sales from ZYNRELEF and initial orders from the launch of APONVIE in March.

With the appointment of Craig Collard as CEO in April and the recent hiring of Jason Grillot as VP of sales and marketing of the acute care franchise, the team is conducting a thorough review of the Company’s business practices and strategies to develop a long-term plan that maximizes the potential of the Company. We have identified two areas of immediate priority for our commercial team: first, is to enhance the value of ZYNRELEF through a broader and deeper penetration of accounts; second, to address application issues through training and expanded indications. Further, we are looking at ways to reduce cash burn through improved operational efficiency. We look forward to updating investors on these fronts in the coming months.

Acute Care Franchise

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ZYNRELEF:
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Net product sales of ZYNRELEF (bupivacaine and meloxicam) extended-release solution for the three months ended March 31, 2023 was $3.5 million.
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Since launch on July 1, 2021 through March 31, 2023, 907 unique accounts purchased ZYNRELEF with 80% of those accounts reordering the product.
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The supplemental New Drug Application (sNDA) for ZYNRELEF, to support expanded use in soft tissue and orthopedic surgical procedures remains on track for the Prescription Drug User Fee Act (PDUFA) approval goal date of October 23, 2023.

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APONVIE:
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The APONVIE (aprepitant) injectable emulsion, the only intravenous (IV) substance P/neurokinin-1 (NK1) receptor antagonist (RA) indicated for the prevention of postoperative nausea and vomiting (PONV) in adults, launched commercially in the U.S. on March 6, 2023.
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Net product sales of APONVIE for the three months ended March 31, 2023 were $0.3 million.

The Centers for Medicare and Medicaid Services granted pass-through payment status for APONVIE, effective April 1, 2023, under C-code C9145.

Oncology Care Franchise

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Oncology Care Franchise Net Product Sales: For the three months ended March 31, 2023, oncology care franchise net product sales were $25.8 million, which increased 15% from $22.4 million for the same period in 2022.
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CINVANTI Net Product Sales: Net product sales of CINVANTI (aprepitant) injectable emulsion for the three months ended March 31, 2023 were $22.8 million, compared to $20.3 million for the same period in 2022.
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SUSTOL Net Product Sales: Net product sales of SUSTOL (granisetron) extended-release injection for the three months ended March 31, 2023 were $3.0 million, compared to $2.1 million for the same period in 2022.

"We continued to make steady progress in the first quarter of 2023 at Heron, highlighted by the approval and launch of our fourth commercial product, APONVIE. We are pleased with the steady growth in the oncology care franchise and remain encouraged by the market potential for ZYNRELEF and APONVIE," said Craig Collard, new Chief Executive Officer of Heron. "Looking ahead, we are focused on reducing our cash burn and advancing a streamlined organization that we believe will begin to show significant growth while also continuing to improve patient’s lives."

Financial Results

Net product sales for the three months ended March 31, 2023 were $29.6 million, compared to $23.5 million for the same period in 2022.

For the three months ended March 31, 2023, total operating expenses were $62.7 million, compared to $86.4 million for the same period in 2022, representing a decrease of $23.7 million, or a 27% reduction year-over-year. This decrease was driven by cost management efforts and a reduction in development projects, offset by higher cost of goods sold and increased litigation expenses. Cost of product sales were $16.9 million in the first quarter of 2023, compared to $11.4 million for the same period in the prior year. The product gross margin rate decreased year-over-year primarily as a result of a one time inventory write-off due to short-dated product. Sales and marketing expenses decreased by $2.3 million, primarily due to a reduction in personnel expenses and external costs to support the ongoing commercialization of ZYNRELEF. Research and development expenses decreased by $28.3 million, primarily driven by lower personnel and project-related expenses, including manufacturing projects to increase operational efficiencies. General and administrative expenses increased by $1.3 million, primarily driven by increased litigation and activist shareholder issues.

Heron’s net loss for the three months ended March 31, 2023 was $32.8 million, or $0.27 per share, compared to $63.9 million, or $0.63 per share, for the same period in 2022. Net loss for the three months ended March 31, 2023 included non-cash, stock-based compensation expense of $7.9 million, compared to $10.9 million for the same period in 2022.

As of March 31, 2023, Heron had cash, cash equivalents and short-term investments of $60.0 million, compared to $84.9 million as of December 31, 2022. Net cash used for operating activities for the three months ended March 31, 2023 was $24.9 million, compared to $43.9 million for the same period in 2022. The decrease in our net cash used for operating activities was primarily due to a decrease in net loss, the reduction in headcount implemented in June 2022 and changes in working capital.

