On April 29, 2022 Theralase Technologies Inc. ("Theralase" or the "Company") (TSXV: TLT) (OTCQB: TLTFF), a clinical stage pharmaceutical company dedicated to the research and development of light activated PhotoDynamic Compounds ("PDC") and their associated drug formulations intended to safely and effectively destroy various cancers reported its audited annual consolidated 2021 financial statements (Press release, Theralase, APR 29, 2022, View Source [SID1234613460]).

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Financial Highlights:

For the years ended December 31st:

Total revenue decreased 16%, year over year, and is primarily attributed to the slower than anticipated Canadian and US economic recovery from the COVID-19 pandemic in 2021.

Cost of sales for the year ended December 31, 2021 was $470,698 or 60% of revenue resulting in a gross margin of $309,943 or 40% of revenue. In comparison, the cost of sales in 2020 was $659,442 or 71% of revenue resulting in a gross margin of $269,680 or 29% of revenue. The gross margin increase, as a percentage of sales, year over year, is primarily attributed to a decrease in labour and material costs.

Selling expenses for the year ended December 31, 2021, decreased to $363,886, from $447,882 in 2020, a 19% decrease. The decrease in selling expenses is primarily attributed to the COVID-19 pandemic, resulting in reduced advertising (43%), commissions (17%) and salaries (8%).

Administrative expenses for the year ended December 31, 2021, decreased to $1,562,867 from $2,070,261 in 2020, a 25% decrease. The decrease in administrative expenses is primarily attributed to decreased spending on director and advisory fees (37%) and general and administrative expenses (21%). Stock based compensation expense decreased 63% in 2021 due to a reduction in stock options granted.

Net research and development expenses for the year ended December 31, 2021, decreased to $2,924,733 from $3,448,243 in 2020, a 15% decrease. The decrease in research and development expenses for the year ended December 31, 2021, is primarily attributed to the significant delay in patient enrollment and treatment in the Phase II NMIBC clinical study ("Study II") due to the COVID-19 pandemic. Research and development expenses represented 62% of the Company’s operating expenses and represents investment primarily into the research and development of the Company’s ACT technology.

The net loss for the year ended December 31, 2021 was $4,411,061 which included $618,586 of net non-cash expenses (i.e.: amortization, stock-based compensation expense and foreign exchange gain/loss).

This compared to a net loss in 2020 of $5,598,540 which included $1,202,017 of net non-cash expenses. The ACT division represented $3,426,488 of this loss (78%) for the year ended December 31, 2021.

The decrease in net loss is primarily attributed to the following:

Significant delay in patient enrollment and treatment due to the COVID-19 pandemic, resulting in decreased research and development expenses in Study II.
Decreased salaries due to the COVID-19 pandemic, resulting in the resignation or termination of certain non-essential administrative, research and production personnel.
Operational Highlights:

1. Break Through Designation Update. In 2020, the FDA granted Theralase Fast Track Designation ("FTD") for Study II. As a Fast Track designee, Theralase has access to early and frequent communications with the FDA to discuss Theralase’s development plans and ensure the timely collection of clinical data to support the approval process. FTD can also lead to Break Through Designation ("BTD"), Accelerated Approval ("AA") and/or Priority Review, if certain criteria are met, which the FDA has previously defined to the Company for BTD to represent a complete clinical dataset on approximately 20 to 25 patients enrolled, treated and followed-up, who demonstrate significant safety and efficacy clinical outcomes.

In 2021, Theralase completed its first significant milestone of Study II by enrolling and treating 25 patients. The Company will compile a clinical data report for submission to the FDA in support of the grant of a BTD approval after completion of the 450 day assessment for 25 patients, expected in 4Q2022, subject to the Clinical Study Sites ("CSS") availability to complete all required assessments.

2. COVID-19 Pandemic Update. In the ACT division, the Company continues to experience delays in patient enrollment and treatment rates in Study II due to the ongoing COVID-19 pandemic; however, these rates have improved as Canada and the US commence their recovery from the business and economic impacts of the COVID-19 pandemic.

