On August 8, 2022 Cyteir Therapeutics, Inc. ("Cyteir") (Nasdaq: CYT), a company focused on the discovery and development of next-generation synthetically lethal therapies for cancer, reported financial results for the second quarter ended June 30, 2022 and provided an update on recent operational highlights (Press release, Cyteir Therapeutics, AUG 8, 2022, View Source [SID1234617782]).

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"We are encouraged by the enrollment of patients in the CYT-0851 Phase 2 monotherapy cohorts and Phase 1 combination therapy cohorts, with initial data expected on the solid tumor cohorts in the fourth quarter this year, and on the lymphoma cohorts in the first half of 2023," said Markus Renschler, MD, President and Chief Executive Officer of Cyteir. "We have made the strategic decision to postpone the CYT-1853 IND, thereby extending our cash runway to focus on CYT-0851 clinical development and our synthetic lethality discovery research."

Second Quarter 2022 Business Update

Updates to the CYT-0851 Clinical Program

Progress continues with enrollment of both the monotherapy and combination cohorts. Initial data from the monotherapy solid tumor cohorts are expected beginning in the fourth quarter of 2022, with initial data from the hematologic malignancy cohorts expected in the first half of 2023. Dose-escalation in combination cohorts with capecitabine and gemcitabine in solid tumors is progressing and expected to be completed in the first half of 2023.
A Phase 2 cohort with CYT-0851 monotherapy in triple negative breast cancer has been opened. Data from this cohort are expected in the first half of 2023. Cyteir has made a strategic decision to halt further enrollment in the Phase 2 multiple myeloma monotherapy cohort and the dose-escalation combination cohort with rituximab plus bendamustine. This decision was based on the evolving treatment landscapes in multiple myeloma and diffuse large B-cell lymphoma, and the feasibility of development given the emerging competition.
We continue to perform metabolomic, genomic, and transcriptomic analyses on patient samples to identify potential patient selection biomarkers. Our understanding of the mechanism of action of CYT-0851 could potentially accelerate development of a biomarker and allow for expansion into additional opportunities in other tumor types. Progress on this work is expected to be updated by year-end 2022.
Update on Progress with CYT-1853

The development of CYT-1853 is paused and the filing of an Investigational New Drug (IND) application is postponed while Cyteir continues to evaluate the clinical results of the ongoing studies with CYT-0851. Accordingly, Cyteir will prioritize its resources on advancing CYT-0851 in the clinic and on its discovery research efforts to expand the company’s synthetically lethal preclinical pipeline.
Second Quarter 2022 Financial Results

Cash and cash equivalents: Cash and cash equivalents as of June 30, 2022 were $166.4 million. As a result of updates from the CYT-0851 program review and postponing CYT-1853 development, cash and cash equivalents are now expected to fund planned operations into the second half of 2024, which is longer than we previously forecasted.

Research and development (R&D) expenses: R&D expenses were $8.8 million for the second quarter of 2022 versus $8.9 million for the same period in 2021. The year-over-year decrease in R&D spending in the comparative periods was due primarily to decreased costs in external research activity offset by increased clinical trial expenses for the ongoing Phase 1/2 study of CYT-0851 and headcount.

General and administrative (G&A) expenses: G&A expenses were $3.4 million for the second quarter of 2022 compared to $2.4 million for the same period in 2021. The year-over-year increase in G&A expenses in the comparative periods was primarily due to employee-related costs, as well as other administrative expenses associated with company growth and operating as a public company.

Net loss: Net loss was $12.1 million, or $0.34 per share, in the second quarter of 2022 compared to $11.3 million, or $4.83 per share, for the same period in 2021.

On August 8, 2022 Akoya Biosciences, Inc. (Nasdaq: AKYA) ("Akoya"), The Spatial Biology Company, reported its financial results for the second quarter ending June 30, 2022 (Press release, Akoya Biosciences, AUG 8, 2022, View Source [SID1234617781]).

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"Akoya delivered another quarter of strong financial performance with record revenue and system placements in the second quarter," said Brian McKelligon, Chief Executive Officer, Akoya Biosciences. "This quarter was further highlighted by the announcement of our partnership with Acrivon Therapeutics and the demonstration of our RNA and multi-omics capabilities at AGBT."

