Vaccinex Reports First Quarter 2022 Results and Provides Corporate Update

On May 16, 2022 Vaccinex, Inc. (Nasdaq: VCNX), a clinical-stage biotechnology company pioneering a differentiated approach to treating cancer and neurodegenerative disease through the inhibition of SEMA4D, reported financial results for the first quarter ended March 31, 2022, and provided a corporate update on key events since the start of 2022 (Press release, Vaccinex, MAY 16, 2022, View Source [SID1234614593]).

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"I am pleased to report that Vaccinex’s clinical programs for oncology and neurodegenerative disease have made substantial progress this year. In oncology, we were gratified to report promising Phase Ib safety results and to observe two complete responses (CRs) in the first three patients enrolled in the open label, Phase 1b/2 KEYNOTE-B84 trial. The trial is evaluating the use of pepinemab in combination with KEYTRUDA (pembrolizumab) as first-line treatment for patients with advanced recurrent or metastatic head and neck cancer. We are hopeful that, with continued positive results, this combination may represent a novel option for patients with head and neck cancer, including those whose tumors express low levels of the PD-L1 biomarker and who have limited treatment choices," said Maurice Zauderer, Ph.D., President and Chief Executive Officer of Vaccinex.

Dr. Zauderer continued, "In neurodegenerative disease, enrollment in the Phase 1/2a SIGNAL-AD trial in mild Alzheimer’s Disease continues to progress, and we plan to soon publish the results of the SIGNAL Huntington’s Disease study that we believe showed promise of slowing or preventing cognitive decline."

Dr. Zauderer continued, "Looking ahead, we expect to complete enrollment in the KEYNOTE-B84 and SIGNAL-AD trials in 2022. Data read outs are planned from the KEYNOTE-B84 during H2:2022 and topline data from the SIGNAL-AD trial are expected in H2:2023. These data will help to guide the regulatory and product development path for pepinemab. We look forward to continue to update the clinical community and investors on our progress."

Pepinemab Clinical Updates and Upcoming Milestones:

Oncology: Head and Neck Cancer

Enrollment is underway in the Phase 1b/2 clinical trial evaluating pepinemab in combination with Merck’s anti-PD-1 immune checkpoint therapy KEYTRUDA (pembrolizumab) in recurrent or metastatic head and neck cancer.

Multiple prior studies1-3 suggest that inhibition of SEMA4D increases immune infiltration and alters the balance of cytotoxic and immunosuppressive cells in the tumor microenvironment. As SEMA4D is highly expressed in head and neck cancer, there is strong rationale for development in this indication.

In January 2022, Vaccinex reported two complete responses in the first three patients enrolled. Vaccinex reported further details of these patient responses (Abstract CT-11) at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) (AACR 2022) on Monday, April 11, 2022.

The KEYNOTE-B84 study is planned to enroll up to 65 subjects across 18 U.S. trial sites and will assess whether combination immunotherapy with pepinemab and pembrolizumab can improve responses in this population. Key endpoints of the study will include objective response, progression free survival and overall survival.

Next Data and Trial Completion: Data read-outs are expected in H2:2022. Enrollment is expected to be completed and topline data presented in H1:2023.

ASCO Abstract Publication: An abstract of the Phase 1b segment of the study of pepinemab, an inhibitor of semaphorin 4D, in combination with pembrolizumab as first-line treatment of recurrent or metastatic head and neck cancer (KEYNOTE-B84) will be published with the ASCO (Free ASCO Whitepaper) proceedings on May 26, 2022.

Vaccinex has exclusive global commercial and development rights to pepinemab and is sponsor of the KEYNOTE-B84 study which is being performed in collaboration with Merck Sharp & Dohme Corp, a subsidiary of Merck and Co, Inc. Kenilworth, NJ, USA. KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp. Additional information about the study is available: here.

Other Trials. Pepinemab is also being evaluated in multiple investigator-sponsored trials (ISTs) being conducted by the Winship Cancer Institute of Emory University to evaluate pepinemab in combination with checkpoint inhibitors in "Window of Opportunity" biomarker studies of head and neck cancer and melanoma.