In the CLT division, the Company continues to experience variations in sales and the timing of these sales due to the ongoing COVID-19 pandemic and has taken actions to minimize expenses by eliminating non-essential personnel and imposing a temporary hiring freeze commencing in March 2020. The Company lifted the temporary hiring freeze in 4Q2021, now that the Canadian and United States ("US") economies have started to demonstrate a sustainable business and economic recovery from COVID-19.

3. Clinical study site status and update. The Company has successfully launched five CSS in Canada and seven CSSs in the US that are open for patient enrollment and treatment for a total of 12 CSSs.

To date, the phase II NMIBC clinical study has enrolled and provided the primary study treatment for 35 patients (including three patients from Phase Ib study treated at the Therapeutic Dose) for a total of 38 patients.

The interim analysis of the Study II Evaluable Patient clinical data (with 3 patients from Study Ib) supports the following provisional conclusions:

Note: Evaluable Patients are defined as patients who have evaluable data; hence, have been evaluated by the principal investigator and thus excludes patients who have clinical data pending.

For evaluable patients, who completed Study II, who achieved a CR at 90 days, 78% continue to demonstrate that CR at 180 and 270 days, while 56% continue to demonstrate that CR at 360 and 450 days.

Note: The current interim analysis presented above, should be read with caution, as the reported clinical data is extremely interim in its presentation, as Study II is still ongoing and new clinical data collected may or may not continue to support the current trends.

Note: The data analysis is only a representation of the data accrued to date with and does not intend to represent a tendency or portray any conclusion as to the effectiveness, duration or safety of the investigational treatment. A significant number of treated patients are still pending assessments.

For a more comprehensive analysis of the interim data please refer to Managements Discussion and Analysis ("MD&A") for the year ended December 31, 2021.

4. Additional cancer indications. The Company has demonstrated significant anti-cancer efficacy of Rutherrin, when activated by laser light or radiation treatment across numerous preclinical models; including: Glio Blastoma Multiforme ("GBM") and Non-Small Cell Lung Cancer ("NSCLC"). The Company has commenced Non – Good Laboratory Practices ("GLP") toxicology studies with Rutherrin in animals to help determine the maximum recommended human dose of the drug, when administered systemically into the human body, via intravenous injections. Theralase plans to commence GLP toxicology studies in animals in 4Q2022.

5. COVID-19 Research Update. In April 2021, Theralase executed a Collaborative Research Agreement ("CRA") with the National Microbiology Laboratory, Public Health Agency of Canada ("PHAC") for the research and development of a Canadian-based SARS-CoV-2 ("COVID-19") vaccine. Under the terms of the agreement, Theralase and PHAC are collaborating on the development and optimization of a COVID-19 vaccine by treating the SARS-CoV-2 virus grown on cell lines with Theralase’s patented PDC and then light activating it with Theralase’s proprietary TLC-3000A light technology to inactivate the virus and create the fundamental building blocks of a COVID-19 vaccine. This inactivated virus would then be purified and used to inoculate naive animals followed by challenge with the SARS-CoV-2 virus, to ascertain the efficacy of the vaccine. The project is entitled, "Photo Dynamic Compound Inactivation of SARS-CoV-2 Vaccine" and commenced in mid-April 2021.

In February, 2022 Theralase reported that PHAC had demonstrated that light-activated TLD-1433, was effective in rapidly inactivating the SARS-CoV-2 virus by up to 99.99%, compared to control in an in vitro study. Further research is required to confirm these findings.

These results have now laid the groundwork for the next phase of the CRA, which is evaluating the Theralase COVID-19 vaccine in the ability to prevent animals from contracting COVID-19, when exposed to the virus, which is expected to commence in 2Q2022 and be completed by 4Q2022.

Note: The Company does not claim or profess that they have the ability to treat, cure or prevent the contraction of the COVID-19 coronavirus.

About Study II

Study II utilizes the therapeutic dose of TLD-1433 (0.70 mg/cm2) activated by the proprietary TLC-3200 medical laser system. Study II is focused on enrolling and treating approximately 100 to 125 BCG-Unresponsive NMIBC Carcinoma In-Situ ("CIS") patients in up to 15 Clinical Study Sites ("CSS") located in Canada and the United States.

About TLD-1433

TLD-1433 is a patented PDC with over 10 years of published peer reviewed preclinical research and is currently under investigation in Study II.

