On February 28, 2024 Applied Therapeutics, Inc. (Nasdaq: APLT), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need, reported that it has entered into a securities purchase agreement for a private placement of $100 million of equity (Press release, Applied Therapeutics, FEB 29, 2024, View Source [SID1234640649]).

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The Company entered into a definitive securities purchase agreement, dated as of February 27, 2024, for the sale of 12,285,714 shares of the Company’s common stock, par value $0.0001 per share at a purchase price of $7.00 per share (the "Shares") and 2,000,000 pre-funded warrants to purchase common stock at a purchase price of $6.999, which is equal to the purchase price per share of common stock less the $0.001 per share exercise price of each pre-funded warrant (the "Pre-Funded Warrants" and together with the Shares, the "Securities"), in a private placement (the "Private Placement"). The Private Placement is expected to result in gross proceeds to the Company of approximately $100 million, before deducting placement agent commissions and other offering expenses.

The financing consisted of participation from new and existing investors, including Perceptive Advisors, Janus Henderson Investors, Venrock Healthcare Capital Partners, Adage Capital Partners, Frazier Life Sciences, Logos Capital, Vestal Point Capital, and Rock Springs Capital.

The Private Placement is expected to close on or about March 1, 2024, subject to the satisfaction of customary closing conditions. Additional details regarding the Private Placement will be included in a Form 8-K to be filed by the Company with the Securities and Exchange Commission ("SEC").

The Company intends to use the net proceeds to fund commercial activities for govorestat (AT-007) and to further develop other pipeline candidates, and for working capital and general corporate purposes. The capital raised in the Private Placement, in addition to current cash and potential milestones expected from its Advanz European licensing partnership, are expected to fund the business into 2026.

Leerink Partners, RBC Capital Markets, Baird, and UBS Investment Bank acted as placement agents in the transaction (the "Placement Agents"). Skadden, Arps, Slate, Meagher & Flom LLP acted as legal counsel for the Company.

The Securities being sold in the Private Placement have not been registered under the Securities Act of 1933, as amended, or state securities laws and may not be offered or sold in the United States absent registration with the SEC or an applicable exemption from such registration requirements. The Company has agreed to file a registration statement with the SEC covering the resale of the Shares and the shares underlying the Pre-Funded Warrants issuable in connection with the Private Placement.

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 jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

Company Update

The Company also provided an update on its cash balance and share count. As of February 23, 2024, the Company had $43.6 million in cash and cash equivalents, 90,101,117 shares of common stock issued and outstanding, 49,301,676 exercisable warrants, including 19,225,000 common warrants, 29,951,058 pre-funded warrants and 125,618 pre-IPO warrants, 4,695,619 options to purchase common stock outstanding and 6,918,422 restricted stock units.

On February 29, 2024 AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM" or the "Company") reported recent accomplishments and provided a business outlook (Press release, AIM ImmunoTech, FEB 29, 2024, View Source [SID1234640648]). AIM’s dsRNA product candidate, Ampligen (rintatolimod), is being evaluated as a combinational therapy for the treatment of a variety of solid tumor types in multiple clinical trials – both underway and planned – at major cancer research centers around the country.

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Recent Highlights

AMP-518 Clinical Study: Phase 2 study evaluating Ampligen as a potential therapeutic for people with the Post-COVID condition of fatigue
Completed treatment in study
Reported positive topline results offering preliminary evidence that Ampligen may reduce fatigue in subjects with Post-COVID conditions
Bolstered intellectual property estate with issuance of key U.S. patent for Ampligen in combination with an anti-PD-L1 antibody for the treatment of cancer
DURIPANC Clinical Study: Phase 1b/2 clinical trial combining AIM’s Ampligen with AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor Imfinzi (durvalumab) for the treatment of pancreatic cancer
Opened for enrollment and enrolled first subject at Erasmus Medical Center ("Erasmus MC")
First subject dosed at Erasmus MC
"AIM’s emphasis throughout 2024 will be building upon our strong foundation of scientific success," said AIM Chief Executive Officer Thomas K. Equels. "Our drug Ampligen is being evaluated in multiple indications – including pancreatic cancer, ovarian cancer and Post-COVID conditions – and we believe that success in any one of these areas would mean both dramatic improvement in people’s lives and significant value for our stockholders."

