On February 24, 2022 GI Innovation, an innovative new drug development company, reported on February 23 that it has signed a biomarker joint research MoU with CellKey, a Glycoprotein biomarker development company, to develop next-generation innovative immuno-oncology (Press release, GI Innovation, FEB 24, 2022, View Source [SID1234609016]).

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The MoU ceremony was held in GI Innovation’s head office and Myoung-Ho Jang Chairman, Na-Ri Yun VP, Ji-Soo Kim director of GI Innovation and Nam-Yong Lee CEO, Kwang-Hoe Kim Head of Bio-R&D center, Sang-Yong Lee COO of CellKey have attended.

Under the MoU, GI Innovation will progress joint biomarker research to develop next-generation protein and antibody drugs using GI Innovation’s bispecific fusion protein development platform GI-SMART and CellKey’s AI-powered biomarker discovery platform SpAC9 Pipeline. In addition, both companies will progress jointly published thesis, academic publication, research business, etc.

A biomarker is biological index that can sense symptoms in the body using protein, DNA, RNA, metabolite, etc. The more the multiple panels are constructed the more possibilities are to raise accuracy and diagnose early cancer.

In particular, AI and cloud-powered SpAC9 Pipeline of CellKey enables the discovery of the most optimal multi-biomarker panels, consisting of glycoproteins and proteins, up to 100 times faster than with conventional analysis methods.

With this strategic partnership, both companies expect that GI Innovation will predict drug responses on GI Innovation’s immuno-oncology and reinforce the reliability and efficacy of treatment through the biomarker discovery that can monitor treatment effects. CellKey also expects to improve upon the effects of personalized treatments and cancer diagnostic biomarker business.

Myoung-Ho Jang, Chairman of GI Innovation said, "By collaborating with Cellkey that has SpAC9 Pipeline, an innovative proteomics biomarker development platform, the opportunities for successful new drug development are increased. We will do our best to choose prime target patients in the clinical trial stage through the early discovery of biomarker."

Nam-Yong Lee, CEO of CellKey said, "I believe we can innovatively improve the effectiveness of cancer treatments through this joint research with GI Innovation who develops immuno-oncology drugs with world-class R&D capabilities. This collaboration can create various business opportunities in the market of antibody drugs and precision medicine."

Agios Pharmaceuticals has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission .

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On February 24, 2022 Vaxart, Inc. (NASDAQ: VXRT) reported its business update today for the fourth quarter and full year 2021, reporting forward momentum for the Company, including its oral norovirus and COVID-19 vaccine candidates (Press release, Aviragen Therapeutics, FEB 24, 2022, View Source [SID1234608950]).

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Vaxart said it expected further material progress across its programs in 2022.

"Vaxart made significant progress in 2021 that has us well-positioned to achieve several important milestones in 2022," said Andrei Floroiu, Vaxart’s Chief Executive Officer. "Our potentially transformative oral vaccine programs continued to advance in clinical development. Patient dosing is underway in our U.S. Phase II COVID-19 trial and we have started a Phase II monovalent norovirus GI.1 challenge study."

"We have improved our manufacturing capacity, added to our research and manufacturing ranks, and hired top leadership talent," Floroiu said. "We anticipate building on 2021’s momentum, and are excited about the continued progress we expect to make in 2022, including launching the international clinical studies of our COVID-19 vaccine."

"In 2021, we generated exciting preclinical and clinical data," said Dr. Sean Tucker, Vaxart’s founder and Chief Scientific Officer. "A hamster challenge study showed that our oral COVID-19 vaccine candidate has the potential ability to reduce transmission of SARS-CoV-2, and a Phase I study showed that our vaccine candidate produced broad cross-reactive T cell and IgA responses against both SARS-CoV-2 and other coronaviruses. Therefore, we believe that our COVID-19 vaccine candidate may be reactive against SARS-CoV-2 variants. In 2022, we are planning to conduct additional trials that may highlight the advantages of triggering mucosal immunity as well as of other aspects of our platform."

Recent Business Highlights

Preclinical and Clinical

COVID-19 Vaccine Developments

During the fourth quarter of 2021, Vaxart began Phase II clinical trials of its oral tablet COVID-19 vaccine in the U.S. Vaxart dosed its first subject in late October 2021.

The U.S. portion of the trial is a randomized open-label dose and age escalation lead-in segment in naïve and previously vaccinated subjects. Vaxart expects data from this portion of the trial to be available during the first half of 2022.

