On August 15, 2022 Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, reported that it has filed a prospectus supplement with the U.S. Securities and Exchange Commission ("SEC") relating to an At-the-Market offering (the "ATM Program") (Press release, Valneva, AUG 15, 2022, View Source [SID1234618340]). Pursuant to this new financing program, the Company may offer and sell, including with unsolicited investors who have expressed an interest, a total gross amount of up to $75.0 million of American Depositary Shares ("ADS"), each ADS representing two of the Company’s ordinary shares, from time to time in sales deemed to be an "at the market offering" as defined in Rule 415(a)(4) promulgated under the Securities Act of 1933, as amended, and pursuant to the terms of an Open Market Sale Agreement (the "Sales Agreement") with Jefferies LLC ("Jefferies"), acting as sales agent, subject to French regulatory limits. The timing of any sales will depend on a variety of factors and the Company is not under any obligation to utilize the ATM Program in a specified amount or at all.

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The ADSs intended to be sold under the Sales Agreement, if any, will be issued and sold pursuant to a shelf registration statement on Form F-3 (the "Registration Statement"), once declared effective by the SEC.

To the extent that ADSs are sold pursuant to the ATM Program, the Company currently intends to use the net proceeds (after deduction of fees and expenses), if any, of sales of ADSs issued under the ATM Program, together with its existing cash and cash equivalents, primarily for research and development of the Company’s product candidates, working capital and other general corporate purposes, at the Company’s discretion.

Jefferies, as sales agent, will use commercially reasonable efforts to arrange on the Company’s behalf for the sale of all ADSs requested to be sold by the Company to eligible investors requesting it, consistent with Jefferies’ normal sales and trading practices. Sales prices may vary based on market prices and other factors. Only eligible investors (as described in greater detail below) may purchase ADSs under the ATM Program.

The ADSs and the underlying ordinary shares will be issued through one or more share capital increases without shareholders’ preferential subscription rights under the provisions of Article L. 225-138 of the French Commercial Code (Code de commerce) and pursuant to and within the limits set forth in the 24th and 28th resolutions adopted by the combined shareholders’ general meeting dated June 23, 2022 (the "General Meeting") (or any substitute resolutions, adopted from time to time), i.e. a maximum number of 30,666,666 ordinary shares (being the maximum authorized by the shareholders for the 24th resolution), representing a maximum potential dilution of approximately 26.1% based on the existing share capital of the Company. In any event the number of underlying ordinary shares to be admitted on the regulated market of Euronext in Paris ("Euronext Paris") shall represent, over a period of 12 months, less than 20% of the ordinary shares already admitted to trading on said market without a French listing prospectus.

The new ordinary shares to be sold in the form of ADSs would be issued in one or more offerings at market prices of the ADSs at the time of pricing of the considered capital increase.

The ATM Program may only be issued to the categories of investors defined in the 24th resolution adopted by the General Meeting (or any similar resolutions that may be substituted for it in the future), comprising (i) natural persons or legal entities, including companies, trusts, investment funds or other investment vehicles, regardless of their form, under French or foreign law, investing on a regular basis in the pharmaceutical, biotechnological or medical technology sector, and/or (ii) French or foreign companies, institutions or entities of any form, carrying out a significant portion of their business in the pharmaceutical, cosmetics or chemical sector or in the field of medical devices and/or technologies or research in these areas. The new ordinary shares will be admitted to trading on the regulated market of Euronext in Paris and the issued ADSs will trade on the Nasdaq Global Select Market ("Nasdaq").

On an illustrative basis, assuming the issuance of the full amount of $75.0 million (or €72.5 million (all convenience translations in this press release are based on an exchange rate of €1.00 = $1.0338, the exchange rate reported by the European Central Bank on August 11, 2022) of ADSs under the ATM Program at an assumed offering price of $20.83 per ADS (or €10.03 per ordinary share), the last reported sale price of the ADSs on Nasdaq on August 11, 2022, a holder of 1.0% of the outstanding Company’s share capital as of the date of this press release, would hold 0.99% of the outstanding Company’s share capital after the completion of the transaction (calculated on the basis of the number of outstanding shares on the date of publication of this press release), it being specified that, in any event, the number of underlying ordinary shares shall not exceed the limit set forth in the 24th resolution adopted by the General Meeting (or any substitute resolutions, adopted from time to time) and shall represent, over a period of 12 months, less than 20% of the ordinary shares already admitted to trading on said market without a listing prospectus.

