Schrödinger Reports Financial Results for the Fourth Quarter and Full Year 2021

On February 24, 2022 Schrödinger, Inc. (Nasdaq: SDGR), whose physics-based software platform is transforming the way therapeutics and materials are discovered, reported financial results for the fourth quarter and full year ended December 31, 2021, and provided its financial outlook for 2022 (Press release, Schrodinger, FEB 24, 2022, View Source [SID1234608987]).

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Schrödinger also announced today the promotion of Karen Akinsanya, Ph.D., from executive vice president and chief biomedical scientist to president of R&D, therapeutics. The promotion reflects Dr. Akinsanya’s extraordinary contributions to leading Schrödinger’s drug discovery team, which leverages the company’s platform at scale, as well as her strategic contributions to expanding and advancing the company’s collaborative and wholly-owned programs.

"We are very pleased to have delivered a strong year, capped by fourth quarter software revenue of $38.6 million, a 55 percent increase over the fourth quarter of 2020. Looking ahead, we expect continued scale up and adoption of our software platform as our collaborators and customers continue to experience success in rapidly generating high-quality molecules to advance the next generation of therapeutics and materials," said Ramy Farid, Ph.D., chief executive officer of Schrödinger. "I’m also thrilled to announce Karen’s promotion today. Karen came to Schrödinger in 2018 with a vision to transform and accelerate drug discovery and has made incredible progress building a pipeline and a team that spans discovery to early clinical development."

"Our software platform is critical to our success in both our collaborative and internal drug discovery pipeline, and we are pleased to see multiple programs advance into preclinical and clinical development. This includes seven collaborative programs that have advanced into the clinic, which underscores the impact of our platform," stated Dr. Akinsanya. "Our internal pipeline is also advancing, and later this year we expect to initiate our first Phase 1 clinical study of our MALT1 inhibitor in patients with relapsed and resistant lymphoma."

2022 Financial Outlook

As of February 24, 2022, Schrödinger outlined the following expectations for the fiscal year ending December 31, 2022:

Total revenue expected to range from $161 million to $181 million, representing 17 percent to 31 percent growth over 2021

Total software revenue expected to range from $126 million to $136 million, representing 11 percent to 20 percent growth over 2021

Total drug discovery expected to range from $35 million to $45 million, representing 42 to 82 percent growth over 2021

Operating expense growth is expected to be slightly lower than the 42 percent reported for the year ended December 31, 2021

Software gross margin percentage is expected to be in the mid-70s

For the first quarter of 2022, software revenue is expected to range from $28 to $30 million.

2022-2023 Key Strategic Goals

Today, Schrödinger laid out the following strategic objectives for 2022-2023:

Ongoing growth in adoption and scale up of software platform, with target ACV growth of over 20 percent in 2023

Inflection in drug discovery revenue in 2023, with target 2023 drug discovery revenue of at least $100 million – excludes potential revenue from partnering the company’s three lead internal programs

IND submission for the MALT1 program in first half of 2022, IND submission for the CDC7 program in early 2023 and IND submission for the Wee1 program in 2023

Initiate a Phase 1 clinical study for the MALT1 program in the second half of 2022, and initiate Phase 1 clinical studies for the CDC7 and Wee1 programs in 2023

Publication of data from internal programs in peer-reviewed forums, including presentation of preclinical data from the Wee1 program in the first half of 2022

Multiple new internal programs leveraging internal structural biology capabilities

Materials science collaborations in multiple verticals, such as clean energy and sustainable materials

Recent Business Highlights

Internal Pipeline

Presented preclinical data from MALT1 program at ASH (Free ASH Whitepaper): In December, Schrödinger presented preclinical data on the company’s MALT1 allosteric inhibitor program at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting demonstrating that its MALT1 inhibitors showed single agent and combination anti-tumor activity with approved anti-cancer therapies in preclinical models of B-cell lymphoma. The data presented suggest that targeting MALT1 may expand therapeutic options for patients with selected B-cell lymphomas, such as activated B-cell subtype of diffuse large B cell lymphoma, with the possibility of expanding into other B-cell lymphomas such as mantle cell lymphoma.

Expanded internal pipeline: During 2021, Schrödinger added two new programs to its internal pipeline in the areas of oncology and immunology.