In October 2021, a Duke University-led study showed Vaxart’s COVID-19 vaccine candidate reduced the airborne transmission of SARS-CoV-2 virus in an animal model and suggested the vaccine candidate would trigger superior mucosal protection.

The study’s findings, published by bioRxiv, are consistent with those from Vaxart’s Phase II human flu challenge study published in 2020, which showed Vaxart’s oral tablet flu vaccine was better at reducing shedding than the injectable flu vaccine competitor.

In February 2022, Vaxart’s COVID-19 non-human primate study was published by bioRxiv. The study demonstrates that Vaxart’s S-only COVID-19 clinical vaccine candidate, now being studied by Vaxart in Phase II trials, generated antibodies to the original COVID-19 virus strain and to the Beta, Delta, Alpha and Gamma variants of SARS-CoV-2 in the serum and nasal mucosa of non-human primates (NHPs).

Vaxart also announced it would test the cross-reactivity of its oral tablet COVID-19 vaccine candidate against the Omicron SARS-CoV-2 variant in two different studies now expected to begin in March 2022.

In the first study, Vaxart will test the activity of its Phase II COVID-19 oral vaccine candidate against Omicron by analyzing mucosal and serum samples from subjects to whom the vaccine was administered in Vaxart’s current COVID-19 vaccine Phase II trials.

In the second study, Vaxart will conduct an animal Omicron challenge study to assess how its current Phase II COVID-19 vaccine candidate performs in comparison to an Omicron-specific vaccine candidate, which Vaxart is currently developing.

Results from Phase I clinical testing and earlier preclinical testing support Vaxart’s belief that its vaccine candidates may be reactive against Omicron.

Vaxart completed enrollment in its Phase IB placebo-controlled, dose-ranging, repeat dose trial investigating its oral norovirus vaccine candidate in elderly subjects aged 55 to 80 years. This study is designed to evaluate the safety and immunogenicity of Vaxart’s GI.1 vaccine candidate.

The Company expects initial data from this study to be available in the first quarter of 2022 and more complete data to be available by the second quarter of 2022.

Vaxart is conducting an additional GI.1 norovirus vaccine study to evaluate the optimal timing for boost administration under VXA-NVV-105. This study has completed enrollment.

The Company expects initial data from this study to be available in the first quarter of 2022 and more complete data to be available in the first half of 2022.

Vaxart launched a Phase II GI.1 norovirus challenge study in January 2022 to evaluate the safety and clinical efficacy of its oral vaccine candidate. This double blind, placebo-controlled study uses a safe, well-characterized challenge with norovirus GI.1 of volunteers vaccinated with our monovalent norovirus vaccine. The study will yield data on efficacy, safety and immune correlates of protection, with data to be reported in the first quarter of 2023.

Manufacturing Updates

During the fourth quarter of 2021, Vaxart purchased its second clinical manufacturing facility and will be producing vaccines at two plants in parallel. Vaxart expects its manufacturing facilities to produce oral tablet vaccines required for Vaxart’s planned clinical trials in 2022.

Corporate Developments

A new Stanford study published in Cell Host and Microbe found that protection against influenza infection may be achieved through mechanisms other than the development of serum antibodies. The Phase II study demonstrated that VXA-A1.1, an investigational oral tablet flu vaccine under development by Vaxart, had cellular correlates of protection against influenza infection.

Vaxart grew its full-time employee headcount from 28 to 110 during 2021, expanding its research, manufacturing and quality groups as well as its management team to better advance its pipeline of vaccine programs.

In February 2022, Vaxart appointed industry veteran Edward B. Berg as the Company’s first in-house General Counsel. Mr. Berg has practiced law for more than 30 years and has represented Fortune 500 and mid-cap companies in biotechnology, pharmaceuticals and life sciences.

2022 Planned Milestones

Vaxart anticipates the progress and momentum of 2021 will continue into 2022:

Initial data from Vaxart’s Phase II COVID-19 vaccine trials is expected to be available in the first half of 2022.

The Company’s international Phase IB and Phase II COVID-19 trials, including a placebo-controlled efficacy trial in India, are anticipated to begin this year.

Results from two norovirus trials that Vaxart began in 2021 are expected in the first half of 2022.

Financial Results for the Three Months Ended December 31, 2021

Vaxart ended the year with cash, cash equivalents and available-for-sale debt securities of $182.7 million, compared to $204.0 million as of September 30, 2021. The decrease was primarily due to $15.8 million of cash used in operations and $4.8 million spent on a business acquisition.