During the term of the ATM Program, the Company will include information in the publication of its half-year and full-year financial reports about its use of the ATM Program during the preceding period and will also provide an update after each capital increase on a dedicated location on its corporate website in order to inform investors about the main features of each issue that may be completed under the ATM Program from time to time.

The Registration Statement (including a prospectus) relating to Valneva’s securities, including the ADSs, was filed with the SEC on August 12, 2022 but has not yet been declared effective. No offers or sales of ADSs under the ATM Program can be made until the Registration Statement is declared effective by the SEC. Before purchasing ADSs in an offering, prospective investors should read the prospectus supplement and the accompanying prospectus, together with the documents incorporated by reference therein. Prospective investors may obtain these documents for free by visiting EDGAR on the SEC’s website at www.sec.gov. Alternatively, a copy of the prospectus supplement (and accompanying prospectus) relating to the offering may be obtained from Jefferies LLC, 520 Madison Avenue, New York, NY 10022 or by telephone at (877) 821-7388 or by email at [email protected]. No prospectus will be subject to the approval of the French Financial Markets Authority (the Autorité des Marchés Financiers or the "AMF") pursuant to Regulation (EU) 2017/1129 of the European Parliament and of the Council dated June 14, 2017, as amended (the "Prospectus Regulation") since the contemplated share capital increase(s) (for the issuance of the ordinary shares underlying the ADSs) would be offered to qualified investors (as such term is defined in Article 2(e) of the Prospectus Regulation) and fall under the exemption provided for in Article 1(5)(a) of the Prospectus Regulation which states that the obligation to publish a prospectus shall not apply to admission to trading on a regulated market of securities fungible with securities already admitted to trading on the same regulated market, provided that they represent, over a period of 12 months, less than 20% of the number of securities already admitted to trading on the same regulated market.

This press release shall 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 any such state or jurisdiction. In particular, no public offering of the ADSs will be made in Europe.

Information Available to the Public

Detailed information concerning the Company, in particular with regard to its business, results, forecasts and corresponding risk factors, is provided in the Company’s Annual Report on Form 20-F (the "Annual Report"), filed with the SEC on March 24, 2022, as well as in the half-yearly financial report (containing an update of the main information on the Company, its development and its projects) (the "Half-Year Report"), and documents filed with the SEC from time to time (the "SEC Filings"). The Annual Report and SEC Filings are available on the SEC’s website (www.sec.gov). The Company’s Universal Registration Document filed with the AMF on March 23, 2022 under number D.22-0140 and the Company’s half year report published on its website on August 11, 2022 as well as other regulated information are available on the AMF website (www.amf-france.org). All of the foregoing documents are available on the Company’s website and are available free of charge on request at the Company’s registered office at 6 rue Alain Bombard, 44800 Saint-Herblain, France.

On August 15, 2022 Genmab A/S (Nasdaq: GMAB) reported the initiation of a share buy-back program to mitigate dilution from warrant exercises and to honor our commitments under our Restricted Stock Units program (Press release, Genmab, AUG 15, 2022, View Source [SID1234618339]).

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The share buy-back program is expected to be completed no later than August 31, 2022 and comprises up to 370,000 shares.

The following transactions were executed under the program from August 8, 2022 to August 12, 2022:

Details of each transaction are included as an appendix to this announcement.

Following these transactions, Genmab holds 482,983 shares as treasury shares, corresponding to 0.73% of the total share capital and voting rights.

The share buy-back program is undertaken in accordance with Regulation (EU) No. 596/2014 (‘MAR’) and the Commission Delegated Regulation (EU) 2016/1052, also referred to as the "Safe Harbour Regulation." Further details on the terms of the share buy-back program can be found in our company announcement no. 22 dated June 17, 2022.