Collaborative Programs

In January 2022, Nimbus announced initiation of a Phase 2b study of its investigational oral allosteric TYK2 inhibitor in patients with active psoriatic arthritis.

In November 2021, Nimbus announced the initiation of its first-in-human Phase 1/2 study of its HPK1 inhibitor, NDI-101150, in patients with solid tumors.

Underlying Science

Published 27 peer-reviewed papers across life sciences and materials science in 2021: During 2021, Schrödinger scientists continued to make scientific advances and were authors on 27 publications in peer-reviewed life sciences and materials sciences journals. Recent publications include an article in collaboration with Janssen to assess the performance of affinity predictions as well as data from a collaboration with scientists at Samyang Corp. aimed at accelerating the design of photoinitiators, which are light sensitive molecules used in inks and coatings, adhesives and other products.

Corporate

Acquired XTAL Biostructures to expand structural biology capabilities: Last month, Schrödinger announced the $6 million all-cash purchase of XTAL BioStructures, Inc., a private company based in the Greater Boston area that provides structural biology services, including biophysical methods, protein production and purification, and X-ray crystallography, to the pharmaceutical and biotechnology industries. The acquisition of XTAL BioStructures enables Schrödinger to pursue scientific advancements in the field of structural biology, augment its ability to produce high quality target structures for its drug discovery programs, and expand its future offerings to include an advanced and differentiated service that provides

customers access to protein structures that have been computationally validated and are ready for structure-based virtual screening and lead optimization.

Established operations in South Korea and expanded presence in India: In January 2022, Schrödinger established operations in Seoul, South Korea to strengthen its global expansion efforts, enhance competitive positioning and support both life science and materials sciences customers in this region. In December 2021, Schrödinger expanded its operations in Hyderabad, India. Employees in the Hyderabad location will focus on a broad range of strategic initiatives across the company, including software development and support of Schrödinger’s software platform, and its drug discovery programs.

Webcast and Conference Call Information

Schrödinger will host a conference call to discuss its fourth quarter and full year 2021 financial results on Thursday, February 24, 2022, at 4:30 p.m. ET. To participate in the live call, please dial (833) 727-9520 (domestic) or +1 (830) 213-7697 (international) and refer to conference ID 3169814. The webcast can also be accessed under "News & Events" in the investors section of Schrödinger’s website, View Source The archived webcast will be available on Schrödinger’s website for approximately 90 days following the event.

SANGAMO THERAPEUTICS REPORTS FOURTH QUARTER AND FULL YEAR 2021 FINANCIAL RESULTS AND RECENT BUSINESS HIGHLIGHTS

On February 24, 2022 Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicines company, reported fourth quarter and full year 2021 financial results and recent business highlights (Press release, Sangamo Therapeutics, FEB 24, 2022, View Source [SID1234608986]).

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"In 2021, we continued to advance the development of genomic medicines for patients across multiple therapeutic areas using our innovative technologies," said Sandy Macrae, Chief Executive Officer of Sangamo. "We along with our partners presented compelling clinical data in our three lead programs and advanced development of preclinical product candidates using our second-generation technologies of CAR-Treg cell therapy for autoimmune diseases and engineered zinc finger transcription factors for neurological disorders. In addition, we completed and brought online our cell therapy manufacturing facilities in Brisbane and Valbonne and now have operational AAV and cell therapy facilities in-house. We believe this progress positions us well to generate long-term value for our shareholders."
Fourth Quarter Updates and Recent Business Highlights
Fabry disease – Updated preliminary Phase 1/2 data show continued safety, tolerability and elevated α-Gal A enzyme activity; Phase 3 planning initiated
•We presented updated preliminary clinical data from the Phase 1/2 STAAR study evaluating isaralgagene civaparvovec, or ST-920, our wholly owned gene therapy product candidate for the treatment of Fabry disease at the 18th Annual WORLDSymposium earlier this month. As of the November 9, 2021 cutoff date:
◦The four patients in Cohorts 1 and 2 all exhibited above normal α-Gal A activity, ranging from 3-fold to 15-fold above mean normal at last measurement.
◦The two patients in Cohort 1 maintained elevated α-Gal A activity for one year and are now in the long-term follow-up study.
◦The first patient in Cohort 3 exhibited α-Gal A activity within mean normal range by week 2.
◦Lyso-Gb3 levels remained significantly reduced in the patient who exhibited the highest baseline levels of this biomarker.
◦The gene therapy candidate continued to be generally well tolerated in the five treated patients.
•The sixth patient in the STAAR study, who is the second patient in Cohort 3, was dosed after the cutoff date. We expect to provide updated data in the second half of 2022.
•Based on the Phase 1/2 data, we have initiated Phase 3 planning.
Sickle cell disease – Updated preliminary Phase 1/2 proof-of-concept safety, tolerability and efficacy results
•We presented updated preliminary proof-of-concept clinical data from the Phase 1/2 PRECIZN-1 study of SAR445136, a zinc finger nuclease gene-edited cell therapy candidate in development with Sanofi, at the 63rd American Society for Hematology Annual Meeting and Exposition (ASH 2021). As of the September 22, 2021 cutoff date:
◦No adverse events related to SAR445136 were reported.
◦All four treated patients experienced increases in total hemoglobin, fetal hemoglobin and percent F cells.
◦None of the patients required blood transfusions post engraftment.
•We expect that the next four patients treated in the study will be dosed with a product candidate manufactured using improved methods, which have been shown in internal experiments to increase long-term progenitor cells. We expect to complete dosing of these patients in the third quarter of this year.

