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.

On March 31, 2023 Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, reported equity awards on March 31, 2023 that were previously approved by the Compensation Committee of its Board of Directors under Sarepta’s 2014 Employment Commencement Incentive Plan, as a material inducement to employment to 18 individuals hired by Sarepta in March 2023 (Press release, Sarepta Therapeutics, MAR 31, 2023, View Source [SID1234629725]). The equity awards were approved in accordance with Nasdaq Listing Rule 5635(c)(4).

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The employees received, in the aggregate, options to purchase 11,075 shares of Sarepta’s common stock, and in the aggregate 5,700 restricted stock units ("RSUs"). The options have an exercise price of $137.83 per share, which is equal to the closing price of Sarepta’s common stock on March 31, 2023 (the "Grant Date"). One-fourth of the shares underlying each employee’s option will vest on the one-year anniversary of the Grant Date and thereafter 1/48th of the shares underlying each employee’s option will vest monthly, such that the shares underlying the option granted to each employee will be fully vested on the fourth anniversary of the Grant Date, in each case, subject to each such employee’s continued employment with Sarepta on such vesting dates.

One-fourth of the RSUs will vest yearly on each anniversary of the Grant Date, such that the RSUs granted to each employee will be fully vested on the fourth anniversary of the Grant Date, in each case, subject to each such employee’s continued employment with Sarepta on such vesting date.

On March 31, 2023 AnHeart Therapeutics ("AnHeart"), a clinical-stage global biopharmaceutical company developing novel precision oncology therapeutics, announced today updated efficacy and safety data from a regional Phase 2 clinical trial of taletrectinib (TRUST-I) in patients with ROS1-positive non-small cell lung cancer (ROS1+ NSCLC) in an oral presentation at the European Lung Cancer Congress (ELCC) 2023 (Press release, AnHeart Therapeutics, MAR 31, 2023, View Source [SID1234629679]). Taletrectinib is a potent, next-generation, central nervous system (CNS)-active ROS1 tyrosine kinase inhibitor (TKI) with selectivity over TRKB.

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The oral presentation reported the updated efficacy and safety data of the TRUST-I Phase 2 trial in China (NCT04395677) with about 1.5-year follow-up time. The confirmed objective response rate (ORR) was 92.5% (62/67) in ROS1 TKI-naïve patients and 52.6% (20/38) in crizotinib-pretreated patients. The intracranial ORR was 91.7% (11/12) regardless of prior ROS1 TKI treatment history. The ORR in patients with a ROS1 G2032R resistance mutation was 80.0% (4/5).

The oral presentation also reported the updated results from a pooled analysis including patients from the TRUST-I Phase 2 trial and two Phase 1 trials conducted in the US and Japan (NCT02279433 and NCT02675491). The median progression-free survival (PFS) was 33.2 months (N=78) in ROS1 TKI-naïve patients and 11.8 months (N=46) in crizotinib-pretreated patients.

In 178 patients treated with taletrectinib at 600 mg once daily (QD), most treatment-emergent adverse events (TEAEs) were grades 1 or 2. Taletrectinib demonstrated a well-tolerable safety profile with low incidence of neurological adverse events (AEs).

"We’re excited to see that, with longer follow-up time, taletrectinib continues to demonstrate robust efficacy outcomes and favorable safety profiles in patients with ROS1 TKI-naïve or crizotinib-pretreated ROS1+ NSCLC," said Prof. Caicun Zhou, Shanghai Pulmonary Hospital and Thoracic Cancer Institute, Tongji University School of Medicine, Shanghai, China. "Additionally, taletrectinib hits a unique balance of strong intracranial activity and low incidence of neurological AEs."

TRUST-I is a multicenter, open-label, single-arm clinical trial with two cohorts: ROS1 TKI-naïve and crizotinib-pretreated patients. The key study endpoints included IRC-confirmed ORR, duration of response (DoR), disease control rate (DCR), PFS and safety.

A pivotal global Phase 2 trial of taletrectinib (TRUST-II, NCT04919811) is actively enrolling patients at clinical sites in North America, Europe and Asia.

Taletrectinib has been granted Breakthrough Therapy Designation (BTD) by both US FDA and China NMPA for the treatment of patients with advanced or metastatic ROS1+ NSCLC, who are either ROS1 TKI treatment naïve or previously treated with crizotinib.