Upcoming Expected Ampligen Milestones

Q1 2024

Advanced Recurrent Ovarian Cancer – Protocol-planned interim results
Q2 2024

Post-COVID Conditions (AMP-518) – Final dataset
2024

Locally Advanced Pancreatic Adenocarcinoma (AMP-270) – First subject dosed
Publications of data in scientific journals
Ongoing Business Development Update

As previously announced, the Company engaged Azenova, LLC ("Azenova"), a professional business development (BD) consulting firm, to support efforts to partner AIM’s pipeline programs with a particular focus on the Company’s lead asset, Ampligen, for the treatment of various malignant solid tumors. Discussions for potential partnership, licensing, and other transactional activities remain ongoing.

In addition to its ongoing clinical and business development activities, the Company will continue to engage with the industry and investment communities by actively participating in meetings, virtual events and key conferences over the course of the year. To stay up to date with the Company’s activities visit aimimmuno.com and connect with the Company on X, LinkedIn, and Facebook.

On February 28, 2024 Iovance Biotherapeutics reported its full yearly results (Press release, Iovance Biotherapeutics, FEB 29, 2024, View Source [SID1234640588]).

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On February 28, 2024 PharmaMar reported total revenues of €158.2 million in 2023, compared with €196.3 million in the same period of the previous year (Press release, PharmaMar, FEB 28, 2024, View Source [SID1234640776]). Recurring revenues, which result from the sum of net sales plus royalties on sales made by our partners, totaled €124.1 million, compared with €156.0 million in 2022. These changes in revenues are mainly due to the introduction of generic trabectedin (Yondelis) products on the European market, which has put significant pressure on prices. Thus, Yondelis recorded net sales of €26.1 million at December 31st, 2023, compared with the €63.8 million reported the previous year.

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Revenues from Zepzelca (lurbinectedin) continued to grow. Both revenues in Europe and royalties from sales in the US recorded significant increases. Revenues from the early access program grew to €29.7 million at year-end, compared with €15.5 million in 2022. These revenues come mainly from France, although other early access programs are also open in countries such as Spain and Austria.

The increase in Zepzelca’s revenues in Europe reflects a positive adjustment made by the French authorities in relation to the previous year’s discounts.

In addition, revenues in Europe in 2023 reflect the first sales of Zepzelca in Switzerland since its commercial launch in the second half of the year.

The sale of raw materials of both Yondelis and Zepzelca to our partners is also included in recurring revenues. These sales reported revenues of €14.9 million at the end of 2023, compared with €21.4 million reported in the previous year. This difference is mainly due to the accumulation of stocks that some of our partners carried out in 2022.

It is important to highlight the growth in royalty revenues, which amounted to €52.2 million in fiscal year 2023. This revenue mainly includes royalties received from our partner Jazz Pharmaceuticals for lurbinectedin sales in the US, which amounted to €48.4 million, compared with the €46.9 million reported in 2022. Excluding the currency effect, royalty growth stood at 8%.

In addition to the royalties received from Jazz Pharmaceuticals, royalties on Yondelis sales from our partners in the US and Japan totaled €3.8 million in 2023, compared with €3.4 million in 2022.

Non-recurring revenues from licensing agreements amounted to €33.6 million at year-end 2023, compared with €40.2 million in the previous year. Most of this revenue came from Zepzelca licensing agreements for a total of €24.2 million, to which must be added the €9.4 million recorded in the last quarter of 2023 for the fulfillment of a commercial milestone under the contract signed with Janssen (Johnson & Johnson) for Yondelis in the United States.

At December 31st, 2023, R&D expenditure amounted to €99.3 million, an increase of 19% compared with the previous year. Of the total R&D investment in 2023, the amount earmarked for the oncology segment increased to €83.6 million compared with €68.1 million in 2022. This increase is largely related to the confirmatory Phase III trial of lurbinectedin in Small Cell Lung Cancer, called LAGOON, which is progressing in patient recruitment and where an additional effort is being made to open new centers. Part of this investment was also designated for a Phase IIb/III trial with lurbinectedin for the first-line treatment of Leiomyosarcoma, which began in the last quarter of the year. The Company continues to invest in the clinical development of other molecules at earlier stages. A Phase II clinical trial is under way with ecubectedin for solid tumors, and Phase I clinical trials are also under way with ecubectedin, PM534 and PM54 for the treatment of solid tumors.

Despite the pressure on Yondelis sales prices and the growing R&D effort, PharmaMar reported net income of €1.1 million at the end of 2023.

At 31st December 2023, PharmaMar Group had a cash and cash equivalents position of €168.6 million and a total debt of €39.9 million, which translates into net cash of €128.8 million. This cash position already reflects dividends paid and the €15 million acquisition in treasury stock, which the Company completed in January of this year 2024.