The Company reported a net loss of $20.8 million for the fourth quarter of 2021, compared to $13.9 million for the fourth quarter of 2020. Net loss per share for the fourth quarter of 2021 was $0.17, compared to a net loss of $0.13 per share in the fourth quarter of 2020. The increase in net loss per share was primarily due to a significant increase in research and development expenses.

Revenue for the fourth quarter of 2021 was $74,000, compared to $356,000 in the fourth quarter of 2020. The decrease was due to lower royalty revenue from sales of Inavir in Japan.

Research and development expenses were $15.5 million for the fourth quarter of 2021, compared to $8.6 million for the fourth quarter of 2020. 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 $5.8 million for the fourth quarter of 2021, compared to $5.1 million for the fourth quarter of 2020. The increase was mainly due to an increase in headcount and related costs.

Financial Results for the Full Year Ended December 31, 2021

Vaxart reported a net loss of $70.5 million for full year 2021, compared to $32.2 million for full year 2020. Net loss per share for 2021 was $0.58, compared to $0.36 for 2020.

Revenue in 2021 was $892,000, compared to $4.0 million in 2020. The decrease was principally due to lower royalty revenue from sales of Inavir in Japan.

Research and development expenses were $48.7 million for 2021 compared to $19.9 million for 2020. 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 $21.9 million for 2021 compared to $15.2 million for 2020. The increase was mainly due to increases in personnel costs, D&O insurance and legal and professional fees.

On February 24, 2022 Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading genome editing company focused on developing potentially curative therapies leveraging CRISPR-based technologies, reported operational highlights and financial results for the fourth quarter and year ended December 31, 2021 (Press release, Intellia Therapeutics, FEB 24, 2022, View Source [SID1234608967]).

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"We began 2022 with strong momentum, executing against our strategic priorities for the advancement of our CRISPR-based pipeline and platform. We continued to make steady progress across our multiple clinical programs. In addition, we nominated two new development candidates – NTLA-2003 and NTLA-6001. Notably, we are looking forward to sharing additional data from the landmark study of NTLA-2001 next week," said Intellia President and Chief Executive Officer John Leonard, M.D. "In parallel, we continue to propel our own scientific innovation, as well as leverage external capabilities from across the industry to generate the next wave of clinical candidates. As part of this strategy, we completed several important transactions to further bolster our industry-leading genome editing toolbox and pipeline. Intellia is well-positioned to extend its leadership position as we aim to harness the full potential of genomic medicines."

Fourth Quarter 2021 and Recent Operational Highlights

In Vivo Program Updates

NTLA-2001 for ATTR amyloidosis: NTLA-2001 is the first investigational CRISPR-based therapy to be systemically delivered to edit genes inside the human body and has the potential to be the first single-dose treatment for transthyretin (ATTR) amyloidosis. Delivered with the Company’s in vivo lipid nanoparticle (LNP) technology, NTLA-2001 offers the possibility of halting and reversing the disease by driving a deep, potentially lifelong reduction in transthyretin (TTR) protein after a single dose. NTLA-2001 is part of a co-development/co-promotion agreement between Intellia, the lead party for this program, and Regeneron Pharmaceuticals, Inc. (Regeneron).
Intellia will be hosting a virtual investor event on February 28, 2022, at 4:30 p.m. ET to present additional interim clinical data from the ongoing Phase 1 study of NTLA-2001 in patients with hereditary ATTR amyloidosis with polyneuropathy (ATTRv-PN). Data to be presented will come from all four ATTRv-PN dose cohorts in Part 1, the single-ascending dose portion, and include safety and serum TTR reduction for Cohorts 3 and 4, as well as an early look at durability across all cohorts. The Company remains on track to initiate Part 2, a single-cohort expansion, in the polyneuropathy arm in the first quarter of 2022.
Intellia continues to dose patients in the cardiomyopathy arm of the Phase 1 study with NTLA-2001. In December 2021, Intellia initiated dosing in new dose-escalation cohorts in patients with ATTR amyloidosis with cardiomyopathy (ATTR-CM) as part of the expanded Phase 1 study. Enrollment across both ATTRv-PN and ATTR-CM patient populations is expected to complete in 2022.
NTLA-2002 for HAE: NTLA-2002 leverages Intellia’s proprietary in vivo LNP delivery technology to knock out the KLKB1 gene in the liver with the potential to permanently reduce total plasma kallikrein protein and activity, a key mediator of hereditary angioedema (HAE). This investigational approach aims to prevent attacks for people living with HAE by providing continuous suppression of plasma kallikrein activity following a single dose and to eliminate the significant treatment burden associated with currently available HAE therapies.
In December 2021, Intellia announced the first patient was dosed with NTLA-2002. The first-in-human study is expected to evaluate the safety, tolerability and activity of NTLA-2002 in adults with Type I or Type II HAE.
The Company anticipates presenting interim data from the Phase 1/2 study in the second half of 2022. The data are expected to characterize the emerging safety and activity profile of NTLA-2002, and to potentially demonstrate preliminary proof of concept.