Conference Call and Webcast

Heron will host a conference call and webcast on May 11, 2023 at 4:30 p.m. ET. The conference call can be accessed by dialing (646) 307-1963 for domestic callers and (800) 715-9871 for international callers. Please provide the operator with the passcode 1933547 to join the conference call. The conference call will also be available via webcast under the Investor Relations section of Heron’s website at www.herontx.com. An archive of the teleconference and webcast will also be made available on Heron’s website for 60 days following the call.

About ZYNRELEF for Postoperative Pain

ZYNRELEF is the first and only dual-acting local anesthetic that delivers a fixed-dose combination of the local anesthetic bupivacaine and a low dose of nonsteroidal anti-inflammatory drug meloxicam. ZYNRELEF is the first and only extended-release local anesthetic to demonstrate in Phase 3 studies significantly reduced pain and significantly increased proportion of patients requiring no opioids through the first 72 hours following surgery compared to bupivacaine solution, the current standard-of-care local anesthetic for postoperative pain control. ZYNRELEF was initially approved by the FDA in May 2021 for use in adults for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours after bunionectomy, open inguinal herniorrhaphy and total knee arthroplasty. In December 2021, the FDA approved an expansion of ZYNRELEF’s indication. In December 2022, we submitted an sNDA to support the proposed indication for greatly expanded use of ZYNRELEF in soft tissue and orthopedic surgical procedures, and the FDA assigned a PDUFA goal date of October 23, 2023. ZYNRELEF is now indicated in the U.S. in adults for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours after foot and ankle, small-to-medium open abdominal, and lower extremity total joint arthroplasty surgical procedures. Safety and efficacy have not been established in highly vascular surgeries, such as intrathoracic, large multilevel spinal, and head and neck procedures.

Please see full prescribing information, including Boxed Warning, at www.ZYNRELEF.com.

About APONVIE for PONV

APONVIE is a substance NK1 RA, indicated for the prevention of PONV in adults. Delivered via a 30-second IV push, APONVIE 32 mg was demonstrated to be bioequivalent to oral aprepitant 40 mg with rapid achievement of therapeutic drug levels. APONVIE is the same formulation as Heron’s approved drug product CINVANTI. APONVIE is supplied in a single-dose vial that delivers the full 32 mg dose for PONV. APONVIE was approved by the FDA in September 2022.

Please see full prescribing information at www.APONVIE.com.

About CINVANTI for Chemotherapy Induced Nausea and Vomiting (CINV) Prevention

CINVANTI, in combination with other antiemetic agents, is indicated in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin as a single-dose regimen, delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC) as a single-dose regimen, and nausea and vomiting associated with initial and repeat courses of MEC as a 3-day regimen. CINVANTI is an IV formulation of aprepitant, an NK1 RA. CINVANTI is the first IV formulation to directly deliver aprepitant, the active ingredient in EMEND capsules. Aprepitant (including its prodrug, fosaprepitant) is the only single-agent NK1 RA to significantly reduce nausea and vomiting in both the acute phase (0–24 hours after chemotherapy) and the delayed phase (24–120 hours after chemotherapy). The FDA-approved dosing administration included in the U.S. prescribing information for CINVANTI include 100 mg or 130 mg administered as a 30-minute IV infusion or a 2-minute IV injection.

Please see full prescribing information at www.CINVANTI.com.

About SUSTOL for CINV Prevention

SUSTOL is indicated in combination with other antiemetics in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy (MEC) or anthracycline and cyclophosphamide (AC) combination chemotherapy regimens. SUSTOL is an extended-release, injectable 5-hydroxytryptamine type 3 RA that utilizes Heron’s Biochronomer drug delivery technology to maintain therapeutic levels of granisetron for ≥5 days. The SUSTOL global Phase 3 development program was comprised of two, large, guideline-based clinical studies that evaluated SUSTOL’s efficacy and safety in more than 2,000 patients with cancer. SUSTOL’s efficacy in preventing nausea and vomiting was evaluated in both the acute phase (0–24 hours after chemotherapy) and delayed phase (24–120 hours after chemotherapy).

Please see full prescribing information at www.SUSTOL.com.

On May 11, 2023 Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company working to develop the world’s most potent vaccines, reported financial results for the first quarter ended March 31, 2023 and provided recent corporate and clinical updates (Press release, Gritstone Bio, MAY 11, 2023, View Source [SID1234631507]).

