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UNITED STATES 

SECURITIES AND EXCHANGE COMMISSION 

Washington, D.C. 20549

 

 

 

FORM 8-K

 

 

 

CURRENT REPORT 

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): August 10, 2023

 

 

 

Rain Oncology Inc. 

(Exact Name of Registrant as Specified in its Charter)

 

 

 

Delaware   001-40356   82-1130967

(State or Other Jurisdiction

of Incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

 

8000 Jarvis Avenue, Suite 204 

Newark, CA 94560

(Address of Principal Executive Offices)

 

(510) 953-5559 

(Registrant’s telephone number, including area code)

 

Not Applicable 

(Former Name or Former Address, if Changed Since Last Report)

 

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2 below):

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 210.14d-2(b))

 

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class   Trading
Symbol(s)
  Name of each exchange
on which registered
Common Stock, par value $0.001 per share   RAIN   The Nasdaq Global Select Market

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).

 

Emerging growth company x

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  ¨

 

 

 

 

 

Item 2.02Results of Operations and Financial Condition.

 

On August 10, 2023, Rain Oncology Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended June 30, 2023. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

 

This Item 2.02 and the Press Release attached hereto as Exhibit 99.1, insofar as they disclose information regarding the Company’s results of operations and financial condition for the quarter ended June 30, 2023, are being furnished to the Securities and Exchange Commission.

 

Item 9.01Financial Statements and Exhibits

 

(d) Exhibits. The following exhibit is being furnished herewith:

 

EXHIBIT INDEX

 

Exhibit

No.

  Description
     
99.1   Press Release, dated August 10, 2023
     
104   Cover Page Interactive Data File (embedded within the Inline XBRL document).

 

 

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

Dated: August 10, 2023 Rain Oncology Inc.
     
  By:

/s/ Avanish Vellanki

    Avanish Vellanki
    Chairman and Chief Executive Officer

 

 

 

Exhibit 99.1

 

Rain Oncology Reports Second Quarter 2023 Financial Results and Provides Corporate Update

 

– Evaluating a number of opportunities to diversify pipeline in precision oncology -

 

– Submitted data abstracts for milademetan in both MANTRA and MANTRA-2 clinical trials; anticipated presentations at medical conferences in 4Q23 –

 

– Quarter-end cash position of $86.3 million expected to provide runway into year-end 2026 –

 

– Management to host conference call and webcast today at 2:00 pm PT/5:00 pm ET –

 

NEWARK, Calif., August 10, 2023 (GLOBE NEWSWIRE) -- Rain Oncology Inc. (NasdaqGS: RAIN), (Rain), today reports financial results for the second quarter ended June 30, 2023, and provides a corporate update.

 

“Rain has been aggressively pursuing a multitude of opportunities as we seek to leverage our clinical execution capabilities and strong cash position to add value to our stockholders”, said Avanish Vellanki, co-founder and chief executive officer of Rain. “Our efforts are focused on licensing or acquiring differentiated clinical-stage programs, as well as avenues to partner with companies utilizing proprietary technology that may help develop drug candidates entering the clinic. We are very excited about the progress we’ve made and recognize that it is important to act expeditiously. We will provide an update publicly on these endeavors at the appropriate time.”

 

Second Quarter 2023 Corporate Highlights and Key Research and Development (R&D) Updates

 

Corporate Activities

oCommenced review of opportunities to maximize stockholder value inclusive of the opportunity to acquire new precision oncology assets and/or novel technology platforms

oReduced headcount to approximately 25 full-time employees, maintaining key personnel to execute on earlier-stage clinical programs and wind down the MANTRA and MANTRA-2 trials for milademetan

oReduced cash burn through various cost saving initiatives, including headcount reduction, to extend runway through end of 2026, in the absence of a corporate transaction and further financing

 

Phase 3 Dedifferentiated Liposarcoma (DD LPS) Trial (MANTRA)

oSubmitted abstracts to upcoming medical conferences; anticipate presentations in 4Q23

 

Phase 2 Basket Trial (MANTRA-2) of Milademetan for MDM2-Amplified Advanced Solid Tumors

oSuspended enrollment in May 2023 and trial expected to be discontinued in 4Q23

oSubmitted abstract to upcoming medical conference; anticipate presentation in 4Q23

 

Second Quarter 2023 Financial Results

 

For the three and six months ended June 30, 2023, Rain reported a net loss of $22.1 million and $42.5 million, respectively, as compared to a net loss of $17.6 million and $35.0 million for the same periods in 2022, respectively.

 

Research and development (R&D) expenses were $15.0 million and $31.7 million for the three and six months ended June 30, 2023, respectively, as compared to $14.3 million and $27.8 million for the same periods in 2022, respectively. The increases were primarily driven by the clinical trial costs for our Phase 3 trial in DD LPS (MANTRA) and Phase 2 tumor-agnostic basket trial (MANTRA-2), as well as personnel costs. Non-cash stock-based compensation expenses included in R&D expenses were approximately $0.5 million and $1.7 million in the three and six months ended June 30, 2023, respectively, as compared to $1.2 million and $2.1 million in the same periods in 2022, respectively.