NTLA-3001 for AATD-associated lung disease: NTLA-3001 is a wholly owned, first-in-class, CRISPR-mediated in vivo targeted gene insertion development candidate for the treatment of alpha-1 antitrypsin deficiency (AATD)-associated lung disease. It is designed with the aim to precisely insert a healthy copy of the SERPINA1 gene, which encodes the alpha-1 antitrypsin (A1AT) protein, with the potential to restore permanent expression of functional A1AT protein to therapeutic levels after a single dose. This approach seeks to eliminate the need for sub-optimal weekly IV infusions of A1AT augmentation therapy or lung transplant in severe cases.
Intellia continues to conduct Investigational New Drug (IND)-enabling activities for NTLA-3001, with plans to file an IND or IND-equivalent in 2023.
NTLA-2003 for AATD-associated liver disease: NTLA-2003 is a wholly owned in vivo knockout development candidate for the treatment of AATD-associated liver disease. It is designed to inactivate the SERPINA1 gene responsible for the production of abnormal A1AT protein in the liver. This approach aims to halt the progression of liver disease and eliminate the need for liver transplant in severe cases.
Today, Intellia announced the nomination of a new development candidate, NTLA-2003, for treatment of AATD-associated liver disease. The Company is advancing towards IND-enabling activities for this program.
Ex Vivo Program Updates

NTLA-5001 for AML: NTLA-5001 is an autologous T cell receptor (TCR)-T cell therapy engineered to target the Wilms’ Tumor 1 (WT1) antigen for the treatment of all genetic subtypes of acute myeloid leukemia (AML).
In the fourth quarter of 2021, Intellia initiated screening of patients in the Phase 1/2a study of NTLA-5001 for patients with AML. The Company has begun enrolling patients and expects to dose its first patient in the coming weeks. Later this year, the Company plans to provide guidance around timing of the first expected data readout, with the goal of demonstrating clinical proof of concept for its TCR-based platform.
NTLA-6001 for CD30+ Lymphomas: NTLA-6001 is Intellia’s wholly owned allogeneic CAR-T development candidate targeting CD30 for the treatment of CD30-expressing hematologic cancers, including relapsed or refractory classical Hodgkin’s Lymphoma (cHL).
Today, Intellia announced the nomination of its first ex vivo allogeneic development candidate, NTLA-6001, for CD30-expressing hematologic cancers, including cHL. NTLA-6001 is developed using Intellia’s proprietary allogeneic cell engineering platform, which leverages a novel combination of sequential gene edits. Preclinical data presented on its differentiated allogeneic engineering platform showed allogeneic T cells were shielded from immune rejection, both host T and natural killer (NK) cell attack.
Intellia is advancing towards IND-enabling activities and plans to present preclinical data leading to the development of NTLA-6001 at an upcoming scientific conference in 2022.
Research and Corporate Updates