•We and Sanofi are collaborating on an orderly transition of Sanofi’s rights and obligations under the program to Sangamo on June 28, 2022, while we explore options to advance the program, including seeking a potential new partner.
Hemophilia A – Updated Phase 1/2 results show sustained bleeding control in highest dose cohort through two years following giroctocogene fitelparvovec gene therapy
•With our collaborator Pfizer, we presented updated follow-up data from the Phase 1/2 Alta study of giroctocogene fitelparvovec, an investigational gene therapy for patients with moderately severe to severe hemophilia A, at ASH (Free ASH Whitepaper) 2021. As of the October 1, 2021 cutoff date:
◦At 104 weeks, the five patients in the highest dose 3e13 vg/kg cohort had mean factor VIII (FVIII) activity of 25.4% via chromogenic clotting assay. In this cohort, mean annualized bleeding rate was 0.0 in the first year post-infusion and was 1.4 throughout the total duration of follow-up. All bleeding events occurred after week 69 post-infusion. Two patients experienced bleeding events necessitating treatment with exogenous FVIII. No participants in the highest dose cohort had resumed prophylaxis.
◦Giroctocogene fitelparvovec continued to be generally well-tolerated.
•Regarding the Phase 3 AFFINE trial of giroctocogene fitelparvovec, Pfizer has announced that it hopes to obtain agreements from health authorities to resume the AFFINE trial and to begin to reopen trial sites in the first half of 2022. This trial was previously paused when some of the patients treated in this trial experienced FVIII activity greater than 150% following treatment. Pfizer has announced that it currently is in the process of submitting a protocol amendment to health authorities in the countries where this trial is being conducted and preparing responses to the U.S. FDA clinical hold. Over 50% of the patients have been enrolled in the Phase 3 AFFINE trial.
Renal Transplant Rejection – First patient enrolled and expected to be dosed soon in Phase 1/2 study
•The first patient has been enrolled and is expected to be dosed soon in our Phase 1/2 STEADFAST study evaluating TX200, our wholly owned autologous HLA-A2 CAR Treg cell therapy product candidate treating patients receiving an HLA-A2 mismatched kidney from a living donor. We expect the second patient in this study to be dosed by the middle of 2022. We continue to open study sites and screen patients.
Manufacturing – AAV and cell therapy cGMP manufacturing facilities fully operational
•We completed and brought online our in-house cell therapy manufacturing facilities in our Brisbane, California headquarters and in our Valbonne, France facilities in 2021, in addition to the in-house AAV manufacturing facilities we brought online in Brisbane in 2020.
Fourth Quarter and Full Year 2021 Financial Results
Consolidated net loss for the fourth quarter ended December 31, 2021 was $37.5 million, or $0.26 per share, compared to net loss of $40.7 million, or $0.29 per share, for the same period in 2020. For the year ended December 31, 2021, consolidated net loss was $178.3 million, or $1.23 per share, compared to consolidated net loss of $121.1 million, or $0.90 per share, for the year ended December 31, 2020.
Revenues
Revenues for the fourth quarter ended December 31, 2021 were $28.0 million, compared to $25.8 million for the same period in 2020.
The increase of $2.2 million in revenues was primarily due to increase in recognition of upfront license fees and research revenue of $3.7 million under our collaboration agreement with Novartis. The increase was partially offset by a decrease of $1.4 million in revenue related to the termination of our licensing agreement with Dow AgroSciences LLC in July 2021.
