On March 31, 2023, Gritstone bio, Inc. (the "Company") entered into a First Amendment to Loan and Security Agreement (the "Loan Amendment") with Silicon Valley Bank, a division of First-Citizens Bank & Trust Company (successor by purchase to the Federal Deposit Insurance Corporation as Receiver for Silicon Valley Bridge Bank, N.A. (as successor to Silicon Valley Bank)) ("SVB"), Hercules Capital, Inc. ("Hercules Capital") Hercules Capital Funding Trust 2022-1 (together with Hercules Capital ("Hercules")), each as Lenders, and Hercules Capital, in its capacity as administrative agent and collateral agent for itself and the financial institutions or entities from time to time party to the Loan Agreement (as defined below), which amends that certain Loan and Security Agreement (as amended, restated, or modified from time to time, the "Loan Agreement"), dated as of July 19, 2022, between the Company, SVB, Hercules and the other financial institutions or entities from time to time party thereto to defer the events triggering certain minimum Qualified Cash (as such term is defined in the Loan Agreement) covenants set forth therein (Filing, Gritstone Bio, MAR 31, 2023, View Source [SID1234629856]).

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The foregoing description of the Loan Amendment does not purport to be complete and is qualified in its entirety by the full text of the Loan Amendment, a copy of which is filed as Exhibit 10.1 hereto and is incorporated herein by reference.

On March 31, 2023, (the "Closing Date"), Cerus Corporation (the "Company") reported to have entered into (i) an Amended and Restated Credit, Security and Guaranty Agreement (Term Loan) (the "Term Loan Credit Agreement"), by and among the Company, the lenders party thereto from time to time and MidCap Financial Trust, as agent and a lender, which amended and restated the Company’s existing Credit, Security and Guaranty Agreement (Term Loan), dated as of March 29, 2019, as amended (the "Existing Term Loan Credit Agreement") and (ii) an Amended and Restated Credit, Security and Guaranty Agreement (Revolving Loan) (the "Revolving Loan Credit Agreement," and together with the Term Loan Credit Agreement, the "Credit Agreements"), by and among the Company, the lenders party thereto from time to time and MidCap Funding IV Trust, as agent and a lender, which amended and restated the Company’s existing Credit, Security and Guaranty Agreement (Revolving Loan), dated as of March 29, 2019, as amended (the "Existing Revolving Loan Credit Agreement") (Filing, 8-K, Cerus, MAR 31, 2023, View Source [SID1234629828]).

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The Term Loan Credit Agreement provides a secured term loan facility in an aggregate principal amount of up to $75.0 million. The Company borrowed the first advance of $40.0 million ("Tranche 1") and the second advance of $15.0 million ("Tranche 2") on the Closing Date to refinance the term loans under the Existing Term Loan Credit Agreement. Under the terms of the Term Loan Credit Agreement, (i) the third advance of $10.0 million ("Tranche 3") will be available to the Company through July 1, 2024, subject to the Company’s satisfaction of certain conditions described in the Term Loan Credit Agreement, and (ii) the fourth advance of $10.0 million ("Tranche 4"), will be available to the Company from July 1, 2024 through July 1, 2025, subject to the Company’s satisfaction of certain other conditions described in the Term Loan Credit Agreement. The proceeds from Tranche 3 and Tranche 4 are expected to be used for working capital and general corporate purposes.

Tranche 1 and Tranche 2 and, if borrowed, Tranche 3 and Tranche 4, each bear interest at a floating rate equal to the sum of the Term SOFR rate (subject to a floor of 1.00%) plus 6.50%. Interest on each term loan advance is due and payable monthly in arrears. Interest only payments are due for the first 36 months, and the remaining payments are due over the remaining 24 months. The interest only payment period can be extended for 12 months upon achievement of a specified trailing twelve month net revenue target. Prepayments of the term loans under the Term Loan Credit Agreement, in whole or in part, will be subject to early termination fees which decline each year until the fourth anniversary, at which time there is no early termination fee. The Company also must pay an annual administrative fee equal to a fractional percentage of the amount outstanding pursuant to the Term Loan Credit Agreement, and upon the final payment must also pay an exit fee of a percentage of the amount borrowed pursuant to the Term Loan Credit Agreement (the "Exit Fee"). The Company is required to pay a pro rata portion of the Exit Fee in connection with any prepayment.