Neurodegenerative Disease:

Alzheimer’s Disease. Enrollment continues in the Phase 1/2a SIGNAL-AD trial of pepinemab in early Alzheimer’s disease which is being funded in part by the Alzheimer’s Drug Discovery Foundation and by a grant from the Alzheimer’s Association under its 2020 Part the Cloud Program. Additional information about this study is available here.

The randomized, double-blind, placebo-controlled, multi-center safety and biomarker study of pepinemab in early AD is planned to enroll 40 subjects across 15 U.S. trial sites.

Next Data and Trial Completion: Enrollment is expected to be completed by year-end 2022 and topline data are expected in H2:2023.

Huntington’s disease. The Phase 2 double-blind, placebo-controlled SIGNAL trial of pepinemab in patients with early manifest Huntington’s disease (HD) has been completed and we believe the program is Phase-3 ready.

While the Phase 2 study did not meet the prespecified primary endpoints, pre-specified exploratory and post-hoc analyses supports the potential cognitive benefit of treatment with pepinemab in HD patients, particularly those with mild cognitive deficits:

Highly significant improvement (p=0.007) in the (Huntington’s Disease Cognitive Assessment Battery (HD-CAB) Composite score
Significant benefit in reducing apathy severity (p=0.017, 1-sided)
Reduced atrophy (p=0.017) in caudate region of striatum
A striking increase in brain metabolic activity as measured by FDG-PET in most brain regions
Next Steps: The company intends to publish the results of the SIGNAL study in mid-2022. In addition, Vaccinex is in ongoing discussions with potential partners on plans to advance pepinemab into a Phase 3 HD trial.

ActivMAb Updates:

As previously announced, we have entered into several collaborations with pharmaceutical and biotechnology companies employing the unique capabilities of our ActivMAb antibody discovery platform to address difficult to drug G-protein Coupled Receptors (GPCRs) and ion channels known to be strongly associated with diseases.

In April, 2022, Vaccinex announced presentation of an abstract at the 18th Annual PEGS Boston Conference & Expo, May 2-3, 2022, related to ActivMAb’s successful expression and selection of antibodies against multi-pass receptors and its potential application as a tool for drug discovery and development projects.

Corporate Update:

In January 2022, the Company sold 8,747,744 shares of the Company’s common stock at a purchase price of $1.11 per share raising aggregate gross proceeds of approximately $9.7 million. In addition, during the first quarter, the company received $3.5 million of net proceeds from the Open Market Sale Agreement by selling 3,115,197 shares of the Company’s common stock at a weighted average price of $1.16 per share.

Financial Results for the Three Months Ended March 31, 2022:
Cash and Cash Equivalents and Marketable Securities. Cash and cash equivalents and marketable securities on March 31, 2022 were $16.8 million, as compared to $8.6 million as of December 31, 2021.

Research and Development Expenses. Research and development expenses for the quarter ended March 31, 2022 were $3.0 million as compared to $5.5 million for the comparable period in 2021.

Research and Development expenses are lower in 2022 compared to 2021 primarily attributed to reduced clinical trial costs as a result of the completion of the CLASSICAL-Lung and SIGNAL studies, partially offset by setup expenses for the KEYNOTE B84 and SIGNAL-AD studies as well as a large production run of pepinemab completed in Q1:21.

General and Administrative Expenses. General and administrative expenses for the quarter ended March 31, 2022 were $1.6 million as compared to $1.6 million for the comparable period in 2021.

Essentially flat level of general and administrative expenses reflects careful cost control measures in light of inflationary pressures.

Comprehensive loss/Net loss per share. The Comprehensive Loss and Net loss per share for the quarter ended March 31, 2022 was $4.6 million and $0.12, respectively, compared to $6.6 million and $0.26 for the comparable period in 2021.

