On May 17, 2021 F-star Therapeutics, Inc. (NASDAQ: FSTX), a clinical-stage biopharmaceutical company dedicated to developing next generation bispecific immunotherapies to transform the lives of patients with cancer, reported that first quarter 2021 financial results and provides a corporate update (Press release, F-star, MAY 17, 2021, View Source [SID1234580120]).

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Strengthens balance sheet with successful closing of $65 million public offering of common stock and;
Received $9.2 million in net proceeds under its "at-the-market" equity offering program
LAG-3 and PD-(L)1 co-targeting validation with LAG-3 validated in late-stage clinical trial as third checkpoint inhibitor pathway
FS118 patent protection granted in Europe expanding F-star’s extensive IP portfolio
FS222 presentation at AACR (Free AACR Whitepaper) on the importance of tuning both affinity and avidity for differentiation
Nature publication on STING agonist demonstrating that SB 11285 enhances preclinical efficacy of radiation therapy
Merck KGaA, Darmstadt, Germany exercises option to bring third target into pipeline
Eliot Forster, CEO of F-star Therapeutics, Inc., said, "I’m very proud of what F-star accomplished in our first full quarter as a publicly traded company. The successful close of our public offering means we have now strengthened our financial position to ensure delivery on our future milestones. We have made excellent progress across all four clinical stage programs. We have also delivered with our partners, as noted in the recent update on our collaboration with Merck KGaA. We have added new insights into the unique properties of our platform technology, including presenting new data on FS222, our potentially best-in-class bispecific antibody targeting CD137 and PD-L1. This year will be another exciting one for F-star with clinical data expected and huge potential to provide transformational treatment options for patients with cancer."

"We have had a great start to 2021 and are very pleased to complete our $65 million underwritten public offering," said Darlene Deptula-Hicks, Chief Financial Officer of F-star Therapeutics. "Based on our current operating plans we believe our current cash and cash equivalents will be sufficient to meet our capital requirements into the second half of 2023."

FIRST QUARTER 2021 AND RECENT HIGHLIGHTS

Clinical validation of LAG-3: Aligning with F-star’s promising internal data, new headline phase 3 data reported during the quarter by a global pharmaceutical company has potentially validated LAG-3 as an immuno-oncology target. Importantly for FS118, these data also confirm the necessity of co-targeting the LAG-3 and PD-1/PD-L1 pathways to achieve efficacy in patients.

FS118 European patent protection granted: The European Patent Office (EPO) granted a patent in January 2021 with claims protecting the composition of matter of F-star’s FS118 molecule giving protection until June 2037. The phase 2 proof-of-concept trial of FS118 is proceeding on plan and the Company plans to provide an update on progress in the first half of 2022.

FS222 Poster presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in 2021: F-star presented a poster at AACR (Free AACR Whitepaper) 2021 entitled ‘FS222, a Tetravalent Bispecific Antibody Targeting CD137 and PD-L1, is Designed for Optimal CD137 Interactions Resulting in Potent T cell Activation Without Toxicity’. This poster and the associated data showcased the differentiation of FS222 from competitor molecules and highlighted the importance of ‘tuning’ for both the affinity and avidity of bispecific antibodies. The ongoing phase 1 clinical trial is proceeding on plan and the Company plans to provide an update on progress before the end of 2021.

SB 11285 in Nature publication: F-star published on its second-generation STING agonist, SB 11285, in the April 2021 issue of Nature Communications. The study, entitled ‘STING enhances cell death through regulation of reactive oxygen species and DNA damage’ demonstrated that systemic administration of a STING agonist in combination with radiation in a preclinical model enhances local control in Head and Neck Squamous Cell Carcinoma (HNSCC) and suggests that STING expression in the tumor is required for maximal therapeutic benefit. The Company plans to provide an update on the progress of SB 11285 in the phase 1 clinical trial in mid-2021.

Merck, KGaA, Darmstadt, Germany exercised third target option: F-star continued to deliver on the collaboration with Merck, KGaA, Darmstadt, Germany. The third option to license an F-star preclinical immuno-oncology program was exercised in the ongoing collaboration in March 2021. The companies entered into the agreement in 2019 with the first option to license. In July 2020, Merck KGaA, Darmstadt, Germany brought the second program from the collaboration into its pipeline, and has recently exercised its third option, taking over future development and commercialization of the program.

Denali Therapeutics announcement: F-star is pleased by the announcement from Denali Therapeutics that following positive preliminary data in a Phase 1/2 study, the Food and Drug Administration (FDA) has granted Fast Track designation to DNL310, which is derived from F-star’s unique Fcab technology, for the treatment of patients with Hunter syndrome.