The Revolving Loan Credit Agreement provides a secured revolving credit facility in an initial aggregate principal amount of up to $20.0 million. The Company may request an increase in the total commitments under the Revolving Loan Credit Agreement by up to an additional $15.0 million, subject to agent and lender approval and the satisfaction of certain conditions. Availability of the revolving credit facility under the Revolving Loan Credit Agreement will be based upon a borrowing base formula and periodic borrowing base certifications valuing certain of the Company’s accounts receivable and inventory, as reduced by certain reserves, if any. As of the Closing Date, there was $18.0 million outstanding under the Revolving Loan Credit Agreement. The proceeds of any loans under the Revolving Loan Credit Agreement may be used for working capital and general corporate purposes.

Loans under the Revolving Loan Credit Agreement accrue interest at a floating rate equal to the Term SOFR rate (subject to a floor of 1.00%) plus 3.75%. Accrued interest on the revolving loans will be paid monthly and revolving loans may be borrowed, repaid and re-borrowed until March 1, 2028, when all outstanding amounts must be repaid. Termination or permanent reductions of the revolving loan commitment under the Revolving Loan Credit Agreement will be subject to termination fees which decline each year until the fourth anniversary, at which time there is no early termination fee.

In connection with the Revolving Loan Credit Agreement, the Company is required to pay customary fees, including an origination fee equal to a fractional percentage of the original commitment amount at closing (and an equivalent origination fee with respect to any increased commitments at the time of the applicable increase), a monthly unused line fee based upon the average daily unused allowable borrowing base of the revolving credit facility and a monthly collateral management fee based upon the average daily used portion of the revolving credit facility. The Company is also required to maintain a minimum drawn balance under the revolving line or pay interest on the minimum drawn balance.

The Company’s obligations under the Credit Agreements are secured by a security interest on substantially all of its assets, with some exclusions.

The Credit Agreements contain customary affirmative covenants and customary negative covenants limiting the Company’s ability and the ability of the Company’s subsidiaries, if any, to, among other things, dispose of assets, undergo a change in control, merge or consolidate, make acquisitions, incur debt, incur liens, pay dividends, repurchase stock and make investments, in each case subject to certain exceptions. The Company must also comply with a financial covenant relating to trailing twelve month minimum net revenue requirements, tested on a quarterly basis.

The Credit Agreements also contain customary events of default relating to, among other things, payment defaults, breaches of covenants, a material adverse change, listing of the Company’s common stock, bankruptcy and insolvency, cross defaults with certain material indebtedness and certain material contracts, judgments, and inaccuracies of representations and warranties. Upon an event of default, agent and the lenders may declare all or a portion of the Company’s outstanding obligations to be immediately due and payable and exercise other rights and remedies provided for under the agreement. During the existence of an event of default, interest on the obligations could be increased.

The foregoing description of the terms of the Credit Agreements does not purport to be complete and is qualified in its entirety by reference to the full text of the Credit Agreements, copies of which will be filed with the Securities and Exchange Commission as exhibits to the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2023.

On March 31, 2023 Fennec Pharmaceuticals Inc. (NASDAQ: FENC; TSX: FRX), a commercial stage specialty pharmaceutical company, reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion and recommended granting a Marketing Authorization for Pedmarqsi (sodium thiosulfate) – known as PEDMARK in the U.S. – for the prevention of ototoxicity (hearing loss) induced by cisplatin chemotherapy in patients 1 month to <18 years of age with localized, non-metastatic, solid tumors (Press release, Fennec Pharmaceuticals, MAR 31, 2023, View Source [SID1234629795]). When formally approved by the European Commission, Pedmarqsi will be the first and only treatment approved in the European Union (EU) to address this area of significant unmet medical need.

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"Children treated with cisplatin for solid tumours carry a very high risk of losing their hearing permanently," said Penelope "Peppy" R. Brock, M.D., Ph.D, of Great Ormond Street Hospital in London and International Chair of the SIOPEL 6 trial. "As cure rates increase into the high nineties for several cancers, the need to resolve these permanently disabling side effects becomes more and more pressing. I am delighted that finally we have something to offer to counter this life impacting side effect and can give children the opportunity to live healthy, happy and fully integrated lives after overcoming cancer."