Second Quarter 2022 Financial Highlights

Total revenue was $17.9 million in the second quarter of 2022, compared to $13.1 million in the prior year period; an increase of 37%.
Product revenue was $14.2 million in the second quarter of 2022, compared to $10.7 million in the prior year period; an increase of 33%; within product revenue, instrument revenue was $9.5 million and reagent revenue was $4.5 million for the quarter.
Services and other revenue totaled $3.7 million in the second quarter of 2022, compared to $2.4 million in the prior year period; an increase of 54%.
Gross profit was $10.3 million in the second quarter of 2022, compared to $8.1 million in the prior year period; an increase of 27%; gross profit margin was 58% in the second quarter of 2022.
60 instruments were sold in the second quarter of 2022; 16 PhenoCyclers, 44 PhenoImagers (which includes Fusion, HT and Mantra); compared to 31 instruments sold in the prior year period (13 PhenoCyclers, 18 PhenoImagers); an increase of 94%.
Instrument installed base of 808 as of June 30, 2022; 212 PhenoCyclers, 596 PhenoImagers
Combined-unit PhenoCycler-Fusion installed base of 55 as of June 30, 2022.
Second Quarter 2022 Business Highlights

As of June 30, 2022, there have been 618 total publications featuring Akoya’s platform; 91% growth from 324 total publications as of June 30, 2021.
Announced a first-of-its-kind spatial signature CDx deal with Acrivon Therapeutics, a long-standing ABS partner, for the developmental oncology agent ACR-368, a targeted DNA damage response inhibitor therapy, in phase 2 clinical trials for platinum resistant ovarian, endometrial and urothelial cancers.
Previewed Akoya’s proprietary RNA chemistry at 100+ plex, scalable to 1000 plex, as well as simultaneous multi-omic targeting of RNA and protein at 100+ plex on a single tissue section of head and neck cancer at AGBT.
Expanded existing credit facility to increase potential total debt capacity by $20 million, and extended interest only period to mid-2025 providing Akoya with additional capital.
$88 million of cash, cash equivalents, and marketable securities as of June 30, 2022, well capitalized to deliver on our existing strategic plan.
YTD 2022 Financial Highlights

Total revenue was $34.8 million YTD as of June 30, 2022 compared to $25.3 million in the prior year period; an increase of 38%.
Product revenue was $27.5 million YTD as of June 30, 2022, compared to $20.7 million in the prior year period; an increase of 33%.
Services and other revenue totaled $7.3 million YTD as of June 30, 2022, compared to $4.6 million in the prior year period; an increase of 59%.
Gross profit was $20.4 million YTD as of June 30, 2022, compared to $15.5 million in the prior year period; an increase of 32%; gross profit margin was 59% YTD as of June 30, 2022.
111 instruments were sold YTD as of June 30, 2022; 30 PhenoCyclers, 81 PhenoImagers (which includes Fusion, HT and Mantra), compared to 68 instruments sold in the prior year period; an increase of 63%.
2022 Financial Outlook

The company, based on its updated plans and initiatives, is raising its full year 2022 revenue guidance range to $71-74 million.

Webcast and Conference Call Details

Akoya will host a conference call today, August 8, 2022, at 5:00 p.m. Eastern Time to discuss its second quarter 2022 financial results. Investors interested in listening to the conference call are required to register online. A live webcast of the conference call will be available on the "Investors" section of the Company’s website at View Source The webcast will be archived on the website following the completion of the call for three months.

On August 8, 2022 Vaxart, Inc. (NASDAQ: VXRT) reported it has begun working on vaccine candidate constructs that directly target new omicron variants of concern and is preparing to release top-line data in the third quarter of 2022 from its Phase II COVID-19 testing of a Wuhan strain vaccine construct (Press release, Vaxart, AUG 8, 2022, View Source [SID1234617780]).

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"We continue to be very excited about the cross-reactivity of our current vaccine candidates, as seen in preclinical and early clinical studies," said Andrei Floroiu, Chief Executive Officer. "The characteristics and prevalence of newer SARS-CoV-2 strains, along with our plans for a human omicron challenge study, led us to begin working on clinical vaccine candidates that directly target omicron variants of concern, which also conforms to recent Food and Drug Administration (FDA) guidance that boosters should target omicron BA.4/5.

"We plan to evaluate these new constructs both as omicron-only monovalent vaccine candidates and bivalent candidates in combination with our Wuhan constructs, and to compare the clinical results of our S-only and S+N constructs to determine the best path forward in developing a vaccine that can hinder viral infection and transmission for current and emerging variants. Our expectation is that the omicron vaccine candidates will be available to evaluate preclinically in the fourth quarter, and clinically in the first half of 2023. In addition, top-line Phase II results from our Wuhan S-only construct are expected in the third quarter of 2022.