Strengthened balance sheet in 2021: In April the Company completed the sale of $9.5 million in gross proceeds through its previously announced "at-the-market" (ATM) equity offering program. In addition, in April the Company entered into and drew down $5 million under its $10 million debt facility with Horizon Technology Finance Corporation and in May raised gross proceeds of $65 million, before deductions of underwriting discounts and commissions, in a public offering.

FIRST QUARTER 2021 FINANCIAL SUMMARY

Cash and cash equivalents as of March 31, 2021 were $3.7 million, compared to $18.5 million at December 31, 2020. Based on the Company’s current operating plan, the Company believes its cash and cash equivalents at March 31, 2021, together with the net proceeds from the recent sales of common stock in the underwritten public offering and under the ATM, and funds from its debt facility will be sufficient to fund its current operating plans into the second half of 2023.

Research & Development (R&D) expenses were $7.3 million for the quarter ended March 31, 2021, compared to $3.4 million for the same quarter in 2020. The increase of $3.9 million in R&D expense was primarily related to manufacturing costs and clinical costs with Q1 being the first full quarter with four programs in the clinic.

General & Administrative (G&A) expenses were $6.4 million for the quarter ended March 31, 2021, compared to $3.2 million for the first quarter of 2020. This $3.2 million increase in G&A expense was primarily due to increased non-cash stock-based compensation expense, professional fees and insurance associated with operating as a public company and rent expense associated with building leases assumed in the share exchange.

Net loss was $9.9 million or a loss per share of $1.08 (basic and diluted), for the quarter ended March 31, 2021, compared to a net loss of $7.2 million or a loss per share of $3.92 (basic and diluted) for the quarter ended March 31, 2020.

CONFERENCE CALL AND WEBCAST

F-star will host a conference call today, May 17, 2021 beginning at 9:00 AM EDT. To join the webcast, go to website. To join by phone, participants may dial 1-833-471-0868 in the US/Canada or 1-914-987-7751 for International calls or 0800 0288438 or 0203 1070289 for the United Kingdom, at least 10 minutes prior to the start of the call.

A recording of the conference call will be available on the ‘Events & Presentations’ section of the Company’s website at www.f-star.com from May 18, 2021.

On May 17, 2021 PerkinElmer, Inc. (NYSE: PKI) ("PerkinElmer") and Immunodiagnostic Systems Holdings PLC (LSE: IHS) ("IDS") reported that they have reached an agreement on the terms of a recommended all cash offer whereby PerkinElmer will acquire IDS for approximately $155 million (£110 Million) (Press release, PerkinElmer, MAY 17, 2021, View Source [SID1234580144]). The transaction has a total enterprise value of approximately $124 million (£88 Million) and is expected to close early in the third quarter of 2021, subject to approvals from the shareholders of IDS, sanction by the High Court of Justice in England and Wales and other customary closing conditions for a public takeover in the United Kingdom.

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Through this acquisition, PerkinElmer will be able to grow its overall Diagnostics business and specifically its immunodiagnostics segment. Moreover, the deal will enable PerkinElmer to combine its channel expertise and testing capabilities with IDS’s best-in-class chemiluminescence products in endocrinology, autoimmunity and infectious diseases to better serve customers around the world.

IDS’s portfolio and expertise will seamlessly integrate within EUROIMMUN, a PerkinElmer company since 2017. EUROIMMUN is a global leader in autoimmune testing and an emerging force in infectious disease, allergy and molecular genetic testing.

Wolfgang Schlumberger, CEO of EUROIMMUN, remarked, "This proposed transaction is highly valuable for both parties as the respective product lines are to a large extent complementary. The cooperation of our global distribution channels, the expansion of the immunoassay portfolio in closely related indication fields and IDS’s fully automated random access chemiluminescence platform strengthens our presence in immunodiagnostics. Our customers will benefit from a broader range of assays and laboratory diagnostic workflows. We are excited about these new opportunities and we look forward to welcoming Immunodiagnostic Systems into the PerkinElmer family following the completion of the transaction."

Headquartered in Boldon, the United Kingdom, IDS is a leading in-vitro diagnostic solution provider to the clinical laboratory market. IDS develops, manufactures, and markets innovative immunoassays and automated immunoanalyzer technologies to provide improved diagnostic outcomes for patients. IDS’s immunoassay portfolio is a combination of an endocrinology specialty testing menu and assay panels in complementary fields. IDS has approximately 300 global employees.