"There are currently no approved treatments in Europe to mitigate the risk of permanent and irreversible bilateral hearing loss which occurs in approximately 60 percent of children treated with cisplatin and can be as high as 90 percent.i The CHMP positive opinion brings European patients and their families closer to having a preventive treatment option to prevent the devastating consequences of hearing loss following the use of cisplatin chemotherapy, an indispensable treatment of choice in many pediatric cancer cases," said Rosty Raykov, chief executive officer of Fennec Pharmaceuticals. "With approximately five thousand children eligible for treatment with a platinum-based chemotherapy each year in Europe, we are excited by the potential this therapy can offer to the pediatric oncology community."

The CHMP adopted its positive opinion on safety and efficacy data from two pivotal open-label, randomized Phase 3 trials (SIOPEL 6 and Clinical Oncology Group [COG] Protocol ACCL0431), which compared Pedmarqsi plus cisplatin-based regimen to cisplatin-based regimens alone for the reduction of cisplatin-induced hearing loss in pediatric patients. In both studies, the incidence of hearing loss was consistently and significantly lower in the Pedmarqsi plus cisplatin arm compared with the cisplatin alone arm 28.6% vs. 56.4% (p = 0.004) and 35.1% vs. 67.3% (p = 0.001) with hearing loss in COG ACCLO431 and SIOPEL6, respectively. The most common adverse reactions (≥25% with difference between arms of >5% compared to cisplatin alone) in SIOPEL6 were vomiting, infection, nausea, decreased hemoglobin, and hypernatremia. The most common adverse reaction (≥25% with difference between arms of >5% compared to cisplatin alone) in COG ACCL0431 was hypokalemia.

The CHMP’s recommendation will now be reviewed by the European Commission, ratification of the CHMP recommendation is expected by early June 2023. PEDMARK was approved by the U.S. Food and Drug Administration (FDA) in September 2022.

About Cisplatin-Induced Ototoxicity

Cisplatin and other platinum compounds are essential chemotherapeutic agents for the treatment of many pediatric malignancies. Unfortunately, platinum-based therapies can cause ototoxicity, or hearing loss, which is permanent, irreversible, and particularly harmful to the survivors of pediatric cancer.ii

The incidence of ototoxicity depends upon the dose and duration of chemotherapy, and many of these children require lifelong hearing aids or cochlear implants, which can be helpful for some, but do not reverse the hearing loss and can be costly over time.iii Infants and young children that are affected by ototoxicity at critical stages of development lack speech and language development and literacy, and older children and adolescents often lack social-emotional development and educational achievement.iv

PEDMARK (sodium thiosulfate injection)

PEDMARK is the first and only U.S. Food and Drug Administration (FDA) approved therapy indicated to reduce the risk of ototoxicity associated with cisplatin treatment in pediatric patients with localized, non-metastatic, solid tumors. It is a unique formulation of sodium thiosulfate in single-dose, ready-to-use vials for intravenous use in pediatric patients.7 PEDMARK is also the only therapeutic agent with proven efficacy and safety data with an established dosing paradigm, across two open-label, randomized Phase 3 clinical studies, the Clinical Oncology Group (COG) Protocol ACCL0431 and SIOPEL 6.

In the U.S. and Europe, it is estimated that, annually, more than 10,000 children may receive platinum-based chemotherapy. The incidence of ototoxicity depends upon the dose and duration of chemotherapy, and many of these children require lifelong hearing aids. There is currently no established preventive agent for this hearing loss and only expensive, technically difficult, and sub-optimal cochlear (inner ear) implants have been shown to provide some benefit. Infants and young children that suffer ototoxicity at critical stages of development lack speech language development and literacy, and older children and adolescents lack social-emotional development and educational achievement.

PEDMARK has been studied by co-operative groups in two Phase 3 clinical studies of survival and reduction of ototoxicity, COG ACCL0431 and SIOPEL 6. Both studies have been completed. The COG ACCL0431 protocol enrolled childhood cancers typically treated with intensive cisplatin therapy for localized and disseminated disease, including newly diagnosed hepatoblastoma, germ cell tumor, osteosarcoma, neuroblastoma, medulloblastoma, and other solid tumors. SIOPEL 6 enrolled only hepatoblastoma patients with localized tumors.

Indications and Usage

PEDMARK (sodium thiosulfate injection) is indicated to reduce the risk of ototoxicity associated with cisplatin in pediatric patients 1 month of age and older with localized, non-metastatic solid tumors.