Modular Platform and Pipeline Expansion: Intellia is expanding its industry-leading genome editing platform and scientific leadership through editing, delivery and cell engineering innovations that may enable broader in vivo and ex vivo applications.
Following the nomination of NTLA-2003, Intellia plans to advance at least one new in vivo development candidate by the end of 2022.
The Company plans to highlight additional advances to its proprietary technology capabilities, including both genome editing and delivery tools, at upcoming scientific conferences in 2022.
Collaboration Updates
In February, the Company executed a licensing and collaboration agreement with ONK Therapeutics Ltd. (ONK) for the development of allogeneic CRISPR-edited NK cell therapies for the treatment of cancer. The agreement grants ONK a non-exclusive license to Intellia’s proprietary ex vivo CRISPR/Cas9-based genome editing platform and its LNP-based delivery technologies and exclusive rights to certain guide RNAs for development of up to five NK cell therapies. ONK will be responsible for preclinical and clinical development for the engineered NK cell therapies covered under the agreement. In addition, the agreement grants Intellia options to co-develop and co-commercialize up to two products worldwide with rights to lead commercialization in the U.S.
In December 2021, the Company executed a licensing and collaboration agreement with Kyverna Therapeutics (Kyverna) for the development of KYV-201, an allogeneic CD19 CAR-T cell investigational candidate for the treatment of select autoimmune diseases. This is a novel approach aimed at targeting CD19 for inflammatory diseases as compared to traditional oncology indications. Kyverna will lead and fund preclinical and clinical development for KYV-201 and, as part of the agreement, Intellia granted Kyverna rights to use its proprietary ex vivo CRISPR/Cas9-based allogeneic platform in exchange for an equity stake in Kyverna. Intellia will be eligible to receive certain development and commercial milestone payments, as well as low- to mid-single-digit royalties on potential future sales and may choose to exercise an option to lead U.S. commercialization for KYV-201 under a co-development and co-commercialization agreement.
In October 2021, the Company executed a strategic collaboration with SparingVision to develop novel genomic medicines utilizing Intellia’s proprietary CRISPR/Cas9 technology for the treatment of ocular diseases. In addition, Intellia received an equity stake in SparingVision. As part of the collaboration, Intellia will receive an option for exclusive U.S. commercialization rights for product candidates arising from two of three collaboration targets, eligibility for development and commercial milestone payments, as well as royalties on potential future sales of products arising from the collaboration. The companies will additionally research and develop novel self-inactivating AAV vectors and LNP-based approaches to address delivery of CRISPR/Cas9 genome reagents to the retina.
Corporate Updates
In February, Intellia completed the acquisition of Rewrite Therapeutics, Inc. (Rewrite), a private biotechnology company focused on advancing novel DNA writing technologies. Rewrite’s DNA writing technology may enable a range of precise editing strategies. These include targeted corrections, insertions, deletions and the full range of single-nucleotide changes, which could provide new ways to edit disease-causing genes and broaden the therapeutic potential for genomic medicines.
In February, the Company announced a lease agreement to develop a 140,000-square-foot manufacturing facility in Waltham, Massachusetts, to support the manufacturing of key components for its CRISPR-based investigational therapies. The new manufacturing facility will be Good Manufacturing Practice (GMP) compliant and support both the preclinical through commercial supply for key components of Intellia’s CRISPR-based therapies. Additionally, this facility, in combination with existing capabilities and partnerships, will provide capacity and capabilities in support of Intellia’s expanding pipeline and commercial readiness.
Upcoming Events

The Company will participate in the following events during the first quarter of 2022:

AAAAI Annual Meeting, February 25-28, Phoenix
Cowen Healthcare Conference, March 7, Virtual
Barclays Capital Global Healthcare Conference, March 15, Miami
Guggenheim Healthcare Talks Genomic Medicines and Rare Disease Day, March 31, Virtual
Upcoming Milestones

The Company has set forth the following for pipeline progression:

NTLA-2001 for ATTR amyloidosis:
Report additional interim data from Phase 1 study on February 28
Initiate Part 2, a single-dose expansion cohort, of the Phase 1 study of NTLA-2001 in Q1 2022
Complete enrollment of Phase 1 study for both ATTRv-PN and ATTR-CM subjects in 2022
NTLA-2002 for HAE: Present interim data from Phase 1/2 study in 2H 2022
NTLA-3001 for AATD: Plan to file an IND or IND-equivalent in 2023
NTLA-5001 for AML: Continue to enroll patients in Phase 1/2a study in 2022
NTLA-6001 for CD30+ Lymphomas: Plan to present preclinical data at an upcoming scientific conference in 2022
Pipeline Expansion:
Advance at least one new in vivo development candidate by the end of 2022
Advance additional novel platform capabilities in 2022