On August 15, 2022 CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers in the brain and central nervous system, reported its financial results for the quarter ended June 30, 2022 and provided a clinical update of its anti-cancer drug candidates currently in development for the treatment of primary and metastatic brain and CNS cancer (Press release, CNS Pharmaceuticals, AUG 15, 2022, View Source [SID1234618338]).

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"Within the past 6 months alone, we have executed on a number of clinical and operational advancements including expanding our global presence with clinical approvals in Spain, France and Switzerland to drive patient enrollment forward, as well as expanding eligibility for patients to participate in our potentially pivotal study of Berubicin for the treatment of GBM with our recently amended protocol, which was approved by the FDA, Swissmedic, National Agency for the Safety of Medicine and Health Products (ANSM) Competent Authority and corresponding European ethics committees. Our focus and priorities remain on advancing our clinical development program for Berubicin to ultimately bring a meaningful treatment to GBM patients, families and clinicians, who currently have extremely limited and often ineffective treatment options," commented John Climaco, CEO of CNS Pharmaceuticals.

Clinical Programs Update

Berubicin – Novel anthracycline

CNS’ lead product candidate, Berubicin, is a novel anthracycline and the first anthracycline to appear to cross the blood-brain barrier. Berubicin is currently being evaluated in a potentially pivotal global study evaluating its efficacy and safety in the treatment of GBM. The potentially pivotal trial is an adaptive, multicenter, open-label, randomized and controlled study in adult patients with recurrent glioblastoma multiforme (WHO Grade IV1) after failure of standard first-line therapy. The primary endpoint of the study is Overall Survival (OS), which is a rigorous endpoint that the FDA has recognized as a basis for approval of oncology drugs when a statistically significant improvement can be shown relative to a randomized control arm. Results from the trial will compare Berubicin to a current standard of care (Lomustine), with a 2 to 1 randomization of patients to receive either Berubicin or Lomustine. The recently amended protocol expands eligibility for the study to patients who have received additional treatments as part of the first line therapy for their disease considering advancements in this area. This change was made due to the complexity of new agents introduced as a component of first line therapy, which allows an additional group of patients that can enroll on the study after what may constitute multiple procedures as their initial treatment.

A pre-planned, non-binding futility analysis will be performed after approximately 30 to 50% of all planned patients have completed the primary endpoint at 6 months. This review will include additional evaluation of safety as well as secondary efficacy endpoints. Enrollment will not be paused during this interim analysis.

The FDA previously granted CNS Pharmaceuticals Fast Track Designation for Berubicin which enables more frequent interactions with the FDA to expedite the development and review process. As previously announced, the Company also received Orphan Drug Designation from the FDA which may provide seven years of marketing exclusivity upon approval of an NDA.

For more information about the potentially pivotal Berubicin trial, visit clinicaltrials.gov and reference identifier NCT04762069.

Upcoming Milestones

Continued site initiations across the U.S., Italy, France, Spain, and Switzerland for potentially pivotal study to evaluate efficacy of Berubicin in the treatment of adult GBM;
Regulatory and ethics approval in Italy;
Commencement of patient enrollment across European clinical sites;
Interim analysis of the trial when 30-50% of the total expected patients have been on study for 6 months (expected mid-year 2023); and
Complete enrollment in potentially pivotal clinical trial for GBM.
WP1244 Portfolio – Novel class of DNA-binding agents

The Company continues to advance the development of its WP1244 drug technology portfolio, which utilizes anthracycline and distamycin-based scaffolds to create small molecule agents and is believed to be 500x more potent than daunorubicin in inhibiting tumor cell proliferation. Preclinical studies of WP1244 demonstrated high uptake in the brain with antitumor activity. The Company’s development work has produced a new mesylate salt of WP1244, now identified as WP1874. The enhanced solubility of this salt may increase its ability to be formulated for use in an IV infusion, while maintaining similar potency and toxicity characteristics. Going forward, WP1874 will be the primary focus in our development efforts of the WP1244 portfolio. CNS Pharmaceuticals is also evaluating the use of WP1244/WP1874 in the treatment of other primary brain and central nervous system cancers, as well as cancers metastatic to the brain including pancreatic, ovarian, and lymphomas.