Full financial tables are included below. For further details on Vaccinex’s financials, refer to its Form 10-Q filed May 16, 2022, with the Securities and Exchange Commission

REFERENCES:

Shafique MR, Fisher TL, Evans EE, Leonard JEE, Pastore DRE, Mallow CL, Smith E, Mishra V, Schroder A, Chin KA, Beck JT, Baumgart MA, Govindan R, Gabrial NY, Spira AI, Seetharamu N, Lou Y, Mansfield AS, Sanborn RE, Goldman JW, Zauderer M. A Phase Ib/2 Study of Pepinemab in Combination with Avelumab in Advanced Non–Small Cell Lung Cancer. Clin Cancer Res 2021, doi: 10.1158/1078-0432.CCR-20-4792
Clavijo PE, Friedman J, Robbins Y, Moore EC, Smith ES, Zauderer M, Evans EE, Allen CT. Semaphorin4D inhibition improves response to immune checkpoint blockade via attenuation of MDSC recruitment and function. Cancer Immunol Res. 2019 Feb;7(2):282-291
Evans EE, Jonason AS Jr, Bussler H, Torno S, Veeraraghavan J, Reilly C, Doherty MA, Seils J, Winter LA, Mallow C, Kirk R, Howell A, Giralico S, Scrivens M, Klimatcheva K, Fisher TL, Bowers WJ, Paris M, Smith ES, Zauderer M. Antibody blockade of semaphorin 4D promotes immune infiltration into tumor and enhances response to other immunomodulatory therapies. Cancer Immunol Res. 2015 Jun;3(6): 689-701. View Source
About Pepinemab
Pepinemab is a humanized IgG4 monoclonal antibody that inhibits SEMA4D, which regulates the actin cytoskeleton of cells that plays an important role in tumor immunity and cell interactions in the brain. Preclinical and clinical data show that pepinemab promotes infiltration/activation of dendritic cells and CD8+ T-cells and reverses immunosuppression within the tumor microenvironment. Pepinemab is being evaluated in several studies in oncology and neurodegenerative disease.

About ActivMAb
Vaccinex has developed a proprietary mammalian cell-based antibody discovery platform with unique multi-pass membrane target capabilities. The ActivMAb technology now has four main applications: complex membrane antigen presentation, antibody or antigen discovery, and protein optimization. Vaccinex has entered into an antibody license with Surface Oncology (Cambridge, MA) and into Material Transfer Agreements for drug discovery or process development with major pharmas utilizing this technology. Vaccinex seeks partnering opportunities for co-development or licensing of existing antibodies in our pipeline, discovery of new antibodies and/or applications for this powerful technology.

Instil Bio Reports First Quarter 2022 Financial Results and Provides Corporate Update

On May 16, 2022 Instil Bio, Inc. ("Instil" or the "Company") (Nasdaq: TIL), a clinical-stage biopharmaceutical company focused on developing tumor infiltrating lymphocyte, or TIL, therapies for the treatment of patients with cancer, reported its first quarter 2022 financial results and provided a corporate update (Press release, Instil Bio, MAY 16, 2022, View Source [SID1234614592]).

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First Quarter 2022 Highlights and Anticipated Milestones:

Enrollment Ongoing in DELTA-1, a Phase 2 trial of ITIL-168 in advanced melanoma with registrational intent: Instil is targeting completion of enrollment by 2022 for the registrational cohort and expects top-line safety and efficacy data in 2023, which could potentially support a biologics license application (BLA) submission and a European Medicines Agency marketing authorization application (MAA) filing.

On track with DELTA-2, a Phase 1 trial of ITIL-168 with pembrolizumab in additional cancers with unmet need: Study is expected to initiate in non-small cell lung cancer (NSCLC), cervical cancer and squamous cell carcinoma of head and neck (HNSCC) in the second quarter of 2022. The study will evaluate ITIL-168 with pembrolizumab in patients who have failed standard therapies.

Readiness to Initiate Phase 1 Study of ITIL-306, the first product candidate from the CoStAR platform, in the second quarter: Instil is on track to initiate a Phase 1 study of ITIL-306, its first genetically engineered TIL using the CoStAR platform in the second quarter of 2022.