PerkinElmer’s comprehensive global diagnostics portfolio includes solutions focused on: reproductive health; autoimmune, infectious disease and allergy testing; gene analyses; and genomics offerings for oncology and other molecular tests through its wide range of instruments, reagents, assay platforms and software offerings.

In terms of financial impact, PerkinElmer expects the acquisition to be modestly accretive to non-GAAP earnings in year-one following the close, and PerkinElmer forecasts IDS’s business to be attractively positioned in markets that are projected to grow at a compound annual growth rate of high-single digits over the next few years.

On May 17, 2021 Nanology Labs, an IND-stage company developing next generation nanomedicines to conquer cancer, reported that its seed capital raise was oversubscribed at $3M (Press release, NanOlogy, MAY 17, 2021, View Source [SID1234580160]). The round was led by FACIT with co-investors Creative Destruction Lab Angels, Ontario Brain Institute, Ontario Center of Innovation, and MEDTEQ. The capital will advance development of T-MX (aka Manganescan), a smart nanomedicine designed to overcome tumor hypoxia, a common cause of resistance in cancer treatment. The financing is timely as T-MX completes GLP-toxicology and GMP-manufacturing in readiness for a Ph1/2 study in patients with oligometastatic brain cancer, planned to start at the Princess Margaret Cancer Center, recognized internationally for expertise in tumor hypoxia.

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"Nanoparticles derived from our platform technology are actively transported into cells and across the blood-brain barrier. Our lead product, T-MX, accumulates in cancer cells, where it becomes detectable by MR-imaging and generates oxygen molecules that reprogram hypoxic tumors from cold to hot. This, in turn, boosts immunogenic cell death and greatly sensitizes solid tumors to destruction by radio, chemo and immunotherapy." says Dr. Mohammad Amini, CEO and co-founder of Nanology Labs, "Extensive safety, efficacy, and manufacturing studies have de‑risked T-MX to the extent that we are confident it could provide greater therapeutic efficacy and longer patient survival, offering healthcare professionals a potentially curative therapy across a broad range of cancers."

On May 17, 2021 Concert Pharmaceuticals, Inc. (NASDAQ: CNCE) reported that Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX) has purchased the potential future milestones under the companies’ 2017 asset purchase agreement relating to VX-561 (deutivacaftor) for $32 million (Press release, Concert Pharmaceuticals, MAY 17, 2021, View Source [SID1234584685]).

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"This transaction provided an opportunity to secure non-dilutive capital and strengthens our balance sheet as we continue to advance CTP-543, our lead asset for alopecia areata, through its Phase 3 program," stated Roger Tung, Ph.D., President and Chief Executive Officer of Concert Pharmaceuticals. "By receiving these proceeds, we now expect our cash, cash equivalents and investments to fund the Company into the second quarter of 2022."

Under the asset purchase agreement, Vertex acquired worldwide development and commercialization rights to VX-561 (formerly known as CTP-656) and other assets related to the treatment of cystic fibrosis. VX-561 is an investigational cystic fibrosis transmembrane conductance regulator (CFTR) potentiator that has the potential to be used as part of future once-daily combination regimens of CFTR modulators that treat the underlying cause of cystic fibrosis. In 2017, Concert received a one-time cash payment of $160 million upon closing the asset purchase, with the potential for $90 million in future milestones. Following receipt of the $32 million, no further milestone obligations remain.

Chestnut Securities, Inc. acted as exclusive financial advisor to Concert in this transaction.

On May 17, 2021 Aerpio Pharmaceuticals, Inc. ("Aerpio") (Nasdaq: ARPO), a biopharmaceutical company focused on developing compounds that activate Tie2, and Aadi Bioscience, Inc. ("Aadi"), a privately-held biopharmaceutical company focusing on precision therapies for genetically-defined cancers with alterations in mTOR pathway genes, reported their entry into a definitive merger agreement (Press release, Aadi, MAY 17, 2021, View Source [SID1234580105]). Following the proposed merger, Aerpio will change its name to "Aadi Bioscience, Inc." and the combined public company will focus on advancing Aadi’s lead product candidate, FYARROTM (sirolimus albumin-bound nanoparticles for injectable suspension; nab-sirolimus; ABI-009).

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In support of the merger, Aerpio has entered into subscription agreements to raise $155 million in a Private Investment in Public Equity (PIPE) financing led by Acuta Capital Partners and KVP Capital and including Avoro Capital Advisors; Avoro Ventures; Venrock Healthcare Capital Partners; BVF Partners, L.P.; Vivo Capital; Alta Bioequities, L.P.; Rock Springs Capital; RTW Investments, LP; Acorn Bioventures; and Serrado Capital LLC as well as other undisclosed institutional investors.