Upcoming Milestones

File IND in 2023.
Summary of Financial Results for the Second Quarter 2022

The net loss for the three months ended June 30, 2022 was approximately $3.6 million compared to approximately $3.8 million for the comparable period in 2021. The change in net loss is attributable to decreases in the timing of drug development expenses (significant manufacturing activity occurred in the prior year period with much less occurring in the current year), as well as a credit to research and development expense for the funds collected from WPD Pharmaceuticals related to their purchase of Berubicin drug product for their clinical trials, partially offset by an increase in contract research organization (CRO) expenses related to continued progress with our Phase 2 clinical trial as well as increases in legal and professional fees and other expenses.

The Company reported research and development expenses of $2.2 million for the three months ended June 30, 2022 compared to approximately $2.7 million for the comparable period in 2021. The decrease in research and development expenses during the period were mainly attributed to the timing of drug development expenses, as well as a credit to research and development expense for the funds collected from WPD Pharmaceuticals related to their purchase of Berubicin drug product for their clinical trials, partially offset by an increase in CRO expenses related to continued progress with our Phase 2 clinical trial.

General and administrative expense was approximately $1.3 million for the three months ended June 30, 2022 compared to approximately $1.1 million for the comparable period in 2021. This increase in general and administrative expense was mainly attributable to an increase in employee compensation (due to the timing of annual employee incentive compensation) and taxes and legal and professional fees, which were offset with decreases in stock-based compensation and other expenses.

As of June 30, 2022, the Company had cash of approximately $9.0 million and working capital of approximately $10.5 million. The Company’s current expectation is that the cash on hand and the proceeds from the offering during January is sufficient to fund our operations into 2023. The timing and costs of clinical trials are difficult to predict and trial plans may change in response to evolving circumstances and as such the foregoing estimates may prove to be inaccurate.

On August 15, 2022 Carina Biotech reported that it has raised $7.5 million at first close of its current funding round, welcoming on board new venture capital business Tenmile as the cornerstone investor together with strong support from existing investors (Press release, Carina Biotech, AUG 15, 2022, View Source [SID1234618337]).

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"We are delighted to welcome Tenmile as an investor in Carina Biotech with its commitment to accelerate high impact, cutting edge Australian health technology innovation. We are also pleased that our other shareholders have continued their strong support," said CEO Dr Deborah Rathjen.

The capital raise enables Carina to complete its Investigational New Drug (IND) enabling studies and initiate a CAR-T clinical trial of our LGR5 CAR-T cell for patients with advanced colorectal (bowel) cancer.

"Colorectal cancer is Australia’s second deadliest cancer and its incidence is rising in people under the age of 50. Many younger people are diagnosed at advanced stages of the disease with very poor prognoses. This is a lethal cancer for all Australians, young and old, that we want to be able to treat. CAR-T therapy is currently used for the treatment of blood cancers and it has proved to be curative.

"We are very excited to be able to bring this personalised form of immunotherapy embedded with Carina’s proprietary CAR-T technology to patients with solid cancers," Dr Rathjen further added.

Tenmile Executive Chair, Dr Steve Burnell, said, "Carina represents the kind of investment opportunity Tenmile looks for – advanced novel technology addressing a major unmet medical need, depth of expertise, global networks and strong intellectual property. It also reflects our commitment to using our capital as a force
for good including backing female-led businesses."

Carina is one of Tenmile’s first cohort of investments. Tenmile is the new $250m healthtech venture capital fund backed by Andrew and Nicola Forrest’s Tattarang investment group.

The capital raise also enables Carina to progress its robust pipeline of CAR-T programs and its technology platform which includes Carina’s Chemokine Receptor Platform that is being used to develop CAR-T cells expressing chemokine receptors that drive CAR-T cells to ‘home in’ on specific cancer cells.

Carina’s proprietary manufacturing process shortens the time required for CAR-T cell generation producing higher numbers of highly active CAR-T cells.

Carina’s approach to institutional and impact investors was undertaken by MST Financial. Peter Wilson of wilsonemmett Pty Ltd acted as financial adviser to Carina.