On April 29, 2022 Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH), a biopharmaceutical company focused on discovering, developing, and commercializing important new medicines to improve the lives of people with cancer, reported the closing of its underwritten public offering of 7,501,239 shares of its common stock, and to certain investors in lieu thereof, pre-funded warrants to purchase 9,748,761 shares of its common stock at an exercise price of $0.01 per share (Press release, Deciphera Pharmaceuticals, APR 29, 2022, View Source [SID1234613225]). The shares of common stock sold include 2,250,000 shares pursuant to the option granted by Deciphera to the underwriters, which option was exercised in full. The public offering price of each share of common stock was $10.00 and the public offering price of each pre-funded warrant was $9.99 per pre-funded warrant. The aggregate gross proceeds to Deciphera from this offering were approximately $172.5 million, before deducting underwriting discounts and commissions and other estimated offering expenses.

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Deciphera intends to use the net proceeds from the offering to continue to fund the development of vimseltinib including in its pivotal Phase 3 MOTION study of vimseltinib in tenosynovial giant cell tumor patients currently underway, additional clinical trials as well as clinical research outsourcing and manufacturing of clinical trial material and pre-commercial and medical affairs capabilities related to vimseltinib; to fund the development of DCC-3116 including multiple Phase 1b combination studies and potential Phase 2 expansion combination cohorts in multiple tumor types as well as clinical research outsourcing and manufacturing of clinical trial material; to fund the research and development of Deciphera’s pan-RAF program and other new research activities for potential drug candidates from its proprietary kinase switch control inhibitor platform; and the remainder for working capital purposes, including general operating expenses.

J.P. Morgan and Jefferies acted as joint book-running managers for the offering.

The securities described above were offered by Deciphera pursuant to a shelf registration statement on Form S-3 (No. 333-236389) that was declared effective by the Securities and Exchange Commission (SEC) on March 10, 2022. A copy of the final prospectus supplement and accompanying prospectus relating to the offering has been filed with the SEC and may be obtained by contacting: J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at 866-803-9204, or by email at [email protected]; or Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at 877-821-7388 or by email at [email protected].

This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that state or jurisdiction.

On April 29, 2022 Forma Therapeutics Holdings, Inc. (Nasdaq: FMTX), a clinical-stage biopharmaceutical company focused on sickle cell disease, prostate cancer and other rare hematologic diseases and cancers, reported that it will release first quarter 2022 financial results Friday, May 6, 2022 (Press release, Forma Therapeutics, APR 29, 2022, View Source [SID1234613240]). Forma management will host an investment community conference call at 8 a.m. Eastern Daylight Time (EDT) on May 6, 2022 to discuss these financial results and provide a business update.

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Investors may participate by dialing (833) 301-1146 in the U.S. or Canada, or (914) 987-7386 internationally, and by referring to Conference ID 1879297. A live webcast of the conference call will be available in the "News & Investors" section of Forma’s website at www.formatherapeutics.com.

On April 29, 2022 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") reported that AstraZeneca (LSE/STO/Nasdaq: AZN) has now dosed the first patient in its Phase 3 clinical trial, PACIFIC-9, evaluating durvalumab (PD-L1) in combination with monalizumab (NKG2A) or AstraZeneca’s oleclumab (anti-CD73) in patients with unresectable, Stage III non-small cell lung cancer (NSCLC) who have not progressed following definitive platinum-based concurrent chemoradiation therapy (CRT) (Press release, Innate Pharma, APR 29, 2022, View Source [SID1234613181]).

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The purpose of the study, which is sponsored by AstraZeneca, is to determine if the addition of monalizumab or oleclumab to standard-of-care durvalumab improves outcomes for patients in this setting.

Monalizumab, Innate’s lead partnered asset, is a potentially first-in-class immune checkpoint inhibitor targeting NKG2A receptors expressed on tumor-infiltrating cytotoxic CD8+ T cells and NK cells.

Dosing of the first patient in this trial has triggered a $50 million milestone payment from AstraZeneca to Innate.