Presenting Preclinical Data on the CoStAR Platform at ASCO (Free ASCO Whitepaper) 2022: Instil plans to present in vivo and supporting in vitro data at the 2022 ASCO (Free ASCO Whitepaper) Annual Meeting. Abstract details are below:

Title: Antitumor activity of T cells expressing a novel anti-folate receptor alpha (FOLR1) costimulatory antigen receptor (CoStAR) in a human xenograft murine solid tumor model and implications for in-human studies.
Presenting Product Characterization Data From Unmodified TILs in Cutaneous Melanoma: Instil plans to present advanced correlative analyses on TIL products administered to patients in a compassionate use program at the 25th Annual ASGCT (Free ASGCT Whitepaper) meeting. Abstract details are below:

Title: Characterization of the Transcriptomic and TCR Clonal Heterogeneity of TIL Therapy Infusion Products by Single-Cell Sequencing and Correlative Analyses With Clinical Efficacy in Patients with Advanced Cutaneous Melanoma. ASGCT (Free ASGCT Whitepaper) link.
Cash Runway Into 2024 through key clinical data expected in 2023: Instil expects its current cash reserves to fund Company operations into 2024.
First Quarter 2022 Financial and Operating Results:

As of March 31, 2022, we had $61.5 million in cash and cash equivalents and $318.0 million in marketable securities, compared to $37.6 million in cash and cash equivalents and $416.5 million in marketable securities as of December 31, 2021. The Company expects that its cash, cash equivalents and marketable securities as of March 31, 2022, will enable it to fund its operating plan into 2024.

Research and development expenses were $39.2 million for the three months ended March 31, 2022, compared to $14.4 million for the three months ended March 31, 2021.

General and administrative expenses were $15.1 million for the three months ended March 31, 2022, compared to $9.0 million for the three months ended March 31, 2021.

InDex Pharmaceuticals Holding AB (publ) interim report January – March 2022

On May 16, 2022 InDex Pharmaceuticals Holding AB (publ) reported that interim report January – March 2022 (Press release, InDex Pharmaceuticals, MAY 16, 2022, View Source [SID1234614591])

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Period January – March 2022
Net sales amounted to SEK 0.0 (0.0) million
Operating loss amounted to SEK –18.9 (–9.3) million
Result after tax amounted to SEK –18.9 (–9.3) million, corresponding to SEK –0.04 per share (–0.02) before and after dilution
Cash flow from operating activities amounted to SEK –18.4 (–8.5) million
Cash and cash equivalents at the end of the period amounted to SEK 417.5 (532.5) million
Number of employees at the end of the period was 9 (7)
Number of shares at the end of the period was 532,687,650
All comparative amounts in brackets refer to the outcome during the corresponding period 2021.

Significant events during the quarter
InDex is planning for self-commercialisation of the drug candidate cobitolimod in the US with strategic collaborations in other regions
Significant events after the reporting period
Peter Zerhouni stepped down as CEO of InDex
Other events
InDex hosted a Capital Markets Day for investors, analysts and media
CEO statement
We are working intensively with the phase III study CONCLUDE. The study evaluates the drug candidate cobitolimod as a novel treatment for patients with moderate to severe left-sided ulcerative colitis. We are making great progress with the process of obtaining approval to start the study in the participating countries, where the study is currently approved by the regulatory authorities in 27 out of the around 30 planned countries. In addition, we see that more and more clinics are starting to screen and randomise patients. The clinics are now also starting to open up for external visits and we will continue our successful strategy of visiting the participating clinics together with Parexel.

To inform about cobitolimod and the phase III study CONCLUDE, InDex will participate with a booth at Digestive Disease Week (DDW), which is the premier medical congress in the world in gastroenterology. DDW takes place on May 21-24 in San Diego, USA and annually attracts over 10,000 participants from more than 100 countries. DDW also provides good opportunities to update our business contacts as all leading companies in the field are attending.

I am very happy to welcome Eva Arlander as Chief Development Officer to InDex. Eva has extensive experience of drug development from senior positions at among others AstraZeneca, Medivir, Affibody and the Medical Products Agency. Eva will be part of InDex’s new management team together with myself, Chief Medical Officer Anders Bröijersén and Chief Scientific Officer Charlotte Admyre.