Revenues were $110.7 million in 2021, compared to $118.2 million in 2020. The decrease in revenues was primarily due to a decrease of $47.4 million of milestone fees and recognition of upfront license fees related to our giroctocogene fitelparvovec and C9ORF72 collaboration agreements with Pfizer resulting from the completion of our activities in 2020 and a decrease of $5.4 million from our collaboration agreements with Kite and Sanofi. These decreases were partially offset by higher revenues of $32.7 million and $14.4 million related to our collaboration agreements with Novartis and Biogen, respectively.
Total operating expenses on a GAAP basis for the fourth quarter ended December 31, 2021 were $67.9 million compared to $69.2 million for the same period in 2020. Non-GAAP operating expenses, which exclude stock-based compensation expense, for the fourth quarter ended December 31, 2021 were $59.8 million, compared to $62.6 million for the same period in 2020.
The decrease in total operating expenses in the fourth quarter on a GAAP basis was primarily due to a reduction of research and development expenses by $5.2 million related to dissolution of the repayment obligation of a grant from California Institute for Regenerative Medicine associated with the discontinuation of the ST-400 program. This decrease was partially offset by an increase of $4.6 million in research and development expenses due to increased headcount to support the advancement of our clinical trials and our ongoing collaborations, and an increase in manufacturing and overhead costs as we ramped up our internal manufacturing operations.
Total operating expenses on a GAAP basis in 2021 were $294.0 million compared to $247.7 million in 2020. Non-GAAP operating expenses, which exclude stock-based compensation expense, were $261.0 million and $222.0 million in 2021 and 2020, respectively.
The increase in total operating expenses in the full year on a GAAP basis was primarily driven by our higher clinical and manufacturing supply expenses along with our increased headcount to support the advancement of our clinical trials and our ongoing collaborations and an increase in manufacturing and overhead costs as we ramped up our internal manufacturing operations.
Cash, cash equivalents and marketable securities
Cash, cash equivalents and marketable securities as of December 31, 2021 were $464.7 million compared to $692.0 million as of December 31, 2020.
Initial Financial Guidance for 2022
On a GAAP basis, we expect total operating expenses in the range of approximately $320 million to $350 million in 2022, which includes non-cash stock-based compensation expense.
We expect non-GAAP total operating expenses, excluding estimated non-cash stock-based compensation expense of approximately $40 million, in the range of approximately $280 million to $310 million in 2022.
Conference Call
Sangamo will host a conference call today, February 24, 2022, at 4:30 p.m. Eastern Time, which will be open to the public. The call will also be webcast with live Q&A and can be accessed via a link on the Sangamo Therapeutics website in the Investors and Media section under Events and Presentations.
The conference call dial-in numbers are (877) 377-7553 for domestic callers and (678) 894-3968 for international callers. The conference ID number for the call is 2235808. Participants may access the live webcast via a link on the Sangamo Therapeutics website in the Investors and Media section under Events and Presentations. A conference call replay will be available for one week following the conference call. The conference call replay numbers for domestic and international callers are (855) 859-2056 and (404) 537-3406, respectively. The conference ID number for the replay is 2235808.