On August 15, 2022 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, reported its financial results for the quarter ended June 30, 2022 (Press release, Moleculin, AUG 15, 2022, View Source [SID1234618320]). The Company also provided an update on its portfolio of oncology drug candidates for the treatment of highly resistant tumors and viruses.

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"The first half of this year has been marked by demonstrated execution resulting in clinical progress, and importantly, continued compelling safety and efficacy data across our development pipeline. As we look to the remainder of the year, we are committed to operational excellence, driving our clinical programs forward and meeting our expected data readout timelines. Based on the progress and positive data demonstrated to date, we believe we are well positioned to continue to execute on our clinical milestones and potentially offer solutions for patients across a number of indications," commented Walter Klemp, Chairman and Chief Executive Officer of Moleculin.

Recent Highlights

Announced the conclusion of the Phase 1b portion of its U.S. Phase 1b/2 clinical trial evaluating Annamycin for the treatment of soft tissue sarcoma lung metastases (STS lung mets) and opened recruitment for the Phase 2 portion of the trial.

Received allowance to proceed with Phase 1/2 study of Annamycin in combination with Cytarabine for the treatment of Acute Myeloid Leukemia (AML).

Commenced dosing in the Phase 1a clinical trial evaluating WP1122 in healthy volunteers in the United Kingdom (UK) for the treatment of COVID-19 and announced the completion of the first and second single ascending dose (SAD) cohorts with preliminary results allowing the Company to proceed to 32 mg/kg dose of WP1122 in the third cohort toward establishing maximum tolerated dose (MTD).
Programs Update

Next Generation Anthracycline – Annamycin

Annamycin is the Company’s next-generation anthracycline that has been designed to be non-cardiotoxic and has been shown in animal models to accumulate in the lungs at up to 30-fold the level of doxorubicin, as well as demonstrating the ability to avoid the multidrug resistance mechanisms that typically limit the efficacy of doxorubicin and other currently prescribed anthracyclines. Annamycin is currently in development for the treatment of relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma (STS) lung metastases and the Company believes it may have the potential to treat additional indications.

STS Lung Mets

The Company recently announced completion of its Phase 1b portion of the U.S. Phase 1b/2 clinical trial evaluating Annamycin for the treatment of STS lung mets. Preliminary results from the study continue to document clinical activity for Annamycin in the treatment of STS. The safety review committee (SRC) deemed the dose of 390 mg/m2 to be safe after conclusion of the fourth cohort. Consistent with the recommendation of the SRC, the Company determined that the RP2D will be 360 mg/m2 for the first three subjects in the Phase 2 portion of the study, for which screening has begun. For more information about the Phase 1b/2 study evaluating Annamycin for the treatment of STS lung metastases, please visit clinicaltrials.gov and reference identifier NCT04887298.

AML

The Company received allowance from the Polish Department of Registration of Medicinal Products (URPL), as well as the requisite Ethics Committee approval, to proceed with its Phase 1/2 clinical trial in Poland of Annamycin in combination with Cytarabine (also known as "Ara-C" and for which the combination of Annamycin and Ara-C is referred to as AnnAraC) in the treatment of subjects with AML who are refractory to or relapsed after induction therapy. The Phase 1/2 AnnAraC trial (MB-106), an open label trial, builds on the safety and dosage data from the two successfully concluded single agent Annamycin AML Phase 1 trials (MB-104 and MB-105) in the U.S. and Europe, respectively, and the preclinical data from the Company’s sponsored research studies.

Annamycin currently has Fast Track Status and Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of STS lung metastases, in addition to Orphan Drug and Fast Track Designation for the treatment of relapsed or refractory acute myeloid leukemia.

Upcoming Milestones Expectations

Q3 2022: Commence enrollment in Phase 1/2 study of Annamycin in combination with Ara-C in Acute Myeloid Leukemia.

H2 2022: Commencement of an investigator-funded, second Phase 1b/2 clinical trial of Annamycin in sarcoma lung metastases in Europe.