InDex has together with external experts analysed the commercialisation options for cobitolimod in the US and Europe. The conclusion is that the market potential, the required commercial footprint, and the profitability profile in the US respectively are well suited for self-commercialisation by a focused commercial organisation to be built closer to launch. The US accounts for approximately 65% of the global market for ulcerative colitis. The fragmented European market, as well as other regions, offer attractive opportunities to enter strategic collaborations as cobitolimod advances towards launch. These conclusions were presented at our well-received Capital Markets Day in mid-March. We are happy that so many have had the opportunity to watch the presentations, both live and afterwards via the recording on our website.

I also would like to take the opportunity to highlight the annual report for 2021, which was published in the beginning of April. It provides a good overview of ulcerative colitis, cobitolimod, the phase III study CONCLUDE and the company’s other activities. We have also this year included a moving patient interview. This time with Sofie, who has lived with ulcerative colitis for 18 years and who really confirms the need for new effective and safe therapies for her and other patients suffering from ulcerative colitis.

On June 1 we have the annual general meeting in InDex, which also this year will be conducted through advance voting. The day after, on June 2, I will present the company at Redeye Growth Day and I hope to see you there.

Johan Giléus, acting CEO

Chairman statement
InDex is in an exciting and important phase, and I look at the future with great optimism. The company’s focus is on the implementation of the phase III study CONCLUDE with cobitolimod, which is progressing according to plan. Phase III is the final stage of development before application for market approval by the regulatory authorities and CONCLUDE is thus a very important milestone for the company.

InDex has a new management team in place which, with its extensive competence and experience, will lead the company forward as we now take cobitolimod through phase III and towards the market. The recruitment of a new CEO is ongoing, and the Board is aiming to present a new permanent CEO in the near future.

Finally, I would like to express a big thank you to all the personnel at InDex, whose hard work and commitment make InDex the great company it is, with the aim of improving the lives of the patients suffering from this severe disease while creating significant value for our shareholders.

The full report is attached as a PDF and is available on the company’s website View Source

Publication
This information is information that InDex Pharmaceuticals Holding AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation (MAR). The information was submitted for publication through the agency of the contact person set out above at 8:00 CET on May 16, 2022.

HOOKIPA Pharma Reports First Quarter 2022 Financial Results and Recent Highlights

On May 16, 2022 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 2022 (Press release, Hookipa Biotech, MAY 16, 2022, View Source [SID1234614590]).

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"We observed strong external validation of our novel arenaviral platform in the first quarter with our collaboration agreement with Gilead and our capital raise, which drew funding from new and existing top-tier investors," said Joern Aldag, Chief Executive Officer at HOOKIPA. "On the heels of our AACR (Free AACR Whitepaper) data presentations, which showcased T cell and tumor response with our technology alone and in novel combinations, we remain focused on advancing our portfolio across cancer types. We look forward to sharing Phase 1 data from our HB-200 program mid-year and early Phase 2 data on HB-200 in combination with pembrolizumab in late 2022, as well as progressing with IND preparations for our HB-300 program in prostate cancer."

Quarter Highlights

In January 2022, the first patient was dosed in the Phase 2 trial to assess HB-200 in combination with pembrolizumab as 1st-line and 2nd-line treatment for advanced head and neck squamous cell carcinoma (HNSCC). Results from the ongoing Phase 1 study have highlighted the potential additive benefits of this combination to improve anti-tumor response. Preliminary data is anticipated in the second half of 2022.

In February 2022, HOOKIPA and Gilead agreed to advance its partnered HIV program, triggering a $54 million commitment from Gilead. HOOKIPA assumed development responsibility for the HB-500 program through the completion of a Phase 1b clinical trial; Gilead has the exclusive right for further development thereafter. Financial terms included a $4 million preclinical milestone, a $15 million non-refundable initiation fee and $35 million equity commitment at a premium to market price. The $35 million equity commitment includes a first tranche of $5 million (purchased at a $3 share price on February 15) and the remaining $30 million can be drawn at a 30 percent premium in a second tranche or at market price in a third tranche. If Gilead pursues further development, HOOKIPA is entitled to potential development and sales milestone payments exceeding $237 million, as well as royalties on net product sales.