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"Strategically prioritizing GRANITE underscores our conviction in the program and focuses our near-term resources on the immense opportunity that lies directly ahead of us: potentially being the first to demonstrate efficacy of a neoantigen-based personalized cancer vaccine in a randomized, controlled trial for MSS-CRC," said Andrew Allen, M.D., Ph.D., Co-founder, President, and Chief Executive Officer of Gritstone bio. "GRANITE is a potentially transformative therapy that has already shown significant promise in our published Phase 1/2 study in patients with metastatic MSS-CRC, who had received two prior lines of chemotherapy. The high demand seen to date for our ongoing Phase 2 is a testament to its potential. Expanding the study from 80 to 100 patients not only increases the statistical power of the study but also generates more time-to-event data to help inform the Phase 3. We are thrilled to have the momentum and capital to expand this study and take this important step forward for patients with newly diagnosed metastatic CRC, as well as those being treated for CRC in the adjuvant setting and other cold tumors. We look forward to sharing preliminary Phase 2 efficacy data from approximately half of the 100 total patients in the first quarter of 2024."

Dr. Allen continued, "Along with the significant progress in GRANITE, the data flowing from our CORAL program is highly encouraging and provides early signals of the potential advantages of self-amplifying mRNA (samRNA) over first-generation mRNA against infectious disease. We recently observed durable neutralizing antibody titers at 6 months following samRNA vaccination in over 100 vaccine-naïve subjects treated within our CORAL-CEPI trial, where interim results were presented at ECCMID 2023. Self-amplifying mRNA has several distinct characteristics including prolonged and elevated antigen expression that suggest it could play a key role in the induction of long-term, variant-proof immune protection. We look forward to continuing to work with our collaborators to demonstrate the full potential of our samRNA platform against SARS-CoV-2 and other important viruses."

Corporate Updates

GRANITE (individualized neoantigen vaccine against cold tumors): Gritstone is focusing its resources to expand the ongoing Phase 2 portion of the Phase 2/3 study, which is evaluating GRANITE as a maintenance therapy in first-line metastatic microsatellite-stable colorectal cancer (MSS-CRC). As of May 10, 2023, the company had randomized 71 of the initially planned 80 total patients. The company plans to expand the study to randomize 100 patients in total. Enrollment of all 100 patients is expected to complete in third quarter of 2023 and preliminary data on approximately 50 of the 100 patients from the Phase 2 portion of the study (circulating tumor DNA [ctDNA] and progression-free survival data [evaluated by both RECIST and iRECIST criteria] on patients completing at least 4 months of treatment) is expected in the first quarter of 2024.

SLATE ("off-the-shelf" neoantigen vaccine program): Given the strategic decision to focus on GRANITE, the company is deferring the initiation of a randomized Phase 2 clinical trial with SLATE until 2024. Previously, a KRAS-dedicated version of SLATE demonstrated strong T cell responses and an observed survival advantage among molecular responders in Phase 1/2 studies of patients with MSS-CRC and non-small cell lung cancer (NSCLC, press release announcing ESMO (Free ESMO Whitepaper) 2022 data available here). The company believes success in GRANITE has the potential to further validate the company’s neoantigen-based approach, which SLATE and GRANITE share, and that SLATE is ready for application across solid tumor indications and shared tumor neoantigen classes.

Infectious Disease: The company will continue its ongoing clinical and preclinical infectious disease efforts as planned, with the vast majority of these efforts being funded via external collaborators. The Bill & Melinda Gates Foundation, the Coalition for Epidemic Preparedness Innovations (CEPI) and the National Institute of Allergy and Infectious Diseases (NIAID) support the company’s CORAL program. Gilead Sciences, Inc. (Gilead) is conducting a Phase 1 study as part of a collaboration with Gritstone to research and develop a therapeutic vaccine against HIV.

Clinical Program Updates
Tumor-Specific Neoantigen Oncology Programs (GRANITE and SLATE)

In April 2023, Gritstone delivered multiple presentations detailing advances in neoantigen prediction capabilities and cancer vaccine programs at the 2023 American Association for Cancer Research (AACR) (Free AACR Whitepaper) (AACR 2023).
GRANITE (individualized neoantigen program) presentation: Longitudinal analysis of participants in the GRANITE Phase 1/2 supports vaccine-elicited priming and boosting of antigen-specific T cell populations associated with conversion of "cold" to "hot" tumors and molecular responses.
EDGE (Epitope Discovery for Genomes Platform) poster: Advances in EDGE models (Gritstone’s AI-driven neoantigen prediction platform) enable potential best-in-class prediction of class II HLA-presented neoantigens that could drive CD4+ T cell responses.
SLATE ("off-the-shelf" neoantigen vaccine program) poster: Description of a novel KRAS G12C class II epitope with evidence of clinical benefit associated with vaccine-elicited T cell response.
In February 2023, Gritstone announced it had entered into a clinical trial agreement with the National Cancer Institute to evaluate an autologous T cell therapy expressing a T cell receptor targeting mutated KRAS in combination with Gritstone’s KRAS-directed vaccine candidate, SLATE-KRAS, in a Phase 1 study led by Steven A. Rosenberg, M.D., Ph.D.
Infectious Disease Programs
CORAL – Second-generation SARS-CoV-2 vaccine program that serves as proof-of-concept for Gritstone’s infectious disease approach and the potential application of samRNA in infectious diseases.