Limitations of Use

The safety and efficacy of PEDMARK have not been established when administered following cisplatin infusions longer than 6 hours. PEDMARK may not reduce the risk of ototoxicity when administered following longer cisplatin infusions, because irreversible ototoxicity may have already occurred.

Important Safety Information

PEDMARK is contraindicated in patients with history of a severe hypersensitivity to sodium thiosulfate or any of its components.

Hypersensitivity reactions occurred in 8% to 13% of patients in clinical trials. Monitor patients for hypersensitivity reactions. Immediately discontinue PEDMARK and institute appropriate care if a hypersensitivity reaction occurs. Administer antihistamines or glucocorticoids (if appropriate) before each subsequent administration of PEDMARK. PEDMARK may contain sodium sulfite; patients with sulfite sensitivity may have hypersensitivity reactions, including anaphylactic symptoms and life-threatening or severe asthma episodes. Sulfite sensitivity is seen more frequently in people with asthma.

PEDMARK is not indicated for use in pediatric patients less than 1 month of age due to the increased risk of hypernatremia or in pediatric patients with metastatic cancers.

Hypernatremia occurred in 12% to 26% of patients in clinical trials, including a single Grade 3 case. Hypokalemia occurred in 15% to 27% of patients in clinical trials, with Grade 3 or 4 occurring in 9% to 27% of patients. Monitor serum sodium and potassium levels at baseline and as clinically indicated. Withhold PEDMARK in patients with baseline serum sodium greater than 145 mmol/L.

Monitor for signs and symptoms of hypernatremia and hypokalemia more closely if the glomerular filtration rate (GFR) falls below 60 mL/min/1.73m2.

Administer antiemetics prior to each PEDMARK administration. Provide additional antiemetics and supportive care as appropriate.

The most common adverse reactions (≥25% with difference between arms of >5% compared to cisplatin alone) in SIOPEL 6 were vomiting, nausea, decreased hemoglobin, and hypernatremia. The most common adverse reaction (≥25% with difference between arms of >5% compared to cisplatin alone) in COG ACCL0431 was hypokalemia.

Please see full Prescribing Information for PEDMARK at: www.PEDMARK.com.

On March 31, 2023 bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company addressing the need for noninvasive detection of early-stage lung cancer and other diseases of the lung, reported financial results for the three and 12 months ended December 31, 2022 (Press release, BioAffinity Technologies, MAR 31, 2023, View Source [SID1234629736]).

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Financial Highlights

● Raised net proceeds of approximately $6.0 million from an initial public offering (IPO) in September 2022

● Converted nearly $16 million in debt, related accrued interest and fair value adjustments into shares of common stock in connection with the IPO

● Raised an additional $7.8 million from the exercise of warrants and stock options

Corporate and Operational Highlights

● Announced publication in Respiratory Research of an article titled "Detection of early-stage lung cancer in sputum using automated flow cytometry and machine learning" detailing results of bioAffinity Technologies’ clinical validation trial, which showed CyPath Lung had 92% sensitivity and 87% specificity in high-risk patients with nodules smaller than 20 millimeters or no nodules in the lung, with an area under the ROC curve of 94%

● Selected a contract research organization to manage the pivotal trial intending to seek U.S. Food and Drug Administration clearance of CyPath Lung as a Class II IVD medical device for the detection of lung cancer; the pivotal trial is expected to recruit 1,800 patients beginning in 2023, with participants followed for at least one year to determine the presence of lung cancer

● Research continues aimed at the expansion of the Company’s flow cytometric platform technology for use in detecting additional lung diseases, including Chronic Obstructive Pulmonary Disease (COPD)

● Announced publication in the Journal of Visualized Experiments of an article titled "Porphyrin-Modified Beads for Use as Compensation Controls in Flow Cytometry" describing the beads engineered by the Company for use with its CyPath Lung test

● Received Notice of Allowance for a U.S. patent protecting the targeted delivery of novel cancer treatments using porphyrin compounds for bioAffinity Technologies’ wholly owned subsidiary, OncoSelect Therapeutics

● Awarded therapeutic patents in China, Mexico and Australia for compounds comprised of porphyrins conjugated to chemotherapeutic agents that can provide selective treatment for cancer; the Company’s global patent portfolio now includes the U.S., Australia, Canada, China, France, Germany, Hong Kong, Italy, Mexico, Spain, Sweden and the United Kingdom