 

 

 

General and administrative (G&A) expenses were $5.4 million and $10.5 million for the three and six months ended June 30, 2023, respectively, as compared to $3.5 million and $7.4 million for the same periods in 2022, respectively. The increases were primarily due to higher costs associated with launch preparation in anticipation to commercially launch milademetan in LPS, personnel, legal, outside consulting, and accounting and audit fees. Non-cash stock-based compensation expense included in G&A expenses were approximately $0.3 million and $0.7 million for the three and six months ended June 30, 2023, as compared to $0.2 million and $0.6 million for the three and six months ended June 30, 2022.

 

In May 2023, the Company announced a reduction in its workforce in connection with the reprioritization of the Company’s clinical strategy designed to optimize Company resources. The Company recorded restructuring charges of $2.8 million in the statements of operations for the three and six months ended June 30, 2023, comprised of $2.8 million cash severance, bonus and related employee benefits and taxes of affected employees, as well as $37,000 of stock-based compensation expense related to option modification.

 

Total non-cash stock-based compensation expenses were approximately $0.8 million and $2.4 million for the three and six months ended June 30, 2023, respectively, as compared to $1.4 million and $2.7 million for the same periods in 2022, respectively.

 

As of June 30, 2023, Rain had $86.3 million in cash, cash equivalents and short-term investments. Rain anticipates that its quarter-end cash position will provide runway into year-end 2026.

 

As of June 30, 2023, Rain had approximately 36.4 million shares of common stock outstanding.

 

Second Quarter 2023 Results Conference Call and Webcast Details

 

The management of Rain Oncology will host a conference call and webcast for the investment community today, August 10, 2023 at 2:00 pm PT (5:00 pm ET). A live webcast may be accessed here:

 

https://viavid.webcasts.com/starthere.jsp?ei=1624922&tp_key=7933f8175f. The conference call can be accessed by dialing (888) 886-7786 (domestic) or (416) 764-8658 (international). The passcode for the conference call is 29873479.

 

Replay of the call will be available by visiting the “Events” section of the Rain website after the conclusion of the presentation and will be archived on the Rain website for 30 days.

 

 

 

About Rain Oncology Inc.

 

Rain Oncology Inc. is a precision oncology company developing therapies that target oncogenic drivers to genetically select patients it believes will most likely benefit. Rain’s product candidate, milademetan, is a small molecule, oral inhibitor of the p53-MDM2 complex that reactivates p53.

 

Forward Looking Statements

 

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding, among other things, Rain’s ability to develop, license, or acquire other product candidates or additional indications for existing products and the timing for public update regarding the same, its clinical strategy, the therapeutic potential of the reactivation of p53, a potential path forward for milademetan, the effectiveness of Rain’s cost-saving measures and its cash runway. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “plans,” “will”, “anticipates,” “goal,” “potential,” “expects” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Rain’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks and uncertainties associated with Rain’s business in general and limited operating history, Rain’s ability to execute on its strategy; the results of preclinical and clinical studies; the FDA regulatory process; positive results from a clinical trial may not necessarily be predictive of the results of future or ongoing clinical studies; the sufficiency of Rain’s capital resources and its ability to successfully manage its cash resources, and the other risks described in Rain’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2023 and subsequent filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. Rain undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

 

 

Investor Contact

Daniel Ferry

LifeSci Advisors

+1.617.430.7576

daniel@lifesciadvisors.com

 

Media Contact

Mahima Agochiya

Rain Oncology

magochiya@rainoncology.com

 

 

 

Rain Oncology Inc.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share amounts)

 

   Three Months Ended
June 30,
   Six Months Ended
June 30,
 
   2023   2022   2022   2021 
Operating expenses:                    
Research and development  $14,980   $14,257   $31,657   $27,812 
General and administrative   5,414    3,461    10,480    7,356 
Restructuring charges   2,837        2,837     
Total operating expenses   23,231    17,718    44,974    35,168 
Loss from operations   (23,231)   (17,718)   (44,974)   (35,168)
Other income:                    
Interest income   1,167    107    2,426    163 
Total other income   1,167    107    2,426    163 
Net loss  $(22,064)  $(17,611)  $(42,548)  $(35,005)
Net loss per share, basic and diluted  $(0.61)  $(0.66)  $(1.17)  $(1.32)
Weighted-average shares used to compute net loss per share, basic and diluted   36,363,315    26,529,482    36,351,648    26,520,662 

 

SUMMARY CONDENSED CONSOLIDATED BALANCE SHEET DATA
(in thousands)

 

   June 30,   December 31, 
   2023   2022(1) 
   (unaudited)     
Cash, cash equivalents and short-term investments  $86,290   $130,454 
Total assets   91,723    135,180 
Stockholders’ equity   73,289    113,036 
           
(1) Derived from audited financial statements          

 

 

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