"We are very pleased that our key late-stage asset, monalizumab, has progressed into a second Phase 3 trial with our partner, AstraZeneca. The launch of PACIFIC-9 represents an important financial milestone for Innate, as it triggers a $50 million milestone payment that reinforces our cash position," said Mondher Mahjoubi, Chief Executive Officer of Innate Pharma. "Based on the recent COAST clinical trial results, we are excited about the potential of extending the clinical benefit of durvalumab with the addition of monalizumab in patients with unresectable, Stage III NSCLC."

Detailed results from the randomized COAST Phase 2 trial were published in the Journal of Clinical Oncology on April 22, 2022. AstraZeneca initially presented the results during the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2021 in September 2021 (see AstraZeneca press release). The results of the interim analysis showed monalizumab in combination with durvalumab increased objective response rate (ORR) and prolonged progression-free survival (PFS) versus durvalumab alone in patients with unresectable, Stage III NSCLC who had not progressed after CRT. The Journal of Clinical Oncology publication now includes exploratory subgroup analysis.

"Durvalumab has transformed the treatment of patients with unresectable, Stage III NSCLC, and we’re excited by the promise of extending its benefit through novel combinations with two potential first-in-class monoclonal antibodies demonstrating strong clinical activity. Based on the stand-out results from COAST, we are pleased that the Phase 3 trial is underway, which we hope will bring new treatment options to patients and further increase the potential for long-term survival benefit in this setting," said Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca.

About PACIFIC-9:

PACIFIC-9 is a Phase 3, randomised, double-blind, multicenter global study to determine the efficacy and safety of durvalumab alone or in combination with oleclumab or monalizumab+ in patients with unresectable, Stage III NSCLC who have not progressed on definitive, platinum-based CRT.​

The first patient has been dosed in April 2022. The PACIFIC-9 Phase 3 trial is now looking to recruit patients across more than 200 centers in the coming months. ​

Stage III NSCLC:

In 2020, an estimated 2.2 million people were diagnosed with lung cancer worldwide1. Lung cancer is broadly split into NSCLC and small cell lung cancer, with 80-85% classified as NSCLC.2,3,4 Stage III NSCLC represents approximately one quarter of NSCLC incidence5.

Stage III (locally advanced) NSCLC is commonly divided into three subcategories (IIIA, IIIB and IIIC), defined by how much the cancer has spread locally. In contrast to Stage IV, when cancer has spread (metastasised), the majority of Stage III patients are currently treated with curative intent2,6.

The majority of Stage III NSCLC patients are diagnosed with unresectable tumours2,5.

About Monalizumab:

Monalizumab is a potentially first-in-class immune checkpoint inhibitor targeting NKG2A receptors expressed on tumor infiltrating cytotoxic CD8+ T cells and NK cells.

NKG2A is an inhibitory checkpoint receptor for HLA-E. By expressing HLA-E, cancer cells can protect themselves from killing by NKG2A+ immune cells. HLA-E is frequently overexpressed in the cancer cells of many solid tumors and hematological malignancies. Monalizumab may reestablish a broad anti-tumor response mediated by NK and T cells, and may enhance the cytotoxic potential of other therapeutic antibodies7.

The ongoing development for monalizumab is focused on investigating monalizumab in various combination strategies in different malignancies, including the Phase 2 NeoCOAST trial in the neoadjuvant early-stage setting.

About the Innate-AstraZeneca monalizumab agreement:

In October 2018, AstraZeneca obtained full oncology rights to monalizumab by exercising its option under the co-development and commercialization agreement initiated in 2015.

The financial terms of the agreement include potential cash payments up to $1.275 billion to Innate Pharma. Including the $50 million payment triggered by dosing the first patient in the Phase 3 PACIFIC-9 clinical trial, Innate Pharma has received $450 million to date.

For any commercialized oncology indication, AstraZeneca will book all sales revenue and will pay Innate low double-digit to mid-teen percentage royalties on net sales worldwide except in Europe where Innate Pharma will receive 50% share of the profits and losses in the territory. Innate will co-fund 30% of the costs of the Phase 3 development program of monalizumab with a pre-agreed limitation of Innate’s financial commitment.

On April 29, 2022 Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the "Company"), a clinical-stage macrophage reprogramming immunotherapy company, reported its full year 2021 financial results, the completion of development of a frozen formulation of Allocetra twelve months ahead of schedule, and provided strategic updates on its clinical programs (Press release, Enlivex Therapeutics, APR 29, 2022, View Source [SID1234613226]).