● Expanded the Company’s Scientific and Medical Advisory Board with the appointments of Sheila Habib, M.D., Director of the Pulmonary Lung Nodule Clinic and the Lung Cancer Screening Program at South Texas Veterans Health Care, and David Hill, M.D., National Board Member of the American Lung Association and assistant clinical professor of medicine at Yale University School of Medicine

● Strengthened the diagnostics division with the appointment of Rossella Titone, Ph.D., and Alvaro Souto Padron de Figueiredo, Ph.D., who bring significant technical expertise in flow cytometry and clinical research across various cancers

● Appointed Julie Anne Overton, a veteran of print and broadcast journalism, corporate communications and federal public affairs, as Director of Communications

● Scheduled to ring the Nasdaq closing bell on April 5 to commemorate the Company’s 2022 IPO

Management Commentary

"Through the capital raised during and following our IPO, 2022 was a landmark year for bioAffinity Technologies as we executed on our goal to become a leader in non-invasive early-stage cancer diagnosis by bringing our first flow cytometry-based diagnostic, CyPath Lung, to market. With key research and leadership appointments, we are engaging clinicians and patients on the value of early lung cancer screening, lowering healthcare costs and raising the survival rate for one of the deadliest cancers," said Maria Zannes, President and Chief Executive Officer of bioAffinity Technologies.

Low-dose computed tomography (LDCT) is the standard of care for screening patients at high risk for lung cancer and can significantly increase survival by finding early-stage cancer. But screening’s low positive predictive rate of 3.8% means that only four people out of 100 who get a positive screening result will actually have lung cancer. CyPath Lung assists clinical decision-making for patients whose screening results are not clear. Physicians can order bioAffinity’s patient-friendly CyPath Lung test to confirm or rule out cancer, reducing the need for biopsy and other costly invasive procedures, and providing greater clarity to determine next steps in patient care.

"Our ongoing pilot launch of CyPath Lung in Texas continues to provide value by helping us to refine positioning, gather valuable insights from labs and healthcare providers, and optimize logistics throughout the care pathway, from ordering the test to reporting results. By building upon real-world feedback from this test market, we are enhancing the value proposition of CyPath Lung and can achieve more impactful adoption as we prepare for commercial expansion," Ms. Zannes said.

Fourth Quarter Financial Results

Revenue for the fourth quarter of 2022 was approximately $2,500, compared with no revenue for the prior-year period. Revenue was derived from the sale of CyPath Lung as a Laboratory Developed Test (LDT).

Research and development expenses were $429,000 for the fourth quarter of 2022, compared with $318,000 for the comparable period in 2021. General and administrative expenses were $1.2 million for the fourth quarter of 2022, compared with $341,000 for the comparable period in 2021.

Net loss for the fourth quarter of 2022 was $1.7 million, compared with a net loss of $5.6 million for the comparable period in 2021.

Full Year Financial Results

Revenue for 2022 was approximately $5,000, compared with no revenue for 2021.

Research and development expenses were $1.1 million in 2022, compared with $1.0 million in 2021. The increase was primarily due to higher personnel, legal and research costs, partially offset by lower stock-based compensation expense.

General and administrative expenses were $2.7 million in 2022, compared with $1.1 million in 2021. The increase was primarily due to higher consulting, legal and professional fees related to the Company’s IPO and compliance with public company reporting requirements. The increase was also attributed to higher stock-based compensation expense, as well as hiring-related expenses to support the commercial launch of CyPath Lung.

Net loss for 2022 was $8.2 million, or $1.81 per share, compared with a net loss for 2021 of $6.3 million, or $2.36 per share.

Cash and cash equivalents as of December 31, 2022, were $11.4 million. On September 6, 2022, bioAffinity Technologies raised net proceeds of $6.0 million from an IPO of 1,282,600 units, with each unit consisting of one share of common stock, one tradeable warrant to purchase one share of common stock and one non-tradable warrant. An additional $7.8 million was raised from the exercise of warrants and options. bioAffinity Technologies believes that its available cash will be sufficient to fund planned operations for at least the next 12 months.

Conference Call and Webcast

Management will host a conference call on Monday, April 3, 2023, at 9:00 a.m. Eastern time to discuss those results and answer questions.

Date: Monday, April 3, 2023
Time: 9:00 a.m. Eastern time
Toll Free: 877-270-2148
International: 412-902-6510
Webcast: Webcast link

A replay of the event will be available for 90 days at the webcast link above, which can also be found in the Investor Relations section of bioAffinity Technologies’ website at ir.bioaffinitytech.com.