In all studies to date, results have shown Gritstone’s samRNA vaccine candidates to be well-tolerated and capable of driving strong, durable and broad immunogenicity across several subject populations and settings.
In April 2023, Gritstone presented new data from two ongoing Phase 1 studies demonstrating persistence of high neutralizing antibodies for at least 6 months following samRNA vaccine across multiple settings and subject populations. Both datasets were presented at the 33rd European Congress of Clinical Microbiology and Infectious Diseases (ECCMID 2023).

CORAL-CEPI poster: Results from Part A of the CORAL-CEPI study (total study n = 342), primary series samRNA vaccination showed to elicit strong neutralizing antibody (nAb) responses that persist for at least 6 months, including variant cross-reactive nAb, in previously unvaccinated ("vaccine-naïve") South African subjects. Enrollment in CORAL-CEPI completed in February 2023.

CORAL-BOOST poster: Results from cohorts 3 and 4 of the CORAL-BOOST study show the samRNA elicited robust nAbs, and that these nAbs persisted for at least 6 months regardless of primary series (adenovirus or mRNA). These results are generally consistent with 6-month neutralizing antibody results from cohorts 1 and 2 of the study, which evaluated samRNA as a boost following Vaxzevria (adenovirus) only (August 2022).
Enrollment in the CORAL-NIH trial completed in 2022. This study is sponsored and executed by NIAID.
HIV – Collaboration with Gilead under Gilead’s HIV Cure Program to research and develop vaccine-based HIV immunotherapy treatment.

The collaboration with Gilead to research and develop a vaccine-based HIV immunotherapy treatment remains active and ongoing.
In February 2023, results from a preclinical study conducted in collaboration with Gilead were presented at Conference on Retroviruses and Opportunistic Infections (CROI) 2023. The first data disclosed from the Gritstone-Gilead HIV Cure collaboration, results showed that simian immunodeficiency virus (SIV) Chimpanzee Adenovirus (ChAd) and self-amplifying mRNA (samRNA) vaccines induced a strong and broad CD8+ T cell immune response, which was significantly enhanced in combination with immune modulators.
First Quarter 2023 Financial Results

Cash, cash equivalents, marketable securities and restricted cash were $153.2 million as of March 31, 2023, compared to $185.2 million as of December 31, 2022.

Research and development expenses were $30.5 million for the three months ended March 31, 2023 compared to $28.2 million for the three months ended March 31, 2022. The increase of $2.3 million was primarily due to increases of $1.5 million in personnel-related expenses, $0.3 million in outside services, $0.7 million in facilities related costs, and $0.8 million in laboratory supplies, offset by a decrease of $1.0 million in milestone and license payments.
General and administrative expenses were $6.7 million for the three months ended March 31, 2023 compared to $8.0 million for the three months ended March 31, 2022. The decrease of $1.3 million was primarily attributable to decreases of $1.1 million in outside services and $0.2 million in facilities-related costs.
Collaboration, license, and grant revenues were $2.4 million for the three months ended March 31, 2023 compared to $7.2 million for the three months ended March 31, 2022. During the three months ended March 31, 2023, we recorded $0.1 million in collaboration revenue related to our collaboration with Gilead, $0.4 million in collaboration revenue related to our collaboration with 2seventy bio, Inc., $1.5 million in grant revenue from CEPI, and $0.4 million in grant revenue from the Gates Foundation. During the three months ended March 31, 2022, we recognized $4.0 million in collaboration revenue related to our collaboration with 2seventy bio, $0.7 million in collaboration revenue related to our collaboration with Gilead, $2.2 million in grant revenue from CEPI, and $0.2 million in grant revenue from the Gates Foundation.
Webcast Details
A webcast to discuss first quarter 2023 results will be held at 4:30pm ET today (May 11):
Conference call: 1-888-999-6281
Conference ID: 1754341
Webcast: View Source;tp_key=c6c637ac24

An archived replay will be accessible at View Source for 30 days following the event.