"During the second quarter, we also continued to make progress on our norovirus program," Floroiu said. "The data from our trial in elderly adults is very encouraging, as it suggests similar activity to that in younger adults, which is often not the case with injectable vaccines. This adds to the already compelling clinical data on this program and increases our confidence as we continue our development."

Recent Business Highlights

COVID-19 Vaccine Developments

Reported multiple data sets supporting the potential of Vaxart’s COVID-19 vaccine candidates to tackle the challenge of an evolving virus that evades immune protection provided by approved vaccines or natural infection.

In May 2022, announced data from a preclinical hamster study conducted by researchers at Duke University and published in Science Translational Medicine, which demonstrated that Vaxart’s S-only COVID-19 candidate reduced disease and airborne transmission.

In June 2022, announced preclinical data demonstrating that two COVID-19 vaccine candidates targeting either the SARS-CoV-2 spike (S) protein for Wuhan or S protein for omicron protected hamsters when challenged with the omicron BA.1 variant.

In July 2022, updated Phase I data showing Vaxart’s Spike/Nucleocapsid (S+N) candidate induced long-lasting mucosal IgA antibodies in saliva and nasal samples against SARS-CoV-2 and was cross-reactive to many different coronaviruses that are more divergent than circulating variants of SARS-CoV-2.

Earlier this year, Vaxart released non-human primate data that demonstrated that administration of Vaxart’s S-only or S+N COVID-19 vaccine candidates to the nasal mucosa of non-human primates produced significant increases in serum IgG and IgA and up to 1,000-fold increases in nasal IgA.

All vaccinated animals challenged with SARS-CoV-2 B.1.351 (beta variant) had a significant reduction in viral titers in the nasal passages compared to unvaccinated controls.

In June 2022, established an agreement with hVIVO Services Limited, a subsidiary of Open Orphan, a research company specializing in human challenge clinical trials for infectious and respiratory disease products, under which hVIVO will conduct a characterization study and, if successful, develop a human challenge model based on the omicron variant of SARS-CoV-2, with the intent to conduct a subsequent Phase II Human Challenge Trial (HCT) of Vaxart’s oral COVID-19 vaccine candidate.

Norovirus Vaccine Developments

In June 2022, Vaxart reported positive top-line data about its norovirus vaccine candidate. No vaccine exists in the United States to treat norovirus, a virus that causes up to 21 million cases, 109,000 hospitalizations and 900 deaths annually in the United States. The June data, from Vaxart’s Phase Ib trial in subjects aged 55-80, demonstrated that Vaxart’s oral norovirus vaccine candidate stimulated a robust immune response across all doses, with a dose-dependent production of IgA antibody secreting cells.

Results were consistent with previous studies conducted in younger populations, which is typically not the case, as the immune system often weakens with age, and older people tend to have less robust responses to vaccination than younger people.

Vaxart also reported in June 2022 on top-line data from a Phase I trial evaluating different boosting regimens with Vaxart’s oral norovirus vaccine candidate. The data showed that the candidate was able to successfully boost antibody responses, with antibody responses trending better with administration spread out over three months versus a shorter interval.

This data and previous results support the continued development of Vaxart’s oral norovirus vaccine candidate in adult populations, including elderly adults, and add to the growing body of evidence supporting its clinical utility.

Planned Clinical Milestones in the COVID-19 and Norovirus Pipelines

Selection of COVID-19 vaccine constructs expected in Q4 2022 with clinical trials to start in 1H 2023of COVID-19 vaccine constructs expected in Q4 2022 with clinical trials to start in 1H 2023.

After determining which COVID-19 vaccine candidate to advance, Vaxart anticipates updating its plans for its India trials.

Planned start of Phase II trial of Vaxart’s bivalent norovirus vaccine candidate in Q4 2022.

Preliminary data from ongoing Phase II norovirus challenge study expected at the end of Q1 2023 or early Q2 2023.

Omicron Human Challenge Study in the UK starting in the 2H 2023 using selected vaccine construct.

Financial Results for the Three Months Ended June 30, 2022

Vaxart ended the second quarter with cash, cash equivalents and available-for-sale debt securities of $131.5 million, compared to $157.0 million as of March 31, 2022. The decrease was primarily due to $25.9 million of cash used in operations. The Company’s existing funds are expected to be sufficient to fund its operations into the second half of 2023.