Fourth Quarter and Full-Year 2021 Financial Results

Cash Position: Cash, cash equivalents and marketable securities were $1,086.0 million as of December 31, 2021, compared to $597.4 million as of December 31, 2020. The increase was driven by net proceeds of $648.3 million from a follow-on offering in the third quarter of 2021, $45.3 million of net proceeds from the Company’s "At the Market" (ATM) agreement, $43.1 million in proceeds from employee-based stock plans, and $6.3 million of funding for cost-sharing agreements received from Regeneron. These increases were offset in part by cash used to fund operations of approximately $254.7 million.
Collaboration Revenue: Collaboration revenue increased by $6.3 million to $12.9 million during the fourth quarter of 2021, compared to $6.6 million during the fourth quarter of 2020. This increase was primarily driven by $5.8 million in revenue recorded in 2021 from our joint venture with AvenCell.
R&D Expenses: Research and development expenses increased by $32.9 million to $71.2 million during the fourth quarter of 2021, compared to $38.2 million during the fourth quarter of 2020. This increase was primarily driven by the advancement of our lead programs, research personnel growth to support these programs and expansion of the development organization.
G&A Expenses: General and administrative expenses increased by $11.3 million to $22.1 million during the fourth quarter of 2021, compared to $10.8 million during the fourth quarter of 2020. This increase was primarily related to employee related expenses, including stock-based compensation of $3.8 million.
Net Loss: The Company’s net loss was $81.2 million for the fourth quarter of 2021, compared to $42.2 million during the fourth quarter of 2020.

Conference Call to Discuss Fourth Quarter and Full-Year 2021 Results

The Company will discuss these results on a conference call today, Thursday, February 24, at 8:00 a.m. ET.

To join the call:

U.S. callers should dial 1-833-316-0545 and international callers should dial 1-412-317-5726, approximately five minutes before the call. All participants should ask to be connected to the Intellia Therapeutics conference call.
Please visit this link for a simultaneous live webcast of the call.
A replay of the call will be available through the Events and Presentations page of the Investors & Media section on Intellia’s website at intelliatx.com, beginning on February 24, at 12:00 p.m. ET.

On February 24, 2022 Pulmatrix, Inc. ("Pulmatrix" or the "Company") (NASDAQ: PULM) a clinical stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary and non-pulmonary disease using its patented iSPERSE technology, reported a 1-for-20 reverse split of its common stock, to be effective as of 4:05 p.m. Eastern Time on February 28, 2022 (Press release, Pulmatrix, FEB 24, 2022, View Source,-Inc-Announces-1-for-20-Reverse-Stock-Split [SID1234608983]). The Company’s common stock is expected to trade on the Nasdaq Capital Market on a split-adjusted-basis when the market opens on March 1, 2022.

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At the special meeting of stockholders held on February 10, 2022, the Company’s stockholders authorized the Board of Directors (the "Board") to amend the Amended and Restated Certificate of Incorporation of the Company to effect a reverse stock split at a ratio in the range of 1-for-2 to 1-for-20, with the ratio within such range to be determined at the discretion of the Board and included in a public announcement. On February 15, 2022, the Board approved the implementation of the reverse stock split at a ratio of 1-for-20 (the "Reverse Split") with the timing described above, which will reduce the number of outstanding shares of the Company’s common stock from approximately 65,965,730 million shares to 3,298,301 million shares. The number of authorized shares of the Company’s common stock will remain at 200,000,000. No fractional shares will be issued following the Reverse Split.

Upon effectiveness, the Reverse Split will cause a reduction in the number of shares of common stock outstanding and issuable upon the conversion of the Company’s outstanding shares of preferred stock and the exercise of its outstanding stock options and warrants in proportion to the ratio of the Reverse Split and will cause a proportionate increase in the conversion and exercise prices of such preferred stock, stock options and warrants. The number of shares of common stock issuable upon exercise or vesting of outstanding stock options and warrants will be appropriately adjusted to give effect to the Reverse Split.

The Company’s common stock will continue to trade on the Nasdaq Capital Market under the symbol "PULM." The new CUSIP number for the common stock following the Reverse Split is 74584P301.

VStock Transfer, LLC, the Company’s transfer agent, will be acting as exchange agent for the Reverse Split. Registered stockholders holding their shares of common stock in book-entry or through a bank, broker or other nominee form will have their positions automatically adjusted to reflect the Reverse Split and do not need to take any action in connection with the Reverse Split, subject to brokers’ particular processes. For those stockholders holding physical stock certificates, VStock Transfer, LLC will send instructions for exchanging those certificates for new certificates representing the post-split number of shares. VStock Transfer, LLC can be reached at (212) 828-8436.

The Company is completing the Reverse Split in order to increase the trading price of its common stock to meet the minimum per share bid price requirement for continued listing on The Nasdaq Capital Market. The Company believes increasing the trading price of its common stock may make its common stock more attractive to a broader range of investors. Accordingly, the Company believes that the Reverse Split is in its stockholders’ best interests.

Additional information about the Reverse Split can be found in the Company’s definitive proxy statement filed with the Securities and Exchange Commission on December 30, 2021, a copy of which is also available at or at under the SEC Filings tab located on the Investors page.