ON March 31, 2023 AnPac Bio-Medical Science Co., Ltd. (the "Company") (NASDAQ: ANPC), a company with operations in the United States and China focused on early cancer screening and detection and plans to enter into the operation of a business-to-business e-commerce food platform focused on the sale of Asian sourced food products, reported that it has entered into a securities purchase agreement with certain institutional investors to purchase $3.0 million of its American Depositary Shares ("ADSs"), pre-funded warrants to purchase ADSs and warrants to purchase ADSs in a registered direct offering (Press release, Anpac Bio, MAR 31, 2023, View Source [SID1234629732]). The Company plans to use the net proceeds from the offering for the advancement of our research and development activities, working capital and general corporate purposes.

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Under the terms of the securities purchase agreement, the Company has agreed to sell to the institutional investors a total of 625,000 ADSs (the "Offered ADS") priced at $4.00 per ADS, with pre-funded warrants exercisable for 125,000 ADSs and warrants exercisable for 750,000 ADSs. The purchase price of each pre-funded warrant is equal to the price per one ADS, minus $0.0001, and the remaining exercise price of each pre-funded warrant will equal $0.0001 per share. The pre-funded warrants will be immediately exercisable and may be exercised at any time until all of the pre-funded warrants are exercised in full. The warrants will be immediately exercisable, will expire five (5) years from the original issuance date and will have an exercise price of $4.00 per ADS. The Company is also issuing to Univest Securities, LLC, which is acting as the sole placement agent for the offering, warrants exercisable for 37,500 ADSs, with an exercise price of $4.80. The placement agent’s warrants are immediately exercisable through the fifth anniversary of issuance.

Subject to certain exemptions outlined in the warrants, if the Company sells, enters into an agreement to sell, or grants any option to purchase, or sells, enters into an agreement to sell, or grants any right to reprice, or otherwise disposes of or issues (or announces any offer, sale, grant or any option to purchase or other disposition) any ordinary shares or ADSs or any other securities that are at any time convertible into, or exercisable or exchangeable for, or otherwise entitle the holder thereof to receive, ordinary shares or ADSs, at an effective price per share less than the exercise price of the warrants then in effect, the exercise price of the warrants will be reduced to an exercise price based on the calculation provided in the warrants.

In addition, pursuant to the terms of the securities purchase agreement, the Company may not, subject to certain exceptions, (i) offer, issue, sell, transfer or otherwise dispose of the Company’s securities for a period of one hundred and twenty (120) days following the closing date of the offering; and (ii) from the closing date of the offering until the six-month anniversary of such date, effect or enter into an agreement to effect any issuance of ordinary shares or ordinary share equivalents involving a Variable Rate Transaction (as defined in the securities purchase agreement).

The gross proceeds to the Company from the registered direct offering are estimated to be approximately $3.0 million before deducting the placement agent’s fees and other standard offering expenses. The offering is expected to close on or about April 5, 2023, subject to the satisfaction of customary closing conditions.

Pursuant to the securities purchase agreement, the executive officers and directors of the Company will enter into lock-up agreements pursuant to which these persons agree that, without the prior consent of the placement agent, they will not, for a period of 60 days following the closing of the offering, subject to certain exceptions, offer, sell or otherwise dispose of or transfer any securities of the Company owned by them as of the date of the closing of the offering or acquired during the lock-up period.

The ADSs, the pre-funded warrants, the warrants and the ADSs underlying the pre-funded warrants, the warrants and the placement agent’s warrants are being offered pursuant to a shelf registration statement on Form F-3 (File No. 333-256630) previously filed and declared effective by the Securities and Exchange Commission (SEC) on June 7, 2021 (the "Shelf Registration Statement"). The offering of the ADSs, the pre-funded warrants, the warrants and the ADSs underlying the pre-funded warrants, the warrants and the placement agent’s warrants will be made only by means of a prospectus supplement that forms a part of the registration statement.

Univest Securities, LLC is acting as the sole placement agent for this offering.

This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor will there be any sales of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction. A prospectus supplement relating to the aforementioned securities will be filed by the Company with the SEC. When available, copies of the prospectus supplement relating to the registered direct offering, together with the accompanying prospectus, can be obtained at the SEC’s website at www.sec.gov.