Klaus Orlinger, Ph.D. was named Chief Scientific Officer. He was promoted from his previous role as Executive Vice President, Research. Klaus has played a leading role in the development of novel arenaviral immunotherapies and advancing them to the clinic since he joined the company in 2012.

In March 2022, HOOKIPA announced the acceptance of four poster presentations on preclinical, translational and clinical biomarker data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April. The data provided further evidence of the potential of the arenaviral platform in various cancers, either alone or with other modalities. Specifically, the data showed:

the combination of co-stimulatory 4-1BB agonists with arenaviral immunotherapy in a preclinical setting increased tumor control and resulted in a higher cure rate than arenaviral immunotherapy alone;
replicating immunotherapy sequentially combined with adoptively transferred TCR transgenic T cells resulted in tumor cures in a preclinical setting;
arenaviral immunotherapy was able to overcome immune tolerance, induce potent T cell responses against two different tumor self-antigens and reduce tumor growth in these cancers in a preclinical setting;
HB-200 induced robust antigen-specific T cells that were high quality, expanding on previously reported data in patients with Human Papillomavirus 16-positive (HPV16+) head and neck cancer. Additional Phase 1 data, including the recommended Phase 2 dose for HB-202/HB-201 was recently accepted for presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) in June.

In April, HOOKIPA reported the addition of Tim Reilly, Ph.D. to its Board of Directors. Tim brings extensive product development experience to the Board.
Upcoming Milestones

Phase 1 HB-200 data in HPV16+ head and neck cancer: Mid-2022
Phase 2 HB-200 data in combination with pembrolizumab in HPV16+ head and neck cancer:
1st-line initial data: 2H 2022
2nd-line initial data: 2H 2022
Randomized Phase 2 HB-200 study in combination with pembrolizumab in 1st line for HPV16+ HNSCC: 1H 2023 (Fast Track designation)
Prostate cancer IND: 3Q 2022
Hepatitis B therapeutic IND: 2022 (Gilead-led)
First Quarter 2022 Financial Results
Cash Position: HOOKIPA’s cash, cash equivalents and restricted cash as of March 31, 2022 was $141.8 million compared to $66.9 million as of December 31, 2021. The increase was primarily attributable to funds resulting from the amended and restated Gilead collaboration agreement, and the follow-on financing in March 2022, partly offset by cash used in operating activities.

Revenue was $1.4 million for the three months ended March 31, 2022, and $5.3 million for the three months ended March 31, 2021. The decrease was primarily due to lower cost reimbursements received under the Collaboration Agreement with Gilead and the fact that the $4.0 million milestone payment and the $15.0 million initiation fee received in the three months ended March 31, 2022 were mostly recorded as deferred revenue to be recognized in future accounting periods.

Research and Development Expenses: HOOKIPA’s research and development expenses were $16.6 million for the three months ended March 31, 2022, compared to $20.2 million for the three months ended March 31, 2021.

The decrease for the three months ended March 31, 2022 compared to the three months ended March 31, 2021 was attributable to a decrease in direct research and development expenses, partially offset by an increase in indirect research and development expenses.

The decrease in direct research and development expenses was primarily driven by lower manufacturing expenses for our HB-200 and Gilead partnered programs and lower clinical study expenses due to the completion of patient enrollment of the Phase 2 study for our HB-101 program. Indirect research and development expenses increased slightly because of an increase in professional and consulting fees, partially offset by a decrease in personnel related costs.

General and Administrative Expenses: General and administrative expenses for the three months ended March 31, 2022 were $5.0 million, compared to $4.3 million for the three months ended March 31, 2021. The increase was primarily due to an increase in professional and consulting fees, and an increase in personnel-related expenses, partially offset by a decrease in other expenses. The increase in personnel-related expenses resulted from increased stock compensation expenses, a growth in headcount along with increased salaries in our general and administrative functions. The increase in professional and consulting fees was primarily attributable to intellectual property costs incurred in connection with filing and prosecuting patent applications as well as third-party license fees.