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Frozen Formulation of Allocetra Completed Twelve Months Ahead of Schedule:

Development of a frozen formulation Allocetra, a cornerstone of Enlivex’s recent R&D efforts, was completed in Q1 2022, twelve months ahead of Enlivex’s schedule. While the liquid formulation of Allocetra has a shelf life of 96 hours, the frozen formulation is expected to have a shelf life spanning multiple years. This is expected to substantially improve the product candidate’s scalability and shipping logistics, lower its production costs, and increase profitability upon potential commercialization. Due to the early completion of the development of frozen formulation Allocetra, Enlivex intends to utilize it in its ongoing Phase II sepsis trial going forward, rather than introducing it only at the start of a Phase III study. In addition, Enlivex plans to utilize the frozen formulation of Allocetra in its upcoming solid tumor trials that are expected to begin in late 2022 and onwards and in all subsequent clinical studies moving forward. Use of frozen formulation Allocetra in clinical trials is subject to the approval of the relevant regulatory authorities.

Sepsis: Integrating Frozen Formulation Allocetra into Phase II Trial, Expanding Study Population

In 2021, Enlivex initiated a placebo-controlled, randomized, dose-finding, multi-center, Phase II trial evaluating liquid Allocetra in patients with pneumonia-associated sepsis. The Company is now working to amend the protocol of this clinical trial to treat newly recruited patients with frozen formulation Allocetra and expand the study population to include patients whose septic condition stems from biliary, urinary tract, or peritoneal infections. Enlivex expects to submit the proposed protocol amendments to regulators in Q2 2022. Due to the anticipated time needed by regulators to review and approve these amendments, this is expected to briefly defer completion of the trial by approximately six to eight months, but Enlivex expects that it will significantly shorten the overall timeline for a potential regulatory approval of frozen formulation Allocetra in sepsis and the associated commercial launch.

Enlivex’s Phase II sepsis trial is supported by previously reported positive results from a Phase Ib trial that demonstrated Allocetra’s favorable safety profile and showed vastly improved clinical outcomes, including SOFA (sequential organ failure assessment) scores, duration of hospitalization, and mortality, in Allocetra-treated sepsis patients compared to a group of matched historical controls who received standard-of-care therapy. Sepsis is a life-threatening disease with no FDA approved therapies and a high unmet need. Each year, more than 1.7 million adults in the United States develop sepsis, with more than 270,000 dying of the disease.

COVID-19 De-Prioritization:

Due to (a) the emergence of variants that may be associated with less severe disease, (b) a more stringent regulatory environment, and (c) increased volatility of the potential business segment, Enlivex is de-prioritizing Allocetra’s clinical development in COVID-19 and re-allocating the program’s cash resources to the Company’s primary development priorities, sepsis and oncology.

Though Enlivex commenced its ongoing Phase IIb COVID-19 trial just prior to the Omicron-driven surge in COVID-19 infections, the majority of Omicron-infected severe/critical patients were not eligible for recruitment into the trial, either because COVID-19 was not the reason for their severe/critical condition (i.e., while they had COVID-19, they were in severe or critical condition for reasons that were not necessarily because of COVID-19), or because they had significant co-morbidities (e.g., renal insufficiency, cancer) that were the drivers of their condition. Those patients that did meet the trial’s inclusion criteria (age < 90, no significant co-morbidities, severe/critical condition driven by COVID-19) were found to be overwhelmingly unvaccinated against COVID-19 and unwilling to participate in a clinical trial of an investigational drug candidate. In conjunction with the decision to de-prioritize its COVID-19 program, the Company plans to cease recruitment of patients into the Phase II trial. Given the slow recruitment, the total patients enrolled in the trial (11, of which 8 were recruited into the placebo arm) has not been sufficient to make any meaningful assessments of Allocetra’s efficacy. Patients already enrolled in Enlivex’s Phase IIb COVID-19 trial will continued to be followed for assessments of safety.