RS Oncology, LLC announces the initiation of its MITOPE Phase 1/2 clinical trial

On February 24, 2022 RS Oncology, LLC, (RSO) a biotechnology company focused on the treatment of patients with malignant pleural effusion (MPE) and mesothelioma, reported the opening of its first-in-human Phase 1/2 clinical trial (MITOPE) at the University Hospitals of Leicester in the U.K (Press release, RS Oncology, FEB 24, 2022, View Source [SID1234608985]). RSO will be evaluating its novel treatment, RSO-021, against mitochondrial PRX3 enzyme, regulating oxidative stress pathways in cancer cells .

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This novel therapeutic approach has proven in pre-clinical studies to significantly reduce tumor burden in malignant mesothelioma and other cancer types by irreversibly binding and inhibiting PRX3 enzyme in the antioxidant signaling network within the mitochondria of malignant cells.

"The RSO team is excited to begin treating patients at The University of Leicester, U.K. The MITOPE trial is a culmination of substantial innovative work completed by our academic collaborators at University of Vermont, College of Medicine and Wake Forest School of Medicine. This trial is an important step in improving treatment options for people suffering from malignant pleural effusion and mesothelioma," stated Jarrett Duncan, RS Oncology’s CEO. "Our novel therapeutic approach has shown pre-clinical efficacy and safety in nearly a dozen cancer types. We eagerly await the clinical data validating RSO-021 as a safe and effective treatment option for patients with cancer. This novel treatment is desperately needed in the clinical community as patients lack effective second line treatment options," added COO and Head of Business Development, George Naumov.

About MITOPE clinical trial

The MITOPE Phase 1/2 clinical trial is a first-in-human study that will evaluate RSO-021 as a treatment for patients suffering from MPE and mesothelioma. RSO-021 is a novel irreversible inhibitor of a key mitochondrial enzyme PRX3 (upregulated in cancer cells) regulating oxidative stress pathways. Treatment with RSO-021 will be administered weekly via an intrapleural catheter after routine pleural effusion drainage. The MITOPE trial is planned to open in six UK-based clinical institutions and will recruit patients with the help of Meso UK. For more MITOPE information review View Source or contact [email protected]. The study is supported by NIHR.

Relay Therapeutics Reports Fourth Quarter and Full Year 2021 Financial Results and Corporate Highlights

On February 24, 2022 Relay Therapeutics, Inc.(Nasdaq: RLAY), a clinical-stage precision medicine company transforming the drug discovery process by combining leading-edge computational and experimental technologies, reported fourth quarter and full year 2021 financial results and corporate highlights (Press release, Relay Therapeutics, FEB 24, 2022, View Source [SID1234608984]).

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"2021 was the year that Relay Therapeutics showed clinical data for the first time, with the RLY-4008 disclosure supporting our belief that our approach of integrating experimental techniques and computational power can make the discovery of medicines more efficient and effective," said Sanjiv Patel, M.D., president and chief executive officer. "We also grew our team, continued to execute against our deep and broad precision medicine pipeline and pushed the boundaries of our Dynamo platform, through both internal innovation and the integration of an acquisition. We’ve entered 2022 with three clinical stage programs, a robust preclinical pipeline and a cash runway into at least 2025. We are excited to continue our efforts to achieve our goal of bringing life-changing therapies to patients."

2021 Corporate Highlights

RLY-4008

•Presented preclinical data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting for RLY-4008, a highly selective irreversible and oral small molecule inhibitor of FGFR2
•Announced interim clinical data at the AACR (Free AACR Whitepaper)-NCI-EORTC Molecular Targets Conference for RLY-4008 in a first-in-human trial in patients with FGFR2-altered cholangiocarcinoma, breast cancer and multiple other solid tumors

oThe data suggest that RLY-4008 is the first investigational therapy designed to selectively bind to FGFR2 to avoid off-isoform toxicities for the treatment of patients with FGFR2-altered tumors, with study investigators reporting robust inhibition of FGFR2 in the first 49 subjects that was not shown to be limited by off-target toxicities, including hyperphosphatemia and diarrhea
oThe interim clinical data included results from FGFR2-altered solid tumors, with approximately 80% of all patients treated achieving reductions in tumor size at the cut-off date of September 9, 2021
oIn pan-FGFRi treatment-naïve cholangiocarcinoma patients, RLY-4008 demonstrated tumor shrinkage in all six pan-FGFR treatment-naïve FGFR2 fusion positive cholangiocarcinoma patients, with three achieving confirmed partial responses, one of whom went on to surgery with curative intent
oRLY-4008 also demonstrated encouraging early activity in gene amplifications and mutations, such as the first reported objective response for an FGFR inhibitor in a patient with FGFR2-mutated breast cancer, based on publicly available information
•Initiated expansion cohorts at 70 mg once daily in December 2021
•In January 2022, the FDA granted orphan drug designation to RLY-4008 for the treatment of cholangiocarcinoma