The Company reported a net loss of $29.4 million for the second quarter of 2022, compared to $16.1 million for the second quarter of 2021. Net loss per share for the second quarter of 2022 was $0.23, compared to a net loss of $0.13 per share in the second quarter of 2021. The increase in net loss was primarily due to a significant increase in research and development expenses.

Research and development expenses were $19.9 million for the second quarter of 2022, compared to $10.7 million for the second quarter of 2021. The increase was mainly due to increases in headcount and related costs, and in manufacturing and clinical trial expenses related to our COVID-19 and norovirus vaccine candidates.

General and administrative expenses were $9.3 million for the second quarter of 2022, compared to $5.2 million the second quarter of 2021. The increase was mainly due to the cost of settling shareholder litigation and increases in legal and professional costs and in headcount and related costs.

Conference Call

The Vaxart senior management team will host a conference call to discuss the business update and financial results for the second quarter of 2022 today, beginning at 4:30 p.m. ET.

The conference call can be accessed using the following information:

A replay of the webcast will be available on the Company’s website at www.vaxart.com following the conclusion of the event.

On August 8, 2022 Atreca, Inc. (Atreca) (NASDAQ: BCEL), a clinical-stage biotechnology company focused on developing novel therapeutics generated through a unique discovery platform based on interrogation of the active human immune response, reported financial results for the second quarter ended June 30, 2022 and provided an overview of recent developments (Press release, Atreca, AUG 8, 2022, View Source [SID1234617779]).

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"While we took steps during the second quarter to extend our cash runway through the end of 2023, we remain committed to the development of ATRC-101 and ATRC-301, as well as the advancement of our earlier-stage pipeline and the discovery of additional novel tumor-targeting lead antibodies using our platform. This is underscored by our hiring of Dr. Stephen Gould as Atreca’s new Chief Scientific Officer," said John Orwin, Chief Executive Officer of Atreca. "We are looking forward to an eventful second half of 2022, as we anticipate reporting updated data from the monotherapy and pembrolizumab combination arms of our Phase 1b clinical trial of ATRC-101, as well as initial toxicology data from our second clinical candidate, ATRC-301."

Recent Developments and Highlights

In June 2022, Atreca appointed Stephen Gould, Ph.D. as Chief Scientific Officer. Dr. Gould joined Atreca following 15 years at Genentech, where he most recently served as Executive Director, Translational Oncology leading a team focused on developing tumor-specific antibodies weaponized with immune-targeting arms or drug payloads for use in both hematologic and solid tumors, including two approved oncology therapeutics.

Enrollment of participants based on ATRC-101 target expression in archival or newly obtained biopsies is ongoing in the Phase 1b clinical trial. To date, 62 total participants have been enrolled in the monotherapy and pembrolizumab-combination cohorts of the trial. Atreca expects to report updated data from the trial in the second half of 2022.

In addition, Atreca has initiated manufacturing activities for the ATRC-301 program to support filing an IND planned for late 2023, and Atreca anticipates reporting preliminary toxicology data in the second half of 2022.

Second Quarter 2022 Financial Results

As of June 30, 2022, cash and cash equivalents and investments totaled $101.7 million.
Research and development expenses for the quarter ended June 30, 2022, were $20.0 million, including non-cash share-based compensation expense of $2.6 million.
General and administrative expenses for the three months ended June 30, 2022, were $8.1 million, including non-cash share-based compensation expense of $2.8 million.
Atreca reported a net loss of $27.9 million, or basic and diluted net loss per share attributable to common stockholders of $0.72, for the three months ended June 30, 2022.

On August 8, 2022 Calithera Biosciences, Inc. (Nasdaq: CALA), a clinical-stage, precision-oncology biopharmaceutical company, reported Company’s second quarter 2022 financial results will be released on Monday, August 15, 2022 (Press release, Calithera Biosciences, AUG 8, 2022, View Source [SID1234617778]). Company management will host a conference call on Monday, August 15, 2022, at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time to discuss the financial results and other recent corporate highlights.

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Participants who wish to join the conference call by telephone can use this link to register and receive the dial-in numbers and unique PIN to access the call. The conference call registration and live audio webcast can be accessed via the Investors section of the Company’s website at www.calithera.com. Please log in approximately 5-10 minutes before the event to ensure a timely connection. The archived webcast will remain available for replay on Calithera’s website for 30 days.