Net Loss: HOOKIPA’s net loss was $18.0 million for the three months ended March 31, 2022 compared to a net loss of $17.2 million for the three months ended March 31, 2021. This increase was due to a decrease in revenues from collaboration and licensing, a decrease in grant income, an increase in general and administrative expenses, partially offset by a decrease in research and development expenses.

Galera Reports First Quarter 2022 Financial Results and Recent Corporate Updates

On May 16, 2022 Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, reported financial results for the first quarter ended March 31, 2022 and provided recent corporate updates (Press release, Galera Therapeutics, MAY 16, 2022, View Source [SID1234614589]).

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"We are excited to announce our plan to submit an NDA for avasopasem by year end following discussions with the FDA," said Mel Sorensen, M.D., Galera’s President and CEO. "Based on the positive data readout from our Phase 3 ROMAN trial, Galera continues to execute on its development strategy to advance its lead program, avasopasem, toward potential commercialization. To that end, we are delighted to attend the upcoming ASCO (Free ASCO Whitepaper) Annual Meeting where our ROMAN data will be highlighted in an oral presentation. In addition, we recently announced positive topline data from our Phase 2a AESOP study of avasopasem for chemoradiotherapy-induced esophagitis in patients with lung cancer. We are encouraged by these results, which further demonstrate avasopasem’s ability to reduce radiation toxicity in high-risk patient populations."

Recent Corporate Updates

Radiotherapy-Induced Toxicity Programs:

Severe Oral Mucositis (SOM)

The Company announced plans to submit a New Drug Application (NDA) for avasopasem, its lead product candidate, for the treatment of radiotherapy-induced SOM to the U.S. Food and Drug Administration (FDA) by the end of 2022.
An abstract on the Phase 3 ROMAN data of avasopasem for SOM was accepted for an oral presentation on June 3rd at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.
Esophagitis

The Company reported positive topline data from the Phase 2a AESOP trial of avasopasem evaluating its ability to reduce the incidence of severe acute radiation-induced esophagitis in patients with lung cancer receiving concurrent chemoradiotherapy. Overall, avasopasem was well tolerated and the incidence of Grade 3 esophagitis was substantially reduced in comparison to literature. No patients experienced Grade 4 or 5 esophagitis at any point during the trial.
Anti-Cancer Programs:

Locally Advanced Pancreatic Cancer (LAPC)

Enrollment is ongoing in the Phase 2b, 160-patient randomized, multicenter, placebo-controlled GRECO-2 trial of rucosopasem, Galera’s second dismutase mimetic product candidate, in combination with stereotactic body radiation therapy (SBRT) in patients with LAPC. The primary endpoint of the trial is overall survival.
A Trials in Progress abstract on GRECO-2 was accepted for presentation at the upcoming 2022 ASCO (Free ASCO Whitepaper) Annual Meeting.
Non-Small Cell Lung Cancer (NSCLC)

Enrollment is ongoing in the Phase 1/2 GRECO-1 trial of rucosopasem in combination with SBRT in patients with NSCLC. The Company expects to report initial data from this trial in the first half of 2022.
First Quarter 2022 Financial Highlights

Research and development expenses were $8.1 million in the first quarter of 2022, compared to $12.4 million for the same period in 2021. The decrease was primarily attributable to a decrease in avasopasem development costs, partially offset by an increase in rucosopasem development costs.
General and administrative expenses were $5.0 million in the first quarter of 2022, consistent with the first quarter of 2021.
Galera reported a net loss of $(15.4) million, or $(0.58) per share, for the first quarter of 2022, compared to a net loss of $(18.7) million, or $(0.75) per share, for the same period in 2021.
As of March 31, 2022, Galera had cash, cash equivalents and short-term investments of $60.9 million. Galera expects that its existing cash, cash equivalents and short-term investments will enable Galera to fund its operating expenses and capital expenditure requirements into the second half of 2023.