RLY-2608

•Presented preclinical data at the AACR (Free AACR Whitepaper)-NCI-EORTC Molecular Targets Conference and 2021 San Antonio Breast Cancer Symposium for RLY-2608, the first known allosteric, pan-mutant and isoform-selective PI3Kα inhibitor in a novel allosteric pocket
oThe data help support the clinical development of RLY-2608 both in single agent and combination clinical trials for patients with PIK3CA (PI3Kα) mutant tumors, including PI3Kα-mutant, HR+/HER2- breast cancer
oThe data indicate RLY-2608 synergizes with fulvestrant and the CDK4/6 inhibitor abemaciclib in cell viability assays in PIK3CAmut/ER+/HER2- cell lines
oOral administration of RLY-2608 in combination with fulvestrant or abemaciclib led to improved efficacy compared to either agent alone in ER+/HER2- xenograft models representing the most commonly observed PIK3CA mutations in breast cancer (H1047R, E542K, E545K)
oThe triple combination of all three agents resulted in deep regressions across all models, and additionally, the combination arms had similar tolerability to monotherapy arms
•Dosed the first patient in the dose escalation part of the RLY-2608 first-in-human trial in December 2021

Corporate Highlights

•Genentech initiated the cohort of RLY-1971/GDC-1971, an inhibitor of SHP2, in combination with GDC-6036, an inhibitor of KRAS G12C, in a Phase 1b trial in July 2021

•Extended leadership in integrating computational and experimental approaches, including by acquiring ZebiAI Therapeutics, Inc. and unlocking our ability to develop our machine learning powered DNA encoded library platform, REL-DEL (Relay DEL)

•Entered into a worldwide strategic collaboration with EQRx, Inc. to discover, develop and commercialize novel medicines against validated oncology targets, starting with one program and with the ability to mutually agree to add additional programs to the collaboration in the future

•Strengthened the executive team with multiple new appointments leveraging the experienced senior leaders from within Relay Therapeutics and greatly expanded the team through the addition of approximately 100 employees

2022 Anticipated Milestones and Objectives

•Continue to enroll patients in the RLY-4008 expansion cohorts and provide a clinical data update in the second half of 2022

•Continue to enroll patients in the RLY-2608 first-in-human trial and gain experience in the clinic while also progressing against the rest of the preclinical PI3Kα mutant franchise

•Disclose an additional target in the first half of this year

•Genentech to continue driving the development and disclosures of RLY-1971/GDC-1971 in combination with GDC-6036 in the ongoing Phase 1b trial

Fourth Quarter and Full Year 2021 Financial Results

Cash, Cash Equivalents and Investments: As of December 31, 2021, cash, cash equivalents and investments totaled approximately $958.1 million, compared to $678.1 million as of December 31, 2020. The change in cash reflects the addition of $382.2 million in net proceeds from Relay Therapeutics’ public financing in October 2021. Relay Therapeutics expects its current cash, cash equivalents and investments will be sufficient to fund its current operating plan into at least 2025.

R&D Expenses: Research and development expenses were $51.9 million for the fourth quarter of 2021, as compared to $32.1 million for the fourth quarter of 2020. This increase was primarily due to $4.2 million of increased employee related costs, $7.9 million of increased outside and consulting expense and $6.9 million of increased clinical trial and related costs. Research and development expenses were $172.7 million for the full year 2021, as compared to $99.9 million for the full year 2020. The increase was primarily due to $30.0 million of increased employee related costs, including $10.2 million of additional stock-based compensation expense, $25.3 million of increased external R&D expenses and $10.9 million of increased clinical trial expenses.

G&A Expenses: General and administrative expenses were $15.5 million in each of the three-month periods ended December 31, 2021 and 2020. General and administrative expenses were $57.4 million for the full year 2021, as compared to $38.6 million for the full year 2020. The increase was primarily due to $12.8 million of increased employee related costs, including $6.3 million of additional stock-based compensation expense, and $6.0 million of other general and administrative expenses.

Net Income/Loss: Net loss was $67.5 million for the fourth quarter of 2021, as compared to net income of $35.3 million for the fourth quarter of 2020. Net loss was $363.9 million for the full year 2021, or a net loss per share of $3.82, as compared to a net loss of $52.4 million for the full year 2020, or a net loss per

share of $5.40. The increase in net loss included one-time expenses of $134.9 million in 2021 associated with the acquisition of ZebiAI Therapeutics, Inc.

Pulmatrix, Inc. Announces 1-for-20 Reverse Stock Split

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.