The PIPE financing is expected to be consummated concurrently with the closing of the merger. Proceeds from the PIPE financing are intended to be used for commercialization of FYARRO in advanced malignant PEComa and a planned tumor-agnostic registrational trial in solid tumors harboring inactivating alterations in the mTOR pathway genes TSC1 and TSC2 expected to be initiated by the end of 2021. Aadi’s first indication, advanced malignant PEComa, is an ultra-rare sarcoma enriched in TSC1 and TSC2 alterations. Aadi has received Orphan designation, Fast Track designation and Breakthrough Therapy designation from the FDA for FYARRO for the treatment of patients with advanced malignant PEComa. Together with the cash expected from both companies at closing, the net proceeds of the PIPE financing are expected to fund the company into 2024, enabling potential approval and commercial launch in PEComa as well as completion of a registrational trial in tumors harboring TSC1 or TSC2 inactivating alterations.

Caley Castelein, a board member of Aerpio and the proposed chairman of the combined company stated, "Aerpio’s board of directors diligently undertook a comprehensive strategic review and has concluded that the proposed transaction with Aadi is in the best interest of our shareholders. We believe Aadi’s late-stage development program may offer significant medical benefit to PEComa patients and important potential for patients with tumors harboring TSC1 or TSC2 inactivating alterations."

Dr. Neil Desai, founder and chief executive officer of Aadi, added, "FYARRO met its safety and efficacy endpoints in our study in patients with advanced malignant PEComa2 and this finding supports our approach of targeting mTOR pathway altered cancers with FYARRO. We are excited about the next chapter of growth for Aadi, thankful for the support of our investors, and are energized to continue to develop important new treatment options for our patients."

Anupam Dalal, chief investment officer of Acuta Capital Partners stated, "Together with a group of renowned institutional investors, we are excited to partner with Aadi as it advances FYARRO and strives to unlock the potential of mTOR as a therapeutic target."

Upon closing of the transaction, the combined company will be led by Aadi’s chief executive officer, Neil Desai, and headquartered in Los Angeles, California. Aadi’s board members Neil Desai and Richard Maroun; Aadi’s board observer Karin Hehenberger; and current Aerpio board members Anupam Dalal and Caley Castelein will be members of the board of directors of the combined company. In addition, Behzad Aghazadeh, managing partner of Avoro Capital Advisors and Avoro Ventures, will also join the board of the combined company upon the closing of the transaction.

About the Proposed Transaction

Under the terms of the merger agreement, shareholders of Aadi will receive shares of newly issued Aerpio common stock. On a pro forma basis, shareholders of Aadi will own approximately 66.8% and shareholders of Aerpio will own approximately 33.2% of the combined company upon the closing of the merger, prior to the additional PIPE financing transaction. Following the closing of the concurrent PIPE financing, Aerpio shareholders will own approximately 14.7% of the combined company. The actual allocation is subject to adjustment based on Aerpio’s cash balance at the time of closing.

The terms of the merger agreement contemplate that a non-transferable contingent value right (a "CVR") will be distributed to Aerpio shareholders as of immediately prior to the effective time of the merger, entitling CVR holders to receive net proceeds received by Aerpio, if any, associated with Aerpio’s legacy assets. The terms and conditions of the CVRs will be pursuant to a CVR Agreement Aerpio will enter into prior to the closing of the merger (the "CVR Agreement").

The merger agreement has been approved by the boards of directors of both companies. The transaction is expected to close in the third quarter of 2021, subject to approval by Aerpio’s shareholders, the completion of the PIPE financing, and customary closing conditions. The PIPE financing is expected to close concurrently with, and is conditioned upon, the closing of the merger.

Additional information about the transaction will be provided in a Current Report on Form 8-K that will be filed by Aerpio with the Securities and Exchange Commission ("SEC") and will be available at www.sec.gov.

Ladenburg Thalmann & Co. Inc. is acting as financial advisor to Aerpio for the transaction and Goodwin Procter LLP is serving as its legal counsel. Perella Weinberg Partners LP and Piper Sandler & Co. are acting as financial advisors to Aadi for the transaction and Wilson Sonsini Goodrich & Rosati, P.C. is serving as legal counsel to Aadi. Jefferies LLC; Cowen and Company, LLC; and Piper Sandler & Co. are acting as placement agents for the PIPE financing.