H2 2022: Report Phase 2 interim data from ongoing Phase 1b/2 study of Annamycin for the treatment of sarcoma lung metastases in the US.
Metabolism/Glycosylation Inhibitor – WP1122 Portfolio

WP1122 was developed as a 2-DG prodrug to provide a more favorable pharmacological profile and was found to have greater potency than 2-DG alone in preclinical models where tumor cells require higher glycolytic activity than normal cells. WP1122 has also been shown to have a greater antiviral effect than 2-DG against SARS-CoV-2 in MRC-5 cells in culture. The improved pharmacokinetic and pharmacodynamic (PK/PD) profile of WP1122 compared to 2-DG was noted in mice following oral dosing at equimolar (i.e., equivalent levels of 2-DG) doses.

COVID-19

The Company is currently evaluating WP1122 in an ongoing Phase 1a, first-in-human, randomized, double-blind, placebo-controlled, overlapping SAD and MAD (Multiple Ascending Dose) clinical trial investigating the effects of WP1122 administered as an oral solution in healthy human volunteers. It is the first step in a planned investigation of WP1122 for the treatment of COVID-19. Dose escalation will take place in sequential SAD cohorts, and MAD will start as soon as SAD has successfully completed at least 3 dosing cohorts. This study in healthy volunteers will explore safety and PK, and subsequent antiviral clinical development is expected to be in patients infected with SARS-CoV-2 to further evaluate safety and establish a favorable risk/benefit profile. The Company expects to enroll approximately 80 subjects in this trial.

The Company’s first completed SAD cohort consisted of 9 subjects dosed with 8 mg/kg or placebo in the dose escalation trial. Based on the overall results in Cohort 1, the safety review committee (SRC) deemed the first cohort dose safe and well-tolerated. The Company’s second completed SAD cohort consisted of 8 subjects dosed with 16 mg/kg or placebo in the dose escalation trial. Based on the overall results in Cohort 2, the SRC deemed the cohort dose safe and well-tolerated and began its SAD Cohort 3 with a dose escalation to 32 mg/kg.

While the Company is in the process of identifying additional countries where potential future Phase 2 COVID-19 clinical studies might occur, the volatility and unpredictability of COVID-19 incidence in various countries may limit the ability to recruit certain subjects and could make it infeasible to conduct a Phase 2 clinical trial. Importantly, however, the safety and tolerability data from this Phase 1 trial will also enable the initiation of future clinical trials in cancer indications.

Glioblastoma Multiforme

Additionally, Moleculin recently received IND clearance from the FDA to initiate a Phase 1 open label, single arm, dose escalation study of the safety, pharmacokinetics and efficacy of oral WP1122 in adult patients with GBM, which the Company expects to commence in 2022.

Upcoming Milestones Expectations

H2 2022: Topline data from Phase 1a study of WP1122 for the treatment of COVID-19 in the UK.

H2 2022: Potential to launch Phase 2 study of WP1122 for the treatment of COVID-19 outside of the US.

2022: Identify investigators interested in initiating a Phase 1 open label, single arm, dose escalation study of the safety, pharmacokinetics and efficacy of oral WP1122 in adult patients with GBM.

Ongoing preclinical development work, including other molecules in the WP1122 Portfolio in additional anti-viral indications such as HIV, Zika, and hemorrhagic fever viruses. Collaborations targeted for 2022.
Summary of Financial Results for the Second Quarter 2022

Research and development (R&D) expense was $4.2 million and $3.0 million for the three months ended June 30, 2022 and 2021, respectively. The increase of $1.2 million is mainly related to increased clinical trial activity as described above, and costs related to manufacturing of additional drug product.

General and administrative expense was $3.2 million and $2.4 million for the three months ended June 30, 2022 and 2021, respectively. The increase of $0.8 million is mainly related to an increase in regulatory and legal services.

For the six months ended June 30, 2022 and 2021, the Company incurred net losses of $13.6 million and $8.7 million, respectively, and had net cash flows used in operating activities of $12.8 million and $10.4 million, respectively

The Company ended the quarter with $58.0 million of cash. The Company believes that this cash is sufficient to meet its projected operating requirements, which include a forecasted increase over its current R&D rate of expenditures, beyond mid-2024.