Solid Tumors: Planned Clinical Trials Evaluating Allocetra in Patients with Solid Tumors in 2022

A major shortcoming of immunotherapeutic cancer treatments is limited efficacy against solid tumors, which represent approximately 90% of all cancer cases. Enlivex believes that this is due in large part to the negative reprogramming of macrophages in the tumor microenvironment, which results in the proliferation of pro-tumor macrophages that contribute to drug resistance, prevent disease resolution, and promote disease severity. Previously reported preclinical data from solid tumor models suggest that Allocetra has the potential to reprogram pro-tumor macrophages back to their homeostatic state, and thereby may promote disease resolution and provide patients that do not respond well to existing FDA-approved immunotherapies with an effective treatment option. Based on these and other data, Enlivex plans to initiate a Phase Ib trial evaluating Allocetra in combination with chemotherapy in solid peritoneal tumors in Q3 2022, (one quarter deferral from previous expectations), and a Phase I/II trial evaluating Allocetra in combination with an immune checkpoint inhibitor in late 2022.

Manufacturing: Positive Regulatory Interaction, Buildup of Plant & Supply Chain Infrastructure On Schedule

Construction of Enlivex’s new cGMP Allocetra manufacturing plant in Israel has continued to proceed as planned following a positive interaction with regulators. The facility will initially be approximately 17,000 square feet, and will have the ability to be expanded to approximately 21,500 square feet in the future. Additional manufacturing capacity provided by the facility is intended to support ongoing clinical trials, future clinical trials, and initial commercial production of Allocetra that may occur if it receives applicable regulatory approvals. The Company’s efforts to establish supply chain infrastructure to support potential commercialization in the future are also advancing on-schedule.

Corporate: Extend Expected Cash Runway to Q3 2024

Enlivex currently expects that its re-prioritization of resources from COVID-19 to its sepsis, oncology, and manufacturing programs will have extended its cash runway by approximately three quarters. The Company expects its existing cash, cash equivalents, and marketable securities to be sufficient to fund its operating expenses into Q3 2024.

"Planned amendments to our sepsis trial are expected to accelerate the program’s projected timeline to regulatory approval while expanding its commercial opportunity and potential therapeutic impact," said Oren Hershkovitz, Ph.D., CEO of Enlivex. "In addition to broadening the trial to include patients with sepsis stemming from biliary, urinary tract, or peritoneal infections, we are planning to utilize Allocetra’s frozen formulation in the study. Given this formulation’s prolonged shelf-life, we expect its use to dramatically reduce our future manufacturing costs and enable the geographic expansion of our clinical programs."

Dr. Hershkovitz continued, "We have also made the decision to de-prioritize Allocetra’s development in COVID-19. Effective treatments for patients with mild-to-moderate disease have proven to be powerful tools that have reduced the need for therapies designed for those in severe or critical condition. In addition, the recent emergence of variants that may be associated with less severe disease and a more stringent regulatory environment have collectively led to a sharp increase in the volatility of this potential business segment. We thus will be focusing our resources on our sepsis and oncology programs. This is expected to extend our cash runway into Q3 2024 and leave us better positioned to execute on our stated clinical objectives."

Full Year 2021 Financial Results:

Research and development expenses were $12.8 million for the year ended December 31, 2021, as compared to $6.0 million for 2020. This increase was primarily attributable to increases in salaries, expenses for preclinical studies and R&D activities, clinical studies and consumption of materials and stock-based compensation to employees and consultants General and administrative expenses were $6.4 million for the year ended December 31, 2021, as compared to $ 3.7 million for 2020. This increase was primarily attributable to increases in stock-based compensation to employees and directors and insurance expenses Net loss for the year ended December 31, 2021 was $14.4 million, as compared to a net loss of $11.8 million for the year ended December 31, 2020.

As of December 31, 2021, Enlivex had cash, cash equivalents, short term deposits , and marketable securities of $84.1 million.

ABOUT ALLOCETRA

Allocetra is being developed as a universal, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state. Diseases such as solid cancers, sepsis, and many others reprogram macrophages out of their homeostatic state. These non-homeostatic macrophages contribute significantly to the severity of the respective diseases. By restoring macrophage homeostasis, Allocetra has the potential to provide a novel immunotherapeutic mechanism of action for life-threatening clinical indications that are defined as "unmet medical needs", as a stand-alone therapy or in combination with leading therapeutic agents.