The Board of Directors of Pharma Mar, S.A. will propose to the General Shareholders’ Meeting the distribution of a dividend of €0.65 per outstanding share that will be charged to unrestricted reserves (share premium), with a maximum distribution amount set at 11,930,689.55 Euros.

PharmaMar Results Conference Call for Investors and Analysts

PharmaMar management will host a conference call and webcast for investors and analysts on Thursday February 29th, 2024 at 13:00 (CET).

The numbers to connect to the teleconference are: +34 91 901 16 44 (from Spain), +1 646 664 1960 (from the US or Canada) or +44 20 3936 2999 (other countries). Participants’ access code: 889062. Interested parties can also follow the webcast live via the following link: View Source

A recording of the teleconference can be accessed on PharmaMar’s website by visiting the Events Calendar section of the Company’s website www.pharmamar.com

On February 28, 2024 Repare Therapeutics Inc. ("Repare" or the "Company") (Nasdaq: RPTX), a leading clinical-stage precision oncology company, reported financial results for the fourth quarter and full year ended December 31, 2023 (Press release, Repare Therapeutics, FEB 28, 2024, View Source [SID1234640631]).

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"2023 was a year of substantial progress for Repare. We advanced each of the four programs in our portfolio and set the stage for meaningful data readouts and new clinical trial starts this year," said Lloyd M. Segal, President and Chief Executive Officer of Repare. "In particular and as leaders and innovators in PKMYT1 inhibition, we look forward to data readouts across all ongoing lunresertib clinical trials in 2024 and are excited to begin a lunresertib and WEE1 combination clinical trial in partnership with Debiopharm."

2023 and Recent Portfolio Highlights:

Lunresertib
Presented initial positive data from its ongoing Phase 1 MYTHIC trial evaluating lunresertib (RP-6306) alone and in combination with camonsertib in patients with advanced solid tumors harboring CCNE1 amplification or FBXW7 or PPP2R1A deleterious alterations at the 2023 American Association for Cancer Research (AACR) (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper). Initial combination data included an overall RECIST response rate of 50% in ten patients with heavily pre-treated gynecological tumors at the preliminary recommended Phase 2 dose.
Announced a partnership with Debiopharm to explore the potential clinical synergy of Debio 0123, a highly selective clinical WEE1 inhibitor, and lunresertib, with dosing of the first patient expected to occur in the first half of 2024 and for which the companies have developed substantial pre-clinical validation. Repare will sponsor the global clinical trial as a new arm in the ongoing MYTHIC trial, with costs being shared equally by Debiopharm and Repare.
Camonsertib
Presented initial clinical data from the Phase 1/2 TRESR and ATTACC trials evaluating camonsertib (RP-3500) in combination with three poly (ADP-ribose) polymerase (PARP) inhibitors in a Clinical Trials Plenary Session at the 2023 AACR (Free AACR Whitepaper) Annual Meeting. Camonsertib, a potent and selective oral small molecule inhibitor of ATR (Ataxia-Telangiectasia and Rad3-related protein kinase), showed 48% overall clinical benefit rate in patients with advanced solid tumors across tumor types regardless of choice of PARP inhibitor or platinum resistance, with a favorable safety and tolerability profile. Data from the TRESR trial were also published in Nature Medicine highlighting the clinical benefit of camonsertib in advanced solid tumors.
Upon dosing of the first patient with camonsertib in Roche’s Phase 2 TAPISTRY trial (NCT04589845), Repare earned a $40 million milestone payment from its collaboration with Roche, which was subsequently received in February 2024. In October 2023, Roche also dosed the first patient in a camonsertib-based arm in its Phase 1b/2 clinical trial of multiple immunotherapy-based treatment combinations in participants with metastatic non-small cell lung cancer (Morpheus Lung; NCT03337698).
Since inception of the Roche camonsertib collaboration, Repare has earned a cumulative total of $182.6 million pursuant to the Roche collaboration agreement, including the upfront payment, the milestone payment, as well as additional reimbursements from Roche. In February 2024, Repare received written notice from Roche of their election to terminate the Roche collaboration agreement. The termination will become effective in May 2024, at which time Repare will regain global development and commercialization rights for camonsertib from Roche.
RP-1664
Dosed the first patient in the multicenter, open-label Phase 1 dose escalation trial of RP-1664 in adult and adolescent patients with TRIM37-high solid tumors in February 2024. Repare disclosed polo-like kinase 4 (PLK4) as the target of the RP-1664 development program and reported that RP-1664 demonstrated potent and selective inhibition of PLK4 and synthetic lethality in TRIM37-high tumor cells in preclinical studies.
RP-3467
Reported comprehensive preclinical data for RP-3467, a potential best-in-class Polθ ATPase inhibitor. RP-3467 demonstrated complete, sustained regressions preclinically in combination with PARP inhibitors, and compelling anti-tumor activity in combination with radioligand therapy and chemotherapy.
2024 Outlook:

Initiate a Phase 1/1b clinical trial of lunresertib and Debio 0123, a WEE1 inhibitor, in the first half of 2024 as a fourth arm of the ongoing MYTHIC clinical trial.
Report initial data from the Phase 1 MINOTAUR trial evaluating lunresertib in combination with FOLFIRI for the treatment of advanced solid tumors in the first half of 2024.
Disclose additional camonsertib clinical development plans beyond the TRESR and ATTACC clinical trials sponsored by Repare in the second quarter of 2024.
Report data from the dose expansion cohorts of the Phase 1 MYTHIC trial evaluating lunresertib in combination with camonsertib in selectively advanced solid tumors in the second half of 2024.
Report initial data from the Phase 1 MAGNETIC trial evaluating lunresertib in combination with gemcitabine for the treatment of advanced solid tumors in the second half of 2024. Enrollment in this trial is now closed.
Initiation of a Phase 1 dose finding trial of RP-3467 in the second half of 2024.
Fourth Quarter and Full Year 2023 Financial Results:

Cash, cash equivalents, and marketable securities: Cash, cash equivalents, and marketable securities as of December 31, 2023 were $223.6 million. In February 2024, Repare received a $40 million milestone payment from Roche upon dosing of the first patient with camonsertib in Roche’s TAPISTRY trial. The Company believes that its cash, cash equivalents, and marketable securities are sufficient to fund its operations into mid-2026.

Revenue from collaboration agreements: Revenue from collaboration agreements was $13.0 million and $51.1 million for the three- and twelve-month periods ended December 31, 2023, respectively, as compared to $18.2 million and $131.8 million for the three- and twelve-month periods ended December 31, 2022, respectively. The decrease in revenue for the three-month period was due to lower deferred revenue recognized from the Roche collaboration and the BMS collaboration. The decrease in revenue for the twelve-month period was primarily due to a decrease in revenue recognized under the Roche collaboration mainly as a result of the $108.0 million revenue recognized in 2022 pursuant to the satisfaction of the Company’s performance obligations for the issuance of the combined licenses and the clinical trial materials transferred. The decrease in the twelve-month period was partially offset by higher deferred revenue recognized from the BMS collaboration and the Ono collaboration.

Research and development expenses, net of tax credits (Net R&D): Net R&D expenses were $35.3 million and $133.6 million for the three- and twelve-month periods ended December 31, 2023, respectively, as compared to $29.9 million and $119.1 million for the three- and twelve-month periods ended December 31, 2022, respectively. The increase in Net R&D expenses for the three- and twelve-month periods were primarily due to higher personnel-related costs and direct external costs related to the progress of our lunresertib clinical program, as well as the advancement of preclinical programs into IND-enabling studies.

General and administrative (G&A) expenses: G&A expenses were $8.6 million and $33.8 million for the three- and twelve-month periods ended December 31, 2023, respectively, compared to $7.9 million and $32.6 million for the three- and twelve-month periods ended December 31, 2022, respectively. The increase in G&A expenses was primarily due to higher personnel-related costs, partially offset by lower D&O insurance premiums and reduced professional fees associated with the Roche collaboration agreement.
Net loss: Net loss was $28.0 million, or $0.67 per share, and $93.8 million, or $2.23 per share, in the three- and twelve-month periods ended December 31, 2023, respectively, and $31.7 million, or $0.75 per share, and $29.0 million, or $0.69 per share, in the three- and twelve-month periods ended December 31, 2022, respectively.
About Repare Therapeutics’ SNIPRx Platform

Repare’s SNIPRx platform is a genome-wide CRISPR-based screening approach that utilizes proprietary isogenic cell lines to identify novel and known synthetic lethal gene pairs and the corresponding patients who are most likely to benefit from the Company’s therapies based on the genetic profile of their tumors. Repare’s platform enables the development of precision therapeutics in patients whose tumors contain one or more genomic alterations identified by SNIPRx screening, in order to selectively target those tumors in patients most likely to achieve clinical benefit from resulting product candidates.